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

Overview

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 Title of Study: “Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: October 2012

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

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Etanercept-MTX-Prednisolone
    • Methotrexate + Prednisolone + Etanercept
  • Other: B, MTX-Prednisolone
    • Methotrexate + Prednisolone

Clinical Trial Outcome Measures

Primary Measures

  • Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
    • Time Frame: One Year

Secondary Measures

  • DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index
    • Time Frame: One Year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tehran University of Medical Sciences
  • Collaborator
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Provider of Information About this Clinical Study
    • Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
  • Overall Official(s)
    • Fereydoun Davatchi, MD, Study Chair, Rheumatology Research Center, Medical Sciences/University of Teheran
  • Overall Contact(s)
    • Fereydoun Davatchi, MD, (98-21) 8802-6956, fddh@davatchi.net

References

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

Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available.

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

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

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