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Sponsors and Collaborators: |
University Health Network, Toronto McGill University Health Center |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00470522 |
The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality and morbidity because the etiology of the disease is unknown. The general aim of this multicentre randomized placebo-controlled trial of low dose intermittent methotrexate with folic acid is to establish whether methotrexate shows efficacy and safety in controlling disease activity in SLE and preventing flares in disease activity or development of end-organ damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A Third aim will be to measure toxicity and utility of methotrexate with folic acid and to perform effectiveness and utility analyses.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: Methotrexate and folic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial. |
Enrollment: | 86 |
Study Start Date: | June 1995 |
Study Completion Date: | December 2001 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | Paul R. Fortin, MD | University Health Network, Toronto |
Study ID Numbers: | TAS Grant 95072 |
Study First Received: | May 2, 2007 |
Last Updated: | May 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00470522 |
Health Authority: | Canada: Health Canada |
methotrexate folic acid systemic lupus erythematosus steroid |
Folic Acid Autoimmune Diseases Lupus Erythematosus, Systemic |
Lupus Connective Tissue Diseases Methotrexate |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Hematinics Growth Substances Physiological Effects of Drugs Hematologic Agents Enzyme Inhibitors |
Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Vitamins Therapeutic Uses Abortifacient Agents Micronutrients Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |