|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Astellas Pharma Inc |
|---|---|
| Collaborator: |
Astellas Pharma US, Inc. |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00036153 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Tacrolimus (Prograf®) Drug: Methotrexate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 210 |
| Study Start Date: | March 2002 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Rheumatology Associates of North Alabama | |
| Huntsville, Alabama, United States, 35801 | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, Arizona | |
| Radiant Research, Pharmaceutical Clinical Trials Division | |
| Scottsdale, Arizona, United States, 85251 | |
| United States, California | |
| Pacific Arthritis Center and Medical Group | |
| Santa Maria, California, United States, 93454 | |
| Boling Clinical Trials | |
| Rancho Cucamonga, California, United States, 91730 | |
| San Diego Arthritis & Osteoporosis Medical Clinic | |
| San Diego, California, United States, 92120 | |
| United States, Connecticut | |
| Stamford Therapeutic Consortium | |
| Stamford, Connecticut, United States, 06905 | |
| Arthritis Associates of CT | |
| Danbury, Connecticut, United States, 06810 | |
| United States, Florida | |
| Center of Rheumatology, Immunology & Arthritis | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| Arthritis & Rheumatology Associates of Palm Beach | |
| West Palm Beach, Florida, United States, 33401 | |
| Arthritis Center | |
| Palm Harbor, Florida, United States, 34684 | |
| Sarasota Arthritis Center, Rheumatology Division | |
| Sarasota, Florida, United States, 34239 | |
| United States, Idaho | |
| Coeur d'Alene Arthritis Clinic | |
| Coeur D'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Illinois Bone & Joint Institute | |
| Morton Grove, Illinois, United States, 60053 | |
| The Arthritis Center | |
| Springfield, Illinois, United States, 62704 | |
| Rockford Clinical | |
| Rockford, Illinois, United States, 61103 | |
| Northwestern Center for Clinical Research | |
| Chicago, Illinois, United States, 60611 | |
| Decatur Memorial Hospital | |
| Decatur, Illinois, United States, 62526 | |
| United States, Maryland | |
| Arthritis & Osteoporosis Center of Maryland | |
| Frederick, Maryland, United States, 21702 | |
| United States, Massachusetts | |
| Phase III Clinical Research | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Michigan | |
| Midwest Arthritis Center | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Missouri | |
| St. Louis Center for Clinical Research | |
| St. Louis, Missouri, United States, 63128 | |
| Arthritis Consultants | |
| St. Louis, Missouri, United States, 63141 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Arthritis Regional Research Center | |
| Mercerville, New Jersey, United States, 08619 | |
| New Jersey Physicians, LLC | |
| Passaic, New Jersey, United States, 07055 | |
| United States, North Carolina | |
| North Carolina Arthritis & Allergy Care Center | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Radiant Research - Columbus | |
| Columbus, Ohio, United States, 43212 | |
| STAT Research, Inc. | |
| Dayton, Ohio, United States, 45402 | |
| United States, Oregon | |
| Portland Medical Associates, P.C. | |
| Portland, Oregon, United States, 97224 | |
| Oregon Health Sciences Center | |
| Portland, Oregon, United States, 97201 | |
| PRO Research | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Center for Assessment & Research of Erie | |
| Erie, Pennsylvania, United States, 16508 | |
| Rheumatic Disease Associates | |
| Willow Grove, Pennsylvania, United States, 19090 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Central Pennsylvania Clinical Research | |
| Mechanicsburg, Pennsylvania, United States, 17055 | |
| Clinical Research Center of Reading, LLP | |
| West Reading, Pennsylvania, United States, 19611 | |
| United States, Texas | |
| San Antonio Center for Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| Radiant Research - Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Utah | |
| Physicians Research Options, L.C. | |
| Sandy, Utah, United States, 84070 | |
| United States, Virginia | |
| Metropolitan Clinical Research | |
| Falls Church, Virginia, United States, 22044 | |
| Lewis-Gale Clinic | |
| Salem, Virginia, United States, 24153 | |
| Canada, Ontario | |
| Doctor's Office | |
| Hamilton, Ontario, Canada, L8N 1Y2 | |
| Doctor's Office | |
| Hamilton, Ontario, Canada, L8N 2B6 | |
| The Arthritis Program Research Group, Inc. | |
| Newmarket, Ontario, Canada, L3Y 3R7 | |
More Information
| Study ID Numbers: | 01-0-103 |
| Study First Received: | May 8, 2002 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00036153 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Tacrolimus, Prograf®, FK506 |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Tacrolimus Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |
