Trial information
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Status: No longer recruiting
Protocol number: WX17796
Sponsor: Hoffmann-La Roche; Aspreva Pharmaceuticals Corporation
Company division: Pharmaceutical
Official Scientific 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.
Brief summary: This study will assess the efficacy and safety of CellCept(1g or 1.5g po bid for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients will undergo gradual dose reduction of corticosteroids, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
64.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Pemphigus Vulgaris (PV)
Intervention type: Drug
Intervention name: mycophenolate mofetil [Cellcept]
Primary outcome: 1. Percentage of patients with responder status
Time frame: Week 52
Key secondary outcomes: 1. Number of days a patient maintains a prednisone dose of <= 10mg/dday, in the absence of a new persistent lesion Time frame: Throughout study
2. Time to relapse Time frame: Event driven
3. Time to initial response Time frame: Event driven
4. AEs, lab parameters, vital signs Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: May, 2004
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Canada
Germany
India
- Ahmedabad
- Chandigarh
- Mumbai
- New Delhi
Israel
Turkey
Ukraine
- Crimea
- Kiev
- Lugnansk
- Uzhgorod
United Kingdom
United States
