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

• 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: Polpharma Biologics S.A.
• Information provided by (Responsible Party): Polpharma Biologics S.A.

Study Description

Brief Summary:

This is a multi-center, randomized, parallel arm, double-blind study with a total duration of subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed Natalizumab.

Condition or disease	Intervention/treatment	Phase
Relapsing-Remitting Multiple Sclerosis (RRMS)	Biological: Intravenous (IV) infusions	Phase 3

Detailed Description:

This is a Phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group study to assess the equivalence in efficacy and similarity in safety of biosimilar PB006 compared to Tysabri in patients with RRMS.

All eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri at a dose of 300 mg at each intravenous (IV) infusion administered with every single one intravenous (IV) infusion administered every 4 weeks of either PB006 or Tysabri at a dose of 300 mg starting at visit 1 (week 0) through visit 12 (week 44), for a total of 12 infusions. The End-of-Study Visit (visit 13, week 48) will be performed 4 weeks after the last infusion

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 265 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: August 23, 2021
• Actual Study Completion Date: February 7, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: PB006; 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.	Biological: Intravenous (IV) infusions; Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
Active Comparator: Tysabri; 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).	Biological: Intravenous (IV) infusions; Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses

Outcome Measures

Primary Outcome Measures :

1. Cumulative Number of New Active Lesions Over 24 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20 and 24. ]
   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.

Secondary Outcome Measures :

1. Cumulative Number of New Active Lesions Over 48 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48. ]
   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].
2. Cumulative Number of New GdE T1-weighted Lesions Over 24 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20 and 24. ]
   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].
3. Cumulative Number of New GdE T1-weighted Lesions Over 48 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48. ]
   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].
4. Number of Patients Without New GdE T1-weighted Lesions Over 24 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20 and 24. ]
   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].
5. Number of Patients Without New GdE T1-weighted Lesions Over 48 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48. ]
   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].
6. Cumulative Number of New/Enlarging T2-weighted Lesions Over 24 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20 and 24. ]
   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.
7. Cumulative Number of New/Enlarging T2-weighted Lesions Over 48 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48. ]
   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.
8. Number of Persistent Lesions After 24 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20 and 24. ]
   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].
9. Number of Persistent Lesions After 48 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48. ]
   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].
10. Annualized Relapse Rate After 24 Weeks [ Time Frame: Up to 24 weeks. ]
    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.
11. Annualized Relapse Rate After 48 Weeks [ Time Frame: Up to 48 weeks. ]
    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.
12. Change From Baseline in Expanded Disability Status Scale (EDSS) After 24 Weeks [ Time Frame: Baseline and week 24. ]
    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.
13. Change From Baseline in Expanded Disability Status Scale (EDSS) After 48 Weeks [ Time Frame: FAS: Baseline (week 0) and week 48. SSW: Baseline (week 24) and week 48. ]
