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Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00989235
Recruitment Status : Completed
First Posted : October 5, 2009
Results First Posted : June 3, 2011
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: Abatacept
Enrollment 108
Recruitment Details IM101023 (NCT00122382) was a 2-year study completing on Day 729, in which subjects were randomized to receive abatacept or placebo in combination with methotrexate (MTX) for the 1st year of the study and were then switched to open-label abatacept+MTX in the 2nd year. All subjects had received abatacept for a least 1 year prior start of sub-study.
Pre-assignment Details Of the 433 participants who completed the main study (IM101-023 NCT00122382), 108 enrolled in the sub-study.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year. All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
Period Title: Overall Study
Started 58 50
Number Rescued to Open-Label Treatment 4 4 [1]
Number Completing Double-Blind Treatment 51 41
Completed 55 44
Not Completed 3 6
Reason Not Completed
Death             0             1
Adverse Event             0             1
Lack of Efficacy             1             0
Withdrawal of Consent             1             1
Desire to Become Pregnant             1             0
Randomized by Mistake             0             2
Lost to Follow-up             0             1
[1]
Of these, 1 was discontinued from open-label treatment (lost to follow-up).
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg) Total
Hide Arm/Group Description All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg Total of all reporting groups
Overall Number of Baseline Participants 58 50 108
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 50 participants 108 participants
50.1  (11.5) 51.1  (13.4) 50.6  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 50 participants 108 participants
Female
44
  75.9%
41
  82.0%
85
  78.7%
Male
14
  24.1%
9
  18.0%
23
  21.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 50 participants 108 participants
Unknown 2 0 2
White 49 46 95
Black 2 0 2
Asian 2 2 4
Other 3 2 5
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 58 participants 50 participants 108 participants
72.9  (14.7) 73.8  (16.0) 73.4  (15.3)
[1]
Measure Description: One participant in the 10 mg/kg group did not have weight reported.
Disease Activity Scores Using C-reactive Protein (DAS 28 [CRP])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 58 participants 50 participants 108 participants
2.1  (0.6) 2.1  (0.6) 2.1  (0.6)
[1]
Measure Description:

The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).DAS 28 is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28 joints, C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm based on the following formula:

DAS 28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96.

1.Primary Outcome
Title Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Hide Description An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).
Time Frame Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: Percentage of Events
Month 1 (n=55, 49) 5.17 2.00
Month 2 (n=52, 47) 8.65 4.00
Month 3 (n=51, 42) 10.41 12.35
Month 4 (n=50, 38) 12.17 22.78
Month 5 (n=47, 35) 13.96 26.96
Month 6 (n=42, 33) 23.11 31.13
Month 7 (n=41, 32) 24.94 33.22
Month 8 (n=40, 31) 26.77 33.22
Month 9 (n=38, 31) 30.43 33.22
Month 10 (n=37, 31) 32.27 33.22
Month 11 (n=37, 30) 32.27 35.37
Month 12 (n=36, 28) 32.27 35.37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Through Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.870
Confidence Interval (2-Sided) 95%
0.45 to 1.69
Estimation Comments Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.
2.Secondary Outcome
Title Number of Participants Experiencing Disease Relapse
Hide Description Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits.
Time Frame After 12 Months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=number randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: Participants
18 17
3.Secondary Outcome
Title Mean Time-Matched Baseline DAS28 CRP Scores
Hide Description Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 29 Cohort (n=45, 40) 2.09  (0.61) 2.05  (0.60)
Day 57 Cohort (n=47, 37) 2.06  (0.59) 2.06  (0.62)
Day 85 Cohort (n=46, 42) 2.10  (0.60) 2.09  (0.60)
Day 113 Cohort (n=49, 39) 2.06  (0.61) 2.09  (0.62)
Day 141 Cohort (n=47, 40) 2.09  (0.59) 2.10  (0.62)
Day 169 Cohort (n=46, 36) 2.10  (0.59) 2.04  (0.61)
Day 197 Cohort (n=44, 38) 2.08  (0.60) 2.06  (0.61)
Day 225 Cohort (n=44, 38) 2.09  (0.60) 2.08  (0.63)
Day 253 Cohort (n=46, 37) 2.07  (0.60) 2.04  (0.61)
Day 281 Cohort (n=45, 38) 2.07  (0.61) 2.06  (0.61)
Day 309 Cohort (n=45, 37) 2.10  (0.58) 2.08  (0.61)
Day 337 Cohort (n=44, 36) 2.09  (0.60) 2.08  (0.62)
Day 365 Cohort (n=41, 35) 2.02  (0.60) 2.08  (0.60)
4.Secondary Outcome
Title Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Hide Description Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).
Time Frame Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Mean (Standard Error)
Unit of Measure: units on a scale
Day 29 (n=45, 40) 0.24  (0.10) 0.06  (0.10)
Day 57 (n=47, 37) 0.05  (0.09) 0.14  (0.10)
Day 85 (n=46, 42) 0.13  (0.10) 0.21  (0.10)
Day 113 (n=49, 39) 0.02  (0.09) 0.25  (0.10)
Day 141 (n=47, 40) 0.32  (0.10) 0.29  (0.11)
Day 169 (n=46, 36) 0.13  (0.09) 0.26  (0.11)
Day 197 (n=44, 38) 0.09  (0.09) 0.22  (0.09)
Day 225 (n=44, 38) 0.25  (0.10) 0.29  (0.10)
Day 253 (n=46, 37) 0.23  (0.09) 0.14  (0.10)
Day 281 (n=45, 38) 0.18  (0.08) 0.05  (0.09)
Day 309 (n=45, 37) 0.07  (0.08) 0.09  (0.09)
Day 337 (n=44, 36) 0.26  (0.11) 0.29  (0.13)
Day 365 (n=41, 35) 0.39  (0.11) 0.16  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 29
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.11 to 0.46
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 57
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.34 to 0.17
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 85
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.37 to 0.20
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 113
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.50 to 0.04
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 141
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.26 to 0.32
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 169
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.41 to 0.15
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 197
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.38 to 0.13
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 225
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.32 to 0.25
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 253
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.19 to 0.36
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 281
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.12 to 0.38
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 309
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.27 to 0.22
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 337
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.37 to 0.31
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments Day 365
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Method of Estimation Estimation Parameter Adjusted Difference
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.09 to 0.55
Estimation Comments Change from Baseline = Post-baseline - Baseline value.
5.Secondary Outcome
Title Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)
Hide Description DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.4
(11.7 to 33.1)
22.0
(10.5 to 33.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation
Comments For 95% CI: normal approximation with continuity correction.
Method of Estimation Estimation Parameter estimate of difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-17.2 to 18.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment
Hide Description Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.4
(-1.2 to 8.1)
12.0
(3.0 to 21.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation
Comments For 95% CI: normal approximation with continuity correction.
Method of Estimation Estimation Parameter estimate of difference
Estimated Value -8.6
Confidence Interval (2-Sided) 95%
-20.3 to 3.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids
Hide Description A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment
Hide Description All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.9
(0.4 to 13.4)
8.0
(0.5 to 15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation
Comments For 95% CI: normal approximation with continuity correction.
Method of Estimation Estimation Parameter estimate of difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-12.9 to 10.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Who Modified Therapy During Double-Blind Treatment
Hide Description Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.3
(2.5 to 18.2)
18.0
(7.4 to 28.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation
Comments 95% CI: normal approximation with continuity correction.
Method of Estimation Estimation Parameter estimate of difference
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-22.6 to 7.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Lost Remission Status
Hide Description Loss of remission is defined as DAS 28 CRP >=2.6.
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.4
(40.6 to 66.3)
64.0
(50.7 to 77.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept (10 mg/kg), Abatacept (5 mg/kg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation
Comments 95% CI: normal approximation with continuity correction.
Method of Estimation Estimation Parameter estimate of difference
Estimated Value -10.6
Confidence Interval (2-Sided) 95%
-31.1 to 10.0
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
Hide Description [Not Specified]
Time Frame Day 701 of the main study; sub-study Days 1, 85, 169, 253
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted..
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Mean (Standard Deviation)
Unit of Measure: ng/mL
Main Study Day 701 (n=41, 36) 22992.0  (9722.1) 21713.5  (9520.5)
Sub-Study Day 1 (n=46, 41) 22213.0  (9275.8) 23620.7  (9648.0)
Sub-Study Day 85 (n=47, 43) 24919.5  (14516.2) 11922.1  (5681.8)
Sub-Study Day 169 (n=48, 43) 25725.7  (18500.5) 9959.2  (5045.0)
Sub-Study Day 253 (n=47, 42) 28524.7  (19989.9) 13516.2  (6564.6)
12.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
Deaths 0 2
SAEs 5.2 6.0
Related SAEs 1.7 0
Discontinued due to SAEs 0 2
AEs 65.5 50.0
Related AEs 20.7 10.0
Discontinued due to AEs 0 2
13.Secondary Outcome
Title Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
Total Participants with Infection and Infestation 37.9 26.0
Upper Respiratory Tract Infection 5.2 12.0
Nasopharyngitis 5.2 6.0
Influenza 5.2 4.0
Bronchitis 5.2 2.0
Urinary Tract Infection 3.4 4.0
Onychomycosis 3.4 2.0
Pharyngitis 3.4 2.0
Rhinitis 3.4 2.0
Ear Infection 3.4 0
Vaginal Infection 3.4 0
Appendicitis 1.7 0
Furuncle 1.7 0
Pneumonia 1.7 0
Sinusitis Bacterial 1.7 0
Endocarditis 0 2
Fungal Skin Infection 0 2
Herpes Simplex 0 2
Labyrinthitis 0 2
Oral Herpes 0 2
Respiratory Tract Infection 0 2
Sinusitis 0 2
14.Secondary Outcome
Title Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment
Hide Description All neoplasms were assessed by medical review as to whether or not the event was malignant.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
0 0
15.Secondary Outcome
Title Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
Total Participants with AIAEs (mild) 0 2
Total Participants with AIAEs (moderate) 0 0
Total Participants with AIAEs (severe) 0 0
Total Participants with AIAEs (very severe) 0 0
Vascular Disorders - Hypertension (mild) 0 2
Vascular Disorders - Hypertension (moderate) 0 0
Vascular Disorders - Hypertension (severe) 0 0
Vascular Disorders - Hypertension (very severe) 0 0
Vascular Disorders - Hypertension (unknown) 0 0
16.Secondary Outcome
Title Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
Total Participants with PIAEs (mild) 6.9 4.0
Total Participants with PIAEs (moderate) 1.7 0
Total Participants with PIAEs (severe) 0 0
Total Participants with PIAEs (very severe) 0 0
Gastrointestinal Disorders, Nausea (mild) 1.7 0
Gastrointestinal Disorders, Nausea (moderate) 0 0
Gastrointestinal Disorders, Nausea (severe) 0 0
Gastrointestinal Disorders, Nausea (very severe) 0 0
Gastrointestinal Disorders, Vomiting (mild) 1.7 0
Gastrointestinal Disorders, Vomiting (moderate) 0 0
Gastrointestinal Disorders, Vomiting (severe) 0 0
Gastrointestinal Disorders, Vomiting (very severe) 0 0
Nervous System Disorders, Dizziness (mild) 1.7 0
Nervous System Disorders, Dizziness (moderate) 0 0
Nervous System Disorders, Dizziness (severe) 0 0
Nervous System Disorders, Dizziness (very severe) 0 0
Nervous System Disorders, Headache (mild) 0 0
Nervous System Disorders, Headache (moderate) 1.7 0
Nervous System Disorders, Headache (severe) 0 0
Nervous System Disorders, Headache (very severe) 0 0
GDASC, Malaise (mild) 1.7 0
GDASC, Malaise (moderate) 0 0
GDASC, Malaise (severe) 0 0
GDASC, Malaise (very severe) 0 0
GDASC, Chest Pain (mild) 0 2
GDASC, Chest Pain (moderate) 0 0
GDASC, Chest Pain (severe) 0 0
GDASC, Chest Pain (very severe) 0 0
RTMD, Asthma (mild) 1.7 0
RTMD, Asthma (moderate) 0 0
