Status:
COMPLETED
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day...
Eligibility Criteria
Inclusion
- Key
- Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
- Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
- Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses
- Key
Exclusion
- Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00409838
Start Date
April 1 2007
End Date
December 1 2011
Last Update
August 8 2013
Active Locations (7)
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1
Local Institution
Seoul, Sungdong-Gu, South Korea, 133-792
2
Local Institution
Anyang, South Korea, 431-070
3
Local Institution
Daegu, South Korea, 705-718
4
Local Institution
Daejeon, South Korea, 302-799