Phase 3
Completed N=94
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Pemphigus Vulgaris (PV)
Source: ClinicalTrials.gov NCT00683930 ↗
Enrolled (actual)
94
Serious AEs
8.5%
Results posted
Jun 2011
Primary outcomePrimary: Percentage of Patients Achieving Responder Status at Week 52 — 63.9; 69.0 Percentage of Participants — p=0.6558
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving Responder Status at Week 52 |
63.9; 69.0 | 0.6558 |
| SECONDARY Time to Initial Response |
31.3; 24.1 | — |
| SECONDARY Time to Sustained Response |
46.0; 32.1 | — |
| SECONDARY Duration of Prednisone Maintenance Dosing |
136.5; 186.0; 185.0; 187.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00683930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.