Colchicine is one of the common drugs in treating patients with Behcet’s disease. This project is conducted with the goal of examining the hypothesis of “effectiveness of adding 1mg Colchicine in Behcet’s disease patients with visual involvement was accomplished “. 80 Behcet’s patients with active visual involvement (in the form of posterior uveities or retinitis) referring to Behcet’s clinic in Shariati hospital whose problem was confirmed with new international criteria, if they had inclusion criteria of the study as well, after signing the consent will be assigned in 2 groups of intervention or control through a balanced block randomization. Participants of 2 groups are Behcet’s patients treating with appropriate dose of Prednizolone plus Methotrioxide+Azatioperin+pulse of Ciclophosphamide or combination of them. 1mg daily Colchicine will be added to the treating regimen. The patients will be visited every 3months by an ophthalmologist who is unaware of the group of patient. Total following time is 12 months in 5 visits. Visual acuity and retinal and posterior chamber inflammation index will be recorded and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808062641N1
Registration date:2010-01-21, 1388/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-21, 1388/11/01
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
2010-01-21, 1388/11/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of 1 mg/day Colchicine in the treatment of patients with ocular involvement in Behcet's Disease
Public title
The effectiveness of 1 mg/day Colchicine in the treatment of patients with ocular involvement in Behcet's Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosed Behcet's disease according to Iran's diagnostic tree criteria, signing the informed consent, not being pregnant or breast feeding, no history of malignancy, age more than16, posterior uveitis or retinitis in latest ophtalmological visit
Exclusion criteria: blood dyscrasia, pregnancy, low compliance
Age
From 17 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
EDRC's Commettee of Medical Ethics
Street address
Shariati hospital, Kargar Ave.
City
Tehran
Postal code
14117
Approval date
2009-10-26, 1388/08/04
Ethics committee reference number
FWA00001331
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
decrease/or not relapsing of ocular inflammatory index
Timepoint
3 months
Method of measurement
ophtalmologist's record
Secondary outcomes
1
Description
decrease/or not relapsing ocular IBDDAM
Timepoint
3 months
Method of measurement
Ophtalmologist's record
2
Description
retinal inflammatory index
Timepoint
3 months
Method of measurement
Ophtalmologist's record
3
Description
posterior chamber inflammatory index
Timepoint
3 months
Method of measurement
Ophtalmologist's record
Intervention groups
1
Description
Colchicine 1mg/day during one year PO
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
Asadollah Madadi
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
Rheumatology Research Center
Full name of responsible person
Bahar Sadeghi
Position
General physician-Research assistant- Researcher
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
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 Rokn Sharifi, 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)