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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Abatacept + Methotrexate
  • IV Solution, Infusion, Depends on subject weight, Monthly, 12 months.
• Drug: Infliximab + Methotrexate
  • IV Solution, Infusion, Depends on subject weight, Every 2 Months, 12 months.
• Drug: Placebo + Methotrexate
  • IV Solution, Infusion, Depends on subject weight, Monthly, 6 months.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A1
• Active Comparator: A2
• Placebo Comparator: A3

Primary Measures

• 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)
  • Time Frame: at 6 months (Day 197)
    

Secondary Measures

• 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)
  • Time Frame: at 6 months
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095147

Study ID Number: IM101-043

ClinicalTrials.gov Identifier: NCT00095147

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

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