High-Dose Intravenous (IV) Cyclophosphamide Versus Monthly IV Cyclophosphamide

Completed · Phase 3

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT00005778

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

100

Starts

2000-01-01

Expected to finish

2006-04-01

Last updated by the study team

2008-11-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Johns Hopkins University Division of Rheumatology — Baltimore, Maryland, United States
• Drexel University School of Medicine, Division of Hematology/Oncology — Philadelphia, Pennsylvania, United States
• Medical College of Wisconsin, Division of Rheumatology — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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