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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pemphigus Vulgaris (PV) Drug: Mycophenolate Mofetil 2 g/Day Drug: Mycophenolate Mofetil (MMF) 3 g/Day Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris
Study Start Date : May 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mycophenolate Mofetil (MMF) 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
 Drug: Mycophenolate Mofetil 2 g/Day
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
Experimental: Mycophenolate Mofetil (MMF) 3 g/Day
Mycophenolate mofetil 500 mg tablets; 6 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
Placebo Comparator: Placebo 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683930


Locations
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United States, California
Los Angeles, California, United States, 90095
United States, Georgia
Atlanta, Georgia, United States, 30033
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10010
Canada, Ontario
Toronto, Ontario, Canada, M5T 3A9
Canada, Quebec
Montreal, Quebec, Canada, H3G 1C6
Germany
Frankfurt Am Main, Germany, 60596
Heidelberg, Germany, 69115
Köln, Germany, 50937
Mainz, Germany, 55131
Münster, Germany, 48149
ULM, Germany, 89081
Israel
Haifa, Israel, 31096
Petach Tikva, Israel, 49100
Switzerland
Zürich, Switzerland, 8091
Turkey
Ankara, Turkey, 6100
Ankara, Turkey
Istanbul, Turkey
Ukraine
Crimea, Ukraine, 95006
Donetsk, Ukraine, 83099
Kiev, Ukraine, 252151
Lugnansk, Ukraine
Uzhgorod, Ukraine, 88011
United Kingdom
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Hoffmann-La Roche
Aspreva Pharmaceuticals
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00683930    
Obsolete Identifiers: NCT00140127
Other Study ID Numbers: WX17796
First Posted: May 26, 2008    Key Record Dates
Results First Posted: June 22, 2011
Last Update Posted: June 22, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
 Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action