Clinical trial NCT00036153: Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Tacrolimus, Prograf®, FK506
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2002-05-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

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