    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.
14. Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 24 Weeks [ Time Frame: Up to 24 weeks. ]
    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.
15. Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 48 Weeks [ Time Frame: Up to 48 weeks. ]
    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.
16. Percentage of Subjects With Neutralizing Antibodies After 24 Weeks [ Time Frame: Up to 24 weeks. ]
    Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 24 weeks.
17. Percentage of Subjects With Neutralizing Antibodies After 48 Weeks [ Time Frame: Up to 48 weeks. ]
    Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 48 weeks.
18. 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 ]
    Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 24 weeks.
19. 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. ]
    Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 48 weeks.
20. Natalizumab Trough Concentration (Ctrough) Over Time, Week 8 [ Time Frame: Week 8 ]
    Natalizumab trough concentration (Ctrough) over time, week 8. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
21. Natalizumab Trough Concentration (Ctrough) Over Time, Week 16 [ Time Frame: Week 16 ]
    Natalizumab trough concentration (Ctrough) over time, week 16. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
22. Natalizumab Trough Concentration (Ctrough) Over Time, Week 24 [ Time Frame: Week 24 ]
    Natalizumab trough concentration (Ctrough) over time, week 24. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
23. Natalizumab Trough Concentration (Ctrough) Over Time, Week 32 [ Time Frame: Week 32 ]
    Natalizumab trough concentration (Ctrough) over time, week 32. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
24. Natalizumab Trough Concentration (Ctrough) Over Time, Week 48 [ Time Frame: Week 48 ]
    Natalizumab trough concentration (Ctrough) over time, week 48. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.
25. Number of Patients Without New/Enlarging T2-weighted Lesions Over 24 Weeks [ Time Frame: Week 0 (baseline), week 8, 16, 20 and 24. ]
    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.
26. Number of Patients Without New/Enlarging T2-weighted Lesions Over 48 Weeks [ Time Frame: Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48. ]
    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.
27. Number of Patients With Abnormal Clinical Laboratory Tests at Week 24 [ Time Frame: At week 24. ]
    Number of patients with abnormal clinical laboratory tests at week 24.
28. Number of Patients With Abnormal Clinical Laboratory Tests at Week 48 [ Time Frame: At week 48. ]
    Number of patients with abnormal clinical laboratory tests at week 48.
29. Number of Patients With Abnormal Findings in Physical Examination at Week 24 [ Time Frame: Week 24. ]
    Number of patients with abnormal findings in physical examination at week 24.
30. Number of Patients With Abnormal Findings in Physical Examination at Week 48 [ Time Frame: End of study (week 48). ]
    Number of patients with abnormal findings in physical examination at week 48.
31. Change From Baseline in Blood Pressure at Week 24 [ Time Frame: At baseline and week 24. ]
    Change from baseline in diastolic and systolic blood Pressure at week 24.
32. Change From Baseline in Blood Pressure at Week 48 [ Time Frame: At baseline and end of study (week 48). ]
    Change from baseline in diastolic and systolic blood Pressure at week 48.
33. Change From Baseline in Heart Rate at Week 24 [ Time Frame: At baseline and week 24. ]
    Change from baseline in heart rate at week 24.
34. Change From Baseline in Heart Rate at Week 48 [ Time Frame: At baseline and end of study (week 48). ]
    Change from baseline in heart rate at week 48.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple sclerosis (RRMS) defined by the 2010 revised McDonald criteria
• At least 1 documented relapse within the previous year and either ≥1 GdE T1-weighted brain lesions or ≥9 T2-weighted brain lesions at Screening
• Kurtzke Expanded Disability Status Scale (EDSS) score from 0 to 5 (inclusive) at Screening

Exclusion Criteria:

• Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiple sclerosis (RRMS)
• Relapse within the 30 days prior Screening and until administration of the first dose of study drug
• Prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab, cladribine, or other B- and T-cell targeting therapies
• Prior total lymphoid irradiation or bone marrow or organ transplantation
• Patients with John Cunningham Virus (JCV) index >1.5 at Screening
• Past or current Progressive Multi-focal leukoencephalopathy (PML) diagnosis
• Severe renal function impairment as defined by serum creatinine values >120 micromol per litre

Contacts and Locations

Locations

Belarus

Grodno Regional Clinical Hospital

Grodno, Belarus, 230017

Minsk City Clinical Hospital #5

Minsk, Belarus, 220026

Republican Research and Development Center for Neurology and Neurosurgery

Minsk, Belarus, 220114

Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

Minsk, Belarus, 220116

Vitebsk Regional Diagnostic Center

Vitebsk, Belarus, 210023

Vitebsk Regional Clinical Hospital

Vitebsk, Belarus, 210037

Croatia

Clinical Hospital Center Osijek, Clinic of Neurology

Osijek, Croatia, 31000

Clinical Hospital Center Split, Clinic of Neurology

Split, Croatia, 21000

University Hospital Centre Zagreb, Clinic of Neurology

Zagreb, Croatia, 10000

Georgia

P. Sarajishvili Institute of Neurology, LTD

Tbilisi, Georgia, 0112

LTD Saint Michael Archangel Multifunctional Clinical Hospital

Tbilisi, Georgia, 0159

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

Tbilisi, Georgia, 0172

LTD S.Khechinashvili University Hospital

Tbilisi, Georgia, 0179

LTD Aversi Clinic

Tbilisi, Georgia

Pineo Medical Ecosystem

Tbilisi, Georgia

Moldova, Republic of

Institute for Emergency Medicine, Department of Neurology

Chisinau, Moldova, Republic of, 2004

Institute for Emergency Medicine, Department of Neurology

Chisinau, Moldova, Republic of, 2028

National Institute of Neurology and Neurosurgery, Vascular Neurology Department

Chisinau, Moldova, Republic of, 2028

Poland

COPERNICUS Podmiot Leczniczy Sp. z o.o N. Copernicus Hospital, Department of Neurology

Gdansk, Pomerania, Poland, 80-803

Neuro-Medic

Katowice, Poland, 40-555

Neurology Center Krzysztof Selmaj

Lodz, Poland, 90-324

Provincial Specialist Hospital in Olsztyn, Department of Neurology

Olsztyn, Poland, 10-561

MED-Polonia, Sp. z o.o. (LLC)

Poznan, Poland

NeuroProtect Medical Center

Warszawa, Poland, 01-684

Serbia

Clinical Center of Serbia, Clinic of Neurology

Belgrade, Serbia, 11000

Clinical Hospital Center Zemun, Department of Neurology

Belgrade, Serbia, 11080

Clinical Center Kragujevac, Clinic of Neurology

Kragujevac, Serbia, 34000

Clinical Center of Vojvodina, Clinic of Neurology

Novi Sad, Serbia, 21000

Ukraine

Cherkasy Regional Hospital of Cherkasy Oblast Council

Cherkasy, Ukraine

Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

Dnipro, Ukraine

Ivano-Frankivsk City Clinical Hospital #1

Ivano-Frankivs'k, Ukraine

Regional Clinical Hospital

Ivano-Frankivs'k, Ukraine

City Clinical Hospital #7

Kharkiv, Ukraine

Institute of Neurology, Psychiatry and Narcology

Kharkiv, Ukraine

Kharkiv Railway Clinical Hospital

Kharkiv, Ukraine

Kyiv City Clinical Hospital

Kyiv, Ukraine

Medical Center of First Private Clinic

Kyiv, Ukraine

National Research Center for Radiation Medicine

Kyiv, Ukraine

Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, Ukraine

Lviv City Clinical Hospital #5

Lviv, Ukraine

Center for Reconstructive and Restorative Medicine (University Clinic)

Odesa, Ukraine

Sklifosovskyi Regional Clinical Hospital

Poltava, Ukraine

Ternopil Regional Clinical Psychonevrological Hospital

Ternopil', Ukraine

Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital

Vinnytsia, Ukraine

Clinical Hospital No. 9 under Zaporizhia City Council

Zaporizhia, Ukraine

City Clinical Hospital #2

Zaporizhzhya, Ukraine

Zaporizhia Regional Clinical Hospital

Zaporizhzhya, Ukraine

O.F. Herbachevskyi Regional Clinical Hospital

Zhytomyr, Ukraine, 10008

Sponsors and Collaborators

Polpharma Biologics S.A.

Investigators

• Study Director: Karsten Roth, Dr.; Polpharma Biologics S.A.

  Study Documents (Full-Text)

Documents provided by Polpharma Biologics S.A.:

Study Protocol  [PDF] July 15, 2020

Statistical Analysis Plan  [PDF] April 28, 2021

More Information

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.

• Responsible Party: Polpharma Biologics S.A.
• ClinicalTrials.gov Identifier: NCT04115488
• Other Study ID Numbers: PB006-03-01
• First Posted: October 4, 2019
• Results First Posted: July 3, 2023
• Last Update Posted: July 3, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases