Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00036153

Run by

Astellas Pharma Inc

People needed

210

Starts

2002-03-01

Expected to finish

2004-01-01

Last updated by the study team

2012-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing to discontinue DMARDs, other than methotrexate
• Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration
• Have been receiving oral or parenteral methotrexate for at least 3 months

You may not qualify if…

• Has received tacrolimus for any indication
• Has moderate or severe liver disease
• Has a known history of HIV infection
• Has serum creatinine outside the normal range

Where it is running

• 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
• Sarasota Arthritis Center, Rheumatology Division — Sarasota, Florida, United States
• Arthritis & Rheumatology Associates of Palm Beach — West Palm Beach, Florida, United States
• Coeur d'Alene Arthritis Clinic — Coeur d'Alene, Idaho, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Illinois Bone & Joint Institute — Morton Grove, Illinois, United States
• Rockford Clinical — Rockford, Illinois, United States
• The Arthritis Center — Springfield, Illinois, United States
• Arthritis & Osteoporosis Center of Maryland — Frederick, Maryland, United States
• Phase III Clinical Research — Fall River, Massachusetts, United States
• Midwest Arthritis Center — Kalamazoo, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• St. Louis Center for Clinical Research — St Louis, Missouri, United States
• Arthritis Consultants — St Louis, Missouri, United States
• Arthritis Regional Research Center — Mercerville, New Jersey, United States

Full record on ClinicalTrials.gov

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