Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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