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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00931957
First received: June 30, 2009
Last updated: November 19, 2010
Last verified: November 2010

June 30, 2009
November 19, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Recruiting
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
Both
16 Years to 60 Years
No
Contact: Fereydoun Davatchi, MD (98-21) 8802-6956 fddh@davatchi.net
Contact: Bahar Sadeghi, MD (98-21) 8820-6956 bahar@bahars.net
Iran, Islamic Republic of
 
NCT00931957
860241-5807
Yes
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