High-Dose Intravenous (IV) Cyclophosphamide Versus Monthly IV Cyclophosphamide
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)