Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Placebo
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Petah Tikva, Israel, 49100
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:16:01 PM


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