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
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Sponsor:
Hoffmann-La Roche
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
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Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
Percentage of patients with responder status [ Time Frame: Week 52 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Pemphigus Vulgaris (PV) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
96 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |