drugset / Trial / NCT00883896

Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

NCT00883896 ↗

Phase 2 Completed 195 enrolled Pfizer
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

EvaluationDrugModalityDoseRoute
Subject FEZAKINUMAB Monoclonal antibody 100 mg Subcutaneous
Subject FEZAKINUMAB Monoclonal antibody 200 mg Subcutaneous

Indications