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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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18 January 2016 |
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Main ID: |
NCT02258867 |
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Date of registration:
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02/10/2014 |
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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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Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
EYEGUARD™-US |
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Scientific title:
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A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02258867 |
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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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have characteristics of Behcet's disease consistent with International Criteria for
Behcet's disease
- Have a documented history of active uveitis with or without retinal vasculitis within
the past 12 months
- Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline
- Effective contraceptive measures
Exclusion Criteria:
- Infectious uveitis and masquerade syndromes
- End stage ocular disease
- History of allergic or anaphylactic reactions to monoclonal antibodies
- Active tuberculosis disease
- History of recurrent infection or predisposition to infection; active ocular
infection
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply
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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Behcet's Disease Uveitis
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Intervention(s)
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Drug: Placebo
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Drug: Gevokizumab
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Primary Outcome(s)
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Time to first ocular exacerbation
[Time Frame: Randomization through Day 280]
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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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