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)
Arthritis & Rheumatology Associates of Palm Beach
🇺🇸West Palm Beach, Florida, United States
Radiant Research - Dallas
🇺🇸Dallas, Texas, United States
Rheumatology Associates of North Alabama
🇺🇸Huntsville, Alabama, United States
Boling Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Arthritis Center
🇺🇸Palm Harbor, Florida, United States
Arthritis Associates of CT
🇺🇸Danbury, Connecticut, United States
Coeur d'Alene Arthritis Clinic
🇺🇸Coeur D'Alene, Idaho, United States
Stamford Therapeutic Consortium
🇺🇸Stamford, Connecticut, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Sarasota Arthritis Center, Rheumatology Division
🇺🇸Sarasota, Florida, United States
The Arthritis Center
🇺🇸Springfield, Illinois, United States
Radiant Research, Pharmaceutical Clinical Trials Division
🇺🇸Scottsdale, Arizona, United States
Northwestern Center for Clinical Research
🇺🇸Chicago, Illinois, United States
San Antonio Center for Clinical Research
🇺🇸San Antonio, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health Sciences Center
🇺🇸Portland, Oregon, United States
Portland Medical Associates, P.C.
🇺🇸Portland, Oregon, United States
San Diego Arthritis & Osteoporosis Medical Clinic
🇺🇸San Diego, California, United States
Center of Rheumatology, Immunology & Arthritis
🇺🇸Ft. Lauderdale, Florida, United States
Illinois Bone & Joint Institute
🇺🇸Morton Grove, Illinois, United States
Phase III Clinical Research
🇺🇸Fall River, Massachusetts, United States
Rockford Clinical
🇺🇸Rockford, Illinois, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Midwest Arthritis Center
🇺🇸Kalamazoo, Michigan, United States
Arthritis & Osteoporosis Center of Maryland
🇺🇸Frederick, Maryland, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
Arthritis Consultants
🇺🇸St. Louis, Missouri, United States
New Jersey Physicians, LLC
🇺🇸Passaic, New Jersey, United States
North Carolina Arthritis & Allergy Care Center
🇺🇸Raleigh, North Carolina, United States
Arthritis Regional Research Center
🇺🇸Mercerville, New Jersey, United States
STAT Research, Inc.
🇺🇸Dayton, Ohio, United States
PRO Research
🇺🇸Eugene, Oregon, United States
Radiant Research - Columbus
🇺🇸Columbus, Ohio, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Center for Assessment & Research of Erie
🇺🇸Erie, Pennsylvania, United States
Rheumatic Disease Associates
🇺🇸Willow Grove, Pennsylvania, United States
Clinical Research Center of Reading, LLP
🇺🇸West Reading, Pennsylvania, United States
Metropolitan Clinical Research
🇺🇸Falls Church, Virginia, United States
Doctor's Office
🇨🇦Hamilton, Ontario, Canada
Lewis-Gale Clinic
🇺🇸Salem, Virginia, United States
Central Pennsylvania Clinical Research
🇺🇸Mechanicsburg, Pennsylvania, United States
Pacific Arthritis Center and Medical Group
🇺🇸Santa Maria, California, United States
Physicians Research Options, L.C.
🇺🇸Sandy, Utah, United States
The Arthritis Program Research Group, Inc.
🇨🇦Newmarket, Ontario, Canada