A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)
Public ClinicalTrials.gov record NCT02383589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02383589
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 135 participants
Conditions and interventions
Conditions
Interventions
- Mycophenolate Mofetil Placebo Drug
- Mycophenolate Mofetil Drug
- Rituximab Drug
- Rituximab Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 26, 2015 (Actual)
- Primary completion
- Nov 28, 2018 (Actual)
- Completion
- Oct 29, 2019 (Actual)
- Last update posted
- Nov 10, 2020
2015 – 2019
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | — |
| University of Arizona Medical Research Office | Tucson | Arizona | 85724 | — |
| UC Davis Department of Dermatology | Sacramento | California | 95816 | — |
| Univ of Calif-San Francisco | San Francisco | California | 94115 | — |
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Massachusetts General Hospital Dermatology | Boston | Massachusetts | 02114 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St Louis University Hospital | St Louis | Missouri | 63104 | — |
| Uni of NY and Roswell Cancer | Buffalo | New York | 14203 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Wake Forest Baptist Hospital Center for Dermatology Research | Winston-Salem | North Carolina | 27104 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health Sciences Uni | Portland | Oregon | 97239 | — |
| Penn University | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02383589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 10, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02383589 live on ClinicalTrials.gov.