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.

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

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Radiant Research, Pharmaceutical Clinical Trials Division
Scottsdale, Arizona, United States, 85251
United States, California
Boling Clinical Trials
Rancho Cucamonga, California, United States, 91730
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, United States, 92120
Pacific Arthritis Center and Medical Group
Santa Maria, California, United States, 93454
United States, Connecticut
Arthritis Associates of CT
Danbury, Connecticut, United States, 06810
Stamford Therapeutic Consortium
Stamford, Connecticut, United States, 06905
United States, Florida
Center of Rheumatology, Immunology & Arthritis
Ft. Lauderdale, Florida, United States, 33334
Arthritis Center
Palm Harbor, Florida, United States, 34684
Sarasota Arthritis Center, Rheumatology Division
Sarasota, Florida, United States, 34239
Arthritis & Rheumatology Associates of Palm Beach
West Palm Beach, Florida, United States, 33401
United States, Idaho
Coeur d'Alene Arthritis Clinic
Coeur D'Alene, Idaho, United States, 83814
United States, Illinois
Northwestern Center for Clinical Research
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
Rockford Clinical
Rockford, Illinois, United States, 61103
The Arthritis Center
Springfield, Illinois, United States, 62704
United States, Maryland
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, United States, 21702
United States, Massachusetts
Phase III Clinical Research
Fall River, Massachusetts, United States, 02720
United States, Michigan
Midwest Arthritis Center
Kalamazoo, Michigan, United States, 49048
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
St. Louis Center for Clinical Research
St. Louis, Missouri, United States, 63128
Arthritis Consultants
St. Louis, Missouri, United States, 63141
United States, New Jersey
Arthritis Regional Research Center
Mercerville, New Jersey, United States, 08619
New Jersey Physicians, LLC
Passaic, New Jersey, United States, 07055
United States, North Carolina
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, United States, 27609
United States, Ohio
Radiant Research - Columbus
Columbus, Ohio, United States, 43212
STAT Research, Inc.
Dayton, Ohio, United States, 45402
United States, Oregon
PRO Research
Eugene, Oregon, United States, 97401
Oregon Health Sciences Center
Portland, Oregon, United States, 97201
Portland Medical Associates, P.C.
Portland, Oregon, United States, 97224
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Center for Assessment & Research of Erie
Erie, Pennsylvania, United States, 16508
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, United States, 17055
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, United States, 19611
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
Radiant Research - Dallas
Dallas, Texas, United States, 75235
San Antonio Center for Clinical Research
San Antonio, Texas, United States, 78229
United States, Utah
Physicians Research Options, L.C.
Sandy, Utah, United States, 84070
United States, Virginia
Metropolitan Clinical Research
Falls Church, Virginia, United States, 22044
Lewis-Gale Clinic
Salem, Virginia, United States, 24153
Canada, Ontario
Doctor's Office
Hamilton, Ontario, Canada, L8N 1Y2
Doctor's Office
Hamilton, Ontario, Canada, L8N 2B6
The Arthritis Program Research Group, Inc.
Newmarket, Ontario, Canada, L3Y 3R7
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.

Additional Information: Identifier: NCT00036153     History of Changes
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:
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