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NCT00005778 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Completed
Registry status
Phase 3
Development phase
100
Enrollment target

NCT00005778 is a Phase 3 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 100 participants.

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The verdict

NCT00005778, a Phase 3 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

COMPLETED
Registry status
Phase 3
Development phase
100 participants
Enrollment target

Study 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.

Interventions

  • DRUG High-dose immunoablative therapy

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2000-01
Est. Completion 2006-04
Phase Phase 3

What the Registry Record Tells You About NCT00005778

The ClinicalTrials.gov registry entry for NCT00005778 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which High-dose immunoablative therapy is the first listed.

NCT00005778 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00005778 about?

NCT00005778 is a clinical study titled "High-Dose Intravenous (IV) Cyclophosphamide Versus Monthly IV Cyclophosphamide". 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 cyclophospha...

What is the current status of trial NCT00005778?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2000-01. Estimated completion is 2006-04.

What interventions are being tested in trial NCT00005778?

The interventions under investigation include: High-dose immunoablative therapy (DRUG).

Who is sponsoring clinical trial NCT00005778?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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