The aim of this study is to compare the safety and efficacy of Iranian interferon beta-1b (Ziferon) with its original brand (Betaferon) in the patient with relapsing-remitting multiple sclerosis. This study contains following Subordinate aims:
1-Comparison of number of relapses during of study
2-Comparison of Disability progression according to EDSS in each group
3-Comparison of MRI parameters e.g. New plaques as well progressive plaques
The study will be randomized double-blind multi center
Study design:
The patient will be referred to the study center and will initially be examined by a neurologist or assistant of neurology. The patients will be briefed on the purpose of the study. The patients will be randomized into Ziferon or Betaferon groups after signing the generic informed consent form.
Inclusion criteria:
1. Patients diagnosed with RRMS
2. Age between18-50
3. EDSS range of 0 to 5.5
4. Two relapses during the last two years.
Exclusion criteria:
1-Unwanted pregnancy or decision for pregnancy during the study
2- Severe depression or psychological disorders
3- Suicide attempts
4- Sensitivity to interferon
5-Intra Venous Immuno Globuline (IVIG) infusion six months prior to study enrolment
6- Plasma exchange in the past six months
7- Injection of beta interferon in the past six months
The sample size will be 76 patients and the individual patients will be studied according to the study protocol for 2 years from their enrolment date.The study was blinded by removing labels of both Ziferon and Betaferon. Therefore, all of the persons involved in the study including patient, physician and nurse except the receptionist nurse were unaware of the products.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806102397N1
Registration date:2015-11-13, 1394/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Hooshmand Ilka
Name of organization / entity
Zist Daru Danesh Co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 0334
Email address
info@zistdaru.ir
Recruitment status
Recruitment complete
Funding source
Zistdaru Danesh Co.
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of safety and efficacy of Ziferon and Betaferon in patients with remitting -relapsing multiple sclerosis
Public title
Comparison of Ziferon and Betaferon in multiple sclerosis management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. Patients with Remitting -Relapsing Multiple Sclerosis (RRMS ) according to M.C. Donald criteria
2. Age between 18-50 years old
3. Expanded Disability Status Scale (EDSS) between 0-5.5
4. Completing informed consent
5. No relapse during last month
6. Negative pregnancy test
7. Having 2 attacks during last 2 years
Exclusion Criteria
1. Pregnancy
2. Severe depression
3. History of suicide
4. Hypersensitivity to interferon beta preparations
5. Receiving IVIG (Intravenous Immunoglobulin) in the previous 6 months
6. History of plasma exchange in the last six months
7. History of interferon beta using in the previous six months
8. History of cytotoxic drug using in the previous six months
9. Impaired liver enzymes
10. Leukopenia
11. Non RRMS
12. Concomitant other autoimmune diseases
13. History of malignancy
14. Chronic liver disease except Gilbert
15. Chronic renal failure (Creatinine>1.1)
16. Claustrophobia
17. Sensitivity to Gadolinium
18. Participating in another trial
19. Nursing
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Two arms of study are prescribed randomly either Betaferon or Ziferon in equal proportion. Neither the physician nor patient is informed about prescribed medicine so both groups are blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciences
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences. Enghelab street, Tehran-Iran
City
Tehran
Postal code
6451/14155
Approval date
2008-11-03, 1387/08/13
Ethics committee reference number
764/425
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Number of Relapses.
Timepoint
Before the study and every three months after the start of the study
Method of measurement
Examining Patients
2
Description
Change in Disability
Timepoint
Before the study and every three months after the start of the study
Method of measurement
EDSS
Secondary outcomes
1
Description
Number of new plaque and plaque enhancement in each group
Timepoint
Before the study and every six months after the start of the study
Method of measurement
MRI
2
Description
Neutralizing Antibody
Timepoint
Before the study and every six months after the start of the study
Method of measurement
cytopathic effect assay (CPE)
Intervention groups
1
Description
Intervention group: Ziferon 250 micrograms produced by Zistdaru Danesh (Iran), every other day subcutaneous injection for two years.
Category
Treatment - Drugs
2
Description
Control: Betaferon 250 micrograms produced by Schering (Germany), every other day subcutaneous injection for two years.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital- Tehran
Full name of responsible person
Mohammad Reza Gheini, Neurologist,Assistant Professor