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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: Completed Phase 3 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2000-01 |
| Est. Completion | 2006-04 |
| Phase | Phase 3 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT00005778 record still lists
NCT00005778 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which High-dose immunoablative therapy is the first listed.
NCT00005778 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005778's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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