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Trial record 2 of 10 for:    Vasculitis Syndromes of the Central and Peripheral Nervous Systems

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

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ClinicalTrials.gov Identifier: NCT00931957
Recruitment Status : Unknown
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : July 2, 2009
Last Update Posted : November 22, 2010
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Tehran University of Medical Sciences

Brief 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

Condition or disease Intervention/treatment Phase
Behcet Syndrome Uveal Disease Drug: Etanercept, Methotrexate, Prednisolone Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Study Start Date : October 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2013


Arm Intervention/treatment
Active Comparator: Etanercept-MTX-Prednisolone
Methotrexate + Prednisolone + Etanercept
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.

Other Name: Enbrel

B, MTX-Prednisolone
Methotrexate + Prednisolone
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.

Other Name: Enbrel




Primary Outcome Measures :
  1. Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index [ Time Frame: One Year ]


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931957


Contacts
Contact: Fereydoun Davatchi, MD (98-21) 8802-6956 fddh@davatchi.net
Contact: Bahar Sadeghi, MD (98-21) 8820-6956 bahar@bahars.net

Locations
Iran, Islamic Republic of
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital) Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Fereydoun Davatchi, MD    (98-21)8802-6956    fddh@davatchi.net   
Contact: Bahar Sadeghi, MD    (98-21)8802-6956    bahar@bahars.net   
Principal Investigator: Fereydoun Davatchi, MD         
Principal Investigator: Farhad Shahram, MD         
Principal Investigator: Hormoz Shams, MD         
Sub-Investigator: Abdolhadi Nadji, MD         
Sub-Investigator: Bahar Sadeghi, MD         
Sub-Investigator: Massoomeh Akhlaghi, MD         
Sub-Investigator: Tahereh Faezi, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Medical Sciences/University of Teheran

Additional Information:
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. 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

Responsible Party: Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
ClinicalTrials.gov Identifier: NCT00931957     History of Changes
Other Study ID Numbers: 860241-5807
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: November 22, 2010
Last Verified: November 2010

Keywords provided by Tehran University of Medical Sciences:
Etanercept
Behcet's syndrome
Behcet's Disease
Ocular Lesions
Uveitis
Retinal Vasculitis

Additional relevant MeSH terms:
Behcet Syndrome
Vasculitis
Peripheral Nervous System Agents
Sensory System Agents
Uveal Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Methotrexate
Etanercept
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents