Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036153
First received: May 8, 2002
Last updated: March 26, 2012
Last verified: December 2011
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
| Estimated Enrollment: | 210 |
| Study Start Date: | March 2002 |
| Study Completion Date: | January 2004 |
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 |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036153
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Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| Rheumatology Associates of North Alabama | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Radiant Research, Pharmaceutical Clinical Trials Division | |
| Scottsdale, Arizona, United States, 85251 | |
| United States, California | |
| Boling Clinical Trials | |
| Rancho Cucamonga, California, United States, 91730 | |
| San Diego Arthritis & Osteoporosis Medical Clinic | |
| San Diego, California, United States, 92120 | |
| Pacific Arthritis Center and Medical Group | |
| Santa Maria, California, United States, 93454 | |
| United States, Connecticut | |
| Arthritis Associates of CT | |
| Danbury, Connecticut, United States, 06810 | |
| Stamford Therapeutic Consortium | |
| Stamford, Connecticut, United States, 06905 | |
| United States, Florida | |
| Center of Rheumatology, Immunology & Arthritis | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| Arthritis Center | |
| Palm Harbor, Florida, United States, 34684 | |
| Sarasota Arthritis Center, Rheumatology Division | |
| Sarasota, Florida, United States, 34239 | |
| Arthritis & Rheumatology Associates of Palm Beach | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Idaho | |
| Coeur d'Alene Arthritis Clinic | |
| Coeur D'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Northwestern Center for Clinical Research | |
| Chicago, Illinois, United States, 60611 | |
| Decatur Memorial Hospital | |
| Decatur, Illinois, United States, 62526 | |
| Illinois Bone & Joint Institute | |
| Morton Grove, Illinois, United States, 60053 | |
| Rockford Clinical | |
| Rockford, Illinois, United States, 61103 | |
| The Arthritis Center | |
| Springfield, Illinois, United States, 62704 | |
| 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 | |
| PRO Research | |
| Eugene, Oregon, United States, 97401 | |
| Portland Medical Associates, P.C. | |
| Portland, Oregon, United States, 97224 | |
| Oregon Health Sciences Center | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Center for Assessment & Research of Erie | |
| Erie, Pennsylvania, United States, 16508 | |
| Central Pennsylvania Clinical Research | |
| Mechanicsburg, Pennsylvania, United States, 17055 | |
| Clinical Research Center of Reading, LLP | |
| West Reading, Pennsylvania, United States, 19611 | |
| Rheumatic Disease Associates | |
| Willow Grove, Pennsylvania, United States, 19090 | |
| United States, Texas | |
| Radiant Research - Dallas | |
| Dallas, Texas, United States, 75235 | |
| San Antonio Center for Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| 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 | |
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00036153 History of Changes |
| Other Study ID Numbers: | 01-0-103 |
| Study First Received: | May 8, 2002 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Tacrolimus, Prograf®, FK506 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Tacrolimus Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013