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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: |
NCT00931957 |
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Date of registration:
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30/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
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Scientific title:
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Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00931957 |
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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: Single Blind (Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Fereydoun Davatchi, MD |
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Address:
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Telephone:
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(98-21)8802-6956 |
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Email:
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fddh@davatchi.net |
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Affiliation:
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Name:
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Fereydoun Davatchi, MD |
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Address:
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Telephone:
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(98-21) 8802-6956 |
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Email:
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fddh@davatchi.net |
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Affiliation:
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Name:
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Fereydoun Davatchi, 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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Rheumatology Research Center, Medical Sciences/University of Teheran |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
- Active posterior uveitis and/or retinal vasculitis
Exclusion Criteria:
- Visual acuity inferior to 1/10 on Snellen chart
- Being under cytotoxic drugs or having received them in the past 2 months
- Not being able to follow the one year treatment and the regular follow ups
Age minimum:
16 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Behcet Syndrome
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Uveal Disease
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Intervention(s)
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Drug: Etanercept, Methotrexate, Prednisolone
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Primary Outcome(s)
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Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
[Time Frame: One Year]
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Secondary Outcome(s)
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DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index
[Time Frame: One Year]
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Secondary ID(s)
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860241-5807
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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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