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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: |
NCT00127764 |
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Date of registration:
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04/08/2005 |
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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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European Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus
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Scientific title:
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European Randomised Placebo-Controlled Trial of Adjuvant Oral Glucocorticoid Pulse Therapy in Pemphigus (Pempuls Trial) |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00127764 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Marcel F Jonkman, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Dermatology, University Medical Center Groningen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- New patients with diagnosis of pemphigus vulgaris
Exclusion Criteria:
- Diagnosis of pemphigus different from vulgaris type
- Current use of adjuvant treatment other than azathioprine. A wash out period of at
least 2 weeks is required before inclusion is acceptable.
- Presence of contra-indications for the use of high dose steroids
- No availability for follow-up.
- Concomitant diseases treated with oral steroids.
- Glucocorticoids administered for pemphigus vulgaris longer than two months.
- Presence of contra-indications for the use of azathioprine.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pemphigus
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Intervention(s)
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Drug: dexamethasone (50mg 1dd6, 3 consecutive days/month)
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Primary Outcome(s)
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The rate of complete remission with pulse therapy
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Number of weeks in complete remission after 12 months
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Secondary Outcome(s)
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Cumulative prednisolone use until 12 months
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Number of weeks in remission until 12 months
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Time from start of pulse therapy until initial control
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Number of adverse events reported
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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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