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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Behcet Syndrome, Uveal Disease

Intervention / Treatment
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* Drug: Etanercept, Methotrexate, Prednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etanercept-MTX-Prednisolone<br>Methotrexate + Prednisolone + Etanercept | Drug: Etanercept, Methotrexate, Prednisolone<br>* In: Arm A, Etanercept-MTX-Prednisolone: Etanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses. In Arm B: Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.<br>* Other names: Enbrel;|
| Other: B, MTX-Prednisolone<br>Methotrexate + Prednisolone | Drug: Etanercept, Methotrexate, Prednisolone<br>* In: Arm A, Etanercept-MTX-Prednisolone: Etanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses. In Arm B: Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etanercept, Behcet's syndrome, Behcet's Disease, Ocular Lesions, Uveitis, Retinal Vasculitis