The objective of this study was to assess the efficacy and safety of Recigen (Interferon beta-1-a, Subcutaneous, 3 times per week) in patients with multiple sclerosis, over a 24 months period. This study will be undertaken in 3 centers in Iran (Tehran, Esfahan and Qazvin). Patients with mild to moderate Relapsing-Remitting Multiple Sclerosis aged between 18-50 years and Expanded Disability Status Score (EDSS) between 0-5.5 will be randomized to receive Rebif (12 mIU/day, 3 days per week) or Recigen (12 mIU/day, 3 days per week). The main efficacy measures will be the number of relapses, the change in EDSS score, MRI findings and neutralizing antibodies compared to baseline. In addition, side effects will be systematically recorded for both treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112201859N3
Registration date:2012-01-12, 1390/10/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-12, 1390/10/22
Registrant information
Name
Mohammad Ali Sahraian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8571
Email address
msahrai@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
CinnaGen Pharmaceutical Company, Tehran University of Medical Sciences
Expected recruitment start date
2008-03-05, 1386/12/15
Expected recruitment end date
2009-09-06, 1388/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of safety and Efficacy of ReciGen and Rebif in patients with Relapsing Multiple Sclerosis
Public title
The Comparison of ReciGen and Rebif in patients with Relapsing Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
-Inclusion Criteria:
1.Relapsing-Remitting MS patients based on McDonald's Criteria
2.ages between 18-50
3.EDSS=<5.5
4.Signing informed consent form
-Inclusion Criteria:
1.Pregnancy during trial or intention to get pregnant in start of trial
2.Psychiatric disease or major depression
3.Past history of Suicide
4.Allergy/hypersensitivity reaction to medication
5.IVIG treatment within 6 months prior to trial
6.Plasma Exchange within 6 months prior to trial
7.Cytotoxic Medication use during study
8.Impaired Liver Function Tests (3times Nl range)
9.Leukopenia (less than half the Nl range)
10.failure to follow-up for more than 4 weeks (with recording the reason)
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:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Qods St, Keshavarz Blv.
City
Tehran
Postal code
Approval date
2007-12-30, 1386/10/09
Ethics committee reference number
130/8020
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Relapse Rate
Timepoint
every month
Method of measurement
Physical examination done by neurologist
Secondary outcomes
1
Description
EDSS
Timepoint
Every month
Method of measurement
Physical Examination done by Neurologist
2
Description
number/size of plaques and their enhancement
Timepoint
Every 6 months
Method of measurement
MRI
3
Description
Neutralizing Antibodies
Timepoint
Every 6 months
Method of measurement
measurment in peripheral blood (NU/ml)
Intervention groups
1
Description
Rebif Ampule, 12MIU, 3 times a week (Saturday,Monday,Wednesday), for 24 months
Category
Treatment - Drugs
2
Description
Recigen Ampule, 12MIU, 3 times a week (Saturday,Monday,Wednesday), for 24 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Dr AmirReza Azimi
Street address
Jalal al Ahmad cross, Northern Kargar St.
City
Tehran
2
Recruitment center
Name of recruitment center
Buali Hospital
Full name of responsible person
Dr AmirReza Azimi
Street address
City
Qazvin
3
Recruitment center
Name of recruitment center
Azzahra Hospital
Full name of responsible person
Dr Masood Etemadifar
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cinnagen Pharmaceutical
Full name of responsible person
Dr Shiva Salami
Street address
N2, 7th Alley, Simay-e-Iran St, Shahrak-e-Qods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cinnagen Pharmaceutical
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
Cinnagen Pharmaceutical
Full name of responsible person
Dr Shiva Salami
Position
General Physician/Clinical Research Manager
Other areas of specialty/work
Street address
N2, 7th Alley, Simay-e-Iran St, Shahrak-e-Qods
City
Tehran
Postal code
1466998741
Phone
+98 21 8856 1556
Fax
Email
shiva.salami45@yahoo.com;salamis@cinnagen.com
Web page address
www.cinnagen.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr AmirReza Azimi
Position
Neurologist/Assistant Professor
Other areas of specialty/work
Street address
Sina Hospital,Hasan abad Sq. , Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Fax
+98 21 6634 8570
Email
amirreza_azimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr MohammadAli Sahraian
Position
Neurologist-MS Fellowship/Associate Professor
Other areas of specialty/work
Street address
Sina Hospital,Hasan abad Sq. , Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Fax
+98 21 6634 8570
Email
msahrai@sina.tums.ac.ir, sahraian1350@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)