drugset / Trial / NCT02015520

Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

NCT02015520 ↗

Phase 2 Completed 143 enrolled CSL Behring
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to identify an appropriate dose of study medication.

Timeline

Start
2012-06
Primary completion
2013-06
Completion
2015-06

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo + Methotrexate (MTX) vs Clazakizumab (5 mg) + MTX; p <0.001; Mixed Models Analysis NCT02015520 ↗

registry analysis (superiority test); Placebo + Methotrexate (MTX) vs Clazakizumab (25 mg) + MTX; p <0.001; Mixed Models Analysis NCT02015520 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clazakizumab Monoclonal antibody — Subcutaneous

Indications