Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

Key facts

Study ID

NCT00095147

Run by

Bristol-Myers Squibb

People needed

431

Starts

2005-02-01

Expected to finish

2009-07-01

Last updated by the study team

2015-03-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Rheumatoid Arthritis
• At least 3 months prior treatment with Methotrexate (MTX)
• At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
• Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

You may not qualify if…

• participants who have failed more than 3 DMARDs
• participants previously treated with an approved biologic drug
• History of cancer in the last 5 years
• Severe or recurrent bacterial infection
• Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
• Women of Child Bearing Potential

Where it is running

• Local Institution — Denver, Colorado, United States
• Local Institution — Boca Raton, Florida, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Largo, Florida, United States
• Local Institution — Indianapolis, Indiana, United States
• Local Institution — New Orleans, Louisiana, United States
• Local Institution — Springfield, Massachusetts, United States
• Local Institution — Worcester, Massachusetts, United States
• Local Institution — Flowood, Mississippi, United States
• Local Institution — Syracuse, New York, United States
• Local Institution — Charlotte, North Carolina, United States
• Local Institution — Cincinnati, Ohio, United States
• Local Institution — Oklahoma City, Oklahoma, United States
• Local Institution — Tulsa, Oklahoma, United States
• Local Institution — Bethlehem, Pennsylvania, United States
• Local Institution — Willow Grove, Pennsylvania, United States
• Local Institution — Austin, Texas, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Quilmes, Buenos Aires, Argentina
• Local Institution — Córdoba, Córdoba Province, Argentina
• Local Institution — San Miguel de Tucumán, Tucumán Province, Argentina
• Local Institution — Cairns, Queensland, Australia
• Local Institution — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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