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

Roche

Status and phase: Completed; Phase 3

Conditions: Pemphigus Vulgaris (PV)

Treatments: Drug: Placebo; Drug: Mycophenolate Mofetil 2 g/Day; Drug: Mycophenolate Mofetil (MMF) 3 g/Day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683930

WX17796

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

Mycophenolate Mofetil (MMF) 2 g/Day

Experimental group

Description:

Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks

Treatment:

Drug: Mycophenolate Mofetil 2 g/Day

Mycophenolate Mofetil (MMF) 3 g/Day

Experimental group

Description:

Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks

Treatment:

Drug: Mycophenolate Mofetil (MMF) 3 g/Day

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo