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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00931957

Enrollment

Registered

2009-07-02

Start date

2010-10-31

Completion date

2013-10-31

Last updated

2010-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behcet Syndrome, Uveal Disease

Keywords

Etanercept, Behcet's syndrome, Behcet's Disease, Ocular Lesions, Uveitis, Retinal Vasculitis

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

Interventions

DRUGEtanercept, Methotrexate, Prednisolone

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index	One Year

Countries

Iran

Contacts

Primary ContactFereydoun Davatchi, MD

fddh@davatchi.net(98-21) 8802-6956

Backup ContactBahar Sadeghi, MD

bahar@bahars.net(98-21) 8820-6956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026