Phase 3
Completed N=1,457
Methotrexate-Inadequate Response Study
Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT00559585 ↗
Enrolled (actual)
1,457
Serious AEs
27.5%
Results posted
Jul 2011
Primary outcomePrimary: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 — 527; 514 participants
Summary
The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 |
527; 514 | — |
| PRIMARY Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 |
357; 341; 183; 170 | — |
| SECONDARY Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 |
1.72; 1.67 | — |
| SECONDARY Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI |
-0.69; -0.70 | — |
| SECONDARY Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 |
483; 442 | — |
| SECONDARY Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation |
2; 5; 31; 35; 5; 12 | — |
| SECONDARY Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With AEs of Special Interest |
234; 221; 3; 5; 7; 6 | — |
| SECONDARY Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements |
0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality |
2; 5; 2; 4; 2; 3 | — |
| SECONDARY Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality |
1; 3; 5; 5; 12; 16 | — |
| SECONDARY Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality |
2; 0; 0; 0; 9; 9 | — |
| SECONDARY Double-blind Period: Minimum Observed Serum Concentration of Abatacept |
31.60; 23.14; 28.30; 20.00; 26.49; 18.76 | — |
| SECONDARY Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept |
25.53; 15.51; 21.51; 12.50; 23.14; 11.10 | — |
| SECONDARY Double-blind Period: Maximum Observed Serum Concentration of Abatacept |
40.39; 222.35 | — |
| SECONDARY Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept |
35.84; 229.88 | — |
| SECONDARY Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept |
5182.37; 39587.08 | — |
| SECONDARY Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept |
4384.80; 34260.55 | — |
| SECONDARY Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA) |
0; 2; 0; 0; 0; 2 | — |
| SECONDARY Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period |
34.16; 33.74; 39.74; 42.52; 47.88; 51.42 | — |
| SECONDARY Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline |
106; 93; 2; 3; 586; 582 | — |
| SECONDARY Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821 |
1087; 973; 904; 356 | — |
| SECONDARY Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821 |
724; 720; 672; 277; 371; 443 | — |
| SECONDARY Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821 |
-2.65; -2.94; -3.09; -3.24 | — |
| SECONDARY Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821 |
334; 411; 425; 169 | — |
| SECONDARY Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821 |
553; 600; 585; 238 | — |
| SECONDARY Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821 |
962; 853; 780; 315 | — |
| SECONDARY Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation |
41; 353; 88; 73; 632; 97 | — |
| SECONDARY Open-Label LT Period: Number of Participants With AEs of Special Interest |
962; 85; 25; 16; 56; 67 | — |
| SECONDARY Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements |
— | — |
| SECONDARY Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities |
— | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Subjects who are considered methotrexate inadequate responders
- 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
Exclusion Criteria
- Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
- Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
- Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
- Subjects with severe chronic or recurrent bacterial infections
- Subjects who have received treatment with rituximab
An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Data sourced from ClinicalTrials.gov (NCT00559585). 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.