NCT00420199

A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The only trial in participants who are methotrexate-inadequate responders and have active Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism-of-action information on how Abatacept exerts its effects (including on bone) through new techniques.

Conditions

• Active Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept	Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment
DRUG	Placebo	Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-08-01
• Completion: 2010-05-01
• First posted: 2007-01-09
• Last updated: 2012-01-18
• Results posted: 2011-05-17

Locations

10 sites across 6 countries: Belgium, Germany, Netherlands, Spain, Sweden, United Kingdom