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

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

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

Sponsors & Collaborators

• CSL Behring

  lead INDUSTRY

Principal Investigators

• Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2012-09-30

Completion

2015-06-30

Countries

• United States
• Argentina
• Belgium
• Brazil
• Canada
• Czechia
• France
• Germany
• Hungary
• Italy
• Japan
• Mexico
• Netherlands
• Poland
• Russia
• South Africa
• South Korea
• Spain
• Taiwan

Study Locations