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

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ClinicalTrials.gov Identifier: NCT00683930
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 19, 2008
First Posted Date  ICMJE May 26, 2008
Results First Submitted Date  ICMJE November 18, 2009
Results First Posted Date  ICMJE June 22, 2011
Last Update Posted Date June 22, 2011
Study Start Date  ICMJE May 2004
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
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 Measures  ICMJE
 (submitted: May 23, 2008)
Percentage of patients with responder status [ Time Frame: Week 52 ]
Change History Complete list of historical versions of study NCT00683930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
  • 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 Measures  ICMJE
 (submitted: May 23, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pemphigus Vulgaris (PV)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Mycophenolate Mofetil (MMF) 2 g/Day
    Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
    Intervention: Drug: Mycophenolate Mofetil 2 g/Day
  • Experimental: Mycophenolate Mofetil (MMF) 3 g/Day
    Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
    Intervention: Drug: Mycophenolate Mofetil (MMF) 3 g/Day
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Beissert S, Mimouni D, Kanwar AJ, Solomons N, Kalia V, Anhalt GJ. Treating pemphigus vulgaris with prednisone and mycophenolate mofetil: a multicenter, randomized, placebo-controlled trial. J Invest Dermatol. 2010 Aug;130(8):2041-8. doi: 10.1038/jid.2010.91. Epub 2010 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2011)
96
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2008)
64
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients 18 to 70 years of age
  • Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids

Exclusion Criteria:

  • Female patients who are pregnant, breastfeeding, or lactating
  • Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
  • CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
  • Use of PV therapies other than those noted above, within 4 weeks prior to randomization
  • Use of topical corticosteroids within 2 weeks prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Israel,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT00683930
Other Study ID Numbers  ICMJE WX17796
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Disclosures Group, Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Aspreva Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP