Clinical Trial: Abatacept and Infliximab in Combination with Methotrexate in Subjects with Rheumatoid Arthritis


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Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb

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

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Official Title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects with Rheumatoid Arthritis Having Inadequate Clinical Response to Methotrexate

Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both

Inclusion Criteria:

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)

Exclusion Criteria:

Subjects who have failed more than 3 DMARDs
Subjects 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

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Alabama
Local Institution, Huntsville, Alabama, United States; Recruiting

Colorado
Local Institution, Denver, Colorado, United States; Recruiting

Florida
Local Institution, Boca Raton, Florida, United States; Recruiting

Local Institution, Ft. Lauderdale, Florida, United States; Recruiting

Local Institution, Largo, Florida, United States; Recruiting

Massachusetts
Local Institution, Worcester, Massachusetts, United States; Recruiting

Mississippi
Local Institution, Flowood, Mississippi, United States; Recruiting

New York
Local Institution, Syracuse, New York, United States; Recruiting

North Carolina
Local Institution, Charlotte, North Carolina, United States; Recruiting

Ohio
Local Institution, Cincinnati, Ohio, United States; Recruiting

Oklahoma
Local Institution, Oklahoma City, Oklahoma, United States; Recruiting

Pennsylvania
Local Institution, Bethlehem, Pennsylvania, United States; Recruiting

Study ID Numbers: IM101-043
Record last reviewed: October 2004
Record first received: November 1, 2004
ClinicalTrials.gov Identifier: NCT00095147
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-18