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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Wi

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 Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of Patients Achieving Responder Status at Week 52 [ Time Frame: 52 weeks ]

The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group


Original Primary Outcome: Percentage of patients with responder status [ Time Frame: Week 52 ]

Current Secondary Outcome:

  • Time to Initial Response [ Time Frame: up to 52 weeks ]
    Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)
  • Time to Sustained Response [ Time Frame: up to 52 weeks ]
    Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.
  • Duration of Prednisone Maintenance Dosing [ Time Frame: 52 weeks ]
    The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.


Original Secondary Outcome:

  • Number of days a patient maintains a prednisone dose of <= 10mg/dday, in the absence of a new persistent lesion [ Time Frame: Throughout study ]
  • Time to relapse [ Time Frame: Event driven ]
  • Time to Initial Response [ Time Frame: Event driven ]
  • AEs, lab parameters, vital signs [ Time Frame: Throughout study ]


Information By: Hoffmann-La Roche

Dates:
Date Received: May 19, 2008
Date Started: May 2004
Date Completion:
Last Updated: May 25, 2011
Last Verified: May 2011