Trial Outcomes & Findings for Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis (NCT NCT00989235)
NCT ID: NCT00989235
Last Updated: 2011-06-21
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Results posted on
2011-06-21
Participant Flow
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.
Of the 433 participants who completed the main study (IM101-023 NCT00122382), 108 enrolled in the sub-study.
Participant milestones
| Measure |
Abatacept (10 mg/kg)
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.
|
Abatacept (5 mg/kg)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
50
|
|
Overall Study
Number Rescued to Open-Label Treatment
|
4
|
4
|
|
Overall Study
Number Completing Double-Blind Treatment
|
51
|
41
|
|
Overall Study
COMPLETED
|
55
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Abatacept (10 mg/kg)
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.
|
Abatacept (5 mg/kg)
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal of Consent
|
1
|
1
|
|
Overall Study
Desire to Become Pregnant
|
1
|
0
|
|
Overall Study
Randomized by Mistake
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
50.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 participants
n=5 Participants
|
46 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Weight
|
72.9 kg
STANDARD_DEVIATION 14.7 • n=5 Participants
|
73.8 kg
STANDARD_DEVIATION 16.0 • n=7 Participants
|
73.4 kg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Disease Activity Scores Using C-reactive Protein (DAS 28 [CRP])
|
2.1 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.
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).
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 1 (n=55, 49)
|
5.17 Percentage of Events
|
2.00 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 2 (n=52, 47)
|
8.65 Percentage of Events
|
4.00 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 3 (n=51, 42)
|
10.41 Percentage of Events
|
12.35 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 4 (n=50, 38)
|
12.17 Percentage of Events
|
22.78 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 5 (n=47, 35)
|
13.96 Percentage of Events
|
26.96 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 6 (n=42, 33)
|
23.11 Percentage of Events
|
31.13 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 7 (n=41, 32)
|
24.94 Percentage of Events
|
33.22 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 8 (n=40, 31)
|
26.77 Percentage of Events
|
33.22 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 9 (n=38, 31)
|
30.43 Percentage of Events
|
33.22 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 10 (n=37, 31)
|
32.27 Percentage of Events
|
33.22 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 11 (n=37, 30)
|
32.27 Percentage of Events
|
35.37 Percentage of Events
|
|
Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)
Month 12 (n=36, 28)
|
32.27 Percentage of Events
|
35.37 Percentage of Events
|
SECONDARY outcome
Timeframe: After 12 Months of treatmentPopulation: Number of participants analyzed=number randomized.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Number of Participants Experiencing Disease Relapse
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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).
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 29 Cohort (n=45, 40)
|
2.09 units on a scale
Standard Deviation 0.61
|
2.05 units on a scale
Standard Deviation 0.60
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 57 Cohort (n=47, 37)
|
2.06 units on a scale
Standard Deviation 0.59
|
2.06 units on a scale
Standard Deviation 0.62
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 85 Cohort (n=46, 42)
|
2.10 units on a scale
Standard Deviation 0.60
|
2.09 units on a scale
Standard Deviation 0.60
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 113 Cohort (n=49, 39)
|
2.06 units on a scale
Standard Deviation 0.61
|
2.09 units on a scale
Standard Deviation 0.62
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 141 Cohort (n=47, 40)
|
2.09 units on a scale
Standard Deviation 0.59
|
2.10 units on a scale
Standard Deviation 0.62
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 169 Cohort (n=46, 36)
|
2.10 units on a scale
Standard Deviation 0.59
|
2.04 units on a scale
Standard Deviation 0.61
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 197 Cohort (n=44, 38)
|
2.08 units on a scale
Standard Deviation 0.60
|
2.06 units on a scale
Standard Deviation 0.61
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 225 Cohort (n=44, 38)
|
2.09 units on a scale
Standard Deviation 0.60
|
2.08 units on a scale
Standard Deviation 0.63
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 253 Cohort (n=46, 37)
|
2.07 units on a scale
Standard Deviation 0.60
|
2.04 units on a scale
Standard Deviation 0.61
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 281 Cohort (n=45, 38)
|
2.07 units on a scale
Standard Deviation 0.61
|
2.06 units on a scale
Standard Deviation 0.61
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 309 Cohort (n=45, 37)
|
2.10 units on a scale
Standard Deviation 0.58
|
2.08 units on a scale
Standard Deviation 0.61
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 337 Cohort (n=44, 36)
|
2.09 units on a scale
Standard Deviation 0.60
|
2.08 units on a scale
Standard Deviation 0.62
|
|
Mean Time-Matched Baseline DAS28 CRP Scores
Day 365 Cohort (n=41, 35)
|
2.02 units on a scale
Standard Deviation 0.60
|
2.08 units on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365Population: Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.
