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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 135 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02383589
The ClinicalTrials.gov registry entry for NCT02383589 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT02383589 reports 0 study locations.
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.
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