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

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept + Methotrexate (Drug); Infliximab + Methotrexate (Drug); Placebo + Methotrexate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: 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.

Official title: A Phase IIIB, 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 an Inadequate Clinical Response to Methotrexate

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: TO DEMONSTRATE THAT THE ABATACEPT IN COMBINATION WITH METHOTREXATE WILL DEMONSTRATE A GREATER REDUCTION INDISEAE ACTIVITY THAN PLACEBO IN COMBINATION WITH METHOTREXATE AS MEASURED BY THE DISEASE ACTIVITY SCORE (das28)

Secondary outcome: To demonstrate that infliximab in combination with methotrexate will demonstrate a greater reduction in disease activity than placebo in combination with methotrexate (mtx) as measured by the disease activity score (DASE28)

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

- Women of Child Bearing Potential

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BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2005
Last updated: June 6, 2008