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Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® (Antelope)

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ClinicalTrials.gov Identifier: NCT04115488
Recruitment Status : Completed
First Posted : October 4, 2019
Results First Posted : July 3, 2023
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Polpharma Biologics S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis (RRMS)
Intervention Biological: Intravenous (IV) infusions
Enrollment 265
Recruitment Details This was a Phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group study to assess the similarity in efficacy, safety, and immunogenicity of biosimilar natalizumab PB006 compared to European Union-approved Tysabri in patients with Relapsing-remitting multiple sclerosis (RRMS).
Pre-assignment Details All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. One subject withdrew consent before receiving study drug and was not included in the results.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Period Title: Overall Study
Started 131 133
Patients Re-randomized and Switched From Tysabri to PB006 at Week 24. 0 30
Patients Continuing on Tysabri Following the Re-randomization at Week 24. 0 95
Completed 117 122
Not Completed 14 11
Reason Not Completed
Adverse Event             8             4
Withdrawal by Subject             3             6
Investigator/ Sponsor Decision             2             0
Patient 's location change             1             0
Due to COVID-19 restrictions at site             0             1
Arm/Group Title PB006 Tysabri Total
Hide Arm/Group Description Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). Total of all reporting groups
Overall Number of Baseline Participants 131 133 264
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) Population includes all patients who were randomized and have received at least one infusion of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 133 participants 264 participants
36.8  (9.05) 36.6  (9.73) 36.7  (9.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 133 participants 264 participants
Female
84
  64.1%
78
  58.6%
162
  61.4%
Male
47
  35.9%
55
  41.4%
102
  38.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 133 participants 264 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
131
 100.0%
133
 100.0%
264
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 133 participants 264 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
131
 100.0%
133
 100.0%
264
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Cumulative Number of New Active Lesions Over 24 Weeks
Hide Description Cumulative number of new active lesions over 24 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted and new/enlarging T2-weighted lesion. Assessment was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol: patients who completed the 24-week treatment period without major protocol deviations that may have influenced the analysis of the primary endpoint and for whom sufficient post-baseline MRI data were available (baseline, Week 24 and at least 1/3 MRI visits). Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switched or not. Subjects with non-missing endpoints in the analysis.
Arm/Group Title PB006 (Per-Protocol) Tysabri (Per-Protocol) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 111 118 122 30 95
Mean (Standard Deviation)
Unit of Measure: lesions
1.4  (3.73) 1.9  (3.97) 1.4  (3.65) 2.1  (3.78) 1.9  (4.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PB006 (Per-Protocol), Tysabri (Per-Protocol)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Data was analyzed using a negative binomial model with a logarithmic link function and fixed effects for the treatment group and stratification factors. Equivalence was tested based 95% confidence interval.
Method of Estimation Estimation Parameter Exponentiated Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.613 to 0.944
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.397
Estimation Comments Difference calculated as Tysabri minus PB006.
2.Secondary Outcome
Title Cumulative Number of New Active Lesions Over 48 Weeks
Hide Description Cumulative number of new active lesions over 48 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted and new/enlarging T2-weighted lesion. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent was administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switched or not. Subjects with non-missing endpoints in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 122 96 119 29 95
Mean (Standard Deviation)
Unit of Measure: lesions
1.5  (3.72) 2.3  (5.68) 1.5  (3.75) 2.1  (3.82) 2.3  (5.70)
3.Secondary Outcome
Title Cumulative Number of New GdE T1-weighted Lesions Over 24 Weeks
Hide Description Cumulative number of new GdE T1-weighted lesions over 24 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switched or not. Subjects with non-missing endpoints in the analysis.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 126 127 122 30 95
Mean (Standard Deviation)
Unit of Measure: lesions
0.3  (1.01) 0.4  (1.25) 0.3  (1.02) 0.4  (0.81) 0.4  (1.37)
4.Secondary Outcome
Title Cumulative Number of New GdE T1-weighted Lesions Over 48 Weeks
Hide Description Cumulative number of new GdE T1-weighted lesions over 48 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch (SSW) Population: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 122 96 119 29 95
Mean (Standard Deviation)
Unit of Measure: lesions
0.3  (1.02) 0.4  (1.39) 0.3  (1.03) 0.4  (0.82) 0.4  (1.40)
5.Secondary Outcome
Title Number of Patients Without New GdE T1-weighted Lesions Over 24 Weeks
Hide Description Number of patients without new GdE T1-weighted lesions over 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 133 122 30 95
Measure Type: Count of Participants
Unit of Measure: Participants
109
  83.2%
105
  78.9%
105
  86.1%
23
  76.7%
80
  84.2%
6.Secondary Outcome
Title Number of Patients Without New GdE T1-weighted Lesions Over 48 Weeks
Hide Description Number of patients without new GdE T1-weighted lesions over 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 103 122 30 95
Measure Type: Count of Participants
Unit of Measure: Participants
105
  80.2%
80
  77.7%
102
  83.6%
22
  73.3%
79
  83.2%
7.Secondary Outcome
Title Cumulative Number of New/Enlarging T2-weighted Lesions Over 24 Weeks
Hide Description Cumulative number of new/enlarging T2-weighted lesions over 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch (SSW) Population: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 126 127 122 30 95
Mean (Standard Deviation)
Unit of Measure: lesions
1.5  (3.79) 2.0  (4.12) 1.5  (3.83) 2.2  (3.84) 2.0  (4.25)
8.Secondary Outcome
Title Cumulative Number of New/Enlarging T2-weighted Lesions Over 48 Weeks
Hide Description Cumulative number of new/enlarging T2-weighted lesions over 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 122 96 119 29 95
Mean (Standard Deviation)
Unit of Measure: lesions
1.6  (3.09) 2.4  (5.79) 1.6  (3.93) 2.2  (3.89) 2.5  (5.81)
9.Secondary Outcome
Title Number of Persistent Lesions After 24 Weeks
Hide Description Number of persistent lesions after 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch : treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 126 127 122 30 95
Mean (Standard Deviation)
Unit of Measure: lesions
0.5  (2.46) 0.4  (2.92) 0.5  (2.49) 0.1  (0.31) 0.6  (3.37)
10.Secondary Outcome
Title Number of Persistent Lesions After 48 Weeks
Hide Description Number of persistent lesions after 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 122 96 119 29 95
Mean (Standard Deviation)
Unit of Measure: lesions
0.5  (2.55) 0.6  (3.35) 0.5  (2.58) 0.1  (0.26) 0.6  (3.37)
11.Secondary Outcome
Title Annualized Relapse Rate After 24 Weeks
Hide Description Annualized relapse rate after 24 weeks. Relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality had to be present for at least 24 hours and have occurred in the absence of fever or infection. Annualized relapse rate: A: Number of medically confirmed relapses overall. B: Duration of follow-up time overall, where follow-up time was defined as: (last day of follow-up - day of randomization + 1) / 365.25. The ratio of relapses per patient-year: A/B. Annualized Relapse Rate was calculated across the entire group.
Time Frame Up to 24 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 133 122 30 95
Measure Type: Number
Unit of Measure: Relapses per patient-year
0.206 0.152 0.194 0.143 0.114
12.Secondary Outcome
Title Annualized Relapse Rate After 48 Weeks
Hide Description Annualized relapse rate after 48 weeks. Relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality had to be present for at least 24 hours and have occurred in the absence of fever or infection. Annualized relapse rate: A: Number of medically confirmed relapses overall. B: Duration of follow-up time overall, where follow-up time was defined as: (last day of follow-up - day of randomization + 1) / 365.25. The ratio of relapses per patient-year: A/B. Annualized Relapse Rate was calculated across the entire group.
Time Frame Up to 48 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 103 122 30 95
Measure Type: Number
Unit of Measure: Relapses per patient-year
0.174 0.133 0.168 0.146 0.113
13.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) After 24 Weeks
Hide Description Change from baseline in Expanded Disability Status Scale (EDSS) after 24 weeks. The Kurtzke EDSS, commonly used to evaluate the degree of neurologic impairment in multiple sclerosis (MS), is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. Based on a standard neurological examination, the 7 functional systems (plus "other") are rated. These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. EDSS ratings were performed by independent examining neurologists. After re-randomization, Week 24 is considered baseline.
Time Frame Baseline and week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 122 125
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.03  (0.211) 0.00  (0.354)
14.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) After 48 Weeks
Hide Description Change from baseline in Expanded Disability Status Scale (EDSS) after 48 weeks. The Kurtzke EDSS, commonly used to evaluate the degree of neurologic impairment in MS, is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. Based on a standard neurological examination, the 7 functional systems (plus "other") are rated. These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. EDSS ratings were performed by independent examining neurologists.
Time Frame FAS: Baseline (week 0) and week 48. SSW: Baseline (week 24) and week 48.
