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

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Behcet Syndrome; Uveal Disease

Intervention: Etanercept, Methotrexate, Prednisolone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Fereydoun Davatchi, MD, Study Chair, Affiliation: Rheumatology Research Center, Medical Sciences/University of Teheran

Overall contact:
Fereydoun Davatchi, MD, Phone: (98-21) 8802-6956, Email: fddh@davatchi.net

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

Clinical Details

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

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

Primary outcome: Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis

Secondary outcome: DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index

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

Eligibility

Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Fereydoun Davatchi, MD, Phone: (98-21) 8802-6956, Email: fddh@davatchi.net

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital), Tehran 14114, Iran, Islamic Republic of; Recruiting
Fereydoun Davatchi, MD, Phone: (98-21)8802-6956, Email: fddh@davatchi.net
Bahar Sadeghi, MD, Phone: (98-21)8802-6956, Email: bahar@bahars.net
Fereydoun Davatchi, MD, Principal Investigator
Farhad Shahram, MD, Principal Investigator
Hormoz Shams, MD, Principal Investigator
Abdolhadi Nadji, MD, Sub-Investigator
Bahar Sadeghi, MD, Sub-Investigator
Massoomeh Akhlaghi, MD, Sub-Investigator
Tahereh Faezi, MD, Sub-Investigator
Additional Information

Rheumatology Research Center, Medical Sciences/University of Tehran

Related publications:

Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Beh├žet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. No abstract available.

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

Starting date: October 2010
Last updated: November 19, 2010

Page last updated: November 27, 2014

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