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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01373151

Run by

CSL Behring

People needed

418

Starts

2011-06-01

Expected to finish

2015-06-01

Last updated by the study team

2021-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previously received or currently receiving concomitant biologic therapy

Where it is running

• San Diego Arthritis Medical Clinic — San Diego, California, United States
• New England Research Associates, Llc — Trumbull, Connecticut, United States
• Quincy Medical Group — Quincy, Illinois, United States
• Rockford Orthopedic Associates, Llc. — Rockford, Illinois, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Arthritis Associates Of Mississippi — Jackson, Mississippi, United States
• Physician Research Collaboration, Llc — Lincoln, Nebraska, United States
• Box Arthritis And Rheumatology Of The Carolinas, Pllc — Charlotte, North Carolina, United States
• Health Research Of Oklahoma — Oklahoma City, Oklahoma, United States
• East Penn Rheumatology Associates, P.C. — Bethlehem, Pennsylvania, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Seattle Rheumatology Associates — Seattle, Washington, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — San Miguel de Tucumán, Tucumán Province, Argentina
• Local Institution — Córdoba, Argentina
• Local Institution — San Juan, Argentina
• Local Institution — Brussels, Belgium
• Local Institution — Hasselt, Belgium
• Local Institution — Goiânia, Goiás, Brazil
• Local Institution — Juiz de Fora, Minas Gerais, Brazil
• Sun Valley Arthritis Center, Ltd. — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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