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).
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 29 (n=45, 40)
|
0.24 units on a scale
Standard Error 0.10
|
0.06 units on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 57 (n=47, 37)
|
0.05 units on a scale
Standard Error 0.09
|
0.14 units on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 85 (n=46, 42)
|
0.13 units on a scale
Standard Error 0.10
|
0.21 units on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 113 (n=49, 39)
|
0.02 units on a scale
Standard Error 0.09
|
0.25 units on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 141 (n=47, 40)
|
0.32 units on a scale
Standard Error 0.10
|
0.29 units on a scale
Standard Error 0.11
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 169 (n=46, 36)
|
0.13 units on a scale
Standard Error 0.09
|
0.26 units on a scale
Standard Error 0.11
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 197 (n=44, 38)
|
0.09 units on a scale
Standard Error 0.09
|
0.22 units on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 225 (n=44, 38)
|
0.25 units on a scale
Standard Error 0.10
|
0.29 units on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 253 (n=46, 37)
|
0.23 units on a scale
Standard Error 0.09
|
0.14 units on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 281 (n=45, 38)
|
0.18 units on a scale
Standard Error 0.08
|
0.05 units on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 309 (n=45, 37)
|
0.07 units on a scale
Standard Error 0.08
|
0.09 units on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 337 (n=44, 36)
|
0.26 units on a scale
Standard Error 0.11
|
0.29 units on a scale
Standard Error 0.13
|
|
Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment
Day 365 (n=41, 35)
|
0.39 units on a scale
Standard Error 0.11
|
0.16 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= number of participants randomized.
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).
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)
|
22.4 percentage of participants
Interval 11.7 to 33.1
|
22.0 percentage of participants
Interval 10.5 to 33.5
|
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= number of participants randomized.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment
|
3.4 percentage of participants
Interval -1.2 to 8.1
|
12.0 percentage of participants
Interval 3.0 to 21.0
|
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= number of participants randomized.
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).
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= number of participants randomized.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment
|
6.9 percentage of participants
Interval 0.4 to 13.4
|
8.0 percentage of participants
Interval 0.5 to 15.5
|
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= number of participants randomized.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants Who Modified Therapy During Double-Blind Treatment
|
10.3 percentage of participants
Interval 2.5 to 18.2
|
18.0 percentage of participants
Interval 7.4 to 28.6
|
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= number of participants randomized.
Loss of remission is defined as DAS 28 CRP \>=2.6.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants Who Lost Remission Status
|
53.4 percentage of participants
Interval 40.6 to 66.3
|
64.0 percentage of participants
Interval 50.7 to 77.3
|
SECONDARY outcome
Timeframe: Day 701 of the main study; sub-study Days 1, 85, 169, 253Population: 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..
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
Sub-Study Day 1 (n=46, 41)
|
22213.0 ng/mL
Standard Deviation 9275.8
|
23620.7 ng/mL
Standard Deviation 9648.0
|
|
Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
Main Study Day 701 (n=41, 36)
|
22992.0 ng/mL
Standard Deviation 9722.1
|
21713.5 ng/mL
Standard Deviation 9520.5
|
|
Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
Sub-Study Day 85 (n=47, 43)
|
24919.5 ng/mL
Standard Deviation 14516.2
|
11922.1 ng/mL
Standard Deviation 5681.8
|
|
Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
Sub-Study Day 169 (n=48, 43)
|
25725.7 ng/mL
Standard Deviation 18500.5
|
9959.2 ng/mL
Standard Deviation 5045.0
|
|
Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment
Sub-Study Day 253 (n=47, 42)
|
28524.7 ng/mL
Standard Deviation 19989.9
|
13516.2 ng/mL
Standard Deviation 6564.6
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
Discontinued due to AEs
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
Deaths
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
SAEs
|
5.2 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
Related SAEs
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
Discontinued due to SAEs
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
AEs
|
65.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment
Related AEs
|
20.7 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Urinary Tract Infection
|
3.4 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Total Participants with Infection and Infestation
|
37.9 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Upper Respiratory Tract Infection
|
5.2 percentage of participants
|
12.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Nasopharyngitis
|
5.2 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Influenza
|
5.2 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Bronchitis
|
5.2 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Onychomycosis
|
3.4 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Pharyngitis
|
3.4 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Rhinitis
|
3.4 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Ear Infection
|
3.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Vaginal Infection
|
3.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Appendicitis
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Furuncle
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Pneumonia
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Sinusitis Bacterial
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Endocarditis
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Fungal Skin Infection
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Herpes Simplex
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Labyrinthitis
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Oral Herpes
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Respiratory Tract Infection
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment
Sinusitis
|
0 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period.
All neoplasms were assessed by medical review as to whether or not the event was malignant.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders - Hypertension (mild)
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Total Participants with AIAEs (mild)
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Total Participants with AIAEs (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Total Participants with AIAEs (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Total Participants with AIAEs (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders - Hypertension (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders - Hypertension (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders - Hypertension (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders - Hypertension (unknown)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period.
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Total Participants with PIAEs (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Chest Pain (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Total Participants with PIAEs (mild)
|
6.9 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Total Participants with PIAEs (moderate)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Total Participants with PIAEs (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Nausea (mild)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Nausea (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Nausea (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Nausea (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Vomiting (mild)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Vomiting (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Vomiting (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Gastrointestinal Disorders, Vomiting (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Dizziness (mild)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Dizziness (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Dizziness (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Dizziness (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Headache (mild)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Headache (moderate)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Headache (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Nervous System Disorders, Headache (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Malaise (mild)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Malaise (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Malaise (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Malaise (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Chest Pain (mild)
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Chest Pain (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
GDASC, Chest Pain (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Asthma (mild)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Asthma (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Asthma (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Asthma (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Cough (mild)
|
1.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Cough (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Cough (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
RTMD, Cough (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders, Hypertension (mild)
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders, Hypertension (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders, Hypertension (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity
Vascular Disorders, Hypertension (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period.
A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
MCTDs - Sjogren's Syndrome (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Total Participants with ADs (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Eye Disorders - Episcleritis (mild)
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Eye Disorders - Episcleritis (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Eye Disorders - Episcleritis (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Eye Disorders - Episcleritis (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
MCTDs - Sjogren's Syndrome (mild)
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
MCTDs - Sjogren's Syndrome (severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
MCTDs - Sjogren's Syndrome (very severe)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Total Participants with ADs (mild)
|
0 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Total Participants with ADs (moderate)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity
Total Participants with ADs (severe)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure
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.
