Conditions: Pemphigus Vulgaris (PV)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 96
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks arm 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks arm 3: None

Interventions: intervention 1: Mycophenolate Mofetil 2 g/Day intervention 2: Mycophenolate Mofetil (MMF) 3 g/Day intervention 3: Placebo
Intervention descriptions: intervention 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks intervention 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks intervention 3: 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

Protocol document: