A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
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
1 other identifier
interventional
96
8 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2004
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
June 22, 2011
CompletedJune 22, 2011
May 1, 2011
4.4 years
May 19, 2008
November 18, 2009
May 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Achieving Responder Status at Week 52
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
52 weeks
Secondary Outcomes (3)
Time to Initial Response
up to 52 weeks
Time to Sustained Response
up to 52 weeks
Duration of Prednisone Maintenance Dosing
52 weeks
Study Arms (3)
Mycophenolate Mofetil (MMF) 2 g/Day
EXPERIMENTALMycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
Mycophenolate Mofetil (MMF) 3 g/Day
EXPERIMENTALMycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
Placebo
PLACEBO COMPARATORInterventions
Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks
Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks
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
You may qualify if:
- Adult patients 18 to 70 years of age
- Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Aspreva Pharmaceuticalscollaborator
Study Sites (26)
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Atlanta, Georgia, 30033, United States
Unknown Facility
Baltimore, Maryland, 21205, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
New York, New York, 10010, United States
Unknown Facility
Toronto, Ontario, M5T 3A9, Canada
Unknown Facility
Montreal, Quebec, H3G 1C6, Canada
Unknown Facility
Cologne, 50937, Germany
Unknown Facility
Frankfurt am Main, 60596, Germany
Unknown Facility
Heidelberg, 69115, Germany
Unknown Facility
Mainz, 55131, Germany
Unknown Facility
Münster, 48149, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Haifa, 31096, Israel
Unknown Facility
Petah Tikva, 49100, Israel
Unknown Facility
Zurich, 8091, Switzerland
Unknown Facility
Ankara, 6100, Turkey (Türkiye)
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Crimea, 95006, Ukraine
Unknown Facility
Donetsk, 83099, Ukraine
Unknown Facility
Kiev, 252151, Ukraine
Unknown Facility
Lugnansk, Ukraine
Unknown Facility
Uzhhorod, 88011, Ukraine
Unknown Facility
Leicester, LE1 5WW, United Kingdom
Unknown Facility
London, SE1 7EH, United Kingdom
Related Publications (1)
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.
PMID: 20410913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 26, 2008
Study Start
May 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
June 22, 2011
Results First Posted
June 22, 2011
Record last verified: 2011-05