Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00409838
Recruitment Status : Completed
First Posted : December 11, 2006
Results First Posted : January 26, 2010
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Abatacept
Drug: Methotrexate
Drug: Placebo
Enrollment 113
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description

Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).

Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.

Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
Period Title: Short-term Period
Started 56 [1] 57 [1]
Treated (Baseline) Population 55 57
Completed 53 52 [2]
Not Completed 3 5
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             0             1
Withdrawal by Subject             2             3
Never Treated             1             0
[1]
Randomized
[2]
Participants who received placebo in this period received abatacept in next period.
Period Title: Long-term Extension Period
Started 105 0
Completed 87 0
Not Completed 18 0
Reason Not Completed
Adverse Event             10             0
Death             1             0
Lack of Efficacy             2             0
Withdrawal by Subject             3             0
Poor compliance/noncompliance             1             0
Pregnancy             1             0
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment). Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment). Total of all reporting groups
Overall Number of Baseline Participants 55 57 112
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 57 participants 112 participants
47.2  (12.2) 49.9  (10.6) 48.6  (11.4)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
Female
47
  85.5%
49
  86.0%
96
  85.7%
Male
8
  14.5%
8
  14.0%
16
  14.3%
[1]
Measure Description: One participant was randomized to the abatacept arm but never treated, and is not included in baseline characteristics.
weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 55 participants 57 participants 112 participants
56.5  (9.5) 54.2  (7.5) 55.3  (8.6)
1.Primary Outcome
Title Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20)
Hide Description The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.
Time Frame At Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug.
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
Participants received placebo IV on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
Overall Number of Participants Analyzed 55 57
Measure Type: Number
Unit of Measure: percentage of participants
65.5 42.1
2.Primary Outcome
Title Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs
Hide Description AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the short-term period and received at least 1 infusion of abatacept during the LTE period
Arm/Group Title All Treated
Hide Arm/Group Description:
Abatacept, administered intravenously IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months in the LTE period on a background of methotrexate
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Participants
Deaths 1
SAEs 41
Related SAEs 10
Discontinuations due to SAEs 8
AEs 100
Related AEs 45
Discontinuations due to AEs 10
3.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169
Hide Description The ACR defines ACR 50 and ACR70 response as a 50% or 70% improvement (compared with baseline values) in tender and swollen joint counts and 50% or 70% improvement in 3 of the remaining 5 core set measures (patient global assessment of pain, patient global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and 1 acute phase reactant value (C-reactive protein).
Time Frame At Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
Participants received placebo intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
Overall Number of Participants Analyzed 55 57
Measure Type: Number
Unit of Measure: Percentage of participants
ACR 50 32.7 15.8
ACR 70 14.5 7.0
4.Secondary Outcome
Title Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components
Hide Description The ACR defines improvement in core components as 20%, 50%, or 70% improvement in tender and swollen joint counts and 3 of the remaining core components: patient global assessment of disease activity, physician global assessment of disease activity, patient assessment of pain, patient self-assessed disability (Health Assessment Questionnaire Disability Index [HAQ-DI]), and levels of 1 acute phase reactant (C-reactive protein levels or erythrocyte sedimentation rate.) The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning; scale=0 (no disability) to 3 (completely disabled); total possible score=24. The higher the score, the greater the disability.
Time Frame From Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug and who were evaluable.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: Percentage of participants
Tender Joints ≥ 20% improvement 81.1 76.9
Tender Joints ≥ 50% improvement 66.0 50.0
Tender Joints ≥ 70% improvement 49.1 23.1
Swollen Joints ≥ 20% improvement 92.5 76.9
Swollen Joints ≥ 50% improvement 77.4 57.7
Swollen Joints ≥ 70% improvement 60.4 40.4
Patient Pain Assessment ≥ 20% improvement 73.6 53.9
Patient Pain Assessment ≥ 50% improvement 47.2 23.1
Patient Pain Assessment ≥ 70% improvement 28.3 11.5
HAQ-DI ≥ 20% improvement 67.9 44.2
HAQ-DI ≥ 50% improvement 32.1 23.1
HAQ-DI ≥ 70% improvement 20.8 5.8
Patient Global Assessment ≥ 20% improvement 66.0 53.9
Patient Global Assessment ≥ 50% improvement 39.6 21.2
Patient Global Assessment ≥ 70% improvement 26.4 11.5
Physician Global Assessment ≥ 20% improvement 86.8 71.2
Physician Global Assessment ≥ 50% improvement 60.4 40.4
Physician Global Assessment ≥ 70% improvement 30.2 19.2
C-reactive Protein ≥ 20% improvement 83.0 61.5
C-reactive Protein ≥ 50% improvement 75.5 53.9
C-reactive Protein ≥ 70% improvement 64.2 28.9
5.Secondary Outcome
Title Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR])
Hide Description Adjusted mean change from baseline. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). CRP or ESR give estimations of DAS28 values on a group level. Change from Baseline=Postbaseline - Baseline value.
Time Frame From Baseline to Days 169 and 1485
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug and who were evaluable.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 55 57
Mean (Standard Error)
Unit of Measure: Units on a scale
Day 169: DAS28 (CRP) -2.12  (0.17) -1.21  (0.17)
Day 169: DAS28 (ESR) -2.22  (0.17) -1.15  (0.16)
Day 1485: DAS28 (CRP) (n=31, 35) -2.97  (0.23) -3.13  (0.22)
Day 1485: DAS28 (ESR) (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Not evaluated
6.Secondary Outcome
Title Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Hide Description Adjusted mean change from baseline. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.
Time Frame From Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 55 57
Mean (Standard Error)
Unit of Measure: Units on a scale
HAQ Disability Index -0.53  (0.07) -0.24  (0.07)
Dressing and Grooming -0.58  (0.09) -0.37  (0.09)
Arising -0.58  (0.10) -0.36  (0.10)
Eating -0.52  (0.09) -0.13  (0.09)
Walking -0.54  (0.10) -0.23  (0.10)
Hygiene -0.37  (0.09) -0.21  (0.09)
Reaching -0.34  (0.11) -0.11  (0.10)
Gripping -0.67  (0.11) -0.36  (0.11)
Activities -0.56  (0.10) -0.25  (0.10)
7.Secondary Outcome
Title Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains
Hide Description Adjusted mean change from baseline. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life and comprised of 8 domains( including 4 physical and 4 mental subscales) used to derive the physical and mental component summary scores. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Change from baseline=postbaseline - baseline value.
Time Frame From Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug and were evaluable.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 54 53
Mean (Standard Error)
Unit of Measure: Units on a scale
Physical Component Summary 6.52  (1.05) 2.16  (1.06)
Mental Component Summary 8.18  (1.37) 4.36  (1.38)
8.Secondary Outcome
Title Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period
Hide Description AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time Frame Throughout double-blind study period (up to Day 169); table includes data up to 56 days past double-blind period or start of the open-label period, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 55 57
Measure Type: Number
Unit of Measure: Percentage of participants
Deaths 0 1.8
SAEs 3.6 5.3
Related SAEs 0 1.8
Discontinued due to SAEs 0 1.8
AEs 70.9 70.2
Related AEs 12.7 15.8
Discontinued due to AEs 0 1.8
9.Secondary Outcome
Title Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half)
Hide Description Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Tmax = the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. T-Half = the biological half-life or elimination half life of a substance is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.
Time Frame At the end of infusion and 2 to 4 hours after the start of infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at stated dose level
Arm/Group Title Abatacept 500 mg Abatacept 750 mg Abatacept 500 mg and 750 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 17 54
Mean (Standard Deviation)
Unit of Measure: Hours
Tmax 1.385  (1.0607) 1.193  (0.9956) 1.325  (1.0351)
T-Half 183.583  (35.2606) 172.451  (28.7270) 180.078  (33.4795)
10.Secondary Outcome
Title Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax)
Hide Description Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Maximum Concentration (Cmax)= the maximum plasma concentration of the drug.
Time Frame At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at stated dose level
Arm/Group Title Abatacept 500 mg Abatacept 750 mg Abatacept 500 mg and 750 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 17 54
Mean (Standard Deviation)
Unit of Measure: μg/mL
241.972  (41.7191) 312.591  (63.3026) 264.204  (59.0589)
11.Secondary Outcome
Title Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC)
Hide Description Area Under the Plasma Concentration-Time Curve (AUC), a measure of drug absorption, in a dosing interval of 28 days from Day 85 to Day 113. Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.
Time Frame At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at stated dose level
Arm/Group Title Abatacept 500 mg Abatacept 750 mg Abatacept 500 mg and 750 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 17 54
Mean (Standard Deviation)
Unit of Measure: μg.h/mL
38940.063  (9731.0561) 48283.479  (10283.2572) 41881.508  (10743.8152)
12.Secondary Outcome
Title Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT)
Hide Description Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Clearance is a pharmacokinetic parameter that describes how quickly drugs are eliminated, metabolized or distributed throughout the body.
Time Frame Day 29, every 28 days until Day 141
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at stated dose level
Arm/Group Title Abatacept 500 mg Abatacept 750 mg Abatacept 500 mg and 750 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 17 54
Mean (Standard Deviation)
Unit of Measure: mL/h/kg
0.269  (0.0730) 0.240  (0.0460) 0.260  (0.0666)
13.Secondary Outcome
Title Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS)
Hide Description The volume of distribution of drug at steady state (VSS). Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.
Time Frame At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at stated dose level
Arm/Group Title Abatacept 500 mg Abatacept 750 mg Abatacept 500 mg and 750 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 17 54
Mean (Standard Deviation)
Unit of Measure: L/kg
0.064  (0.0165) 0.055  (0.0142) 0.061  (0.0162)
14.Secondary Outcome
Title Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept
Hide Description Minimum concentration (Cmin) of Abatacept 500 mg and 750 mg at given time points
Time Frame At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurement at timepoint
Arm/Group Title Abatacept 500 mg Abatacept 750 mg Abatacept 500 mg and 750 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 17 54
Mean (Standard Deviation)
Unit of Measure: μg/mL
Day 29 37.76  (10.971) 52.19  (19.619) 42.30  (15.611)
Day 57 19.96  (11.337) 24.42  (7.697) 21.31  (10.504)
Day 85 17.45  (7.442) 20.83  (10.749) 18.52  (8.661)
Day 113 17.51  (6.858) 22.06  (9.365) 18.94  (7.936)
15.Secondary Outcome
Title Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169
Hide Description Immunogenicity was determined by measuring adult subject sera for reactivity against the whole Abatacept molecule (CTLA4Ig) and CTLA4-T (CTLA4 without the Ig regions).
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug (abatacept)
Arm/Group Title Abatacept + Background Methotrexate
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
Reactivity toward CTLA4-T 0
Reactivity toward CTLA4Ig 0
16.Secondary Outcome
Title Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169
Hide Description Mean change in surrogate marker mean ESR. A surrogate marker is an indirect measurement of effectiveness. Change from Baseline = postbaseline - baseline value.
Time Frame From Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study drug. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 55 57
Mean (Standard Error)
Unit of Measure: mm/h
-30.0  (2.86) -4.44  (3.87)
17.Secondary Outcome
Title Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169
Hide Description Mean change in RF. A surrogate marker is an indirect measurement of effectiveness. Mean change from Baseline = postbaseline - baseline value.
Time Frame Baseline, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized and Treated Participants. The summary was based on the last observation carried forward (LOCF) procedure. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
Overall Number of Participants Analyzed 55 57
Mean (Standard Error)
Unit of Measure: IU/mL
-54.1  (20.52) -12.1  (14.38)
18.Secondary Outcome
Title LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples
Hide Description Positive antibody titers were identified by validated enzyme-linked immunosorbent assay results. On-treatment samples were obtained during the LTE period, and posttreatment samples were following the last infusion of study medication.
Time Frame Days 169, at 6-month intervals on-treatment, and at Days 28, 56, and 85 after the last infusion of study medication in the LTE period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who during the LTE period, received at least 1 infusion of abatacept and had at least 1 immunogenicity sample collected.
Arm/Group Title All Treated
Hide Arm/Group Description:
Abatacept was administered intravenously monthly at a fixed dose of approximately 10 mg/kg in the LTE period on a background of methotrexate
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Participants
Overall 14
On-treatment 9
Posttreatment 11
19.Secondary Outcome
Title Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time
Hide Description The ACR 20, ACR50, and ACR70 are based on 20%, 50% and 70% improvement, respectively, (compared with baseline values) in tender and swollen joint counts and on 20%, 50% and 70%, respectively, improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.
Time Frame Days 15 through 1569
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the ST period and received at least 1 infusion of abatacept during the LTE period. n=evaluable participants at that timepoint for that measure.
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Abatacept administered IV in a body-weight tiered dose approximating 10 mg/kg. Study medication was administered on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
Short-term Period: Placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 15 ACR20
13.2
(4.1 to 22.3)
11.5
(2.9 to 20.2)
Day 15 ACR50
1.9
(0.0 to 10.1)
3.8
(0.5 to 13.2)
Day 15 ACR70
0
(NA to NA)
0
(NA to NA)
Day 29 ACR20
24.5
(12.9 to 36.1)
21.2
(10.1 to 32.3)
Day 29 ACR50
1.9
(0.0 to 10.0)
7.7
(2.1 to 18.5)
Day 29 ACR70
1.9
(0.0 to 10.0)
3.8
(0.5 to 13.2)
Day 57 ACR20 (n=52, 52)
51.9
(38.3 to 65.5)
23.1
(11.6 to 34.5)
Day 57 ACR50 (n=52, 52)
5.8
(1.2 to 15.9)
7.7
(2.1 to 18.5)
Day 57 ACR70 (n=52, 52)
1.9
(0.0 to 10.3)
5.8
(1.2 to 15.9)
Day 85 ACR20
58.5
(45.2 to 71.8)
36.5
(23.5 to 49.6)
Day 85 ACR50
17.0
(6.9 to 27.1)
9.6
(1.6 to 17.6)
Day 85 ACR70
5.7
(1.2 to 15.7)
7.7
(2.1 to 18.5)
Day 113 ACR20
64.2
(51.2 to 77.1)
48.1
(34.5 to 61.7)
Day 113 ACR50
30.2
(17.8 to 42.5)
11.5
(2.9 to 20.2)
Day 113 ACR70
3.8
(0.5 to 13.0)
7.7
(2.1 to 18.5)
Day 141 ACR20
66.0
(53.3 to 78.8)
53.8
(40.3 to 67.4)
Day 141 ACR50
30.2
(17.8 to 42.5)
11.5
(2.9 to 20.2)
Day 141 ACR70
15.1
(5.5 to 24.7)
7.7
(2.1 to 18.5)
Day 169 ACR20
67.9
(55.4 to 80.5)
46.2
(32.6 to 59.7)
Day 169 ACR50
34.0
(21.2 to 46.7)
17.3
(7.0 to 27.6)
Day 169 ACR70
15.1
(5.5 to 24.7)
7.7
(2.1 to 18.5)
Day 197 ACR20 (n=53, 50)
75.5
(63.9 to 87.1)
60.0
(46.4 to 73.6)
Day 197 ACR50 (n=53, 51)
45.3
(31.9 to 58.7)
37.3
(24.0 to 50.5)
Day 197 ACR70 (n=53, 51)
22.6
(11.4 to 33.9)
11.8
(2.9 to 20.6)
Day 225 ACR20
75.5
(63.9 to 87.1)
65.4
(52.5 to 78.3)
Day 225 ACR50
49.1
(35.6 to 62.5)
32.7
(19.9 to 45.4)
Day 225 ACR70
22.6
(11.4 to 83.9)
13.5
(4.2 to 22.7)
Day 253 ACR20 (n=52, 51)
71.2
(58.8 to 83.5)
64.7
(51.6 to 77.8)
Day 253 ACR50 (n=52, 51)
44.2
(30.7 to 57.7)
35.3
(22.2 to 48.4)
Day 253 ACR70 (n=52, 51)
21.2
(10.1 to 32.3)
13.7
(4.3 to 23.2)
Day 337 ACR20 (n=52, 51)
78.8
(67.7 to 89.9)
62.7
(49.5 to 76.0)
Day 337 ACR50 (n=52, 51)
48.1
(34.5 to 61.7)
43.1
(29.5 to 56.7)
Day 337 ACR70 (n=52, 51)
30.8
(18.2 to 43.3)
17.6
(7.2 to 28.1)
Day 421 ACR20 (n=51, 51)
84.3
(74.3 to 94.3)
78.4
(67.1 to 89.7)
Day 421 ACR50 (n=51, 51)
49.0
(35.3 to 62.7)
56.9
(43.3 to 70.5)
Day 421 ACR70 (n=51, 51)
29.4
(16.9 to 41.9)
31.4
(18.6 to 44.1)
Day 505 ACR20 (n=50, 51)
88.0
(79.0 to 97.0)
84.3
(74.3 to 94.3)
Day 505 ACR50 (n=50, 51)
62.0
(48.5 to 75.5)
56.9
(43.3 to 70.5)
Day 505 ACR70 (n=50, 51)
40.0
(26.4 to 53.6)
25.5
(13.5 to 37.5)
Day 561 ACR20 (n=50, 50)
88.0
(79.0 to 97.0)
86.0
(76.4 to 95.6)
Day 561 ACR50 (n=50, 50)
64.0
(50.7 to 77.3)
60.0
(46.4 to 73.6)
Day 561 ACR70 (n=50, 50)
38.0
(24.5 to 51.5)
32.0
(19.1 to 44.9)
Day 645 ACR20 (n=50, 50)
86.0
(76.4 to 95.6)
82.0
(71.4 to 92.6)
Day 645 ACR50 (n=50, 50)
54.0
(40.2 to 67.8)
56.0
(42.2 to 69.8)
Day 645 ACR70 (n=50, 50)
38.0
(24.5 to 51.5)
34.0
(20.9 to 47.1)
Day 729 ACR20 (n=49, 50)
83.7
(73.3 to 94.0)
74.0
(61.8 to 86.2)
Day 729 ACR50 (n=49, 50)
63.3
(49.8 to 76.8)
54.0
(40.2 to 67.8)
Day 729 ACR70 (n=49, 50)
34.7
(21.4 to 48.0)
32.0
(19.1 to 44.9)
Day 813 ACR20 (n=48, 49)
91.7
(83.8 to 99.5)
79.6
(68.3 to 90.9)
Day 813 ACR50 (n=48, 49)
58.3
(44.4 to 72.3)
59.2
(45.4 to 72.9)
Day 813 ACR70 (n=48, 49)
41.7
(27.7 to 55.6)
34.7
(21.4 to 48.0)
Day 897 ACR20 (n=46, 49)
80.4
(69.0 to 91.9)
79.6
(68.3 to 90.9)
Day 897 ACR50 (n=46, 49)
56.5
(42.2 to 70.8)
53.1
(39.1 to 67.0)
Day 897 ACR70 (n=46, 49)
39.1
(25.0 to 53.2)
34.7
(21.4 to 48.0)
Day 981 ACR20 (n=44, 48)
84.1
(73.3 to 94.9)
79.2
(67.7 to 90.7)
Day 981 ACR50 (n=44, 48)
61.4
(47.0 to 75.8)
60.4
(46.6 to 74.3)
Day 981 ACR70 (n=43, 48)
34.9
(20.6 to 49.1)
41.7
(27.7 to 55.6)
Day 1065 ACR20 (n=45, 48)
80.0
(68.3 to 91.7)
79.2
(67.7 to 90.7)
Day 1065 ACR50 (n=45, 48)
64.4
(50.5 to 78.4)
60.4
(46.6 to 74.3)
Day 1065 ACR70 (n=45, 48)
42.2
(27.8 to 56.7)
43.8
(29.7 to 57.8)
Day 1149 ACR20 (n=45, 48)
84.4
(73.9 to 95.0)
75.0
(62.8 to 87.2)
Day 1149 ACR50 (n=45, 48)
55.6
(41.0 to 70.1)
62.5
(48.8 to 76.2)
Day 1149 ACR70 (n=45, 48)
35.6
(21.6 to 49.5)
43.8
(29.7 to 57.8)
Day1233 ACR20 (n=44, 48)
84.1
(73.3 to 94.9)
79.2
(67.7 to 90.7)
Day1233 ACR50 (n=44, 48)
63.6
(49.4 to 77.9)
52.1
(38.0 to 66.2)
Day1233 ACR70 (n=44, 48)
43.2
(28.5 to 57.8)
41.7
(27.7 to 55.6)
Day 1317 ACR20 (n=44, 47)
90.9
(82.4 to 99.4)
76.6
(64.5 to 88.7)
Day 1317 ACR50 (n=44, 47)
63.6
(49.4 to 77.9)
53.2
(38.9 to 67.5)
Day 1317 ACR70 (n=44, 47)
40.9
(26.4 to 55.4)
36.2
(22.4 to 49.9)
Day 1401 ACR20 (n=41, 43)
90.2
(81.2 to 99.3)
81.4
(69.8 to 93.0)
Day 1401 ACR50 (n=41, 43)
68.3
(54.0 to 82.5)
51.2
(36.2 to 66.1)
Day 1401 ACR70 (n=41, 43)
39.0
(24.1 to 54.0)
39.5
(24.9 to 54.1)
Day 1485 ACR20 (n=31, 35)
83.9
(70.9 to 96.8)
85.7
(74.1 to 97.3)
Day 1485 ACR50 (n=31, 35)
67.7
(51.3 to 84.2)
62.9
(46.8 to 78.9)
Day 1485 ACR70 (n=31, 35)
38.7
(21.6 to 55.9)
45.7
(29.2 to 62.2)
Day 1569 ACR20 (n=20, 18)
100.0
(100.0 to 100.0)
88.9
(74.4 to 100.0)
Day 1569 ACR50 (n=20, 18)
80.0
(62.5 to 97.5)
72.2
(51.5 to 92.9)
Day 1569 ACR70 (n=20, 18)
30.0
(9.9 to 50.1)
44.4
(21.5 to 67.4)
20.Secondary Outcome
Title Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI)
Hide Description Improvement is measured by an improved response of at least 0.3 units from baseline on the HAQ-DI score. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.
Time Frame At Day 1485
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and who were evaluable
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 31 35
Measure Type: Number
Unit of Measure: Percentage of participants
77.4 60.0
