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
  Purpose

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 Intervention
Behcet Syndrome
Uveal Disease
Drug: Etanercept, Methotrexate, Prednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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
Study First Received: June 30, 2009
Last Updated: November 19, 2010
Health Authority: Iran: Ethics Committee

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
Uveal Diseases
Mouth Diseases
Stomatognathic Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Disease
Syndrome
Uveitis, Anterior
Panuveitis
Uveitis
Vasculitis
Pathologic Processes
Methotrexate
TNFR-Fc fusion protein
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014