A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Inclusion Criteria
- Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis
of RA.
- Participants must have been taking methotrexate for at least 3 months with at least a
weekly dose of 15 mg.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169
Outcome Description:
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Outcome Time Frame:
Day 169
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
IM101-102
NCT ID:
NCT00048568
Start Date:
December 2002
Completion Date:
October 2009
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
Name | Location |
|---|---|
| Local Institution | Chicago, Illinois |
| Local Institution | Baltimore, Maryland |
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
| Local Institution | Green Bay, Wisconsin |
| Local Institution | Birmingham, Alabama |
| Local Institution | Phoenix, Arizona |
| Local Institution | Corona, California |
| Local Institution | Aurora, Colorado |
| Local Institution | Hamden, Connecticut |
| Local Institution | Washington, District of Columbia |
| Local Institution | Fort Lauderdale, Florida |
| Local Institution | Wichita, Kansas |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Duluth, Minnesota |
| Local Institution | Lincoln, Nebraska |
| Local Institution | New Brunswick, New Jersey |
| Local Institution | Albuquerque, New Mexico |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Oklahoma City, Oklahoma |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Austin, Texas |
| Local Institution | Arlington, Virginia |
