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

March 26, 2012 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

May 8, 2002

First Submitted That Met QC Criteria

May 8, 2002

First Posted (Estimate)

May 9, 2002

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-0-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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