Phase IIIB Subcutaneous Abatacept Monotherapy Study

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis (RA)

In brief

To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Key facts

Study ID

NCT00547521

Run by

Bristol-Myers Squibb

People needed

119

Starts

2007-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-03-23

Who can join

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

You may qualify if…

• Clinical diagnosis of Rheumatoid Arthritis
• Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog scale
• Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except for methotrexate

You may not qualify if…

• Received treatment with rituximab
• Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine

Where it is running

• Rheumatology Associates Of North Alabama — Huntsville, Alabama, United States
• Coastal Clinical Research Inc — Mobile, Alabama, United States
• Stanford University School Of Medicine — Palo Alto, California, United States
• Boulder Medical Center — Boulder, Colorado, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Medical Towers South — Louisville, Kentucky, United States
• Westroads Medical Group — Omaha, Nebraska, United States
• Regional Rheumatology Associates — Binghamton, New York, United States
• Physicians East, Pa — Greenville, North Carolina, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• East Penn Rheumatology Associates — Bethlehem, Pennsylvania, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Low Country Rheumatology, Pa — Charleston, South Carolina, United States
• Columbia Arthritis Center — Columbia, South Carolina, United States
• Rheumatic Disease Center — Glendale, Wisconsin, United States
• Local Institution — Maroochydore, Queensland, Australia
• Local Institution — Hobart, Tasmania, Australia
• Local Institution — Malvern, Victoria, Australia
• Local Institution — Guadalajara, Jalisco, Mexico
• Local Institution — D.f., Mexico City, Mexico
• Local Institution — Berea, KwaZulu-Natal, South Africa
• Local Institution — Panorama, Western Cape, South Africa

Full record on ClinicalTrials.gov

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