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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036153
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : March 27, 2012
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tacrolimus (Prograf®) Drug: Methotrexate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2002
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036153

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Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Additional Information:
Layout table for additonal information Identifier: NCT00036153    
Other Study ID Numbers: 01-0-103
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: December 2011
Keywords provided by Astellas Pharma Inc:
Tacrolimus, Prograf®, FK506
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors