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

This study is currently recruiting participants.

Verified November 2010 by Tehran University of Medical Sciences

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2009

Last Updated Date

November 19, 2010

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00931957 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Behcet Syndrome
Uveal Disease

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Etanercept-MTX-Prednisolone
Methotrexate + Prednisolone + Etanercept

Intervention: Drug: Etanercept, Methotrexate, Prednisolone
B, MTX-Prednisolone
Methotrexate + Prednisolone

Intervention: Drug: Etanercept, Methotrexate, Prednisolone

Publications *

Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behçet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. No abstract available.
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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT00931957

Other Study ID Numbers ^ICMJE

860241-5807

Has Data Monitoring Committee

Yes

Responsible Party

Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences

Study Sponsor ^ICMJE

Tehran University of Medical Sciences

Collaborators ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators ^ICMJE

Study Chair:

Fereydoun Davatchi, MD

Rheumatology Research Center, Medical Sciences/University of Teheran

Information Provided By

Tehran University of Medical Sciences

Verification Date

November 2010

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

To Top