Phase IIIB Subcutaneous Missed Dose Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.

Key facts

Study ID

NCT00533897

Run by

Bristol-Myers Squibb

People needed

270

Starts

2007-11-01

Expected to finish

2014-02-01

Last updated by the study team

2015-04-23

Who can join

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

You may qualify if…

• Clinical diagnosis of Rheumatoid Arthritis
• Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
• On background methotrexate at least 3 months (≥10mg weekly)
• Must be able to self injection or allow a care giver to do it for them
• Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate

You may not qualify if…

• Participants who had prior exposure to abatacept or CTLA-4 Ig
• Received treatment with rituximab.
• Participants who have received treatment with leflunomide within 1 year of screening
• Participants who have received treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.

Where it is running

• Wallace Rheumatic Study Center — Los Angeles, California, United States
• New England Research Associates, Llc — Trumbull, Connecticut, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Diagnostic Rheumatology And Research,Pc — Indianapolis, Indiana, United States
• Klein And Associates, M.D., Pa — Cumberland, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• St. Paul Rheumatology, P.A. — Eagan, Minnesota, United States
• Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
• East Penn Rheumatology Associates — Bethlehem, Pennsylvania, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Center For Assessment And Research Of Erie — Erie, Pennsylvania, United States
• Columbia Arthritis Center — Columbia, South Carolina, United States
• Mountain State Clinical Research — Clarksburg, West Virginia, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Córdoba, Córdoba Province, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Santa Fe, Santa Fe Province, Argentina
• Local Institution — Trois-Rivières, Quebec, Canada
• Local Institution — León, Guanajuato, Mexico
• Local Institution — Mexico City, Mexico City, Mexico
• Local Institution — Metepec, State of Mexico, Mexico
• Local Institution — Mérida, Yucatán, Mexico
• Local Institution — Bloemfontein, Free State, South Africa
• Local Institution — Muckleneuk, Gauteng, South Africa
• Local Institution — Pretoria, Gauteng, South Africa

Full record on ClinicalTrials.gov

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