CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 418 enrolled
Drug / intervention
BMS-945429 Placebo +10 moredrug
Likely dose
BMS-945429 Placebo 0 mgfrom 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/NCT01373151
NCT01373151Phase 2Completed
CompareCT.gov

A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

CSL Behring·interventional·Posted Jun 14, 2011·Updated Dec 6, 2021

In Brief

A Phase 2 clinical trial evaluating BMS-945429 Placebo, BMS-945429, and 4 other interventions for Rheumatoid Arthritis. Completed, enrolled 418 participants across 100 sites in 19 countries.

Detailed Summary

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2012
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.0 years ago

Interventions

BMS-945429 Placebodrug

Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only

BMS-945429biological

Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only

BMS-945429biological

Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks

BMS-945429biological

Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48

BMS-945429biological

Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks

Methotrexatedrug

Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only

Methotrexatedrug

Tablets, Oral, 15 mg, Weekly, 48 weeks

Methotrexate Placebodrug

Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only

Methotrexatedrug

Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only

Adalimumab Placebodrug

Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks

Adalimumabdrug

Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks