NCT01373151

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	BMS-945429 Placebo	Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
DRUG	Methotrexate	Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
DRUG	Methotrexate	Tablets, Oral, 15 mg, Weekly, 48 weeks
DRUG	Methotrexate Placebo	Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
DRUG	Methotrexate	Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
DRUG	Adalimumab Placebo	Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
DRUG	Adalimumab	Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-09-01
• Completion: 2015-06-01
• First posted: 2011-06-14
• Last updated: 2021-12-06
• Results posted: 2021-12-06

Locations

100 sites across 19 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Africa, South Korea, Spain, Taiwan