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

Behcet Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00931957
• Other study ID #: 860241-5807
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2009
• Last updated: November 19, 2010
• Start date: October 2010
• Est. completion date: October 2013

Study information

• Verified date: November 2010
• Source: Tehran University of Medical Sciences
• Contact: Fereydoun Davatchi, MD
• Phone: (98-21) 8802-6956
• Email: fddh[@]davatchi.net
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behcet Syndrome
• Uveal Disease

Intervention

Drug:
• Etanercept, 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

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. — View Citation

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

Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145

Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-a blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis		One Year	No
Secondary	DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index		One Year	No

External Links

•   Rheumatology Research Center, Medical Sciences/University of Tehran