Purpose: To evaluate the effect of various disease-modifying therapies (DMTs) on quality of life in multiple sclerosis (MS).
Design: Three-arm parallel study with balanced randomization.
Participants: Ninety newly diagnosed, definite MS subjects referred to Ghaem Medical Center, Mashhad, Iran were enrolled into this study between 2006 and 2009.
Method: Patients were randomly allocated into three DMT groups; Avonex, Rebif and Betaferon. Health-related quality of life was assessed in MS patients at baseline and 12 months after treatment with DMTs using the MSQOL-54 questionnaire.
Patients were excluded if they had history of substance abuse, treatment with any other type of DMTs or had any signs of depression using semi-structural psychiatric interviews as well as the Beck Depression Inventory.
Treatment protocol
Patients were randomly assigned using a computer-generated list of random numbers to receive three distinct commercially available forms of interferon beta; Avonex, Rebif, and Betaferon.
Avonex was administered 30mcg once per week via intramuscular injection. Rebif was administered 44mcg three times per week via subcutaneous injection. Betaferon was administered 0.25mg every other day via subcutaneous injection. Patients (or their caregivers) were trained by the study neurologist (MRA) to self-administer their assigned medication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404195280N16
Registration date:2014-04-26, 1393/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-26, 1393/02/06
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2006-07-23, 1385/05/01
Expected recruitment end date
2009-07-23, 1388/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The therapeutic effect of Avonex, Rebif and Betaferon on disability and quality of life in multiple sclerosis: A Randomized Clinical Trial
Public title
The therapeutic effect of Avonex, Rebif and Betaferon on disability and quality of life in multiple sclerosis: A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: newly diagnosed MS subjects.
Exclution criteria: had history of substance abuse;treatment with any other type of DMTs ; had any signs of depression.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreish building, Daneshgah Street.
City
Mashhad
Postal code
Approval date
2006-07-19, 1385/04/28
Ethics committee reference number
84394
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
disability
Timepoint
baseline and 12 months after treatment
Method of measurement
The expanded disability status scale (EDSS)
2
Description
quality of life
Timepoint
baseline and 12 months after treatment
Method of measurement
MSQOL-54 questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Avonex was administered 30mcg once per week via intramuscular injection
Category
Treatment - Drugs
2
Description
Rebif was administered 44mcg three times per week via subcutaneous injection
Category
Treatment - Drugs
3
Description
Betaferon was administered 0.25mg every other day via subcutaneous injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ardakanian Marjan
Street address
Ghoreish building, Daneshgah street.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Ghaem Hospital
Full name of responsible person
Dr Elias Orouji
Position
MD
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1712 4184
Fax
Email
pbsrc@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Naghmeh Mokhber
Position
Professor
Other areas of specialty/work
Street address
Ibn-E- Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
mokhbern@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Nejati
Position
MSc
Other areas of specialty/work
Street address
Ebn-e-Sina Hospital.
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
+98 51 1712 4184
Email
nejatir2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)