drugset / Trial / NCT02638948

Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

NCT02638948

Phase 2 Completed 508 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

Timeline

Start
2016-02-16
Primary completion
2018-05-03
Completion
2018-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986142 Small molecule 100 mg Oral
Subject BMS-986142 Small molecule 200 mg Oral
Subject BMS-986142 Small molecule 350 mg Oral
Background Methotrexate Small molecule

Indications