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NCT02383589 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT02383589: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02383589 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02383589, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening. Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness. The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.
Interventions
- DRUG Rituximab
- DRUG Mycophenolate Mofetil
- DRUG Mycophenolate Mofetil Placebo
- DRUG Rituximab Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2015-05-26 |
| Est. Completion | 2019-10-29 |
| Phase | Phase 3 |
What the finished NCT02383589 record still lists
NCT02383589 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT02383589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02383589 about?
NCT02383589 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)". This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equiv...
What is the current status of trial NCT02383589?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2015-05-26. Estimated completion is 2019-10-29.
What interventions are being tested in trial NCT02383589?
The interventions under investigation include: Rituximab (DRUG), Mycophenolate Mofetil (DRUG), Mycophenolate Mofetil Placebo (DRUG), Rituximab Placebo (DRUG).
Who is sponsoring clinical trial NCT02383589?
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 NCT02383589's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 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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