The goal of this study is to evaluate the efficacy of Etanercept in Ocular Manifestations of Behcet's Disease. The main Inclusion Criteria is Behcet's Disease with Active posterior uveitis and/or retinal vasculitis. The main Exclusion Criteria is Being under cytotoxic drugs or having received them during the past 2 months. The study population is Behcet's patients whose disease was diagnosed according to the International Criteria for Behcet's disease (ICBD). To achieve the goal of the study, drug efficacy will be compared between 40 patients in each intervention and control arms. Patients will be randomly assigned to Etanercept or control group. Patients in the intervention group will receive Etanercept as 50 mg weekly IM injection for one year. All patients will receive Methotrexate as 15 mg weekly during the one year period of the trial and prednisolone as 30 mg daily, at the entry to the study. The dose of prednisolone will be adjusted and tapered if frank improvement or remission occurs. The duration of the study will be one year and visual acuity, disease activity index for anterior uveitis, posterior uveitis, retinal vasculitis, Total Inflammatory Activity Index (TIAI), and Total Adjusted Disease Activity Index (TADAI) will be measured for each eye and each patient every 2 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901292641N2
Registration date:2010-04-18, 1389/01/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-04-18, 1389/01/29
Registrant information
Name
Fereydoun Davatchi
Name of organization / entity
Rheumatology Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 6956
Email address
davachif@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Etanercept Versus Placebo in Ocular Manifestations of Behcet's Disease, a single Blind Controlled trial
Public title
Etanercept Versus Placebo in Ocular Manifestations of Behcet's Disease, a single Blind Controlled trial
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 16 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT00931957
Registration date
2010-01-26, 1388/11/06
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor-central university department-Ghods street-Keshavarz Avenue
City
Tehran
Postal code
Approval date
2008-02-16, 1386/11/27
Ethics committee reference number
5807
Health conditions studied
1
Description of health condition studied
Ocular involvement in Behcet's disease
ICD-10 code
M35.2
ICD-10 code description
behcet's disease
Primary outcomes
1
Description
Inflammatory Activity Index
Timepoint
2 months
Method of measurement
Total Inflammatory Activity Index
2
Description
Visual acuity
Timepoint
2 months
Method of measurement
Total Inflammatory Activity Index
Secondary outcomes
1
Description
Total Inflammatory Activity Index (TIAI)
Timepoint
2 months
Method of measurement
ophtalmologist's record
2
Description
Visual acuity
Timepoint
2 months
Method of measurement
ophtalmologist's record
3
Description
disease activity index for anterior uveitis
Timepoint
2 months
Method of measurement
ophtalmologist's record
4
Description
retinal vasculitis
Timepoint
2 months
Method of measurement
ophtalmologist's record,Top con TR angiography 50S, skiascopy,ocular coherenttomography
5
Description
Total Adjusted Disease Activity Index (TADAI)
Timepoint
2 months
Method of measurement
ophtalmologist's record
6
Description
disease activity index for posterior uveitis
Timepoint
2 months
Method of measurement
ophtalmologist's record
Intervention groups
1
Description
Etanercept 50 mg weekly for one year as well as Methotrexate as 15 mg weekly during the one year plus prednisolone as 30 mg daily, at the entry to the study. The dose will be adjusted and tapered if frank improvement or remission occurs
Category
Treatment - Drugs
2
Description
Methotrexate as 15 mg weekly during the one year plus prednisolone as 30 mg daily, at the entry to the study. The dose will be adjusted and tapered if frank improvement or remission occurs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Behcet's Clinic-Rheumatology Research Center
Full name of responsible person
Bahar Sadeghi, MD
Street address
Shariati hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Haniyeh Rostamabadian
Street address
Tehran University Of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Researcher-General Physician
Full name of responsible person
Bahar Sadeghi MD
Position
Rheumatology Research Center
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8802 6956
Fax
Email
bahar@bahars.net
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rheumatology Research Center
Full name of responsible person
Prof. Fereydoun Davatchi
Position
Doctorate degree, Rheumatology subspeciality
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8802 6956
Fax
Email
fddh@neda.net
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rheumatology Research Center
Full name of responsible person
Shima RoknSharifi MD.
Position
General Physician-Research Assistant
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8802 6956
Fax
Email
info@rrciran.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)