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NCT00683930 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
NCT00683930: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00683930 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 96 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00683930, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
Study Summary
This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipated time on study treatment was 12 months, and the target sample size was \<100 individuals.
Primary Outcome
The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group
Interventions
- DRUG Placebo
- DRUG Mycophenolate Mofetil 2 g/Day
- DRUG Mycophenolate Mofetil (MMF) 3 g/Day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00683930 record still lists
NCT00683930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00683930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00683930 about?
NCT00683930 is a clinical study titled "A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)". This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to trea...
What is the current status of trial NCT00683930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2004-05. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00683930?
The interventions under investigation include: Placebo (DRUG), Mycophenolate Mofetil 2 g/Day (DRUG), Mycophenolate Mofetil (MMF) 3 g/Day (DRUG).
Who is sponsoring clinical trial NCT00683930?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00683930's enrollment target sits among peer trials
96 1718th of 2000 higher than 282 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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