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 117 93 117 29 93
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.14  (0.536) -0.05  (0.443) -0.10  (0.498) -0.03  (0.325) -0.02  (0.312)
15.Secondary Outcome
Title Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 24 Weeks
Hide Description Percentage of subjects with anti-drug (natalizumab) antibodies (ADA) and persistent antibodies after 24 weeks. A positive ADA patient was defined as a patient who had at least 1 positive ADA result in any post-baseline sample. A persistently positive ADA patient was defined as a patient with confirmed positive ADAs in 2 or more consecutive positive ADA samples at post-dose visits.
Time Frame Up to 24 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Safety) Tysabri (Safety) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 122 125 122 30 95
Measure Type: Number
Unit of Measure: Percentage of subjects
Persistently positive (confirmed) 28.7 27.2 28.7 43.3 22.1
Positive, confirmed 30.3 29.6 30.3 43.3 25.3
16.Secondary Outcome
Title Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 48 Weeks
Hide Description Percentage of subjects with anti-drug (natalizumab) antibodies (ADA) and persistent antibodies after 48 weeks. A positive ADA patient was defined as a patient who had at least 1 positive ADA result in any post-baseline sample. A persistently positive ADA patient was defined as a patient with confirmed positive ADAs in 2 or more consecutive positive ADA samples at post-dose visits.
Time Frame Up to 48 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Safety) Tysabri (Safety) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 115 121 115 28 93
Measure Type: Number
Unit of Measure: Percentage of subjects
Persistently positive (confirmed) 10.4 11.6 10.4 17.9 9.7
Positive, confirmed) 11.3 11.6 11.3 17.9 9.7
17.Secondary Outcome
Title Percentage of Subjects With Neutralizing Antibodies After 24 Weeks
Hide Description Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 24 weeks.
Time Frame Up to 24 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Safety) Tysabri (Safety) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 37 37 37 13 24
Measure Type: Number
Unit of Measure: Percentage of subjects
67.6 64.9 67.6 61.5 66.7
18.Secondary Outcome
Title Percentage of Subjects With Neutralizing Antibodies After 48 Weeks
Hide Description Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 48 weeks.
Time Frame Up to 48 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Safety) Tysabri (Safety) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 13 14 13 5 9
Measure Type: Number
Unit of Measure: Percentage of subjects
61.5 50.0 61.5 60.0 44.4
19.Secondary Outcome
Title Number of Subjects With Any Treatment-Emergent Adverse Event (TEAE) or Any Treatment-Emergent Serious Adverse Event (SAE) After 24 Weeks
Hide Description Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 24 weeks.
Time Frame Up to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 131 133
Measure Type: Number
Unit of Measure: participants
TEAE 62 64
Treatment-emergent SAE 1 0
20.Secondary Outcome
Title Number of Subjects With Any Treatment-Emergent Adverse Event (TEAE) or Any Treatment-Emergent Serious Adverse Event (SAE) After 48 Weeks
Hide Description Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 48 weeks.
Time Frame Up to 48 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated.
Arm/Group Title PB006 (Safety) Tysabri Switched to PB006 at Week 24 (Safety) Tysabri Continued at Week 24 (Safety)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 30 103
Measure Type: Number
Unit of Measure: participants
TEAE 85 22 71
Treatment-emergent SAE 3 0 2
21.Secondary Outcome
Title Natalizumab Trough Concentration (Ctrough) Over Time, Week 8
Hide Description Natalizumab trough concentration (Ctrough) over time, week 8. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 118 125
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter (ng/mL)
26804.75  (12949.541) 25010.49  (12557.895)
22.Secondary Outcome
Title Natalizumab Trough Concentration (Ctrough) Over Time, Week 16
Hide Description Natalizumab trough concentration (Ctrough) over time, week 16. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 117 122
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter (ng/mL)
33872.92  (18151.190) 32543.28  (14636.925)
23.Secondary Outcome
Title Natalizumab Trough Concentration (Ctrough) Over Time, Week 24
Hide Description Natalizumab trough concentration (Ctrough) over time, week 24. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 117 121
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter (ng/mL)
36853.93  (15292.389) 35617.65  (16049.669)
24.Secondary Outcome
Title Natalizumab Trough Concentration (Ctrough) Over Time, Week 32
Hide Description Natalizumab trough concentration (Ctrough) over time, week 32. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
Time Frame Week 32
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Only subjects with non-missing endpoints were included in the analysis. For this outcome measure, only participants who remain in the same treatment group through study period were included.