21.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Hide Description The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.
Time Frame Day 1485
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and who were evaluable
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 31 35
Mean (Standard Error)
Unit of Measure: Units on a scale
-0.76  (0.14) -0.53  (0.11)
22.Secondary Outcome
Title Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries
Hide Description The SF-36 is a 36-item questionnaire used to measure Quality of Life over 8 physically and emotionally based areas: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Answers to each question correspond to a precoded numeric value. An aggregate percentage score is reached for each of the 8 sections and is based on answers to questions. The mean average is worked out for each section. Scores range from 0% (lowest level of functioning) to 100% (highest level of functioning, with higher score indicated increasing levels of functioning.
Time Frame At Day 1485
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and who were evaluable
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 31 35
Mean (Standard Error)
Unit of Measure: Units on a scale
Physical component score 10.34  (1.80) 8.48  (1.57)
Mental component score 7.93  (2.44) 7.73  (2.34)
23.Secondary Outcome
Title Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission
Hide Description EULAR defines LDAS as a disease activity score as measured by c-reactive protein (DAS28-CRP) ≤3.2 and remission as DAS28-CRP <2.6
Time Frame At Days 169 and 1485
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and who were evaluable
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Unit of Measure: Percentage of participants
EULAR-defined LDAS (Day 169) 35.8 13.5
EULAR-defined LDAS (Day 1485) (n=31, 35) 61.3 68.6
EULAR-defined remission (Day 169) 24.5 9.6
EULAR-defined remission(Day 1485) (n=31, 35) 35.5 54.3
24.Secondary Outcome
Title Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores
Hide Description The SDAI is the sum of 5 parameters: Tender joint (TJC) and swollen joint(SJC)counts, based on a 28-joint assessment; patient global (PtGA)and physician global assessments (PGA), assessed on 0-10 cm visual analog scale (VAS), on which higher scores=greater affection due to disease activity DA); and C-reactive protein level. SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low DA, >11 to 26=moderate DA, and >26=high DA. SJC is assessed at each visit, with no swelling=0, swelling=1. TJC is assessed through identification of joints painful under pressure or to passive motion at each visit, with no tenderness=0, tenderness=1. Higher score=greater affection due to DA. CDAI is sum of 4 parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score=0-76. CDAI <=2.8 indicates disease remission, >2.8 to 10=low DA, >10 to 22=moderate DA, and >22=high DA.
Time Frame At Days 169 and 1569
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and who were evaluable
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 53 52
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
SDAI score (Day 169)
-22.84
(-26.58 to -19.0)
-14.07
(-17.28 to -10.87)
SDAI score (Day 1569) (n=20, 18)
-29.74
(-34.06 to -25.43)
-29.20
(-33.70 to -24.70)
CDAI score (Day 169)
-20.99
(-24.52 to -17.46)
-13.49
(-16.42 to -10.56)
CDAI score (Day 1569) (n=20, 18)
-27.79
(-31.78 to -23.80)
-27.34
(-31.54 to -23.15)
25.Secondary Outcome
Title Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission
Hide Description LDAS is defined as a Disease Activity Score C-reactive protein (DAS28-CRP) level <=3.2. Remission is defined as a DAS28-CRP level <2.6.
Time Frame At Days 169, 337, 729, 1149, and 1485
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who finished the Short-term period. n=Number of evaluable participants
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period: Participants received placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
LDAS (Day 169)
35.8
(22.9 to 48.8)
13.5
(4.2 to 22.7)
LDAS (Day 337) (n=52, 51)
51.9
(38.3 to 65.5)
35.3
(22.2 to 48.4)
LDAS (Day 729) (n=48, 50)
62.5
(48.8 to 76.2)
56.0
(42.2 to 69.8)
LDAS (Day 1149) (n=44,48)
63.6
(49.4 to 77.9)
60.4
(46.6 to 74.3)
LDAS (Day 1485) (n=31, 35)
61.3
(44.1 to 78.4)
68.6
(53.2 to 84.0)
Remission (Day 169)
24.5
(12.9 to 36.1)
9.6
(1.6 to 17.6)
Remission (Day 337) (n=52, 51)
34.6
(21.7 to 47.5)
23.5
(11.9 to 35.2)
Remission (Day 729) (n=48, 50)
43.8
(29.7 to 57.8)
38.0
(24.5 to 51.5)
Remission (Day 1149) (n=44,8)
38.6
(24.2 to 53.0)
50.0
(35.9 to 64.1)
Remission (Day 1485) (n=31, 35)
35.5
(18.6 to 52.3)
54.3
(37.8 to 70.8)
26.Secondary Outcome
Title Change From Baseline in Levels of C-reactive Protein (CRP)
Hide Description [Not Specified]
Time Frame Days 169 to 1569
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the Short-term Period. n=Number of evaluable participants.
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 53 52
Mean (Standard Error)
Unit of Measure: mg/dL
Day 169 -1.85  (0.29) -0.58  (0.34)
Day 197 (n=53, 49) -1.87  (0.28) -1.23  (0.36)
Day 225 -1.73  (0.51) -1.62  (0.32)
Day 253 (n=52, 51) -1.91  (0.31) -1.52  (0.32)
Day 337 (n=52, 51) -1.94  (0.30) -1.67  (0.32)
Day 421 (n=51, 51) -2.06  (0.26) -1.77  (0.33)
Day 505 (n=50, 51) -2.10  (0.28) -1.75  (0.33)
Day 561 (n=50, 50) -2.23  (0.27) -1.68  (0.39)
Day 645 (n=50, 50) -2.24  (0.28) -1.88  (0.34)
Day 729 (n=49, 50) -2.29  (0.28) -1.63  (0.37)
Day 813 (n=48, 49) -2.24  (0.29) -1.81  (0.34)
Day 897 (n=46, 49) -2.41  (0.30) -1.76  (0.35)
Day 981 (n=44, 48) -1.99  (0.33) -1.99  (0.36)
Day 1065 (n=45, 48) -2.06  (0.32) -1.47  (0.40)
Day 1149 (n=45, 48) -2.00  (0.34) -1.86  (0.36)
Day 1233 (n=44, 48) -1.96  (0.33) 1.70  (0.37)
Day 1317 (n=44, 47) -2.00  (0.35) -1.81  (0.40)
Day 1401 (n=41, 43) -1.93  (0.33) -1.83  (0.40)
Day 1485 (n=31, 35) -1.95  (0.47) -1.86  (0.41)
Day 1569 (n=20, 18) -2.43  (0.43) -1.68  (0.42)
27.Secondary Outcome
Title Change From Baseline in Erythrocyte Sedimentation Rate
Hide Description [Not Specified]
Time Frame Days 169 to 1569
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the Short-term Period. n=Number of evaluable participants.
