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.
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.
Treatment, Randomized, Double-Blind, Placebo Control
Eligibility & Criteria
Criteria 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
Australian Center’s exist please contact Bristol-Myers Squibb for details.