Only patients who stayed on their randomized treatment were included in the endpoint, patients who switch from Tysabri to PB006 were excluded.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 115 94
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter (ng/mL)
37450.04  (16877.010) 36865.81  (19756.050)
25.Secondary Outcome
Title Natalizumab Trough Concentration (Ctrough) Over Time, Week 48
Hide Description Natalizumab trough concentration (Ctrough) over time, week 48. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Only subjects with non-missing endpoints were included in the analysis. For this outcome measure, only participants who remain in the same treatment group through study period were included.

Only patients who stayed on their randomized treatment were included in the endpoint, patients who switch from Tysabri to PB006 were excluded.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 110 91
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter (ng/mL)
39097.58  (16801.710) 38432.86  (16495.407)
26.Secondary Outcome
Title Number of Patients Without New/Enlarging T2-weighted Lesions Over 24 Weeks
Hide Description Number of patients without new/enlarging T2-weighted lesions over 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.
Time Frame Week 0 (baseline), week 8, 16, 20 and 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 133 122 30 95
Measure Type: Count of Participants
Unit of Measure: Participants
75
  57.3%
72
  54.1%
72
  59.0%
18
  60.0%
52
  54.7%
27.Secondary Outcome
Title Number of Patients Without New/Enlarging T2-weighted Lesions Over 48 Weeks
Hide Description Number of patients without new/enlarging T2-weighted lesions over 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.
Time Frame Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set: patients who were randomized and have received at least one (complete or partial) infusion of the study drug. Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.

Tysabri (FAS): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Full Analysis Set) Tysabri (Full Analysis Set) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 131 103 122 30 95
Measure Type: Count of Participants
Unit of Measure: Participants
71
  54.2%
52
  50.5%
69
  56.6%
17
  56.7%
51
  53.7%
28.Secondary Outcome
Title Number of Patients With Abnormal Clinical Laboratory Tests at Week 24
Hide Description Number of patients with abnormal clinical laboratory tests at week 24.
Time Frame At week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF).
Arm/Group Title PB006 (Safety Population) Tysabri (Safety Population)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 122 125
Measure Type: Count of Participants
Unit of Measure: Participants
116
  95.1%
114
  91.2%
29.Secondary Outcome
Title Number of Patients With Abnormal Clinical Laboratory Tests at Week 48
Hide Description Number of patients with abnormal clinical laboratory tests at week 48.
Time Frame At week 48.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switched or not.
Arm/Group Title PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 117 29 93
Measure Type: Count of Participants
Unit of Measure: Participants
108
  92.3%
26
  89.7%
88
  94.6%
30.Secondary Outcome
Title Number of Patients With Abnormal Findings in Physical Examination at Week 24
Hide Description Number of patients with abnormal findings in physical examination at week 24.
Time Frame Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF).
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 122 125
Measure Type: Count of Participants
Unit of Measure: Participants
10
   8.2%
12
   9.6%
31.Secondary Outcome
Title Number of Patients With Abnormal Findings in Physical Examination at Week 48
Hide Description Number of patients with abnormal findings in physical examination at week 48.
Time Frame End of study (week 48).
Hide Outcome Measure Data
Hide Analysis Population Description

Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF).

Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switched or not.
Arm/Group Title PB006 (Safety) Tysabri (Safety) PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 117 122 117 29 93
Measure Type: Count of Participants
Unit of Measure: Participants
11
   9.4%
10
   8.2%
11
   9.4%
3
  10.3%
7
   7.5%
32.Secondary Outcome
Title Change From Baseline in Blood Pressure at Week 24
Hide Description Change from baseline in diastolic and systolic blood Pressure at week 24.
Time Frame At baseline and week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 122 125
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
Diastolic Blood Pressure -2.2  (7.30) -0.6  (7.35)
Systolic Blood Pressure -1.0  (9.76) -1.5  (11.33)
33.Secondary Outcome
Title Change From Baseline in Blood Pressure at Week 48
Hide Description Change from baseline in diastolic and systolic blood Pressure at week 48.
Time Frame At baseline and end of study (week 48).
Hide Outcome Measure Data
Hide Analysis Population Description

Safety-Switch Population: Patients who were included in the SAF and received at least 1 infusion of the study drug after the timepoint of re-randomization, independent of whether they switched or not, were included in the Safety-Switch Population (SSW). Patients in this group were analyzed as treated after re-randomization, also considering treatment before re-randomization.

Tysabri (SSW): Patients who switch from Tysabri to PB006 are excluded.
Arm/Group Title PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 117 29 93
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
Diastolic Blood Pressure 1.0  (7.58) 1.8  (8.16) 0.8  (7.68)
Systolic Blood Pressure 1.7  (8.67) 2.4  (12.38) 3.0  (10.18)
34.Secondary Outcome
Title Change From Baseline in Heart Rate at Week 24
Hide Description Change from baseline in heart rate at week 24.
Time Frame At baseline and week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Patients who received at least 1 (complete or partial) infusion of the study drug were included in the Safety Population (SAF). Patients in this group were analyzed as treated. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Overall Number of Participants Analyzed 122 125
Mean (Standard Deviation)
Unit of Measure: beats/minute
-0.4  (9.05) -1.4  (9.10)
35.Secondary Outcome
Title Change From Baseline in Heart Rate at Week 48
Hide Description Change from baseline in heart rate at week 48.
Time Frame At baseline and end of study (week 48).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety-Switch: treated patients who received at least one infusion of the study drug after the time point of re-randomization, independent of whether they switch or not. Only subjects with non-missing endpoints were included in the analysis.
Arm/Group Title PB006 (Safety-Switch) Tysabri Switched to PB006 at Week 24 (Safety-Switch) Tysabri Continued at Week 24 (Safety-Switch)
Hide Arm/Group Description:
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006). This arm concerns patients who started on Tysabri and continued on PB006 following the re-randomization at week 24.
Patients with relapsing-remitting multiple sclerosis (RRMS) received IV infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. This arm concerns patients who started on Tysabri and continued on Tysabri following the re-randomization at week 24.
Overall Number of Participants Analyzed 117 29 93
Mean (Standard Deviation)
Unit of Measure: beats/minute
0.8  (7.07) 1.7  (10.53) 1.1  (9.66)
Time Frame From first infusion till the last + 4 weeks, up to 48 weeks. Deaths (all causes): From first infusion till the last (at Week 44) + 24 ± 2 weeks, up to 68 ± 2 weeks.
Adverse Event Reporting Description Patients participating in this study who receive at least one (complete or partial) infusion of the study drug were included in the Safety Population (SAF).
 
Arm/Group Title PB006 Tysabri
Hide Arm/Group Description Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. This arm includes patients who switched from Tysabri to PB006 during the re-randomization step at week 24. Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
All-Cause Mortality
PB006 Tysabri
Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)   0/133 (0.00%) 
Hide Serious Adverse Events
PB006 Tysabri
Affected / at Risk (%) Affected / at Risk (%)
Total   3/161 (1.86%)   2/133 (1.50%) 
Infections and infestations     
Pneumonia † 1  1/161 (0.62%)  0/133 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1  0/161 (0.00%)  1/133 (0.75%) 
Nervous system disorders     
Tremor † 1  0/161 (0.00%)  1/133 (0.75%) 
Respiratory, thoracic and mediastinal disorders     
Nasal septum deviation † 1  1/161 (0.62%)  0/133 (0.00%) 
Vascular disorders     
Hypotension † 1  1/161 (0.62%)  0/133 (0.00%) 
1
Term from vocabulary, MedDRA 23
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PB006 Tysabri
Affected / at Risk (%) Affected / at Risk (%)
Total   100/161 (62.11%)   93/133 (69.92%) 
Blood and lymphatic system disorders     
Anaemia † 1  4/161 (2.48%)  0/133 (0.00%) 
Iron deficiency anaemia † 1  0/161 (0.00%)  1/133 (0.75%) 
Lymphadenitis † 1  0/161 (0.00%)  1/133 (0.75%) 
Lymphopenia † 1  1/161 (0.62%)  0/133 (0.00%) 
Neutropenia † 1  0/161 (0.00%)  1/133 (0.75%) 
Normocytic anaemia † 1  0/161 (0.00%)  1/133 (0.75%) 
Cardiac disorders     
Tachycardia † 1  0/161 (0.00%)  1/133 (0.75%) 
Ear and labyrinth disorders     
Hypoacusis † 1  1/161 (0.62%)  0/133 (0.00%) 
Vertigo † 1  1/161 (0.62%)  0/133 (0.00%) 
Eye disorders     
Ocular discomfort † 1  0/161 (0.00%)  1/133 (0.75%) 
Visual impairment † 1  1/161 (0.62%)  0/133 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1  3/161 (1.86%)  5/133 (3.76%) 
Nausea † 1  4/161 (2.48%)  3/133 (2.26%) 
Constipation † 1  2/161 (1.24%)  3/133 (2.26%) 
Vomiting † 1  0/161 (0.00%)  2/133 (1.50%) 
Abdominal pain † 1  1/161 (0.62%)  0/133 (0.00%) 
Chronic gastritis † 1  0/161 (0.00%)  1/133 (0.75%) 
Dental caries † 1  0/161 (0.00%)  1/133 (0.75%) 
Dyspepsia † 1  0/161 (0.00%)  1/133 (0.75%) 
Haemorrhoidal haemorrhage † 1  1/161 (0.62%)  0/133 (0.00%) 
Haemorrhoids † 1  1/161 (0.62%)  0/133 (0.00%) 
Large intestine polyp † 1  1/161 (0.62%)  0/133 (0.00%) 
Pancreatitis † 1  1/161 (0.62%)  0/133 (0.00%) 
Stomatitis † 1  1/161 (0.62%)  0/133 (0.00%) 
Toothache † 1  1/161 (0.62%)  0/133 (0.00%) 
General disorders     
Asthenia † 1  5/161 (3.11%)  2/133 (1.50%) 
Fatigue † 1  5/161 (3.11%)  1/133 (0.75%) 
Pyrexia † 1  1/161 (0.62%)  4/133 (3.01%) 
Hyperthermia † 1  2/161 (1.24%)  1/133 (0.75%) 
Feeling hot † 1  1/161 (0.62%)  2/133 (1.50%) 
Oedema peripheral † 1  1/161 (0.62%)  1/133 (0.75%) 
Discomfort † 1  0/161 (0.00%)  1/133 (0.75%) 
Infusion site pain † 1  0/161 (0.00%)  1/133 (0.75%) 
Hepatobiliary disorders     
Biliary dyskinesia † 1  1/161 (0.62%)  1/133 (0.75%) 
Hyperbilirubinaemia † 1  2/161 (1.24%)  1/133 (0.75%) 
Immune system disorders     
Hypersensitivity † 1  0/161 (0.00%)  1/133 (0.75%) 
Infections and infestations     
Nasopharyngitis † 1  14/161 (8.70%)  13/133 (9.77%) 
COVID-19 † 1  14/161 (8.70%)  10/133 (7.52%) 
Upper respiratory tract infection † 1  2/161 (1.24%)  4/133 (3.01%) 
Pharyngitis † 1  1/161 (0.62%)  4/133 (3.01%) 
Respiratory tract infection † 1  2/161 (1.24%)  2/133 (1.50%) 
Urinary tract infection † 1  2/161 (1.24%)  2/133 (1.50%) 
Bronchitis † 1  1/161 (0.62%)  3/133 (2.26%) 
Cystitis † 1  2/161 (1.24%)  1/133 (0.75%) 
Oral herpes † 1  2/161 (1.24%)  2/133 (1.50%) 
Pneumonia † 1  2/161 (1.24%)  1/133 (0.75%) 
Rhinitis † 1  1/161 (0.62%)  2/133 (1.50%) 
Herpes simplex † 1  1/161 (0.62%)  1/133 (0.75%) 
Respiratory tract infection viral † 1  2/161 (1.24%)  1/133 (0.75%) 
Sinusitis † 1  1/161 (0.62%)  1/133 (0.75%) 
Vaginal infection † 1  1/161 (0.62%)  1/133 (0.75%) 
Acute sinusitis † 1  0/161 (0.00%)  1/133 (0.75%) 
COVID-19 pneumonia † 1  1/161 (0.62%)  1/133 (0.75%) 
