Phase 3
Completed N=1,046
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
Source: ClinicalTrials.gov NCT00124982 ↗Enrolled (actual)
1,046
Serious AEs
10.9%
Results posted
Jun 2011
Primary outcomePrimary: Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations — 1; 1; 50; 59 participants
Summary
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations |
1; 1; 50; 59; 10; 16 | — |
| PRIMARY Short-term Period: Number of Participants With AEs of Special Interest |
26; 38; 6; 7; 8; 7 | — |
| PRIMARY Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria |
2; 3; 1; 2; 1; 2 | — |
| PRIMARY Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria |
0; 0; 1; 2; 2; 1 | — |
| PRIMARY Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria |
0; 2; 0; 0; 1; 3 | — |
| PRIMARY Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria |
7; 17; 12; 21; 0; 0 | — |
| PRIMARY Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure |
— | — |
| PRIMARY Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) |
12; 0 | — |
| PRIMARY Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations |
1; 61; 15; 11; 328; 146 | — |
| PRIMARY Long-term Period: Number of Participants With AEs of Special Interest |
177; 4; 8; 42; 14 | — |
| PRIMARY Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria |
1; 1; 1; 0; 1; 1 | — |
| PRIMARY Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria |
0; 1; 5; 10; 1; 5 | — |
| PRIMARY Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria |
1; 3; 4; 1; 1; 1 | — |
| PRIMARY Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria |
15; 17; 1; 0; 1; 0 | — |
| PRIMARY Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time |
0.40; -0.22; 0.13; 0.47; -0.59; 0.16 | — |
| PRIMARY Long-term Period: Change From Baseline in Hematocrit Over Time |
1.00; 0.81 | — |
| PRIMARY Long-term Period: Change From Baseline in Erythrocytes Over Time |
0.04; 0.06 | — |
| PRIMARY Long-term Period: Change From Baseline in Platelets (PLT) Over Time |
-41.2; -67.7 | — |
| PRIMARY Long-term Period: Change From Baseline in White Blood Cells Over Time |
-0.86; -0.83; -0.01; 0.00; 0.00; 0.08 | — |
| PRIMARY Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time |
0.81; 0.64; 0.76; 2.21; -8.44; 1.35 | — |
| PRIMARY Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time |
0.04; 0.85; 0.05; 0.11; 0.13; 0.83 | — |
| PRIMARY LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time |
-0.91; -0.08; -0.37; 1.23; -0.06; 1.42 | — |
| PRIMARY Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time |
125.1; 125.3; 124.4; 123.9; 123.9; 123.4 | — |
| PRIMARY Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time |
75.1; 74.9; 74.0; 74.4; 73.9; 73.7 | — |
| PRIMARY Long-term Period: Mean Heart Rate (HR) Over Time |
74.4; 73.0; 74.4; 72.8; 74.7; 72.5 | — |
| PRIMARY Long-term Period: Mean Temperature (T) Over Time |
36.5; 36.5; 36.6; 36.5; 36.5; 36.5 | — |
| SECONDARY Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169 |
267; 320; 101; 133; 54; 82 | — |
| SECONDARY Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label |
6.21; 6.17; 5.46; 5.49; 6.22; 6.17 | — |
| SECONDARY Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label |
-0.75; -0.68; -1.18; -1.07; -1.57; -1.44 | — |
| SECONDARY Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP) |
-0.88; -0.68 | — |
| SECONDARY Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) |
-32.2; -22.8 | — |
| SECONDARY Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.34; -0.41 | — |
| SECONDARY Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response |
208; 281 | — |
| SECONDARY Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores |
28.81; 28.75; 42.45; 42.43; 27.72; 28.22 | — |
| SECONDARY Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores |
5.50; 6.08; 4.79; 5.43; 4.31; 4.66 | — |
| SECONDARY Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS) |
73.33; 72.70 | — |
| SECONDARY Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS) |
-18.3; -20.2 | — |
| SECONDARY Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time |
163; 70; 31; 105; 43; 25 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term |
6.18; 3.90; 6.16; 3.55; 6.16; 3.52 | — |
| SECONDARY Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term |
-2.28; -2.62; -2.64; -2.72; -2.66; -2.97 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term |
16.90; 6.04; 16.57; 4.39; 16.14; 4.34 | — |
| SECONDARY Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term |
-10.9; -12.2; -11.8; -12.5; -12.4; -13.7 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term |
12.72; 4.56; 12.50; 3.63; 11.91; 2.81 | — |
| SECONDARY Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term |
-8.16; -8.87; -9.09; -9.01; -8.56; -10.3 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term |
2.36; 1.24; 2.48; 0.97; 2.65; 0.93 | — |
| SECONDARY Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term |
-1.12; -1.51; -1.72; -2.02; -1.49; -1.92 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term |
74.05; 40.61; 73.20; 38.74; 73.41; 39.27 | — |
| SECONDARY Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term |
-33.4; -34.5; -34.1; -31.4; -30.6; -34.9 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term |
1.80; 1.62; 1.39; 1.84; 1.43; 2.08 | — |
| SECONDARY Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term |
1.34; 1.15; 0.85; 1.26; 1.03; 1.70 | — |
| SECONDARY Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term |
-0.46; -0.47; -0.54; -0.58; -0.39; -0.38 | — |
| SECONDARY Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time |
124; 69; 62; 53; 38; 26 | — |
| SECONDARY Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term |
28.96; 41.09; 28.04; 31.17; 31.07; 35.04 | — |
| SECONDARY Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term |
35.00; 47.15; 33.33; 37.85; 39.78; 38.58 | — |
| SECONDARY Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term |
6.04; 6.06; 5.29; 6.69; 8.70; 3.54 | — |
| SECONDARY LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Completed double-blind portion of the IM101064 study.
- Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
- American College of Rheumatology (ACR) functional class I, II, III
- Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months
Exclusion Criteria
- Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
- History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
Data sourced from ClinicalTrials.gov (NCT00124982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.