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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
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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
Fort Lauderdale, Florida, United States
Arthritis Center
Palm Harbor, Florida, United States
...and 35 more locations