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

Tehran University of Medical Sciences

Status: Unknown

Conditions: Uveal Disease; Behcet Syndrome

Treatments: Drug: Etanercept, Methotrexate, Prednisolone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00931957

860241-5807

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Etanercept-MTX-Prednisolone

Active Comparator group

Description:

Methotrexate + Prednisolone + Etanercept

Treatment:

Drug: Etanercept, Methotrexate, Prednisolone

B, MTX-Prednisolone

Other group

Description:

Methotrexate + Prednisolone

Treatment:

Drug: Etanercept, Methotrexate, Prednisolone