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Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Clinical research trials and Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis. Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis clinical trial. Human subjects often receive the most effective healthcare possible for their Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 210
Location and Contact Information:
New Jersey Physicians, LLC
Passaic, New Jersey, 07055
United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053
United States
Physicians Research Options, L.C.
Sandy, Utah, 84070
United States
Arthritis Center
Palm Harbor, Florida, 34684
United States
PRO Research
Eugene, Oregon, 97401
United States
Arthritis Regional Research Center
Mercerville, New Jersey, 08619
United States
Center of Rheumatology, Immunology & Arthritis
Ft. Lauderdale, Florida, 33334
United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
United States
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Radiant Research - Columbus
Columbus, Ohio, 43212
United States
Radiant Research - Dallas
Dallas, Texas, 75235
United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
United States
The Arthritis Center
Springfield, Illinois, 62704
United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730
United States
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, 27609
United States
Lewis-Gale Clinic
Salem, Virginia, 24153
United States
Rockford Clinical
Rockford, Illinois, 61103
United States
Arthritis Associates of CT
Danbury, Connecticut, 06810
United States
Doctor's Office
Hamilton, Ontario, L8N 2B6
Canada
Arthritis & Rheumatology Associates of Palm Beach
West Palm Beach, Florida, 33401
United States
Midwest Arthritis Center
Kalamazoo, Michigan, 49048
United States
Portland Medical Associates, P.C.
Portland, Oregon, 97224
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
Center for Assessment & Research of Erie
Erie, Pennsylvania, 16508
United States
Arthritis Consultants
St. Louis, Missouri, 63141
United States
Sarasota Arthritis Center, Rheumatology Division
Sarasota, Florida, 34239
United States
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055
United States
San Antonio Center for Clinical Research
San Antonio, Texas, 78229
United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Doctor's Office
Hamilton, Ontario, L8N 1Y2
Canada
STAT Research, Inc.
Dayton, Ohio, 45402
United States
Pacific Arthritis Center and Medical Group
Santa Maria, California, 93454
United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
United States
Coeur d'Alene Arthritis Clinic
Coeur D Alene, Idaho, 83814
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611
United States
Stamford Therapeutic Consortium
Stamford, Connecticut, 06905
United States
Phase III Clinical Research
Fall River, Massachusetts, 02720
United States
St. Louis Center for Clinical Research
St. Louis, Missouri, 63128
United States
Metropolitan Clinical Research
Falls Church, Virginia, 22044
United States
The Arthritis Program Research Group, Inc.
Newmarket, Ontario, L3Y 3R7
Canada
Radiant Research, Pharmaceutical Clinical Trials Division
Scottsdale, Arizona, 85251
United States
Oregon Health Sciences Center
Portland, Oregon, 97201
United States
Additional Information:
Study ID Numbers: 01-0-103;
Study Start Date: March 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036153
Other Rheumatoid Arthritis Studies:
1. Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
2. Safety and efficacy of a monoclonal antibody for treatment of rheumatoid arthritis.
3. Identification of Genes Associated with Lung Disease in Patients with Rheumatoid Arthritis
4. Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
5. Efficacy & Safety of an Investigational Drug + Methotrexate Compared to Methotrexate Alone in Patients with Rheumatoid Arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other Alabama Clinical Trials
Other Huntsville Clinical Trials
Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
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