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

Phase 3 Completed 96 enrolled Hoffmann-La Roche Aspreva Pharmaceuticals · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-05
Primary completion: 2008-10
Completion: 2008-10

Outcome

Missed primary endpoint

registry p = 0.6558; Treatment difference in response rate 5.1 (97.5% CI -17.4 to 27.6) NCT00683930 ↗

paper Although MMF did not show an advantage on the primary end point PMID 20410913 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Mofetil	Small molecule	2 g	Oral
Subject	Mycophenolate Mofetil	Small molecule	3 g	Oral