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=58 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=50 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Leukocytes, Low: <0.75 x LLN (n=51, 48)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
N+B (absolute), Low: < 1.00 x 10^3 c/uL (n=55, 49)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Lymphocytes (absolute), Low (*) (n=55, 49)
|
1.8 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Lymphocytes (absolute), High (*) (n=55, 49)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Monocytes (absolute), High: >2000/mm^3 (n=55, 49)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Basophils (absolute), High: > 400/mm^3 (n=55, 49)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Eosinophils (absolute), High (*) (n=55, 49)
|
5.5 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
AST, High: >3 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
ALT, High: >3 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
GGT, High: >2 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Bilirubin Total, High: >1.5 x ULN (n=52, 46)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Blood Urea Nitrogen, High: >2 x pre rx (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Sodium, Low: <0.95 x LLN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Sodium, High: >1.05 x ULN, (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Potassium, Low: <0.9 x LLN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Potassium, High: >1.1 x ULN (n=52, 47)
|
0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Chloride, Low: <0.9 x LLN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Chloride, High: >1.1 x ULN, (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Total Calcium, High: >1.2 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Inorganic Phosphorus, Low: <0.75 x LLN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Inorganic Phosphorus, High: >1.25 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Glucose, Low: <65 mg/dL (n=55, 48)
|
5.5 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Serum Glucose, High: >220 mg/dL (n=55, 48)
|
3.6 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Total Protein, Low: <0.9 x LLN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Total Protein, High: >1.1 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Hemoglobin, Low: >3 g/dL ↓ from pre rx (n=51, 48)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Hematocrit, Low: <0.75 x pre rx (n=51, 48)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Erythrocytes, Low: <0.75 x pre rx (n=51, 48)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
ALP, High: >2 x upper limit normal (ULN)(n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Total Calcium, Low: <0.8 x Lower LN(LLN)(n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Platelet Count, Low: <0.67 x LLN (n=51, 48)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Platelet Count, High: >1.5 x ULN (n=51, 48)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Albumin, Low: <0.9 x LLN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Urine Leukocyte Esterase, High: >=2-4 (n=20, 16)
|
15.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Urine White Blood Cells, High: >=2-4 (n=22, 14)
|
45.5 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Urine Red Blood Cells, High: >=2-4 (n=22, 14)
|
22.7 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Uric Acid, High: >1.5 x ULN (n=52, 47)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Urine Protein, High: >=2-4 (n=55, 47)
|
1.8 percentage of participants
|
6.4 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Urine Glucose, High: >=2-4 (n=55, 47)
|
5.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment
Urine Blood, High: >=2-4 (n=55, 47)
|
12.7 percentage of participants
|
10.6 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.
Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After 12 months of treatmentPopulation: Number of participants analyzed= Number of participants with available immunogenicity measurements
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'
Outcome measures
| Measure |
Abatacept (10 mg/kg)
n=56 Participants
All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
|
Abatacept (5 mg/kg)
n=49 Participants
All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
|
|---|---|---|
|
Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment
CTLA4 and Possibly IG
|
4 participants
|
1 participants
|
|
Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment
IG and/or Junction Region
|
0 participants
|
1 participants
|
Adverse Events
Abatacept 5mg/kg (ST)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Abatacept 10mg/kg (ST)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Abatacept 10mg/kg (Open-Label)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept 5mg/kg (ST)
n=50 participants at risk
|
Abatacept 10mg/kg (ST)
n=58 participants at risk
|
Abatacept 10mg/kg (Open-Label)
n=8 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Cardiac disorders
Cardiopulmonary Failure
|
2.0%
1/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Infections and infestations
Appendicitis
|
0.00%
0/50
|
1.7%
1/58
|
0.00%
0/8
|
|
Infections and infestations
Endocarditis
|
2.0%
1/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
2.0%
1/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Acquired Claw Toe
|
0.00%
0/50
|
1.7%
1/58
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
4.0%
2/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.0%
1/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/50
|
1.7%
1/58
|
0.00%
0/8
|
Other adverse events
| Measure |
Abatacept 5mg/kg (ST)
n=50 participants at risk
|
Abatacept 10mg/kg (ST)
n=58 participants at risk
|
Abatacept 10mg/kg (Open-Label)
n=8 participants at risk
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
4.0%
2/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Eye disorders
Xerophtalmia
|
0.00%
0/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.0%
1/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50
|
0.00%
0/58
|
25.0%
2/8
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50
|
1.7%
1/58
|
12.5%
1/8
|
|
General disorders
Fatigue
|
6.0%
3/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50
|
5.2%
3/58
|
0.00%
0/8
|
|
Infections and infestations
Influenza
|
4.0%
2/50
|
5.2%
3/58
|
0.00%
0/8
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50
|
5.2%
3/58
|
12.5%
1/8
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.0%
6/50
|
5.2%
3/58
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.0%
3/50
|
0.00%
0/58
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50
|
1.7%
1/58
|
12.5%
1/8
|
|
Nervous system disorders
Headache
|
4.0%
2/50
|
5.2%
3/58
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/50
|
0.00%
0/58
|
12.5%
1/8
|
|
Vascular disorders
Hypertension
|
8.0%
4/50
|
3.4%
2/58
|
12.5%
1/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER