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

This study has been completed.
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00683930
First received: May 19, 2008
Last updated: May 25, 2011
Last verified: May 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Pemphigus Steroids
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Patients Achieving Responder Status at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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:
  • Time to Initial Response [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 96
Study Start Date: May 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683930

  Show 26 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Aspreva Pharmaceuticals
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Clinical Study Report Synopsis  This link exits the ClinicalTrials.gov site

No publications provided by Hoffmann-La Roche

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

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00683930     History of Changes
Obsolete Identifiers: NCT00140127
Other Study ID Numbers: WX17796
Study First Received: May 19, 2008
Results First Received: November 18, 2009
Last Updated: May 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013