Ear infection † 1  1/161 (0.62%)  0/133 (0.00%) 
Fungal skin infection † 1  1/161 (0.62%)  0/133 (0.00%) 
Furuncle † 1  0/161 (0.00%)  1/133 (0.75%) 
Gastroenteritis † 1  1/161 (0.62%)  0/133 (0.00%) 
Helicobacter gastritis † 1  1/161 (0.62%)  0/133 (0.00%) 
Herpes zoster † 1  0/161 (0.00%)  1/133 (0.75%) 
Infected fistula † 1  0/161 (0.00%)  1/133 (0.75%) 
Laryngitis † 1  1/161 (0.62%)  1/133 (0.75%) 
Pyelonephritis acute † 1  1/161 (0.62%)  0/133 (0.00%) 
Pyoderma streptococcal † 1  1/161 (0.62%)  1/133 (0.75%) 
Tinea versicolour † 1  1/161 (0.62%)  0/133 (0.00%) 
Tonsillitis † 1  0/161 (0.00%)  1/133 (0.75%) 
Tracheitis † 1  1/161 (0.62%)  0/133 (0.00%) 
Urinary tract infection enterococcal † 1  0/161 (0.00%)  1/133 (0.75%) 
Viral upper respiratory tract infection † 1  1/161 (0.62%)  0/133 (0.00%) 
Vulvovaginal candidiasis † 1  0/161 (0.00%)  1/133 (0.75%) 
Injury, poisoning and procedural complications     
Contusion † 1  0/161 (0.00%)  2/133 (1.50%) 
Ankle fracture † 1  0/161 (0.00%)  1/133 (0.75%) 
Ligament sprain † 1  1/161 (0.62%)  0/133 (0.00%) 
Limb injury † 1  0/161 (0.00%)  1/133 (0.75%) 
Muscle injury † 1  1/161 (0.62%)  0/133 (0.00%) 
Investigations     
Weight decreased † 1  2/161 (1.24%)  4/133 (3.01%) 
Alanine aminotransferase increased † 1  2/161 (1.24%)  1/133 (0.75%) 
Blood pressure increased † 1  1/161 (0.62%)  2/133 (1.50%) 
C-reactive protein increased † 1  2/161 (1.24%)  1/133 (0.75%) 
Gamma-glutamyltransferase increased † 1  1/161 (0.62%)  1/133 (0.75%) 
Aspartate aminotransferase increased † 1  0/161 (0.00%)  1/133 (0.75%) 
Bilirubin conjugated increased † 1  1/161 (0.62%)  0/133 (0.00%) 
Blood triglycerides increased † 1  1/161 (0.62%)  0/133 (0.00%) 
Lymphocyte count increased † 1  0/161 (0.00%)  1/133 (0.75%) 
White blood cell count increased † 1  0/161 (0.00%)  1/133 (0.75%) 
Scar † 1  1/161 (0.62%)  0/133 (0.00%) 
Thermal burn † 1  1/161 (0.62%)  0/133 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  0/161 (0.00%)  1/133 (0.75%) 
Hyperlipidaemia † 1  0/161 (0.00%)  1/133 (0.75%) 
Hypertriglyceridaemia † 1  0/161 (0.00%)  1/133 (0.75%) 
Vitamin D deficiency † 1  1/161 (0.62%)  0/133 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  7/161 (4.35%)  4/133 (3.01%) 
Pain in extremity † 1  2/161 (1.24%)  3/133 (2.26%) 
Muscle spasms † 1  2/161 (1.24%)  1/133 (0.75%) 
Myalgia † 1  2/161 (1.24%)  1/133 (0.75%) 
Neck pain † 1  1/161 (0.62%)  2/133 (1.50%) 
Arthralgia † 1  2/161 (1.24%)  0/133 (0.00%) 
Musculoskeletal stiffness † 1  0/161 (0.00%)  2/133 (1.50%) 
Arthritis reactive † 1  1/161 (0.62%)  0/133 (0.00%) 
Intervertebral disc disorder † 1  1/161 (0.62%)  0/133 (0.00%) 
Rotator cuff syndrome † 1  1/161 (0.62%)  0/133 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Fibroadenoma of breast † 1  1/161 (0.62%)  0/133 (0.00%) 
Haemangioma of spleen † 1  1/161 (0.62%)  0/133 (0.00%) 
Nervous system disorders     
Headache † 1  27/161 (16.77%)  23/133 (17.29%) 
Dizziness † 1  3/161 (1.86%)  3/133 (2.26%) 
Hypoaesthesia † 1  3/161 (1.86%)  2/133 (1.50%) 
Paraesthesia † 1  1/161 (0.62%)  1/133 (0.75%) 
Presyncope † 1  2/161 (1.24%)  1/133 (0.75%) 
Tension headache † 1  2/161 (1.24%)  1/133 (0.75%) 
Burning sensation † 1  0/161 (0.00%)  1/133 (0.75%) 
