Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00036153
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.
- Detailed Description
This is a Phase III, 6 month randomized, double-blind, placebo controlled multi-center study with a 6 month open-label extension. Patients will be randomized to the tacrolimus + methotrexate arm or the placebo + methotrexate arm in a ratio of 2:1. Patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Rheumatology Associates of North Alabama
🇺🇸Huntsville, Alabama, United States
Radiant Research, Pharmaceutical Clinical Trials Division
🇺🇸Scottsdale, Arizona, United States
Boling Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
San Diego Arthritis & Osteoporosis Medical Clinic
🇺🇸San Diego, California, United States
Pacific Arthritis Center and Medical Group
🇺🇸Santa Maria, California, United States
Arthritis Associates of CT
🇺🇸Danbury, Connecticut, United States
Stamford Therapeutic Consortium
🇺🇸Stamford, Connecticut, United States
Center of Rheumatology, Immunology & Arthritis
🇺🇸Ft. Lauderdale, Florida, United States
Arthritis Center
🇺🇸Palm Harbor, Florida, United States
Scroll for more (34 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States