Behcet Syndrome Clinical Trial
Official title:
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital) | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences | Wyeth is now a wholly owned subsidiary of Pfizer |
Iran, Islamic Republic of,
Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behçet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. — View Citation
Davatchi F, Shams H, Nadji A, Jamshidi AR, Akhlaghi M, Sadeghi Abdollahi B, Ziaie N, Akbarian M, Gharibdoost F. Management of ocular manifestations of Behcet's Disease: outcome with cytotoxic drugs. APLAR Journal of Rheumatology 2005; 8: 119-123
Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145
Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-a blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis | One Year | No | |
Secondary | DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index | One Year | No |
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