Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
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
1 other identifier
interventional
210
2 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Mar 2002
Shorter than P25 for phase_3 rheumatoid-arthritis
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 8, 2002
CompletedFirst Posted
Study publicly available on registry
May 9, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedMarch 27, 2012
December 1, 2011
May 8, 2002
March 26, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (45)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
Radiant Research, Pharmaceutical Clinical Trials Division
Scottsdale, Arizona, 85251, United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120, United States
Pacific Arthritis Center and Medical Group
Santa Maria, California, 93454, United States
Arthritis Associates of CT
Danbury, Connecticut, 06810, United States
Stamford Therapeutic Consortium
Stamford, Connecticut, 06905, United States
Center of Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, 33334, United States
Arthritis Center
Palm Harbor, Florida, 34684, United States
Sarasota Arthritis Center, Rheumatology Division
Sarasota, Florida, 34239, United States
Arthritis & Rheumatology Associates of Palm Beach
West Palm Beach, Florida, 33401, United States
Coeur d'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814, United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053, United States
Rockford Clinical
Rockford, Illinois, 61103, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
Phase III Clinical Research
Fall River, Massachusetts, 02720, United States
Midwest Arthritis Center
Kalamazoo, Michigan, 49048, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Arthritis Consultants
St Louis, Missouri, 63141, United States
Arthritis Regional Research Center
Mercerville, New Jersey, 08619, United States
New Jersey Physicians, LLC
Passaic, New Jersey, 07055, United States
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, 27609, United States
Radiant Research - Columbus
Columbus, Ohio, 43212, United States
STAT Research, Inc.
Dayton, Ohio, 45402, United States
PRO Research
Eugene, Oregon, 97401, United States
Oregon Health Sciences Center
Portland, Oregon, 97201, United States
Portland Medical Associates, P.C.
Portland, Oregon, 97224, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Center for Assessment & Research of Erie
Erie, Pennsylvania, 16508, United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, United States
Radiant Research - Dallas
Dallas, Texas, 75235, United States
San Antonio Center for Clinical Research
San Antonio, Texas, 78229, United States
Physicians Research Options, L.C.
Sandy City, Utah, 84070, United States
Metropolitan Clinical Research
Falls Church, Virginia, 22044, United States
Lewis-Gale Clinic
Salem, Virginia, 24153, United States
Doctor's Office
Hamilton, Ontario, L8N 1Y2, Canada
Doctor's Office
Hamilton, Ontario, L8N 2B6, Canada
The Arthritis Program Research Group, Inc.
Newmarket, Ontario, L3Y 3R7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2002
First Posted
May 9, 2002
Study Start
March 1, 2002
Study Completion
January 1, 2004
Last Updated
March 27, 2012
Record last verified: 2011-12