NCT00683930

A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pemphigus Vulgaris (PV)

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil 2 g/Day	Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
DRUG	Mycophenolate Mofetil (MMF) 3 g/Day	Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
DRUG	Placebo	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

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-05-26
• Last updated: 2011-06-22
• Results posted: 2011-06-22

Locations

26 sites across 8 countries: United States, Canada, Germany, Israel, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom