Status:
COMPLETED
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Aspreva Pharmaceuticals
Conditions:
Pemphigus Vulgaris (PV)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00683930
Start Date
May 1 2004
End Date
October 1 2008
Last Update
June 22 2011
Active Locations (26)
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1
Los Angeles, California, United States, 90095
2
Atlanta, Georgia, United States, 30033
3
Baltimore, Maryland, United States, 21205
4
St Louis, Missouri, United States, 63110