Comparison of the efficacy of Infliximab with cyclophosphamide on resistant uveitis in Behcet disease
Design
The investigation is designed as a double-blind pilot study on Behcet's patients with resistance to uveitis. Patients are randomly divided into two groups of ten by coin throwing. In one group the effect of cyclophosphamide and in the other group the effect of Infliximab will be evaluated according to the data protocol.
Settings and conduct
This study is done for the first time (in the form of a pilot) as a double blinded interventional study on 20 patients with Behcet's disease with refractory uveitis. The patients are randomly divided into two groups and will be treated. In the first group, treatment with infliximab, prednisolone, azathioprine and methotrexate or cyclosporine will be performed. The second group will be treated with cyclophosphamide, prednisolone, azathioprine and methotrexate or cyclosporine.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Behcet's disease
Resistance to commonly used uveitis
Retinal vesiculitis
Exclusion criteria:
Patient consent
Contraindication for prescribing infliximab or cyclophosphamide
No response to medication
Intervention groups
Group 1 includes Behcet patients with refractory uveitis treatment receiving Infliximab
Group 2 includes Behcet patients with refractory uveitis treatment receiving Endoxan
Main outcome variables
The total inflammatory activity index calculated based on parameters including the anterior uveitis, posterior uveitis and retinal vasculitis.
The inflammatory activity index of the disease is based on the visual acuity that is calculated based on parameters including the anterior uveitis, posterior uveitis and retinal vasculitis and visual acuity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038297N1
Registration date:2018-05-02, 1397/02/12
Registration timing:retrospective
Last update:2018-05-02, 1397/02/12
Update count:0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Azadeh Behnam Ghader
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3773 2240
Email address
abehnamghader@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Efficacy of Infliximab in comparison with Cyclophosphamide in refractory uveitis in Behcet’s diseases
Public title
Efficacy of Infliximab comparing with Cyclophosphamide in refractory uveitis in Behcet’s diseases
Patient dissatisfaction
Contraindications for administration of Infliximab or cyclophosphamide
Non response to medication
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment as coin throw
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study in order to blind the investigator, another person (a nurse) who does not participate in the study, will randomly assign both of Endoxan and Infliximab to each patient. Beyond this, drugs will be the same in color and equally used in serum to blind the patient. Patients’ information together with the type of drugs, will be stored in sealed envelopes and will be kept by the nurse until the end of follow-up and recording of the consequences or any serious complications for the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhouri Eslami Blvd, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
ZUMS.REC.1395.233
Health conditions studied
1
Description of health condition studied
Refractory uveitis in patients with Behcet
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease
Primary outcomes
1
Description
Total Inflammatory Activity Index
Timepoint
Measuring the total inflammatory activity index at the beginning of the study (prior to the intervention) and 2, 6 and 8 weeks after starting Infliximab, as well as measuring the index at the beginning of the study (before the intervention) and 1, 2 and 3 months later Start taking Endoxan
Method of measurement
Total inflammatory activity index is defined as right eye ([AU ×1] + [PU ×2] + [RV ×3]) + left eye ([AU ×1]+[PU ×2] + [RV ×3]) in which the PU stands for Posterior Uveitis, AU denotes Anterior Uveitis and RV shows Retinal Vasculitis.
2
Description
Total Adjusted Disease Activity Index
Timepoint
Measuring the total inflammatory activity index at the beginning of the study (prior to the intervention) and 2, 6 and 8 weeks after starting Infliximab, as well as measuring the index at the beginning of the study (before the intervention) and 1, 2 and 3 months later Start taking Endoxan
Method of measurement
Total Adjusted Disease Activity Index is defined as TIAI + right eye ([VA-10] ×2) + left eye ([VA-10] ×2) in which TIAI stands for Total inflammatory activity index and VA is the visual acuity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The 10-membered group receiving infliximab by intravenous injection at a dose of 3 mg / kg in weeks 0, 2, 6 and then 8 weeks later (a total of four injections) with methotrexate 25 mg weekly (or cyclosporine 5 mg / kg daily), azathioprine is given as mg / kg 3 and daily prednisone 1 mg / kg.
Category
Treatment - Drugs
2
Description
Control group: Control group: The 10-person group received Endoxan with intravenous injection of 1000 mg per month (four consecutive months) with azathioprine (mg / kg 3) daily, methotrexate 25 mg weekly (or cyclosporine 5 mg / kg daily) and Prednisolone 1 mg / kg daily Became
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Rheumatology of Valiasr Hospital in Zanjan
Full name of responsible person
Alireza Sadeghi
Street address
Education and treatment center of Valiasr, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Fax
+98 24 3377 0757
Email
valiasr@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=9
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
علیرضا شغلی
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Email
valiasr@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=9
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azadeh Behnam Ghader
Position
Internal Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Education and treatment center of Valiasr, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Email
abehnamghader@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azadeh Behnam Ghader
Position
Internal Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Education and treatment center of Valiasr, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Email
abehnamgheder@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azadeh Behnam Ghader
Position
Internal Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Education and treatment center of Valiasr, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
7797845157
Phone
+98 24 3377 0801
Email
abehnamghader@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
For patients, visual acuity, anterior uveitis, posterior uveitis and retinal vasculitis are measured before and during treatment, and the results are disseminated.
When the data will become available and for how long
Six months after the publication of the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
In order to continue the study or do the same scientific research
From where data/document is obtainable
Azadeh Behnam Ghader
What processes are involved for a request to access data/document
The interested scholar can receive the necessary information by email with the respective responsible person and provide the personal details and field of research after a maximum of one week.