Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
NCT ID: NCT00931957
Last Updated: 2010-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2010-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Etanercept-MTX-Prednisolone
Methotrexate + Prednisolone + Etanercept
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.
B, MTX-Prednisolone
Methotrexate + Prednisolone
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active posterior uveitis and/or retinal vasculitis
Exclusion Criteria
* 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
16 Years
60 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Tehran University of Medical Sciences
OTHER
Responsible Party
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Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigators
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Fereydoun Davatchi, MD
Role: STUDY_CHAIR
Rheumatology Research Center, Medical Sciences/University of Teheran
Locations
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Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Fereydoun Davatchi, MD
Role: primary
Bahar Sadeghi, MD
Role: backup
References
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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
Related Links
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Rheumatology Research Center, Medical Sciences/University of Tehran
Other Identifiers
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860241-5807
Identifier Type: -
Identifier Source: org_study_id