NCT00036153

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (planned)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tacrolimus (Prograf®)
DRUG	Methotrexate

Timeline

• Start date: 2002-03-01
• Completion: 2004-01-01
• First posted: 2002-05-09
• Last updated: 2012-03-27

Locations

45 sites across 2 countries: United States, Canada