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

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.

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.

Conditions

Rheumatoid Arthritis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control

Further Details

Study Start

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

Total Enrolment

Contact Details

Australian Center’s exist please contact Bristol-Myers Squibb for details.