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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00005778 |
This study compares the effectiveness of high-dose cyclophosphamide treatment with the "gold standard" treatment, monthly intravenous (IV) cyclophosphamide, in people with moderate to severe lupus that does not respond to high-dose corticosteroid therapy. We will give patients either IV cyclophosphamide (750 milligrams per square meter of body surface area) monthly for 6 months, followed by quarterly maintenance therapy, or high-dose IV cyclophosphamide (50 milligrams per kilogram body weight per day) for the first four days of the study. Patients will be followed for 24 months after therapy.
Condition | Intervention | Phase |
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Lupus Erythematosus, Systemic |
Drug: High-dose immunoablative therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Randomized Trial of High-Dose IV Cyclophosphamide Versus Monthly IV Cyclophosphamide |
Estimated Enrollment: | 100 |
Study Start Date: | January 2000 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Systemic lupus erythematosus (SLE or lupus) remains the prototypic autoimmune disease. Recent data show that its incidence has tripled since 1970 and its prevalence is 1 in 800 in Rochester, Minnesota. The natural history of lupus in our cohort is one of (1) relapsing/ remitting or (2) chronic activity, with only 17 percent of patients having periods of long quiescence. Over 75 percent of our African-American patients and 50 percent of our Caucasian patients have renal (kidney) involvement. Over 50 percent suffer permanent damage in one or more organ systems, and over 15 percent have renal failure.
Researchers at the National Institutes of Health (NIH) have shown that, for patients with severe lupus, especially with renal involvement, monthly IV pulse cyclophosphamide (500 to 1000 mg/m squared BSA) for 6 months followed by quarterly maintenance for 2 years is superior to high-dose corticosteroid treatment. NIH and others have shown that IV pulse cyclophosphamide is also effective for severe lupus in other organs. However, even monthly IV cyclophosphamide is not successful in all cases, and it, too, has associated toxicity, especially premature ovarian failure. For that reason, we have pioneered the use of high-dose immunoablative cyclophosphamide (200 mg/kg) in 10 patients with severe lupus refractory to other treatments.
Because of the initial success of this approach, including 75 percent complete response (on no medications) in renal lupus, we are conducting a controlled trial of high-dose immunoablative cyclophosphamide versus the "gold standard" monthly IV cyclophosphamide in people with moderate to severe lupus refractory to high-dose corticosteroid therapy. We will give patients either 750 mg/m2 of body surface area IV cyclophosphamide monthly for 6 months, followed by quarterly maintenance therapy (we will readmit patients, if necessary, for infections or other complications) or cyclophosphamide 50 mg/kg/d intravenously on days 1-4. We will calculate the dose of cyclophosphamide according to ideal body weight. Patients are scheduled to receive only one course of therapy. We will follow patients according to the infective guidelines for BMT.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
All patients with moderate-to-severe SLE will be considered for this trial, including women and minorities. SLE is too rare a disease in children for it to be feasible to include them. Patients must meet the following criteria to be eligible for participation in this clinical trial:
And/or:
And/or:
And/or:
Exlcusion Criteria:
United States, Maryland | |
Johns Hopkins University Division of Rheumatology | |
Baltimore, Maryland, United States, 21205 | |
United States, Pennsylvania | |
Drexel University School of Medicine, Division of Hematology/Oncology | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Wisconsin | |
Medical College of Wisconsin, Division of Rheumatology | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Michelle Petri, MD, MPH | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Michelle Petri Professor of Medicine ) |
Study ID Numbers: | N01 AR92243, NIAMS-046 |
Study First Received: | June 3, 2000 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00005778 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Systemic Lupus Erythematosus (SLE) Cytoxan Cyclophosphamide High-dose immunoablative therapy |
Autoimmune Diseases Immunologic Factors Lupus Erythematosus, Systemic Lupus Connective Tissue Diseases |
Antineoplastic Agents, Alkylating Cyclophosphamide Antirheumatic Agents Alkylating Agents Immunosuppressive Agents |
Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents |
Pharmacologic Actions Lupus Erythematosus, Systemic Therapeutic Uses Myeloablative Agonists Connective Tissue Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |