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The Comparison of clinical and side effects of Cinnaferon with Betaferon in patients with Relapsing- Remitting Multiple Sclerosis

Protocol summary

Summary
The aim of this study is the assessment of the efficacy and safety of Cinnaferon (Interferon beta-1- b, Subcutaneous, every other day) in patients with Relapsing- Remitting multiple sclerosis, over a 24-month period. This study will be undertaken in one center in Iran (Tehran, Sina Hospital). Relapsing-Remitting Multiple Sclerosis patients aged between 18-50 years and Expanded Disability Status Score (EDSS) between 0-5.5 will be included. These individuals are randomly divided into two groups. The intervention group receives Cinnaferon (250µgr / 8 mIU / day, subcutaneous, every other day) and the control group receives Betaferon (250µgr / 8 mIU / day, subcutaneous, every other day). To avoid any prejudgment, both patients group and physicians will not informed about the type of prescribed medication (Cinnaferon or Betaferon) , but they will be informed about chemical formulation of the drug as beta interferon1-b. The patients in both groups will be evaluated and compared by the number of relapses, the change in EDSS score, MRI findings and neutralizing antibodies. In addition, side effects will be systematically recorded for both treatments.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205221859N4
Registration date: 2012-10-09, 1391/07/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-10-09, 1391/07/18
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
2012-06-21, 1391/04/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of clinical and side effects of Cinnaferon with Betaferon in patients with Relapsing- Remitting Multiple Sclerosis
Public title
The Comparison of effects of Cinnaferon with Betaferon in Relapsing- Remitting Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
-Inclusion criteria: 1. Patients with Relapsing- Remitting Multiple Sclerosis based on McDonald's Criteria 2.age between 18-50 years old 3. Expanded Disability Status Scale (EDSS) 0- 5.5 4. Negative pregnancy test at baseline 5. Patients without Relapse in one last month 6. Signing consent form. -Exclusion criteria: 1. Being pregnant during trial or intention to get pregnant in start of trial 2.Psychiatric disease or major depression 3.The history of suicide4. Allergy or hypersensitivity reaction to injected medication in the start of trial 5. Treatment with Intravenous immunoglobulin (IVIG) within six months prior to trial 6. The history of plasma exchange within 6 months prior to trial 7.Using cytotoxic medication within six months prior to trial 8. The history of using beta interferon within three months prior to trial 9.Impaired Liver Function Tests (more than 2times normal range) 10.Leukopenia (less than half of the normal range) 11. Other types of multiple sclerosis except relapsing- remitting type 12. Association with other autoimmune diseases 13. The history of malignancy 14 .The history of chronic liver disease except Gilbert's syndrome 15. The history of renal dysfunction with creatinine (Cr) more than 1.1mg/dl 16. Patients with the history of fear from Magnetic resonance Imaging (MRI)or Claustrophobia 17 .The history of sensitivity to Gadolinium (Gd) 18. Patient participation in another clinical trial at the same time 19. Breastfeeding .
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: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method and process: All patients fulfilling inclusion criteria - without any exclusion item – will enter one of two study arms, Cinnaferon Vs. Betaferon, via a permuted block method, after they sign an informed consent letter. Permuted block method will create randomized numbers, one for each patient, in order to divide them in two complete equal arms with randomized based selection.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Vice chancellor for research ,Tehran University of Medical Sciences, Qods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-01-07, 1390/10/17
Ethics committee reference number
2248-ص-90-130

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Disseminated Multiple Sclerosis

Primary outcomes

1

Description
Relapse Rate
Timepoint
Before intervention and every month after intervention
Method of measurement
Physical examination done by neurologist and EDSS

Secondary outcomes

1

Description
EDSS Expanded Disability Status Scale
Timepoint
Before intervention and every month after intervention
Method of measurement
Physical examination done by neurologist based on revised Mc-Donald (2010)

2

Description
Number and size of plaques and their enhancement
Timepoint
Before intervention and every six months after intervention
Method of measurement
Magnetic resonance Imaging ( MRI )

3

Description
Neutralizing Antibodies
Timepoint
Before intervention and every six months after intervention
Method of measurement
measurement in peripheral blood

Intervention groups

1

Description
Amp Cinnaferon ,chemical formulation beta interferon1-b, (250µgr / 8 mIU / day, subcutaneous, every other day) for 24 months ,made in Cinnagen Pharmaceutical company in Islamic Republic Of Iran, generic name Amp Cinnaferon
Category
Treatment - Drugs

2

Description
Amp Betaferon ,chemical formulation beta interferon1-b, (250µgr / 8 mIU / day, subcutaneous , every other day)for 24 months, made in Bayer company in Germany, generic name Amp Betaferon
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr AmirReza Azimi
Street address
Hasan abad Sq. , Imam Khomeini St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cinnagen Pharmaceutical Company
Full name of responsible person
Dr Shiva Salami
Street address
No. 2, 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 Company
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research ,Tehran University of Medical Sciences
Full name of responsible person
-
Street address
Vice chancellor for research ,Tehran University of Medical Sciences, Qods St, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research ,Tehran University of Medical Sciences
Proportion provided by this source
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 Company
Full name of responsible person
Dr Shiva Salami
Position
General Physician/Clinical Research Manager
Other areas of specialty/work
Street address
No. 2, 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
Sina Hospital
Full name of responsible person
Dr Mohammad Ali 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
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr.Rozita Doosti
Position
General Physician/Researcher
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
ardavan5th@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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