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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00931957
Other study ID # 860241-5807
Secondary ID
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


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
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