Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease

Not Applicable

• Conditions: Behcet Syndrome; Uveal Disease
• Interventions: Drug: Etanercept, Methotrexate, Prednisolone

• Registration Number: NCT00931957
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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

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

Study Timeline

• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Study Start: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-19
• Last Update Posted: 2010-11-22
• Primary Completion: 2012-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etanercept-MTX-Prednisolone	Etanercept, Methotrexate, Prednisolone	Methotrexate + Prednisolone + Etanercept
B, MTX-Prednisolone	Etanercept, Methotrexate, Prednisolone	Methotrexate + Prednisolone

Primary Outcome Measures

Name	Time	Method
Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis	One Year

Secondary Outcome Measures

Name	Time	Method
DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index	One Year

Trial Locations

Locations (1)

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital); 🇮🇷 Tehran, Iran, Islamic Republic of