Clinical trial NCT00683930: A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pemphigus Vulgaris (PV)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Aspreva Pharmaceuticals
First posted: 2008-05-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Patients Achieving Responder Status at Week 52
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to Initial Response
timeFrame: up to 52 weeks
measure: Time to Sustained Response
timeFrame: up to 52 weeks
measure: Duration of Prednisone Maintenance Dosing
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: St Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Frankfurt Am Main
country: Germany
city: Heidelberg
country: Germany
city: Köln
country: Germany
city: Mainz
country: Germany
city: Münster
country: Germany
city: ULM
country: Germany
city: Haifa
country: Israel
city: Petach Tikva
country: Israel
city: Zürich
country: Switzerland
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Crimea
country: Ukraine
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lugnansk
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.