RTMD, Asthma (severe) 0 0
RTMD, Asthma (very severe) 0 0
RTMD, Cough (mild) 1.7 0
RTMD, Cough (moderate) 0 0
RTMD, Cough (severe) 0 0
RTMD, Cough (very severe) 0 0
Vascular Disorders, Hypertension (mild) 0 2
Vascular Disorders, Hypertension (moderate) 0 0
Vascular Disorders, Hypertension (severe) 0 0
Vascular Disorders, Hypertension (very severe) 0 0
17.Secondary Outcome
Title Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Hide Description A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
Total Participants with ADs (mild) 0 4
Total Participants with ADs (moderate) 0 0
Total Participants with ADs (severe) 0 0
Total Participants with ADs (very severe) 0 0
Eye Disorders - Episcleritis (mild) 0 2
Eye Disorders - Episcleritis (moderate) 0 0
Eye Disorders - Episcleritis (severe) 0 0
Eye Disorders - Episcleritis (very severe) 0 0
MCTDs - Sjogren's Syndrome (mild) 0 2
MCTDs - Sjogren's Syndrome (moderate) 0 0
MCTDs - Sjogren's Syndrome (severe) 0 0
MCTDs - Sjogren's Syndrome (very severe) 0 0
18.Secondary Outcome
Title Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Hide Description Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 58 50
Measure Type: Number
Unit of Measure: percentage of participants
Hemoglobin, Low: >3 g/dL ↓ from pre rx (n=51, 48) 0 0
Hematocrit, Low: <0.75 x pre rx (n=51, 48) 0 0
Erythrocytes, Low: <0.75 x pre rx (n=51, 48) 0 0
ALP, High: >2 x upper limit normal (ULN)(n=52, 47) 0 0
Total Calcium, Low: <0.8 x Lower LN(LLN)(n=52, 47) 0 0
Platelet Count, Low: <0.67 x LLN (n=51, 48) 0 0
Platelet Count, High: >1.5 x ULN (n=51, 48) 0 0
Leukocytes, Low: <0.75 x LLN (n=51, 48) 0 0
N+B (absolute), Low: < 1.00 x 10^3 c/uL (n=55, 49) 0 0
Lymphocytes (absolute), Low (*) (n=55, 49) 1.8 2.0
Lymphocytes (absolute), High (*) (n=55, 49) 0 0
Monocytes (absolute), High: >2000/mm^3 (n=55, 49) 0 0
Basophils (absolute), High: > 400/mm^3 (n=55, 49) 0 0
Eosinophils (absolute), High (*) (n=55, 49) 5.5 2.0
AST, High: >3 x ULN (n=52, 47) 0 0
ALT, High: >3 x ULN (n=52, 47) 0 0
GGT, High: >2 x ULN (n=52, 47) 0 0
Bilirubin Total, High: >1.5 x ULN (n=52, 46) 0 0
Blood Urea Nitrogen, High: >2 x pre rx (n=52, 47) 0 0
Serum Sodium, Low: <0.95 x LLN (n=52, 47) 0 0
Serum Sodium, High: >1.05 x ULN, (n=52, 47) 0 0
Serum Potassium, Low: <0.9 x LLN (n=52, 47) 0 0
Serum Potassium, High: >1.1 x ULN (n=52, 47) 0 2.1
Serum Chloride, Low: <0.9 x LLN (n=52, 47) 0 0
Serum Chloride, High: >1.1 x ULN, (n=52, 47) 0 0
Total Calcium, High: >1.2 x ULN (n=52, 47) 0 0
Inorganic Phosphorus, Low: <0.75 x LLN (n=52, 47) 0 0
Inorganic Phosphorus, High: >1.25 x ULN (n=52, 47) 0 0
Serum Glucose, Low: <65 mg/dL (n=55, 48) 5.5 6.3
Serum Glucose, High: >220 mg/dL (n=55, 48) 3.6 4.2
Total Protein, Low: <0.9 x LLN (n=52, 47) 0 0
Total Protein, High: >1.1 x ULN (n=52, 47) 0 0
Albumin, Low: <0.9 x LLN (n=52, 47) 0 0
Uric Acid, High: >1.5 x ULN (n=52, 47) 0 0
Urine Protein, High: >=2-4 (n=55, 47) 1.8 6.4
Urine Glucose, High: >=2-4 (n=55, 47) 5.5 0
Urine Blood, High: >=2-4 (n=55, 47) 12.7 10.6
Urine Leukocyte Esterase, High: >=2-4 (n=20, 16) 15.0 25.0
Urine White Blood Cells, High: >=2-4 (n=22, 14) 45.5 14.3
Urine Red Blood Cells, High: >=2-4 (n=22, 14) 22.7 28.6
19.Secondary Outcome
Title Clinically Significant Changes in Vital Signs and Physical Findings
Hide Description Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.
Time Frame From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment
Hide Description A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'
Time Frame After 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed= Number of participants with available immunogenicity measurements
Arm/Group Title Abatacept (10 mg/kg) Abatacept (5 mg/kg)
Hide Arm/Group Description:
All participants in the sub-study treated with double-blind abatacept 10 mg/kg
All participants in the sub-study treated with double-blind abatacept 5 mg/kg
Overall Number of Participants Analyzed 56 49
Measure Type: Number
Unit of Measure: participants
CTLA4 and Possibly IG 4 1
IG and/or Junction Region 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept 5mg/kg (ST) Abatacept 10mg/kg (ST) Abatacept 10mg/kg (Open-Label)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Abatacept 5mg/kg (ST) Abatacept 10mg/kg (ST) Abatacept 10mg/kg (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept 5mg/kg (ST) Abatacept 10mg/kg (ST) Abatacept 10mg/kg (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/50 (6.00%)   3/58 (5.17%)   2/8 (25.00%) 
Blood and lymphatic system disorders       
Leukopenia  1  1/50 (2.00%)  0/58 (0.00%)  0/8 (0.00%) 
Neutropenia  1  1/50 (2.00%)  0/58 (0.00%)  0/8 (0.00%) 
Cardiac disorders       
Cardiopulmonary Failure  1  1/50 (2.00%)  0/58 (0.00%)  0/8 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/50 (0.00%)  0/58 (0.00%)  1/8 (12.50%) 
Infections and infestations       
Appendicitis  1  0/50 (0.00%)  1/58 (1.72%)  0/8 (0.00%) 
Endocarditis  1  1/50 (2.00%)  0/58 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders       
Diabetes Mellitus Inadequate Control  1  1/50 (2.00%)  0/58 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders       
Acquired Claw Toe  1  0/50 (0.00%)  1/58 (1.72%)  0/8 (0.00%) 
Osteoarthritis  1  1/50 (2.00%)  0/58 (0.00%)  1/8 (12.50%) 
Rheumatoid Arthritis  1  2/50 (4.00%)  0/58 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders       
Renal Failure Acute  1  1/50 (2.00%)  0/58 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleurisy  1  0/50 (0.00%)  1/58 (1.72%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept 5mg/kg (ST) Abatacept 10mg/kg (ST) Abatacept 10mg/kg (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/50 (34.00%)   18/58 (31.03%)   7/8 (87.50%) 
Eye disorders       
Conjunctivitis  1  2/50 (4.00%)  0/58 (0.00%)  1/8 (12.50%) 
Xerophtalmia  1  0/50 (0.00%)  0/58 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders       
Abdominal Distension  1  1/50 (2.00%)  0/58 (0.00%)  1/8 (12.50%) 
Abdominal Pain Upper  1  0/50 (0.00%)  0/58 (0.00%)  1/8 (12.50%) 
Diarrhoea  1  1/50 (2.00%)  0/58 (0.00%)  2/8 (25.00%) 
Hiatus Hernia  1  0/50 (0.00%)  0/58 (0.00%)  1/8 (12.50%) 
Vomiting  1  0/50 (0.00%)  1/58 (1.72%)  1/8 (12.50%) 
General disorders       
Fatigue  1  3/50 (6.00%)  0/58 (0.00%)  0/8 (0.00%) 
Infections and infestations       
Bronchitis  1  1/50 (2.00%)  3/58 (5.17%)  0/8 (0.00%) 
Influenza  1  2/50 (4.00%)  3/58 (5.17%)  0/8 (0.00%) 
Nasopharyngitis  1  3/50 (6.00%)  3/58 (5.17%)  1/8 (12.50%) 
Upper Respiratory Tract Infection  1  6/50 (12.00%)  3/58 (5.17%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  3/50 (6.00%)  0/58 (0.00%)  0/8 (0.00%) 
Osteoarthritis  1  0/50 (0.00%)  1/58 (1.72%)  1/8 (12.50%) 
Nervous system disorders       
Headache  1  2/50 (4.00%)  3/58 (5.17%)  0/8 (0.00%) 
Reproductive system and breast disorders       
Fibrocystic Breast Disease  1  0/50 (0.00%)  0/58 (0.00%)  1/8 (12.50%) 
Vascular disorders       
Hypertension  1  4/50 (8.00%)  2/58 (3.45%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00989235     History of Changes
Other Study ID Numbers: IM101-023 LT (Sub study)
Eudrac # 2002-000784-26
First Submitted: October 2, 2009
First Posted: October 5, 2009
Results First Submitted: May 12, 2011
Results First Posted: June 3, 2011
Last Update Posted: June 21, 2011