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Phase IIIB Subcutaneous Abatacept Monotherapy Study

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ClinicalTrials.gov Identifier: NCT00547521
Recruitment Status : Completed
First Posted : October 22, 2007
Results First Posted : January 24, 2011
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis (RA)
Interventions Drug: abatacept
Drug: Methotrexate (MTX)
Enrollment 119
Recruitment Details Short term (ST) Study results (2 arms) were released in 2010. Final long term extension (LTE) results (1 arm with pooled data), up to 2014, are now included. During the LTE Study, 125 mg abatacept, was continued to be self-administered weekly and adjustments to RA medications including MTX were permitted at investigators discretion.
Pre-assignment Details 119 participants enrolled;100 treated in the ST Study. Reasons not treated: 17 no longer met criteria, 2 withdrew consent. 96 completed ST treatment but only 95 completed Primary endpoint evaluation. 90 enrolled in LTE Study. Reasons why participants did not enroll in LTE Study: 2 lack of efficacy, 2 had adverse events, 1 no longer met criteria.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Cohort
Hide Arm/Group Description In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
Period Title: Short Term Study (4 Months)
Started 51 [1] 49 [1]
Completed 50 45
Not Completed 1 4
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             0             2
Withdrawal of consent             0             1
primary endpoint evaluation not complete             0             1
[1]
Number of participants treated.
Period Title: Long Term Extension (LTE) Study
Started 0 [1] 90 [1]
Completed 0 59
Not Completed 0 31
Reason Not Completed
Lack of Efficacy             0             14
Adverse Event             0             9
Lost to Follow-up             0             3
Withdrawal by Subject             0             2
Not Specified             0             2
Poor/Non-Compliance             0             1
[1]
ST Study had 2 arms, LTE Study pooled all participants who had abatacept injection.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort Total
Hide Arm/Group Description In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. Total of all reporting groups
Overall Number of Baseline Participants 51 49 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants 49 participants 100 participants
55.0
(34.0 to 84.0)
54.0
(26.0 to 68.0)
54.0
(26.0 to 84.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
Female
34
  66.7%
41
  83.7%
75
  75.0%
Male
17
  33.3%
8
  16.3%
25
  25.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
White 42 34 76
Black 7 4 11
American Indian/Alaska Native 1 0 1
Asian 1 10 11
Other races 0 1 1
Weight continuous  
Mean (Standard Deviation)
Unit of measure:  Kilogram (Kg)
Number Analyzed 51 participants 49 participants 100 participants
84.6  (18.8) 81.6  (22.4) 83.1  (20.6)
Weight customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
< 60 Kg 4 8 12
60 - 100 Kg 36 31 67
> 100 Kg 11 10 21
Disease activity score C-reactive protein (DAS 28-CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 49 participants 100 participants
5.1  (1.2) 5.8  (1.5) 5.4  (1.4)
[1]
Measure Description: DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and participant assessment of disease activity measured on a visual analogue scale (VAS) of 100 millimeters (mm). DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.
Tender joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Tender joints
Number Analyzed 51 participants 49 participants 100 participants
23.9  (18.0) 24.3  (14.2) 24.1  (16.2)
[1]
Measure Description: Total number of joints analyzed=68.
Swollen joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Swollen joints
Number Analyzed 51 participants 49 participants 100 participants
16.2  (12.0) 18.3  (12.2) 17.2  (12.1)
[1]
Measure Description: Total number of joints analyzed=66.
Subject pain assessment per Visual Analogue Scale(VAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters (mm)
Number Analyzed 51 participants 49 participants 100 participants
63.3  (19.1) 70.5  (19.6) 66.8  (19.6)
[1]
Measure Description: Subject Pain Assessment measured by VAS (100 mm). A Visual Analogue Scale (VAS) is a measurement instrument for characteristics that range across a continuum of values. Range is 1-100; a lower value signifies a better Subject Pain Assessment.
Subject global assessment per VAS   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 51 participants 49 participants 100 participants
60.4  (18.9) 69.9  (22.6) 65.0  (21.2)
[1]
Measure Description: Subject Global Assessment is measured by VAS (100 mm). A Visual Analogue Scale (VAS) is a measurement instrument for characteristics that range across a continuum of values. Range is 1-100; a lower score indicates a better Subject Assessment of Global Health.
Physician global assessment per VAS   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 51 participants 49 participants 100 participants
51.6  (16.4) 63.9  (20.5) 57.7  (19.5)
[1]
Measure Description: Physician Global Assessment is measured by VAS (100 mm). A Visual Analogue Scale (VAS) is a measurement instrument for characteristics that range across a continuum of values. Range is 1-100; a lower score indicates a better Physician Assessment of Global Health.
Health Assessment Questionnaire - Disability Index (HAQ-DI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 49 participants 100 participants
1.3  (0.7) 1.5  (0.7) 1.4  (0.7)
[1]
Measure Description: HAQ-DI takes into account participant's use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.
Rheumatoid Factor (RF) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 49 participants 100 participants
Unknown 1 2 3
Positive 35 32 67
Negative 15 15 30
[1]
Measure Description: RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 International Unit (IU)/mL (>= 15 IU/mL resulted in a positive result).
1.Primary Outcome
Title Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study
Hide Description ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.
Time Frame Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 50 45
Measure Type: Number
Unit of Measure: participants
0 0
2.Primary Outcome
Title Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study
Hide Description ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.
Time Frame Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Day 15, (n= 51,47) 0 0
Day 29, (n= 50,48) 2 0
Day 43, (n= 50,48) 2 0
Day 57, (n= 50,47) 1 1
Day 85, (n= 50,47) 0 0
Day 113, (n= 50,45) 0 0
Overall on Treatment visits, (n=51,49) 2 1
28 Days last post dose, (n=2,3) 0 0
56 Days last post dose, (n=2,3) 0 0
85 Days last post dose, (n=4,4) 0 1
Overall post visits, (n=4,4) 0 1
Overall, (n=51,49) 2 2
3.Primary Outcome
Title Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study
Hide Description The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.
Time Frame Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Day 15, (n= 51,47) 1 1
Day 29, (n= 50,48) 1 0
Day 43, (n= 50,48) 1 0
Day 57, (n= 50,47) 1 0
Day 85, (n= 50,47) 1 0
Day 113, (n=50,45) 1 0
Overall on Treatment visits, (n=51,49) 1 1
28 Days last post dose, (n=2,3) 0 0
56 Days last post dose, (n=2,3) 0 0
85 Days last post dose, (n=4,4) 0 1
Overall post visits, (n=4,4) 0 1
Overall, (n=51,49) 1 2
4.Primary Outcome
Title Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results)
Hide Description ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.
Time Frame Day 113.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results)
Hide Description The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.
Time Frame Day 113.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results)
Hide Description ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.
Time Frame Baseline and on day 15, 29, 43, 57, 85 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results)
Hide Description The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.
Time Frame Baseline and day 15, 29, 43, 57, 85 and 113.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study
Hide Description DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.
Time Frame Baseline and Month 4 (Day113).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 48 45
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-1.67
(-2.06 to -1.28)
-1.94
(-2.46 to -1.42)
9.Secondary Outcome
Title Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study
Hide Description A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.
Time Frame Day 113.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 48 45
Measure Type: Number
Unit of Measure: participants
30 30
10.Secondary Outcome
Title Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study
Hide Description HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.
Time Frame Baseline and Month 4 (Day 113).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 49 46
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.31
(-0.43 to -0.19)
-0.58
(-0.74 to -0.42)
11.Secondary Outcome
Title Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study
Hide Description HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.
Time Frame Baseline and Month 4 (Day113).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Dressing and Grooming, (n= 50,46)
-0.44
(-0.63 to -0.25)
-0.57
(-0.79 to -0.34)
Arising, (n= 50,46)
-0.26
(-0.44 to -0.08)
-0.59
(-0.81 to -0.36)
Eating, (n= 50,46)
-0.28
(-0.50 to -0.06)
-0.57
(-0.85 to -0.28)
Walking, (n= 50,46)
-0.26
(-0.46 to -0.06)
-0.54
(-0.75 to -0.34)
Hygiene, (n= 49,46)
-0.33
(-0.55 to -0.10)
-0.43
(-0.65 to -0.22)
Reaching, (n= 49,46)
-0.24
(-0.47 to -0.02)
-0.50
(-0.74 to -0.26)
Gripping, (n= 49,46)
-0.31
(-0.54 to -0.07)
-0.76
(-1.04 to -0.48)
Activities, (n= 49,46)
-0.39
(-0.58 to -0.19)
-0.67
(-0.90 to -0.45)
12.Secondary Outcome
Title Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study
Hide Description RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.
Time Frame Baseline and Day 113.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 47 45
Measure Type: Number
Unit of Measure: participants
Negative at Baseline, negative at Day 113 12 15
Negative at Baseline, positive at Day 113 2 0
Positive at Baseline, negative at Day 113 1 1
Positive at Baseline, positive at Day 113 32 29
13.Secondary Outcome
Title Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study
Hide Description AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.
Time Frame Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Deaths 0 0
SAEs 2 3
AEs 37 32
All SAEs Leading to Discontinuation 1 1
All AEs Leading to Discontinuation 3 1
14.Secondary Outcome
Title Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study
Hide Description Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.
Time Frame Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Drug-related AEs 14 12
Drug-related SAEs 1 1
15.Secondary Outcome
Title Number of Participants With AEs of Special Interest During the ST Study
Hide Description An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.
Time Frame Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Infections 18 14
Malignant neoplasm 0 0
Autoimmune disorders 0 0
Local injection reactions 3 4
Systemic injection reactions 4 4
16.Secondary Outcome
Title Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx.
Time Frame Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Low Hemoglobin 0 0
Low Hematocrit 0 0
Low Platelet Count 0 0
High Platelet Count 0 0
High Leukocytes 1 2
Low Erythrocytes 0 0
17.Secondary Outcome
Title Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.
Time Frame Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Low Neutrophils + Bands (absolute) 0 0
Low Lymphocytes (absolute) 3 3
High Lymphocytes (absolute) 0 0
High Monocytes (absolute) 0 0
High Basophils (absolute) 0 0
High Eosinophils (absolute) 2 2
18.Secondary Outcome
Title Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN)
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx.
Time Frame Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
High ALP 0 0
High AST 1 0
High ALT 1 0
High GGT 0 2
High Bilirubin (total) 0 0
High BUN 1 1
19.Secondary Outcome
Title Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total)
Hide Description MAs= laboratory measurements marked as abnormal: creatinine: >1.5 * pre-Rx; sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN).
Time Frame Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
High Chloride (serum) 0 0
Low Chloride (serum) 0 0
High Calcium (total) 0 0
Low Calcium (total) 0 0
High Protein (total) 0 0
Low Protein (total) 0 0
High Creatinine 0 1
High Sodium (serum) 0 0
Low Sodium (serum) 0 0
Low Potassium (serum) 1 0
High Potassium (serum) 0 0
20.Secondary Outcome
Title Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or < LLN); glucose (serum): <65 mg/dL or >220 mg/dL.
Time Frame Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
High Glucose (Fasting Serum) (n=8; n=21) 0 0
Low Glucose (Fasting Serum) (n=8; n=21) 0 0
Low Albumin (n=51; n=49) 0 1
Low Glucose (Serum) (n=51; n=49) 6 1
High Glucose(Serum) (n=51; n=49) 2 1
High Uric Acid (n=51; n=49) 0 0
High Phosphorous (inorganic) (n=51; n=49) 0 0
Low Phosphorous (inorganic) (n=51; n=49) 1 1
21.Secondary Outcome
Title Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC)
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).
Time Frame Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
High Protein, urine (n= 51,49) 0 2
High Glucose, urine (n= 51,49) 1 0
High Blood, urine (n= 51,49) 1 3
High Leukocyte Esterase, urine (n= 18,17) 2 3
High WBC, urine (n= 15,19) 3 6
High RBC, urine (n= 12,17) 1 7
22.Secondary Outcome
Title Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study
Hide Description ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.
Time Frame Day 113.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 47 44
Measure Type: Number
Unit of Measure: participants
Negative 36 32
Positive 11 12
23.Secondary Outcome
Title Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study
Hide Description Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.
Time Frame Day 113.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: participants
Negative 41 37
Positive 4 8
24.Secondary Outcome
Title Number of Participants With Clinically Meaningful Vital Signs During the ST Study
Hide Description Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.
Time Frame At screening and on days 1,15,29,43, 57, 85 and 113.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
0 0
25.Secondary Outcome
Title Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study
Hide Description Cmin serum abatacept concentration was obtained directly from the concentration-time data.
Time Frame Days 1, 15, 29, 43, 57, 85 and 113.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.
