At a glance
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Randomized Trial of High-Dose IV Cyclophosphamide Versus Monthly IV Cyclophosphamide
In Brief
A Phase 3 clinical trial evaluating High-dose immunoablative therapy for Lupus Erythematosus, Systemic. Completed, enrolled 100 participants across 3 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
1. High dose cyclophosphamide for 4 days. 2. NIH monthly IV cytoxan for 6 months followed by quarterly for 2 years.