Official Title: “A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate”

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: abatacept and methotrexate
  • abatacept: IV, 10mg/kg, monthly, 24 months methotrexate: Tablets, Oral, 20 mg MTX, weekly, 24 months
• Drug: placebo and methotrexate
  • placebo: IV, monthly, 12months methotrexate: Tablets, Oral, 20 mg, weekly, 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• The proportion of subjects who achieve remission as defined by a DAS 28 score less that 2.6.
  • Time Frame: in 12 months of treatment (Day 365)
    Safety Issue?: No
• Joint damage progression measured by radiographic evaluation using the Genant‑Modified Sharp total score
  • Time Frame: at 12 months of treatment (Day 365)
    Safety Issue?: No

Secondary Measures

• Compare the proportion of subjects with an ACR50 response
  • Time Frame: at month 12 (Day 365)
    Safety Issue?: No
• Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response
  • Time Frame: at month 12 (Day 365)
    Safety Issue?: No
• Compare the disease activity as measured by DAS 28 score
  • Time Frame: at month 12 (Day 365)
    Safety Issue?: No
• Compare the improvement in physical function using the HAQ disability index
  • Time Frame: at month 12 (Day 365)
    Safety Issue?: No
• Compare the improvement in health-related quality of life using SF-36
  • Time Frame: at month 12 (Day 365)
    Safety Issue?: No
• Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing
  • Time Frame: at month 12 (Day 365)
    Safety Issue?: No
• Assess the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, joint space narrowing and total score
  • Time Frame: at month 24 (Day 729)
    Safety Issue?: No
• Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept.
  • Time Frame: throughout the study
    Safety Issue?: Yes
• Assess the improvement in physical function
  • Time Frame: at month 24 (Day 729)
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis (RA) <2 years; never received treatment with methotrexate; erosions noted on x-ray.
• CRP >= 8.0 mg/L
• Rheumatoid factor or anti CCP positive
• Additional laboratory requirements

Exclusion Criteria:

• Women and men who are not willing to use birth control
• Diagnosed with other rheumatic disease
• History of cancer within 5 years
• Active tuberculosis
• Treatment with another investigation drug within 28 days
• Active bacterial or viral infection

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

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 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00122382

Study ID Number: IM101-023

ClinicalTrials.gov Identifier: NCT00122382

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