Abatacept Versus Adalimumab Head-to-Head

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

Key facts

Study ID

NCT00929864

Run by

Bristol-Myers Squibb

People needed

869

Starts

2009-10-01

Expected to finish

2012-11-01

Last updated by the study team

2014-02-04

Who can join

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

You may qualify if…

• Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
• Methotrexate failure
• Naive to RA biologics
• ≤5 years duration of disease
• Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
• Willingness to self-inject subcutaneous (SC) drug

You may not qualify if…

• Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
• History of active or chronic hepatitis
• Cancer in the last 5 years
• History of severe chronic or recurrent bacterial or viral infections
• Risk of tuberculosis
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• Clinical And Translational Research Center Of Alabama, Pc — Tuscaloosa, Alabama, United States
• Sun Valley Arthritis Center, Ltd. — Peoria, Arizona, United States
• Mercy Clinic Hot Springs Communities — Hot Springs, Arkansas, United States
• Talbert Medical Group — Huntington Beach, California, United States
• Allergy & Rheumatology Medical Clinic, Inc. — La Jolla, California, United States
• Valerius Med Group & Res Ctr Of Greater Long Beach, Inc. — Long Beach, California, United States
• Irene Y. Tong — Pasadena, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Healthcare Partners Medical Group — Torrance, California, United States
• Drs. Goldin, Nies, Klashman & Eng — Torrance, California, United States
• Inland Rheumatology & Osteoporosis Medical Group — Upland, California, United States
• Arthritis And Rheumatic Disease Specialties — Aventura, Florida, United States
• University Of Florida College Of Medicine At Jacksonville — Gainesville, Florida, United States
• Center For Arthritis And Rheumatic Diseases — Miami, Florida, United States
• Arthritis Research Of Florida, Inc. — Palm Harbor, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• West Broward Rheumatology Associates — Tamarac, Florida, United States
• Lovelace Scientific Resources, Inc — Venice, Florida, United States
• Arthritis & Rheumatology Of Georgia — Atlanta, Georgia, United States
• Laureate Clinical Research Group — Atlanta, Georgia, United States
• Arthritis Center Of North Georgia — Gainesville, Georgia, United States
• St. Luke'S Clinic - Rheumatology — Boise, Idaho, United States
• Rheumatology Associates, Pc — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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