Arm/Group Title Abatacept, 10 mg/kg Placebo
Hide Arm/Group Description:
Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
Overall Number of Participants Analyzed 53 52
Mean (Standard Error)
Unit of Measure: mm/h
Day 169 -30.60  (2.93) -7.12  (3.84)
Day 197 (n=53, 49) -28.43  (3.27) -15.14  (3.79)
Day 225 -27.30  (3.09) -20.27  (3.51)
Day 253 (n=52, 51) -27.85  (3.24) -20.78  (3.97)
Day 337 (n=52, 51) -28.58  (3.35) -23.86  (3.78)
Day 421 (n=51, 51) -28.45  (3.34) -24.94  (3.86)
Day 505 (n=50, 51) -31.30  (3.46) -24.69  (4.07)
Day 561 (n=50, 49) -29.32  (3.63) -24.90  (4.24)
Day 645 (n=50, 50) -28.22  (3.74) -27.38  (4.10)
Day 729 (n=49, 50) -32.80  (3.70) -23.04  (3.60)
Day 813 (n=48, 47) -31.52  (3.95) -22.91  (4.03)
Day 897 (n=46, 49) -34.37  (4.13) -18.22  (4.65)
Day 981 (n=44, 48) -33.61  (3.68) -21.54  (4.53)
Day 1065 (n=45, 47) -31.53  (3.95) -22.09  (4.37)
Day 1149 (n=45, 48) -31.00  (4.59) -20.29  (4.61)
Day 1233 (n=42, 48) -30.93  (5.08) -22.10  (4.70)
Day 1317 (n=43, 47) -33.67  (4.45) -21.89  (4.48)
Day 1401 (n=41, 43) -32.41  (4.83) -23.88  (4.91)
Day 1485 (n=31, 35) -33.81  (6.96) -25.69  (5.70)
Day 1569 (n=20, 18) -46.80  (6.79) -23.33  (5.85)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept 10 mg/kg Placebo
Hide Arm/Group Description 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment). Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
All-Cause Mortality
Abatacept 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/55 (3.64%)   3/57 (5.26%) 
Endocrine disorders     
ADRENAL CYST  1  0/55 (0.00%)  1/57 (1.75%) 
Infections and infestations     
SEPSIS  1  0/55 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications     
ROAD TRAFFIC ACCIDENT  1  1/55 (1.82%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders     
PAIN IN EXTREMITY  1  0/55 (0.00%)  1/57 (1.75%) 
LUMBAR SPINAL STENOSIS  1  1/55 (1.82%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
PNEUMOTHORAX  1  0/55 (0.00%)  1/57 (1.75%) 
INTERSTITIAL LUNG DISEASE  1  0/55 (0.00%)  1/57 (1.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   27/55 (49.09%)   26/57 (45.61%) 
Gastrointestinal disorders     
DYSPEPSIA  1  3/55 (5.45%)  2/57 (3.51%) 
MOUTH ULCERATION  1  3/55 (5.45%)  1/57 (1.75%) 
EPIGASTRIC DISCOMFORT  1  3/55 (5.45%)  1/57 (1.75%) 
General disorders     
FATIGUE  1  3/55 (5.45%)  1/57 (1.75%) 
Infections and infestations     
NASOPHARYNGITIS  1  4/55 (7.27%)  9/57 (15.79%) 
URINARY TRACT INFECTION  1  1/55 (1.82%)  3/57 (5.26%) 
UPPER RESPIRATORY TRACT INFECTION  1  5/55 (9.09%)  6/57 (10.53%) 
Investigations     
WEIGHT INCREASED  1  4/55 (7.27%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  3/55 (5.45%)  2/57 (3.51%) 
Nervous system disorders     
HEADACHE  1  3/55 (5.45%)  3/57 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  6/55 (10.91%)  3/57 (5.26%) 
PRODUCTIVE COUGH  1  3/55 (5.45%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders     
SWELLING FACE  1  1/55 (1.82%)  3/57 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00409838     History of Changes
Other Study ID Numbers: IM101-124
First Submitted: December 8, 2006
First Posted: December 11, 2006
Results First Submitted: November 16, 2009
Results First Posted: January 26, 2010
Last Update Posted: August 8, 2013