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Status unknownNCT00931957Updated Nov 22, 2010

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

An interventional study of Etanercept, Methotrexate, Prednisolone in Behcet Syndrome and Uveal Disease, sponsored by Tehran University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-11-22.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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

Read the 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

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Conditions studied

  • Behcet Syndrome
  • Uveal Disease

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Keywords

  • Etanercept
  • Behcet's syndrome
  • Behcet's Disease
  • Ocular Lesions
  • Uveitis
  • Retinal Vasculitis
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In context

Behcet Syndrome

136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 70 interventional studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
  • Active posterior uveitis and/or retinal vasculitis

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Etanercept-MTX-Prednisolone

    Methotrexate + Prednisolone + Etanercept

    Drug: Etanercept, Methotrexate, Prednisolone

  • Other
    B, MTX-Prednisolone

    Methotrexate + Prednisolone

    Drug: Etanercept, Methotrexate, 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.

    Also known as: Enbrel

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What researchers measure

Primary outcomes

  1. Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis

    Time frame: One Year

Secondary outcomes

  1. DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index

    Time frame: One Year

07

Study locations

1 of 1 sites recruiting
  • Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
    Tehran, 14114, Iran, Islamic Republic of
    • Fereydoun Davatchi, MD · Contact · fddh@davatchi.net · (98-21)8802-6956
    • Bahar Sadeghi, MD · Contact · bahar@bahars.net · (98-21)8802-6956
    • 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
    Recruiting
08

References and documents

Publications

  • 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. PubMed 12918769 ↗
  • 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00931957
Lead sponsor
Tehran University of Medical Sciences
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jul 2, 2009
Start date
Oct 2010
Primary completion
Oct 2012 (estimated)
Completion
Oct 2013 (estimated)
Last update
Nov 22, 2010

Study contacts

Fereydoun Davatchi, MD
Contact
fddh@davatchi.net
(98-21) 8802-6956
Bahar Sadeghi, MD
Contact
bahar@bahars.net
(98-21) 8820-6956
Fereydoun Davatchi, MD
study chair · Rheumatology Research Center, Medical Sciences/University of Teheran

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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