Arm/Group Title Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort SC Abatacept Monotherapy Cohort
Hide Arm/Group Description:
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Overall Number of Participants Analyzed 51 49
Geometric Mean (Full Range)
Unit of Measure: microgram/mL
Day 15, (n= 40,41)
13.69
(4.80 to 27.40)
11.23
(2.70 to 27.10)
Day 29, (n= 49,45)
19.39
(6.10 to 41.80)
15.64
(4.40 to 42.20)
Day 43, (n= 41,38)
23.40
(10.80 to 44.40)
18.06
(5.20 to 48.10)
Day 57, (n= 48,38)
24.38
(10.90 to 41.10)
21.71
(9.60 to 68.00)
Day 85, (n= 47,39)
28.77
(11.30 to 69.20)
20.38
(2.60 to 50.00)
Day 113, (n=46,37)
28.46
(10.10 to 66.50)
23.74
(6.60 to 70.80)
26.Secondary Outcome
Title Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study
Hide Description The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.
Time Frame Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.
Arm/Group Title Abatacept Long Term Extension (LTE) Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
Days 197, 281, 365, 449 (n=86, 87, 85, 79) 0
Day 533 (n=76) 1
Days 617, 729, 813 (n=74, 70, 66) 0
Days 897, 981 (n=66, 58) 0
Day 1093 (n=65) 2
Day 1177 (n=8) 0
Day 1261 (n=57) 1
Day 1345 (n=24) 0
Day 1457 (n=59) 3
Day 1541 (n=24) 1
Day 1625 (n=18) 2
Days 1709, 1821 (n=2, 11) 0
Day 1989 (n=13) 1
Overall on Treatment (n=88) 11
28 days post last dose (n=18) 0
56 days post last dose (n=15) 2
85 days post last dose (n=16) 2
168 days post last dose (n=3) 2
Overall post last dose visits (n=23) 4
Overall (n=90) 13
27.Secondary Outcome
Title Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study
Hide Description DAS28-CRP 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, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.
Time Frame Baseline, Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 88
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Day 113 (n=88)
-1.89
(-2.2 to -1.5)
Day 1345 (n=61)
-2.39
(-2.8 to -1.9)
28.Secondary Outcome
Title Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study
Hide Description A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.
Time Frame Baseline, Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: participants
Day 113 (n=88) 59
Day 1345 (n=61) 43
29.Secondary Outcome
Title Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE
Hide Description DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.
Time Frame Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
Remission at Day 113 (n=90) 28
Remission at Day 1345 (n=63) 28
LDA at Day 113 (n=90) 45
LDA at Day 1345 (n=63) 37
30.Secondary Outcome
Title Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study
Hide Description HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.
Time Frame Baseline, Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 89
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
HAQ-DI at Day 113 (n=89)
-0.47
(-0.57 to -0.36)
HAQ-DI at Day 1345 (n=64)
-0.56
(-0.71 to -0.42)
31.Secondary Outcome
Title Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy
Hide Description HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.
Time Frame Baseline, Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: participants
HAQ DI Response at Day 113 (n=89) 53
HAQ DI Response at Day 1345 (n=64) 41
32.Secondary Outcome
Title Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study
Hide Description RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result).
Time Frame Continuously from start of LTE period up to 7 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
20
33.Secondary Outcome
Title Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup
Hide Description Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.
Time Frame Baseline, Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.
Arm/Group Title Abatacept Monotherapy Subgroup
Hide Arm/Group Description:
Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
Overall Number of Participants Analyzed 32
Mean (Standard Error)
Unit of Measure: units on a scale
DAS-CRP at Day 113 (n=31) -2.42  (0.29)
DAS-CRP at Day 1345 (n=23) -2.58  (0.30)
HAQ-DI at Day 113 (n=32) -0.60  (0.10)
HAQ-DI at Day 1345 (n=25) -0.65  (0.12)
34.Secondary Outcome
Title Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup
Hide Description Remission was defined as DAS 28-CRP < 2.6 and LDA was defined as DAS 28-CRP <= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
Time Frame Day 113, Day 1345
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.
Arm/Group Title Abatacept Monotherapy Subgroup
Hide Arm/Group Description:
Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
Remission at Day 113 (n=32) 14
Remission at Day 1345 (n=24) 9
LDA at Day 113 (n=32) 18
LDA at Day 1345 (n=24) 13
35.Secondary Outcome
Title Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study
Hide Description AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.
Time Frame Continuously from start of LTE Study up to 56 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
Deaths 0
SAEs 34
Related SAEs 6
Discontinued due to SAEs 3
AEs 86
Related AEs 34
Discontinued due to AEs 8
36.Secondary Outcome
Title Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study
Hide Description An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.
Time Frame Continuously from start of LTE Study up to 56 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
Infections 69
Autoimmune Disorders 5
Malignancies 4
Local Injection Site Reactions 2
Systemic Injection Reaction 12
37.Secondary Outcome
Title Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.
Time Frame Continuously from start of LTE Study up to 56 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
Low Hemoglobin (n=90) 1
Low Hematocrit (n=90) 0
Low Erythrocytes (n=90) 0
Low Platelet Count (n=89) 0
High Platelet Count (n=89) 0
Low Leukocytes (n=90) 2
High Leukocytes (n=90) 5
Low Neutrophils + bands 0
Low Lymphocytes (n=90) 6
High Lymphocytes (n=90) 1
High Monocytes (n=90) 2
High Basophils (n=90) 0
High Eosinophils (n=90) 13
38.Secondary Outcome
Title Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx; creatinine: >1.5 * pre-Rx.
Time Frame Continuously from start of LTE Study up to 56 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
High ALP (n=90) 0
High AST (n=90) 1
High ALT (n=90) 3
High G-GT (n=90) 2
High Bilirubin (n=90) 0
High BUN (n=90) 6
High Creatinine (n=90) 7
39.Secondary Outcome
Title Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study
Hide Description Sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or <LLN); glucose (serum): <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx).
Time Frame Continuously from start of LTE Study up to 56 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
High and/or Low Sodium (n=90) 0
Low Potassium (n=90) 2
High Potassium (n=90) 0
High and/or Low Chloride 0
High and/or Low Total Calcium (n=90) 0
High and/or Low Inorganic Phosphorus (n=90) 0
Low Glucose (n=90) 21
High Glucose (n=90) 1
Low Fasting Glucose (n=28) 3
High Fasting Glucose (n=28) 1
High and/or Low Total Protein (n=90) 0
Low Albumin (n=90) 0
High Uric Acid (n=90) 1
40.Secondary Outcome
Title Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).
Time Frame Continuously from start of LTE Study up to 56 days post the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.
Arm/Group Title Abatacept Long Term Extension Study
Hide Arm/Group Description:
During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: participants
High Urine Protein (n=89) 6
High Urine Glucose (n=89) 2
High Urine Blood (n=89) 13
High Urine Esterase (n=45) 12
High Urine WBC (n=51) 26
High Urine RBC (n=47) 16
Time Frame Short Term (ST) Study: Day 1 up to Day 113. LTE Study: Start of LTE Study up to 56 days post the last dose. Study initiated 2007 and completed LTE 2014.
Adverse Event Reporting Description ST: includes data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first. Participants could enter LTE at the conclusion of the ST and could continue in the LTE until the SC formulation was commercially available or until the study was terminated by the sponsor.
 
Arm/Group Title Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate Short Term Study: SC Abatacept Monotherapy Long Term Extension (LTE):125 mg SC Abatacept
Hide Arm/Group Description In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
All-Cause Mortality
Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate Short Term Study: SC Abatacept Monotherapy Long Term Extension (LTE):125 mg SC Abatacept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate Short Term Study: SC Abatacept Monotherapy Long Term Extension (LTE):125 mg SC Abatacept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/51 (3.92%)   3/49 (6.12%)   34/90 (37.78%) 
Cardiac disorders       
Angina pectoris  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Myocardial ischaemia  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Atrial fibrillation  1  0/51 (0.00%)  0/49 (0.00%)  2/90 (2.22%) 
Myocardial infarction  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
General disorders       
Chest pain  1  0/51 (0.00%)  0/49 (0.00%)  2/90 (2.22%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/51 (0.00%)  0/49 (0.00%)  2/90 (2.22%) 
Cholecystitis chronic  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Infections and infestations       
Pneumonia  1  0/51 (0.00%)  1/49 (2.04%)  1/90 (1.11%) 
Bronchopneumonia  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Diverticulitis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Pneumonia haemophilus  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Pelvic inflammatory disease  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Gastroenteritis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Lower Respiratory Tract Infection * 2  0/51 (0.00%)  1/49 (2.04%)  0/90 (0.00%) 
Pneumocystis Jiroveci Pneumonia * 2  1/51 (1.96%)  0/49 (0.00%)  0/90 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Tendon rupture  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Cartilage Injury * 2  0/51 (0.00%)  1/49 (2.04%)  0/90 (0.00%) 
Metabolism and nutrition disorders       
Obesity  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Patellofemoral pain syndrome  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Osteoarthritis  1  0/51 (0.00%)  0/49 (0.00%)  3/90 (3.33%) 
