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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 February 2015 |
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Main ID: |
NCT00431119 |
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Date of registration:
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02/02/2007 |
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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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Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
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Scientific title:
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A Comparison of Oral Methylprednisolone Plus Azathioprine or Mycophenolate Mofetil for the Treatment of Bullous Pemphigoid |
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Date of first enrolment:
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October 1997 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00431119 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Stefan Beissert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dermatology, Univ. of Muenster, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- clinical lesions suggestive of bullous pemphigoid
- subepidermal blistering upon histological analysis of skin biopsies
- linear deposition of IgG and C3 along the dermo-epidermal junction
- deposition of autoantibodies at the blister roof upon split-skin analysis
Exclusion Criteria:
- treatment with oral or topical corticosteroids, and other immunosuppressive drugs
during the previous four weeks
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bullous Pemphigoid
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Intervention(s)
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Drug: Azathioprine or Mycophenolate mofetil
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Primary Outcome(s)
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The cumulative total methylprednisolone doses and rate of remission.
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Secondary Outcome(s)
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Secondary outcome measures were safety profiles and duration of remission.
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Secondary ID(s)
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Beissert-BP#1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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