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

NCT ID: NCT00036153

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tacrolimus (Prograf®)

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Radiant Research, Pharmaceutical Clinical Trials Division

Scottsdale, Arizona, United States

Site Status

Boling Clinical Trials

Rancho Cucamonga, California, United States

Site Status

San Diego Arthritis & Osteoporosis Medical Clinic

San Diego, California, United States

Site Status

Pacific Arthritis Center and Medical Group

Santa Maria, California, United States

Site Status

Arthritis Associates of CT

Danbury, Connecticut, United States

Site Status

Stamford Therapeutic Consortium

Stamford, Connecticut, United States

Site Status

Center of Rheumatology, Immunology & Arthritis

Fort Lauderdale, Florida, United States

Site Status

Arthritis Center

Palm Harbor, Florida, United States

Site Status

Sarasota Arthritis Center, Rheumatology Division

Sarasota, Florida, United States

Site Status

Arthritis & Rheumatology Associates of Palm Beach

West Palm Beach, Florida, United States

Site Status

Coeur d'Alene Arthritis Clinic

Coeur d'Alene, Idaho, United States

Site Status

Northwestern Center for Clinical Research

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Illinois Bone & Joint Institute

Morton Grove, Illinois, United States

Site Status

Rockford Clinical

Rockford, Illinois, United States

Site Status

The Arthritis Center

Springfield, Illinois, United States

Site Status

Arthritis & Osteoporosis Center of Maryland

Frederick, Maryland, United States

Site Status

Phase III Clinical Research

Fall River, Massachusetts, United States

Site Status

Midwest Arthritis Center

Kalamazoo, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

St. Louis Center for Clinical Research

St Louis, Missouri, United States

Site Status

Arthritis Consultants

St Louis, Missouri, United States

Site Status

Arthritis Regional Research Center

Mercerville, New Jersey, United States

Site Status

New Jersey Physicians, LLC

Passaic, New Jersey, United States

Site Status

North Carolina Arthritis & Allergy Care Center

Raleigh, North Carolina, United States

Site Status

Radiant Research - Columbus

Columbus, Ohio, United States

Site Status

STAT Research, Inc.

Dayton, Ohio, United States

Site Status

PRO Research

Eugene, Oregon, United States

Site Status

Oregon Health Sciences Center

Portland, Oregon, United States

Site Status

Portland Medical Associates, P.C.

Portland, Oregon, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Center for Assessment & Research of Erie

Erie, Pennsylvania, United States

Site Status

Central Pennsylvania Clinical Research

Mechanicsburg, Pennsylvania, United States

Site Status

Clinical Research Center of Reading, LLP

West Reading, Pennsylvania, United States

Site Status

Rheumatic Disease Associates

Willow Grove, Pennsylvania, United States

Site Status

Radiant Research - Dallas

Dallas, Texas, United States

Site Status

San Antonio Center for Clinical Research

San Antonio, Texas, United States

Site Status

Physicians Research Options, L.C.

Sandy City, Utah, United States

Site Status

Metropolitan Clinical Research

Falls Church, Virginia, United States

Site Status

Lewis-Gale Clinic

Salem, Virginia, United States

Site Status

Doctor's Office

Hamilton, Ontario, Canada

Site Status

Doctor's Office

Hamilton, Ontario, Canada

Site Status

The Arthritis Program Research Group, Inc.

Newmarket, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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01-0-103

Identifier Type: -

Identifier Source: org_study_id

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