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

Last updated: March 26, 2012
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

3

Condition

Musculoskeletal Diseases

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00036153
01-0-103
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 210
Study Start date:
March 01, 2002
Estimated Completion Date:
January 31, 2004

Study 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.

Connect with a study center

  • Doctor's Office

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • The Arthritis Program Research Group, Inc.

    Newmarket, Ontario L3Y 3R7
    Canada

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Rheumatology Associates of North Alabama

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Radiant Research, Pharmaceutical Clinical Trials Division

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Boling Clinical Trials

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • San Diego Arthritis & Osteoporosis Medical Clinic

    San Diego, California 92120
    United States

    Site Not Available

  • Pacific Arthritis Center and Medical Group

    Santa Maria, California 93454
    United States

    Site Not Available

  • Arthritis Associates of CT

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Stamford Therapeutic Consortium

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Center of Rheumatology, Immunology & Arthritis

    Ft. Lauderdale, Florida 33334
    United States

    Site Not Available

  • Arthritis Center

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Sarasota Arthritis Center, Rheumatology Division

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Arthritis & Rheumatology Associates of Palm Beach

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Coeur d'Alene Arthritis Clinic

    Coeur D'Alene, Idaho 83814
    United States

    Site Not Available

  • Northwestern Center for Clinical Research

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Illinois Bone & Joint Institute

    Morton Grove, Illinois 60053
    United States

    Site Not Available

  • Rockford Clinical

    Rockford, Illinois 61103
    United States

    Site Not Available

  • The Arthritis Center

    Springfield, Illinois 62704
    United States

    Site Not Available

  • Arthritis & Osteoporosis Center of Maryland

    Frederick, Maryland 21702
    United States

    Site Not Available

  • Phase III Clinical Research

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • Midwest Arthritis Center

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Arthritis Consultants

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Arthritis Regional Research Center

    Mercerville, New Jersey 08619
    United States

    Site Not Available

  • New Jersey Physicians, LLC

    Passaic, New Jersey 07055
    United States

    Site Not Available

  • North Carolina Arthritis & Allergy Care Center

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Radiant Research - Columbus

    Columbus, Ohio 43212
    United States

    Site Not Available

  • STAT Research, Inc.

    Dayton, Ohio 45402
    United States

    Site Not Available

  • PRO Research

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Oregon Health Sciences Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • Portland Medical Associates, P.C.

    Portland, Oregon 97224
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Center for Assessment & Research of Erie

    Erie, Pennsylvania 16508
    United States

    Site Not Available

  • Central Pennsylvania Clinical Research

    Mechanicsburg, Pennsylvania 17055
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLP

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Rheumatic Disease Associates

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Radiant Research - Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • San Antonio Center for Clinical Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Physicians Research Options, L.C.

    Sandy, Utah 84070
    United States

    Site Not Available

  • Metropolitan Clinical Research

    Falls Church, Virginia 22044
    United States

    Site Not Available

  • Lewis-Gale Clinic

    Salem, Virginia 24153
    United States

    Site Not Available

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