Tenosynovitis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bowen's disease  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Uterine leiomyoma  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Benign lung neoplasm  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Salivary gland cancer  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Squamous cell carcinoma of skin  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Uterine cancer  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Nervous system disorders       
Carotid artery stenosis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Nerve compression  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Gliosis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Cerebrovascular accident  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Syncope * 2  1/51 (1.96%)  0/49 (0.00%)  0/90 (0.00%) 
Renal and urinary disorders       
Renal colic  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Calculus ureteric  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Calculus urinary  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Renal failure acute  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Reproductive system and breast disorders       
Rectocele  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Cystocele  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Pelvic prolapse  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Postmenopausal haemorrhage  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/51 (0.00%)  0/49 (0.00%)  2/90 (2.22%) 
Dyspnoea  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Pneumonitis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Respiratory failure  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Rash generalised  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Vascular disorders       
Peripheral vascular disorder  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Deep vein thrombosis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Aortic stenosis  1  0/51 (0.00%)  0/49 (0.00%)  1/90 (1.11%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
2
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate Short Term Study: SC Abatacept Monotherapy Long Term Extension (LTE):125 mg SC Abatacept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/51 (31.37%)   13/49 (26.53%)   70/90 (77.78%) 
Gastrointestinal disorders       
Nausea  1  0/51 (0.00%)  0/49 (0.00%)  5/90 (5.56%) 
Diarrhoea  1  3/51 (5.88%)  1/49 (2.04%)  6/90 (6.67%) 
Vomiting * 2  0/51 (0.00%)  4/49 (8.16%)  0/90 (0.00%) 
General disorders       
Fatigue  1  0/51 (0.00%)  0/49 (0.00%)  5/90 (5.56%) 
Injection site pruritus * 2  3/51 (5.88%)  1/49 (2.04%)  0/90 (0.00%) 
Pyrexia * 2  1/51 (1.96%)  3/49 (6.12%)  0/90 (0.00%) 
Infections and infestations       
Pneumonia  1  0/51 (0.00%)  0/49 (0.00%)  5/90 (5.56%) 
Sinusitis  1  0/51 (0.00%)  0/49 (0.00%)  22/90 (24.44%) 
Upper respiratory tract infection  1  6/51 (11.76%)  2/49 (4.08%)  21/90 (23.33%) 
Cellulitis  1  0/51 (0.00%)  0/49 (0.00%)  5/90 (5.56%) 
Bronchitis  1  0/51 (0.00%)  0/49 (0.00%)  12/90 (13.33%) 
Influenza  1  0/51 (0.00%)  0/49 (0.00%)  7/90 (7.78%) 
Nasopharyngitis  1  0/51 (0.00%)  0/49 (0.00%)  12/90 (13.33%) 
Gastroenteritis  1  0/51 (0.00%)  0/49 (0.00%)  5/90 (5.56%) 
Tooth abscess  1  0/51 (0.00%)  0/49 (0.00%)  7/90 (7.78%) 
Herpes zoster  1  0/51 (0.00%)  0/49 (0.00%)  7/90 (7.78%) 
Urinary tract infection  1  1/51 (1.96%)  3/49 (6.12%)  17/90 (18.89%) 
Injury, poisoning and procedural complications       
Contusion  1  0/51 (0.00%)  0/49 (0.00%)  8/90 (8.89%) 
Fall  1  0/51 (0.00%)  0/49 (0.00%)  8/90 (8.89%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/51 (0.00%)  0/49 (0.00%)  7/90 (7.78%) 
Musculoskeletal pain  1  0/51 (0.00%)  0/49 (0.00%)  6/90 (6.67%) 
Nervous system disorders       
Headache  1  5/51 (9.80%)  3/49 (6.12%)  5/90 (5.56%) 
Psychiatric disorders       
Insomnia  1  0/51 (0.00%)  0/49 (0.00%)  6/90 (6.67%) 
Depression  1  0/51 (0.00%)  0/49 (0.00%)  5/90 (5.56%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 2  0/51 (0.00%)  3/49 (6.12%)  0/90 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/51 (0.00%)  0/49 (0.00%)  6/90 (6.67%) 
Vascular disorders       
Hypertension  1  0/51 (0.00%)  0/49 (0.00%)  8/90 (8.89%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
2
Term from vocabulary, MedDRA (11.1)
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: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00547521     History of Changes
Other Study ID Numbers: IM101-173
First Submitted: October 19, 2007
First Posted: October 22, 2007
Results First Submitted: October 15, 2010
Results First Posted: January 24, 2011
Last Update Posted: March 23, 2015