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Trial record 1 of 1 for:    NCT02592798
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Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02592798
Recruitment Status : Completed
First Posted : October 30, 2015
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nephrotic Syndrome
Focal Segmental Glomerulosclerosis
Minimal Change Disease
Interventions Drug: Abatacept
Other: Normal Saline
Other: D5W
Enrollment 36
Recruitment Details  
Pre-assignment Details 36 participants were randomized and treated.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Period Title: Double-Blind Period 1 (DB1)
Started 17 19
Completed 14 13
Not Completed 3 6
Reason Not Completed
Pregnancy             1             0
No longer meeting study criteria             0             1
Lack of Efficacy             1             3
Adverse Event             1             2
Period Title: Transition From DB1 to DB2
Started 14 13
Completed 11 11
Not Completed 3 2
Reason Not Completed
Skipped DB2 and moved into subsequent OLE             3             2
Period Title: Double-Blind Period 2 (DB2)
Started 11 11
Completed 6 9
Not Completed 5 2
Reason Not Completed
Other reasons             1             0
Participant request to discontinue             1             0
No longer meeting study criteria             1             0
Lack of Efficacy             1             2
Adverse Event             1             0
Period Title: Transition From DB2 to OLE
Started 6 9
Completed 5 9
Not Completed 1 0
Reason Not Completed
Other reasons             1             0
Period Title: Open Label Period (OLE)
Started [1] 10 13
Completed 6 4
Not Completed 4 9
Reason Not Completed
Other reasons             0             2
Participant request to discontinue             1             0
Lost to Follow-up             0             1
Lack of Efficacy             3             5
Adverse Event             0             1
[1]
The starting pool of OLE period consists of participants who completed the Double-Blind Period + participants who escaped from DB1 and/or DB2 to OLE period
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
 Total of all reporting groups
Overall Number of Baseline Participants 17 19 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 19 participants 36 participants
22.5  (13.21) 28.7  (19.35) 25.8  (16.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
Female
8
  47.1%
12
  63.2%
20
  55.6%
Male
9
  52.9%
7
  36.8%
16
  44.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
Hispanic or Latino
2
  11.8%
5
  26.3%
7
  19.4%
Not Hispanic or Latino
15
  88.2%
14
  73.7%
29
  80.6%
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 17 participants 19 participants 36 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
4
  23.5%
3
  15.8%
7
  19.4%
White
13
  76.5%
14
  73.7%
27
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
  10.5%
2
   5.6%
1.Primary Outcome
Title Percentage of Participants in Renal Response at Day 113
Hide Description

Renal Response is defined as the presence of all the following criteria:

PROTEINURIA: Reduction of baseline urine protein/creatinine ratio (UPCR) of >= 50% and to less than 3.

RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
Time Frame From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
Double-Blind Period Day 113 Number Analyzed 13 participants 13 participants
0.0
(0.0 to 24.7)
7.7
(0.2 to 36.0)
Open Label Period Day 113 Number Analyzed 8 participants 9 participants
12.5
(0.3 to 52.7)
33.3
(7.5 to 70.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-46.8 to 33.3
Estimation Comments Abatacept - Placebo for Double-Blind Period Day 113
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.8
Confidence Interval (2-Sided) 95%
-63.3 to 24.3
Estimation Comments Abatacept - Placebo for Open Label Period Day 113
2.Secondary Outcome
Title Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113
Hide Description [Not Specified]
Time Frame From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Mean (Standard Error)
Unit of Measure: mg/mg
Double-Blind Period Day 113 Number Analyzed 13 participants 13 participants
0.12  (0.5738) -0.25  (0.7914)
Open Label Period Day 113 Number Analyzed 8 participants 8 participants
1.98  (1.1598) 0.02  (1.3049)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-1.6495 to 2.3855
Estimation Comments Abatacept - Placebo for Double-Blind Period Day 113
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
-1.7933 to 5.6954
Estimation Comments Abatacept - Placebo for Open Label Period Day 113
3.Secondary Outcome
Title Mean Change From Baseline in Serum Albumine at Day 113
Hide Description [Not Specified]
Time Frame From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Mean (Standard Error)
Unit of Measure: g/dL
Double-Blind Period Day 113 Number Analyzed 11 participants 12 participants
0.08  (0.1016) -0.05  (0.0892)
Open Label Period Day 113 Number Analyzed 9 participants 9 participants
0.21  (0.1829) 0.09  (0.2360)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.1483 to 0.4119
Estimation Comments Abatacept - Placebo for Double-Blind Period Day 113
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.5107 to 0.7551
Estimation Comments Abatacept - Placebo for Open Label Period Day 113
4.Secondary Outcome
Title Percentage of Participants Achieving Complete Remission at Day 113
Hide Description

Complete Remission is defined as the presence of all the following criteria:

PROTEINURIA: Urine protein/creatinine ratio (UPCR) ≤ 0.3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline.
Time Frame From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
Double-Blind Period Day 113 Number Analyzed 13 participants 13 participants
0.0
(0.0 to 24.7)
0.0
(0.0 to 24.7)
Open Label Period Day 113 Number Analyzed 8 participants 9 participants
12.5
(0.3 to 52.7)
11.1
(0.3 to 48.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-44.7 to 44.7
Estimation Comments Abatacept - Placebo for Open Label Period Day 113
5.Secondary Outcome
Title Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants
Hide Description

PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:

Fatigue: Short From (SF) Fatigue v1.0 Adult 8a, composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).

Pain Interference: SF Pain Interference v1.0 Adult 8a, (measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).

Physical Function: SF Physical Function v1.2 Adult 8b, composed of 8 questions, each one scored from 1 (Without any difficulty) to 5 (Unable to do). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome).
Time Frame From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 9 11
Mean (Standard Error)
Unit of Measure: Score on a scale
Fatigue Number Analyzed 8 participants 8 participants
-5.56  (2.2907) -4.87  (2.6125)
Pain Interference Number Analyzed 8 participants 8 participants
-4.88  (2.6395) -1.18  (3.9785)
Physical Function Number Analyzed 8 participants 8 participants
0.78  (1.7350) 1.77  (1.9346)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-8.1395 to 6.7645
Estimation Comments Abatacept - Placebo for Fatigue
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.70
Confidence Interval (2-Sided) 95%
-13.9402 to 6.5402
Estimation Comments Abatacept - Placebo for Pain interference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.00
Confidence Interval (2-Sided) 95%
-6.5736 to 4.5736
Estimation Comments Abatacept - Placebo for Physical function
6.Secondary Outcome
Title Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants
Hide Description

PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements:

Fatigue: Short From (SF) Fatigue v1.0 Peds 10a, composed of 10 questions, each one scored from 0 (Never) to 4 (Almost Always). Output presented as Total score, ranging from 0 (most desirable outcome) to 40 (least desirable outcome).

Pain Interference: SF Pain Interference v1.0 Peds 8a, ( measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 0 (Never) to 4 (Almost always). Output presented as Total score, ranging from 0 (most desirable outcome) to 32 (least desirable outcome).

Mobility: SF Physical Function-Mobility v1.0 Peds 8a, composed of 8 questions, each one scored from 0 (Not able to do) to 4 (With no trouble). Output presented as Total score, ranging from 0 (least desirable outcome) to 32 (most desirable outcome).
Time Frame From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 8 8
Mean (Standard Error)
Unit of Measure: Score on a scale
Fatigue Number Analyzed 4 participants 5 participants
6.43  (6.7142) -6.02  (3.6526)
Pain Interference Number Analyzed 4 participants 5 participants
5.70  (3.9781) -1.44  (1.9180)
Mobility Number Analyzed 4 participants 5 participants
0.80  (3.5007) 1.68  (3.1905)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.45
Confidence Interval (2-Sided) 95%
-4.5950 to 29.4850
Estimation Comments Abatacept - Placebo for Fatigue
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.14
Confidence Interval (2-Sided) 95%
-2.5917 to 16.8717
Estimation Comments Abatacept - Placebo for Pain interference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-12.1068 to 10.3468
Estimation Comments Abatacept - Placebo for Mobility
7.Secondary Outcome
Title Number of Participants Experiencing Adverse Events
Hide Description

This outcome describes the number of participants experiencing various types of any grade Adverse Events (AEs).

The Cumulative Abatacept Safety Period starts at the time of the first dose of Abatacept (either in the Double-Blind Period or in the Open Label Period) and lasts 56 days after the last dose of Abatacept
Time Frame From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept During Double-Blind Period Placebo During Double-Blind Period Abatacept During Cumulative Abatacept Safety Period
Hide Arm/Group Description:
Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
Any participants receiving at least 1 dose of Abatacept, starting either in the Double-Blind Period or in the Open Label Period
Overall Number of Participants Analyzed 17 19 32
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Events (AEs)
13
  76.5%
15
  78.9%
26
  81.3%
Serious Adverse Events (SAEs)
5
  29.4%
4
  21.1%
10
  31.3%
AEs leading to discontinuation
1
   5.9%
2
  10.5%
2
   6.3%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants Experiencing Adverse Events of Special Interest
Hide Description Number of participants experiencing various types of Adverse Events of interest, including infections, malignancies, autoimmune disorders, and infusional related reactions.
Time Frame From first dose on day 1 to 56 days following last dose (approximately 330 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Measure Type: Count of Participants
Unit of Measure: Participants
Peri-infusional Adverse Event (AE)
6
  35.3%
3
  15.8%
AE within 24 hours of Infusion
8
  47.1%
9
  47.4%
Malignancies
0
   0.0%
0
   0.0%
Infections/Infestations
12
  70.6%
10
  52.6%
Autoimmune disorders
0
   0.0%
1
   5.3%
9.Secondary Outcome
Title Percentage of Participants With Positive Antibody Response Relative to Baseline
Hide Description

A positive response relative to baseline is defined as a positive response at a post-baseline visit that has a titer value greater than the positive baseline titer value. If the baseline titer is missing or negative, any post-baseline positive titer value is considered a positive response relative to baseline.

Immunogenicity response is presented as the total of immunogenicity response for "CTLA4 and possibly Ig" and "Ig and/or Junction Region".
Time Frame From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Measure Type: Number
Unit of Measure: Percent of Participants
Day 113 from first dose Number Analyzed 14 participants 12 participants
7.1 0.0
Day 56 from last dose Number Analyzed 5 participants 3 participants
40.0 66.7
Day 84 from last dose Number Analyzed 7 participants 3 participants
28.6 66.7
Day 168 from last dose Number Analyzed 6 participants 4 participants
16.7 25.0
10.Secondary Outcome
Title Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants
Hide Description [Not Specified]
Time Frame From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113
Hide Outcome Measure Data
Hide Analysis Population Description
All adult participants receiving Abatacept during the Double Blind Period with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Day 15 Number Analyzed 9 participants 0 participants
7.613
(63.7%)
Day 29 Number Analyzed 8 participants 0 participants
12.274
(86.7%)
Day 57 Number Analyzed 9 participants 0 participants
3.641
(66.5%)
Day 85 Number Analyzed 7 participants 0 participants
4.101
(52.7%)
Day 113 Number Analyzed 7 participants 0 participants
2.786
(68.2%)
11.Secondary Outcome
Title Minimum Blood Plasma Concentration (Cmin) of Abatacept - Pediatric Participants
Hide Description [Not Specified]
Time Frame From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113
Hide Outcome Measure Data
Hide Analysis Population Description
All pediatric participants receiving Abatacept during the Double Blind Period with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Day 15 Number Analyzed 8 participants 0 participants
2.829
(116.4%)
Day 29 Number Analyzed 7 participants 0 participants
2.588
(138.7%)
Day 57 Number Analyzed 8 participants 0 participants
0.504
(143.2%)
Day 85 Number Analyzed 5 participants 0 participants
1.617
(123.5%)
Day 113 Number Analyzed 6 participants 0 participants
0.990
(163.1%)
12.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Abatacept
Hide Description [Not Specified]
Time Frame Day 85 after first dose in the Double Blind Period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving Abatacept during the Double Blind Period with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
Adult participants Number Analyzed 7 participants 0 participants
200.46
(43.9%)
Pediatric participants Number Analyzed 6 participants 0 participants
174.65
(30.0%)
13.Secondary Outcome
Title Area Under the Serum Concentration Time Curve Over a Dosing Interval (AUC(TAU)) of Abatacept
Hide Description [Not Specified]
Time Frame From Day 85 to Day 113 in the Double Blind Period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving Abatacept during the Double Blind Period with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug*h/mL
Adult participants Number Analyzed 7 participants 0 participants
20394.83
(44.3%)
Pediatric participants Number Analyzed 4 participants 0 participants
18282.50
(41.9%)
14.Secondary Outcome
Title Time to Reach Peak Serum Concentration (Tmax(h)) of Abatacept
Hide Description [Not Specified]
Time Frame Day 85 after first dose in the Double Blind Period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving Abatacept during the Double Blind Period with available measurements
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
  • Double Blind Periods 1 and 2 (DB1 and DB2): Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
  • Double Blind Periods 1 and 2 (DB1 and DB2): Normal Saline or Dextrose 5% in Water (D5W) administer on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period.
  • Open Label Period (OLE): Abatacept IV administered every 28 days
Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: Hours
Adult participants Number Analyzed 7 participants 0 participants
0.883  (0.242)
Pediatric participants Number Analyzed 6 participants 0 participants
0.589  (0.285)
Time Frame From first dose to 100 days following administration of last dose (approximately 1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept During Double-Blind Period 1 (DB1) Placebo During Double-Blind Period 1 (DB1) Abatacept During Double-Blind Period 2 (DB2) Placebo During Double-Blind Period 2 (DB2) Abatacept During Open Label Period (OLE)
Hide Arm/Group Description Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period. Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period. Abatacept IV administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period. Normal Saline or Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days until the end of the Double Blind Period. Abatacept IV administered every 28 days
All-Cause Mortality
Abatacept During Double-Blind Period 1 (DB1) Placebo During Double-Blind Period 1 (DB1) Abatacept During Double-Blind Period 2 (DB2) Placebo During Double-Blind Period 2 (DB2) Abatacept During Open Label Period (OLE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%)   0/11 (0.00%)   0/11 (0.00%)   0/23 (0.00%) 
Hide Serious Adverse Events
Abatacept During Double-Blind Period 1 (DB1) Placebo During Double-Blind Period 1 (DB1) Abatacept During Double-Blind Period 2 (DB2) Placebo During Double-Blind Period 2 (DB2) Abatacept During Open Label Period (OLE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/17 (29.41%)   4/19 (21.05%)   0/11 (0.00%)   2/11 (18.18%)   6/23 (26.09%) 
Blood and lymphatic system disorders           
Anaemia † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Thrombotic microangiopathy † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Cardiac disorders           
Palpitations † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Eye disorders           
Periorbital swelling † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Gastrointestinal disorders           
Diarrhoea † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Lip swelling † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
General disorders           
Chest pain † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Generalised oedema † 1  2/17 (11.76%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Oedema † 1  2/17 (11.76%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Oedema peripheral † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Infections and infestations           
Parainfluenzae virus infection † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Pneumonia † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Pneumonia respiratory syncytial viral † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Investigations           
Blood creatinine increased † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  2/23 (8.70%) 
Metabolism and nutrition disorders           
Fluid overload † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Metabolic acidosis † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Nervous system disorders           
Seizure † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Renal and urinary disorders           
Acute kidney injury † 1  0/17 (0.00%)  2/19 (10.53%)  0/11 (0.00%)  1/11 (9.09%)  1/23 (4.35%) 
Nephrotic syndrome † 1  1/17 (5.88%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Renal disorder † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Renal failure † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/23 (4.35%) 
Renal impairment † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Renal tubular necrosis † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept During Double-Blind Period 1 (DB1) Placebo During Double-Blind Period 1 (DB1) Abatacept During Double-Blind Period 2 (DB2) Placebo During Double-Blind Period 2 (DB2) Abatacept During Open Label Period (OLE)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/17 (76.47%)   15/19 (78.95%)   7/11 (63.64%)   8/11 (72.73%)   16/23 (69.57%) 
Blood and lymphatic system disorders           
Anaemia † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/23 (4.35%) 
Leukopenia † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Nephrogenic anaemia † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Splenomegaly † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Cardiac disorders           
Tachycardia † 1  1/17 (5.88%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Ear and labyrinth disorders           
Middle ear effusion † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Endocrine disorders           
Hypothyroidism † 1  2/17 (11.76%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Eye disorders           
Eye inflammation † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Gastrointestinal disorders           
Abdominal discomfort † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Abdominal pain † 1  1/17 (5.88%)  0/19 (0.00%)  1/11 (9.09%)  1/11 (9.09%)  0/23 (0.00%) 
Abdominal pain upper † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  2/23 (8.70%) 
Diarrhoea † 1  4/17 (23.53%)  3/19 (15.79%)  0/11 (0.00%)  1/11 (9.09%)  3/23 (13.04%) 
Dyspepsia † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  2/23 (8.70%) 
Gastrooesophageal reflux disease † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Mouth ulceration † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Nausea † 1  2/17 (11.76%)  2/19 (10.53%)  1/11 (9.09%)  1/11 (9.09%)  4/23 (17.39%) 
Rectal haemorrhage † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Vomiting † 1  5/17 (29.41%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  3/23 (13.04%) 
General disorders           
Chest pain † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Complication associated with device † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Energy increased † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Face oedema † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  2/23 (8.70%) 
Fatigue † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Feeling cold † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Malaise † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Nodule † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Non-cardiac chest pain † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Oedema † 1  4/17 (23.53%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Oedema peripheral † 1  0/17 (0.00%)  3/19 (15.79%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Pain † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Pyrexia † 1  1/17 (5.88%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  4/23 (17.39%) 
Swelling † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/23 (4.35%) 
Immune system disorders           
Hypersensitivity † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Seasonal allergy † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Infections and infestations           
Bronchitis † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Ear infection † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Furuncle † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Gastroenteritis viral † 1  2/17 (11.76%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Gastrointestinal infection † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Gastrointestinal viral infection † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Influenza † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Nasopharyngitis † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Pulpitis dental † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Sinusitis † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Upper respiratory tract infection † 1  0/17 (0.00%)  1/19 (5.26%)  1/11 (9.09%)  1/11 (9.09%)  4/23 (17.39%) 
Viral pharyngitis † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Viral upper respiratory tract infection † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  1/11 (9.09%)  1/23 (4.35%) 
Injury, poisoning and procedural complications           
Contusion † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Fall † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Heat cramps † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Infusion related reaction † 1  2/17 (11.76%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Patella fracture † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Post-traumatic pain † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Tendon rupture † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Investigations           
Blood albumin decreased † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Blood creatinine increased † 1  0/17 (0.00%)  2/19 (10.53%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Blood pressure increased † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Blood triglycerides increased † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  1/11 (9.09%)  0/23 (0.00%) 
Influenza A virus test positive † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Respiratory syncytial virus test positive † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Weight increased † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite † 1  1/17 (5.88%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Dehydration † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Gout † 1  1/17 (5.88%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Hypoalbuminaemia † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  0/17 (0.00%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Back pain † 1  0/17 (0.00%)  1/19 (5.26%)  1/11 (9.09%)  1/11 (9.09%)  0/23 (0.00%) 
Flank pain † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Muscle spasms † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Myalgia † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Pain in extremity † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  2/11 (18.18%)  0/23 (0.00%) 
Nervous system disorders           
Dizziness † 1  3/17 (17.65%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Headache † 1  2/17 (11.76%)  5/19 (26.32%)  1/11 (9.09%)  2/11 (18.18%)  2/23 (8.70%) 
Visual field defect † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Psychiatric disorders           
Depression † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  3/23 (13.04%) 
Insomnia † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/23 (4.35%) 
Panic attack † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Renal and urinary disorders           
Nephrotic syndrome † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Reproductive system and breast disorders           
Amenorrhoea † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Dysmenorrhoea † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Menorrhagia † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Polymenorrhoea † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Vaginal haemorrhage † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Bronchitis chronic † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Cough † 1  1/17 (5.88%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  2/23 (8.70%) 
Dyspnoea † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Hyperventilation † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Nasal congestion † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  4/23 (17.39%) 
Oropharyngeal pain † 1  0/17 (0.00%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  2/23 (8.70%) 
Pharyngeal erythema † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Wheezing † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders           
Acne † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Alopecia † 1  0/17 (0.00%)  0/19 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/23 (0.00%) 
Alopecia areata † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Dry skin † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
Ecchymosis † 1  0/17 (0.00%)  1/19 (5.26%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Eczema † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Hyperhidrosis † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Pruritus † 1  0/17 (0.00%)  0/19 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/23 (0.00%) 
Rash † 1  0/17 (0.00%)  1/19 (5.26%)  1/11 (9.09%)  0/11 (0.00%)  1/23 (4.35%) 
Skin lesion inflammation † 1  1/17 (5.88%)  0/19 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  0/23 (0.00%) 
Vascular disorders           
Hypertension † 1  0/17 (0.00%)  2/19 (10.53%)  0/11 (0.00%)  0/11 (0.00%)  1/23 (4.35%) 
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
Amendment 02 of the Clinical Protocol (18 April 2018) modified the study design, so that the Double-Blind Period (DB) would not include anymore 2 consecutive periods (DB1 and DB2). However, for transparency and completeness reasons, in the Participant Flow and Adverse Events sections data about DB1 and DB2 are reported separately.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please email
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02592798    
Other Study ID Numbers: IM101-566
2015-005450-36 ( EudraCT Number )
First Submitted: October 29, 2015
First Posted: October 30, 2015
Results First Submitted: January 19, 2021
Results First Posted: March 5, 2021
Last Update Posted: March 5, 2021