CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 508 enrolled
Drug / intervention
BMS-986142 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02638948
NCT02638948Phase 2Completed
CompareCT.gov

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

Bristol-Myers Squibb·interventional·Posted Dec 23, 2015·Updated May 28, 2019

In Brief

A Phase 2 clinical trial evaluating BMS-986142, Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 508 participants across 104 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Austria, Brazil, Canada, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Africa, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 23, 2015
Enrollment StartFeb 16, 2016
Primary CompletionMay 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.5 years ago

Interventions

BMS-986142drug

BMS986142 specific dose on specific days

Placebodrug

Placebo of BMS-986142 specific dose on specific days

Methotrexatedrug

Methotrexate specific dose on specific days