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

Primary Purpose

Behcet Syndrome, Uveal Disease

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Etanercept, Methotrexate, Prednisolone

About this trial

This is an interventional treatment trial for Behcet Syndrome focused on measuring Etanercept, Behcet's syndrome, Behcet's Disease, Ocular Lesions, Uveitis, Retinal Vasculitis

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Etanercept-MTX-Prednisolone

B, MTX-Prednisolone

Arm Description

Methotrexate + Prednisolone + Etanercept

Methotrexate + Prednisolone

Outcomes

Primary Outcome Measures

Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis

Secondary Outcome Measures

DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index

Full Information

NCT ID

NCT00931957

First Posted

June 30, 2009

Last Updated

November 19, 2010

Sponsor

Tehran University of Medical Sciences

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00931957

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

October 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tehran University of Medical Sciences

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behcet Syndrome, Uveal Disease

Keywords

Etanercept, Behcet's syndrome, Behcet's Disease, Ocular Lesions, Uveitis, Retinal Vasculitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Etanercept-MTX-Prednisolone

Arm Type

Active Comparator

Arm Description

Methotrexate + Prednisolone + Etanercept

Arm Title

B, MTX-Prednisolone

Arm Type

Other

Arm Description

Methotrexate + Prednisolone

Intervention Type

Drug

Intervention Name(s)

Etanercept, Methotrexate, Prednisolone

Other Intervention Name(s)

Enbrel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis

Time Frame

One Year

Secondary Outcome Measure Information:

Title

DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index

Time Frame

One Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fereydoun Davatchi, MD

Phone

(98-21) 8802-6956

fddh@davatchi.net

First Name & Middle Initial & Last Name or Official Title & Degree

Bahar Sadeghi, MD

Phone

(98-21) 8820-6956

bahar@bahars.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fereydoun Davatchi, MD

Organizational Affiliation

Rheumatology Research Center, Medical Sciences/University of Teheran

Official's Role

Study Chair

Facility Information:

Facility Name

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)

City

Tehran

ZIP/Postal Code

14114

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fereydoun Davatchi, MD

Phone

(98-21)8802-6956

fddh@davatchi.net

First Name & Middle Initial & Last Name & Degree

Bahar Sadeghi, MD

Phone

(98-21)8802-6956

bahar@bahars.net

First Name & Middle Initial & Last Name & Degree

Fereydoun Davatchi, MD

First Name & Middle Initial & Last Name & Degree

Farhad Shahram, MD

First Name & Middle Initial & Last Name & Degree

Hormoz Shams, MD

First Name & Middle Initial & Last Name & Degree

Abdolhadi Nadji, MD

First Name & Middle Initial & Last Name & Degree

Bahar Sadeghi, MD

First Name & Middle Initial & Last Name & Degree

Massoomeh Akhlaghi, MD

First Name & Middle Initial & Last Name & Degree

Tahereh Faezi, MD

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

background

PubMed Identifier

12918769

Citation

Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available.

Results Reference

background

Citation

Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145

Results Reference

background

Citation

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

Results Reference

background

Links:

URL

http://rrc.tums.ac.ir/

Description

Rheumatology Research Center, Medical Sciences/University of Tehran

Learn more about this trial

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

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