Evaluation of the effect of fingolimod in relapsing-remitting multiple sclerosis compared to interferons
Design
"before and after" clinical trial without blinding performed on 50 patients with 1 year of follow-up
Settings and conduct
In this clinical trial, 50 patients with relapsing-remitting multiple sclerosis who were qualified based on inclusion and exclusion criteria were chosen. Patients received oral fingolimod for 12 months. Relapses within 1 year prior to study was recorded. Before initiation of therapy and 12 months after initiation of intervention, MRI scan was performed and expanded disability status scale(EDSS) was calculated. During treatment course, relapses(attacks) were assessed. During study, blood lymphocyte levels, liver enzymes were evaluated. The patients were monitored for side effects, macular edema, skin lesions and cardian arrhythmia. This study did not have blinding and it was performed in a tertiary hospital center in Mashhad which is a refferal center for multiple sclerosis.
Participants/Inclusion and exclusion criteria
inclusion criteria: age 18-50, patients with relapsing remitting multiple sclerosis, no response to first line therapies
exclusion criteria: severe systemic disease, varicella infection
Intervention groups
Intervention group: Daily use of 0.5 mg oral "Fingolimod" for 12 months. It is produced in Iran by "Osve" company with brand name of "fingolid". Chemical structure of findolimod is 2-amino-2-[2-(4 octylphenyl)ethyl]propane-1,3-diol(C19H33NO2).
Main outcome variables
Number of attacks; MRI(magnetic resonance imaging) lesions, expanded disability status scale(EDSS), lymphocyte count, liver enzymes(alanine aminotransferase and aspartate aminotransferase)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170604034325N1
Registration date:2018-11-29, 1397/09/08
Registration timing:retrospective
Last update:2018-11-29, 1397/09/08
Update count:0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Fatemeh Yavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 3103
Email address
mana_baba_110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2014-11-22, 1393/09/01
Actual recruitment end date
2017-02-19, 1395/12/01
Trial completion date
2018-01-10, 1396/10/20
Scientific title
Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis compared to interferons
Public title
Effects of fingolimod in treatment of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Relapsing remitting multiple sclerosis according to the McDonald criteria
No response or complications to first line multiple sclerosis(MS) drugs
Needle phobia
Age between 18 - 50
Informed consent form
Exclusion criteria:
Significant systemic disease, especially heart disease
Lymphopenia
Other chronic immune system diseases
Varicella zoster, HTLV-1 or TB infection
Macular edema
Malignancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
37
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, 94 Fakori Ave, Fakori Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.MUMS.fm.REC.1394.350
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
Proportion of relapse-free patients within 12 months of fingolimod therapy
Timepoint
Number of attacks before intervention and 12 months after initiation of intervention
Method of measurement
No specific measurement tool. Evaluation by a neurologist according to clinical and radiologic findings.
2
Description
T1 and T2 MRI lesions
Timepoint
MRI scan at baseline (before intervention) and 12 months after treatment with fingolimod
Method of measurement
Magnetic resonance imaging device
Secondary outcomes
1
Description
Expanded disability status scale (EDSS)
Timepoint
At baseline (before intervention) and 12 months after initiation of fingolimod therapy
Method of measurement
Expanded disability status scale test
2
Description
Blood lymphocyte count
Timepoint
At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy
Method of measurement
Blood sampling-measurement using cell count device
3
Description
Aspartate aminotransferase
Timepoint
At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy
Method of measurement
Blood sampling. Measurement using biochemistry auto-analyzer device
4
Description
Alanine aminotransferase
Timepoint
At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy
Method of measurement
Blood sampling. Measurement using biochemistry auto-analyzer device
Intervention groups
1
Description
Intervention group: Daily use of 0.5 mg oral "Fingolimod" for 12 months. It is produced in Iran by "Osve" company with brand name of "fingolid". Chemical structure of findolimod is 2-amino-2-[2-(4 octylphenyl)ethyl]propane-1,3-diol(C19H33NO2).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem hospital of Mashhad University of Medical Science
Full name of responsible person
Morteza Saeidi
Street address
Quaem hospital, Ahmad abad street, Dr. Ali Shariati square.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
Quaem.Medical.Center@mums.ac.ir
Web page address
http://quaem.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Science, Fakori Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
tafaghodim@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?