Dysgeusia † 1  1/161 (0.62%)  0/133 (0.00%) 
Head titubation † 1  0/161 (0.00%)  1/133 (0.75%) 
Hyposmia † 1  0/161 (0.00%)  1/133 (0.75%) 
Multiple sclerosis relapse † 1  0/161 (0.00%)  1/133 (0.75%) 
Muscle spasticity † 1  1/161 (0.62%)  0/133 (0.00%) 
Trigeminal neuralgia † 1  1/161 (0.62%)  0/133 (0.00%) 
Psychiatric disorders     
Depression † 1  4/161 (2.48%)  4/133 (3.01%) 
Insomnia † 1  4/161 (2.48%)  1/133 (0.75%) 
Sleep disorder † 1  0/161 (0.00%)  1/133 (0.75%) 
Somatic symptom disorder † 1  1/161 (0.62%)  0/133 (0.00%) 
Renal and urinary disorders     
Leukocyturia † 1  0/161 (0.00%)  2/133 (1.50%) 
Dysuria † 1  0/161 (0.00%)  1/133 (0.75%) 
Haematuria † 1  0/161 (0.00%)  1/133 (0.75%) 
Renal pain † 1  0/161 (0.00%)  1/133 (0.75%) 
Urinary retention † 1  0/161 (0.00%)  1/133 (0.75%) 
Urinary tract inflammation † 1  1/161 (0.62%)  0/133 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea † 1  1/161 (0.62%)  0/133 (0.00%) 
Menorrhagia † 1  1/161 (0.62%)  0/133 (0.00%) 
Metrorrhagia † 1  1/161 (0.62%)  0/133 (0.00%) 
Organic erectile dysfunction † 1  0/161 (0.00%)  1/133 (0.75%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain † 1  5/161 (3.11%)  3/133 (2.26%) 
Rhinitis allergic † 1  1/161 (0.62%)  1/133 (0.75%) 
Rhinorrhoea † 1  1/161 (0.62%)  1/133 (0.75%) 
Allergic sinusitis † 1  1/161 (0.62%)  0/133 (0.00%) 
Asthma † 1  0/161 (0.00%)  1/133 (0.75%) 
Catarrh † 1  1/161 (0.62%)  0/133 (0.00%) 
Paranasal sinus mucosal hypertrophy † 1  1/161 (0.62%)  0/133 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria † 1  2/161 (1.24%)  1/133 (0.75%) 
Alopecia † 1  1/161 (0.62%)  1/133 (0.75%) 
Erythema † 1  1/161 (0.62%)  1/133 (0.75%) 
Hyperhidrosis † 1  1/161 (0.62%)  1/133 (0.75%) 
Pruritus † 1  2/161 (1.24%)  0/133 (0.00%) 
Angioedema † 1  0/161 (0.00%)  1/133 (0.75%) 
Idiopathic angioedema † 1  1/161 (0.62%)  0/133 (0.00%) 
Petechiae † 1  1/161 (0.62%)  0/133 (0.00%) 
Rash † 1  0/161 (0.00%)  1/133 (0.75%) 
Skin depigmentation † 1  1/161 (0.62%)  0/133 (0.00%) 
Nephrolithiasis † 1  0/161 (0.00%)  1/133 (0.75%) 
Nephroptosis † 1  0/161 (0.00%)  1/133 (0.75%) 
Vascular disorders     
Blood pressure fluctuation † 1  1/161 (0.62%)  0/133 (0.00%) 
Hypertension † 1  1/161 (0.62%)  1/133 (0.75%) 
Hypotension † 1  1/161 (0.62%)  0/133 (0.00%) 
Thrombophlebitis † 1  1/161 (0.62%)  0/133 (0.00%) 
1
Term from vocabulary, MedDRA 23
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Research and Development
Organization: Polpharma Biologics S.A.
Phone: +48 607 697 896
EMail: clinicaltrials@polpharmabiologics.com
Publications of Results:
Hemmer B, Wiendl H, Roth K, Wessels H, Hofler J, Hornuss C, Liedert B, Selmaj K. Efficacy and Safety of Proposed Biosimilar Natalizumab (PB006) in Patients With Relapsing-Remitting Multiple Sclerosis: The Antelope Phase 3 Randomized Clinical Trial. JAMA Neurol. 2023 Mar 1;80(3):298-307. doi: 10.1001/jamaneurol.2022.5007.
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Responsible Party: Polpharma Biologics S.A.
ClinicalTrials.gov Identifier: NCT04115488    
Other Study ID Numbers: PB006-03-01
First Submitted: September 10, 2019
First Posted: October 4, 2019
Results First Submitted: April 28, 2023
Results First Posted: July 3, 2023
Last Update Posted: July 3, 2023