CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 96 enrolled
Drug / intervention
Mycophenolate Mofetil 2 g/Day +2 moredrug
Likely dose
Mycophenolate Mofetil 2 g/Dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00683930
NCT00683930Phase 3Completed
CompareCT.gov

A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris

Hoffmann-La Roche·interventional·Posted May 26, 2008·Updated Jun 22, 2011

In Brief

A Phase 3 clinical trial evaluating Mycophenolate Mofetil 2 g/Day, Mycophenolate Mofetil (MMF) 3 g/Day, and 1 other intervention for Pemphigus Vulgaris (PV). Completed, enrolled 96 participants across 26 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPemphigus Vulgaris (PV)
CountriesCanada, Germany, Israel, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsAspreva Pharmaceuticals

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2008
Enrollment StartMay 1, 2004
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.1 years ago

Interventions

Mycophenolate Mofetil 2 g/Daydrug

Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks

Mycophenolate Mofetil (MMF) 3 g/Daydrug

Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks

Placebodrug

Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks