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

This study has been completed.
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc Identifier:
First received: May 8, 2002
Last updated: March 26, 2012
Last verified: December 2011
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tacrolimus (Prograf®)
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

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Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 210
Study Start Date: March 2002
Study Completion Date: January 2004
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00036153

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Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
  More Information

Additional Information: Identifier: NCT00036153     History of Changes
Other Study ID Numbers: 01-0-103 
Study First Received: May 8, 2002
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Tacrolimus, Prograf®, FK506

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents processed this record on May 30, 2016