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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pemphigus Vulgaris (PV)

In brief

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.

Key facts

Study ID

NCT00683930

Run by

Hoffmann-La Roche

People needed

96

Starts

2004-05-01

Expected to finish

2008-10-01

Last updated by the study team

2011-06-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients 18 to 70 years of age
• Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Cologne, Germany
• Study site — Frankfurt am Main, Germany
• Study site — Heidelberg, Germany
• Study site — Mainz, Germany
• Study site — Münster, Germany
• Study site — Ulm, Germany
• Study site — Haifa, Israel
• Study site — Petah Tikva, Israel
• Study site — Zurich, Switzerland
• Study site — Ankara, Turkey (Türkiye)
• Study site — Ankara, Turkey (Türkiye)
• Study site — Istanbul, Turkey (Türkiye)
• Study site — Crimea, Ukraine
• Study site — Donetsk, Ukraine
• Study site — Kiev, Ukraine
• Study site — Lugnansk, Ukraine
• Study site — Uzhhorod, Ukraine
• Study site — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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