drugset / Trial / NCT00883896
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.
Timeline
- Start
- 2009-06-18
- Primary completion
- 2011-02-18
- Completion
- 2011-02-18
Outcome
Missed primary endpoint
registry analysis (unspecified test); Placebo vs ILV-094 100 mg Every 4 Weeks; p = 0.558; Percent Difference -5.9 (95% CI -25.0 to 13.3); Cochran-Mantel-Haenszel NCT00883896 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FEZAKINUMAB | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | FEZAKINUMAB | Monoclonal antibody | 200 mg | Subcutaneous |