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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00683930 |
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Date of registration:
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19/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
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Scientific title:
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A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00683930 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Germany
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India
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Israel
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Switzerland
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pemphigus Vulgaris (PV)
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Intervention(s)
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Drug: Placebo
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Drug: Mycophenolate Mofetil (MMF) 3 g/Day
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Drug: Mycophenolate Mofetil 2 g/Day
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Primary Outcome(s)
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Percentage of Patients Achieving Responder Status at Week 52
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Time to Initial Response
[Time Frame: up to 52 weeks]
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Duration of Prednisone Maintenance Dosing
[Time Frame: 52 weeks]
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Time to Sustained Response
[Time Frame: up to 52 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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