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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: |
NCT00664599 |
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Date of registration:
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20/04/2008 |
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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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Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease
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Scientific title:
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Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study) |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00664599 |
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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: Single Blind (Outcomes Assessor), 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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Iran, Islamic Republic of
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Contacts
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Name:
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Hormoz Shams, 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, Tehran University for Medical Sciences |
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Name:
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Cheyda Chams-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, Tehran University for Medical Sciences |
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Name:
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Farhad Shahram, 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, Tehran University for Medical Sciences |
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Name:
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Mozhgan Rezaipoor, 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, Tehran University for Medical Sciences |
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Name:
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Bahar Sadeghi, 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, Tehran University for Medical Sciences |
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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, Tehran University for Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
- Having active ocular lesions (posterior and/or retinal vasculitis)
- Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg
Exclusion Criteria:
- Visual acuity less than 1/10 on Snellen chart
- Antecedent of allergic reaction to any component of the therapeutic regimen
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Behcet's Syndrome
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Intervention(s)
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Drug: Rituximab
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Drug: Cytotoxic Combination
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Primary Outcome(s)
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Visual acuity
[Time Frame: 6 months]
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Secondary Outcome(s)
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Total Adjusted Disease Activity Index (TADAI)
[Time Frame: 6 months]
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Inflammatory index for retinal vasculitis, especially for edema
[Time Frame: 6 months]
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Inflammatory index for posterior uveitis
[Time Frame: 6 months]
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Secondary ID(s)
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132/12487
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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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