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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931957
First Posted: July 2, 2009
Last Update Posted: November 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Tehran University of Medical Sciences
June 30, 2009
July 2, 2009
November 22, 2010
October 2010
October 2012   (Final data collection date for primary outcome measure)
Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis [ Time Frame: One Year ]
Same as current
Complete list of historical versions of study NCT00931957 on ClinicalTrials.gov Archive Site
DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index [ Time Frame: One Year ]
Same as current
Not Provided
Not Provided
 
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
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
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Behcet Syndrome
  • Uveal Disease
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
  • Active Comparator: Etanercept-MTX-Prednisolone
    Methotrexate + Prednisolone + Etanercept
    Intervention: Drug: Etanercept, Methotrexate, Prednisolone
  • B, MTX-Prednisolone
    Methotrexate + Prednisolone
    Intervention: Drug: Etanercept, Methotrexate, Prednisolone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
October 2013
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00931957
860241-5807
Yes
Not Provided
Not Provided
Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
Tehran University of Medical Sciences
Wyeth is now a wholly owned subsidiary of Pfizer
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Medical Sciences/University of Teheran
Tehran University of Medical Sciences
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP