A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
NCT ID: NCT00683930
Last Updated: 2011-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
2004-05-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mycophenolate Mofetil (MMF) 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
Mycophenolate Mofetil 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
Mycophenolate Mofetil (MMF) 3 g/Day
Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
Mycophenolate Mofetil (MMF) 3 g/Day
Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
Placebo
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
Interventions
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Mycophenolate Mofetil 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
Mycophenolate Mofetil (MMF) 3 g/Day
Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Aspreva Pharmaceuticals
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles, California, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
New York, New York, United States
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Cologne, , Germany
Frankfurt am Main, , Germany
Heidelberg, , Germany
Mainz, , Germany
Münster, , Germany
Ulm, , Germany
Haifa, , Israel
Petah Tikva, , Israel
Zurich, , Switzerland
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Crimea, , Ukraine
Donetsk, , Ukraine
Kiev, , Ukraine
Lugnansk, , Ukraine
Uzhhorod, , Ukraine
Leicester, , United Kingdom
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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WX17796
Identifier Type: -
Identifier Source: org_study_id
NCT00140127
Identifier Type: -
Identifier Source: nct_alias
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