Phase 3
Completed N=1,441
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00048932 ↗Enrolled (actual)
1,441
Serious AEs
23.2%
Results posted
May 2011
Primary outcomePrimary: Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation — 5; 4; 123; 59 participants
Summary
The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation |
5; 4; 123; 59; 23; 13 | — |
| PRIMARY DB; Number of Participants With AEs of Special Interest |
95; 40; 17; 5; 34; 17 | — |
| PRIMARY DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria |
12; 14; 9; 12; 0; 0 | — |
| PRIMARY DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria |
12; 3; 16; 9; 41; 29 | — |
| PRIMARY DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities |
0; 0 | — |
| PRIMARY Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation |
32; 425; 124; 70; 1123; 737 | — |
| PRIMARY OL; Number of Participants With AEs of Special Interest |
957; 168; 56; 112; 67; 82 | — |
| PRIMARY OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria |
70; 53; 25; 23; 10; 110 | — |
| PRIMARY OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria |
12; 38; 54; 91; 9; 108 | — |
| PRIMARY OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria |
16; 1; 77; 72; 5; 2 | — |
| PRIMARY OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria |
207; 61; 647; 41; 12; 2 | — |
| PRIMARY OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities |
— | — |
| SECONDARY DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) |
13; 9; 22 | — |
| SECONDARY DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA |
66; 48; 107 | — |
Eligibility Criteria
Inclusion Criteria
- Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV
- Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day 1.
Exclusion:
- Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus [SLE], Scleroderma)
- Active tuberculosis (TB) requiring treatment within last 3 years
Data sourced from ClinicalTrials.gov (NCT00048932). 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.