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...
Date First Received: May 8, 2002
Last Updated: June 27, 2008
Verified by: Astellas Pharma Inc, June 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2002
Overall Status: Completed
Estimated Enrollment: 210
Brief Summary
Official Title: “A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Tacrolimus (Prograf®)
- Drug: Methotrexate
Criteria for Participation in this Clinical Trial
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Astellas Pharma Inc
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00036153
Study ID Number: 01-0-103
ClinicalTrials.gov Identifier: NCT00036153
Health Authority: United States: Food and Drug Administration
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