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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036153
• Other study ID #: 01-0-103
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2002
• Last updated: March 26, 2012
• Start date: March 2002
• Est. completion date: January 2004

Study information

• Verified date: December 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tacrolimus (Prograf®)

• Methotrexate

Locations

Country	Name	City	State
Canada	Doctor's Office	Hamilton	Ontario
Canada	Doctor's Office	Hamilton	Ontario
Canada	The Arthritis Program Research Group, Inc.	Newmarket	Ontario
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern Center for Clinical Research	Chicago	Illinois
United States	Coeur d'Alene Arthritis Clinic	Coeur D'Alene	Idaho
United States	Radiant Research - Columbus	Columbus	Ohio
United States	Radiant Research - Dallas	Dallas	Texas
United States	Arthritis Associates of CT	Danbury	Connecticut
United States	STAT Research, Inc.	Dayton	Ohio
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center for Assessment & Research of Erie	Erie	Pennsylvania
United States	PRO Research	Eugene	Oregon
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	Metropolitan Clinical Research	Falls Church	Virginia
United States	Arthritis & Osteoporosis Center of Maryland	Frederick	Maryland
United States	Center of Rheumatology, Immunology & Arthritis	Ft. Lauderdale	Florida
United States	Rheumatology Associates of North Alabama	Huntsville	Alabama
United States	Midwest Arthritis Center	Kalamazoo	Michigan
United States	Central Pennsylvania Clinical Research	Mechanicsburg	Pennsylvania
United States	Arthritis Regional Research Center	Mercerville	New Jersey
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois
United States	Arthritis Center	Palm Harbor	Florida
United States	New Jersey Physicians, LLC	Passaic	New Jersey
United States	Oregon Health Sciences Center	Portland	Oregon
United States	Portland Medical Associates, P.C.	Portland	Oregon
United States	North Carolina Arthritis & Allergy Care Center	Raleigh	North Carolina
United States	Boling Clinical Trials	Rancho Cucamonga	California
United States	Rockford Clinical	Rockford	Illinois
United States	Lewis-Gale Clinic	Salem	Virginia
United States	San Antonio Center for Clinical Research	San Antonio	Texas
United States	San Diego Arthritis & Osteoporosis Medical Clinic	San Diego	California
United States	Physicians Research Options, L.C.	Sandy	Utah
United States	Pacific Arthritis Center and Medical Group	Santa Maria	California
United States	Sarasota Arthritis Center, Rheumatology Division	Sarasota	Florida
United States	Radiant Research, Pharmaceutical Clinical Trials Division	Scottsdale	Arizona
United States	The Arthritis Center	Springfield	Illinois
United States	Arthritis Consultants	St. Louis	Missouri
United States	St. Louis Center for Clinical Research	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stamford Therapeutic Consortium	Stamford	Connecticut
United States	Arthritis & Rheumatology Associates of Palm Beach	West Palm Beach	Florida
United States	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania
United States	Rheumatic Disease Associates	Willow Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

External Links

•   Link to results on JAPIC