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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alder Biopharmaceuticals, Inc.; CSL Behring
• Treatments: Adalimumab; Methotrexate

Criteria

Inclusion Criteria:

• Inadequate response to Methotrexate

• Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization

• American College of Rheumatology (ACR) global function status class 1-3

• Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist

• High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

Exclusion Criteria:

• Previously received or currently receiving concomitant biologic therapy