Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Behcet Syndrome; Uveal Disease
Intervention: Etanercept, Methotrexate, Prednisolone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s): Fereydoun Davatchi, MD, Study Chair, Affiliation: Rheumatology Research Center, Medical Sciences/University of Teheran
Overall contact: Fereydoun Davatchi, MD, Phone: (98-21) 8802-6956, Email: fddh@davatchi.net
Summary
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
Clinical Details
Official title: Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
Secondary outcome: DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index
Detailed description:
To test in a randomized single blind control trial the efficacy of Etanercept in patients
with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with
Methotrexate and prednisolone
Eligibility
Minimum age: 16 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Fereydoun Davatchi, MD, Phone: (98-21) 8802-6956, Email: fddh@davatchi.net
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital), Tehran 14114, Iran, Islamic Republic of; Recruiting Fereydoun Davatchi, MD, Phone: (98-21)8802-6956, Email: fddh@davatchi.net Bahar Sadeghi, MD, Phone: (98-21)8802-6956, Email: bahar@bahars.net Fereydoun Davatchi, MD, Principal Investigator Farhad Shahram, MD, Principal Investigator Hormoz Shams, MD, Principal Investigator Abdolhadi Nadji, MD, Sub-Investigator Bahar Sadeghi, MD, Sub-Investigator Massoomeh Akhlaghi, MD, Sub-Investigator Tahereh Faezi, MD, Sub-Investigator
Additional Information
Rheumatology Research Center, Medical Sciences/University of Tehran
Related publications: Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-α blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400 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. Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145 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
Starting date: October 2010
Last updated: November 19, 2010
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