Phase 3
N=62
Methotrexate - Inadequate Response Device Sub-Study
Rheumatoid Arthritis (RA)
Bottom Line
View on ClinicalTrials.gov: NCT01173120 ↗Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation — 0; 2; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Abatacept combination product (ACP) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation |
0; 2; 0; 0; 36; 11 | — |
| PRIMARY Number of Participants With AEs of Special Interest in the ACP Device Substudy |
17; 5; 2 | — |
| PRIMARY Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy |
1; 1; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy |
0; 1; 1; 2; 0; 1 | — |
| PRIMARY Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy |
0; 0; 1; 1; 0; 0 | — |
| PRIMARY Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy |
2; 2; 0; 0; 0; 0 | — |
| PRIMARY Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy |
128.1; 130.7; 128.0; 127.3; 135.3 | — |
| PRIMARY Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy |
76.4; 78.7; 75.7; 78.1; 77.5 | — |
| PRIMARY Mean Heart Rate Over Time in the ACP Device Substudy |
73.4; 74.0; 73.4; 76.9; 84.3 | — |
| PRIMARY Mean Temperature Over Time in the ACP Device Substudy |
36.6; 36.6; 36.6; 36.6; 36.4 | — |
| SECONDARY Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy |
24.34; 27.61; 31.52; 27.46; 26.85; 24.41 | — |
| SECONDARY Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy |
0; 1; 1; 0; 1; 1 | — |
Summary
The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.
Eligibility Criteria
Inclusion Criteria
- Men and women, ages ≥ 18
- Participants who are considered methotrexate inadequate responders (MTX-IR)
- 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
- Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period
Exclusion Criteria
- Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies
- Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus)
- Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
- Participants with severe chronic or recurrent bacterial infections
- Participants who have received treatment with rituximab
Data sourced from ClinicalTrials.gov (NCT01173120). 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.