If Fingolimod is effective to the extent of Interferon in reducing of relapse and improving of disease disability ،it can be used instead of interferon
Design
Clinical trial phase 2، without control group ،sample size 30 participants
Settings and conduct
The study will be conducted on Razi and Emam Reza hospitals' patients in Tabriz
Participants/Inclusion and exclusion criteria
Relapsing Remitting multiple sclerosis،patients' age between 18 to 55 years old،disease disability score between 0 to 5.5
Intervention groups
All the patients in this study will receive Fingolimod
Main outcome variables
determining of disease disability،determining of relapse rate of disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180204038608N1
Registration date:2018-03-21, 1397/01/01
Registration timing:registered_while_recruiting
Last update:2018-03-21, 1397/01/01
Update count:0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Sheida Shaafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3381 0810
Email address
shaafis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Fingolimod whit Interferon Therapy in Patients with Multiple Sclerosis
Public title
Effect of Fingolimod in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age should be between 18 to 55 years old
The type of disease should be Relapsing Remitting
There should not be any evidence of relapse in the past 30 days
EDSS score should be between 0 to 5.5
Exclusion criteria:
Have Relapse or use of Corticosteroids in the past 30 days
Have an active infection
Have a history of diabetes
Have cardiac problems and use of anti arrhythmic drugs
Taking drugs such as Azathioprine and Methotrexate
WBCs less than 3500 and lymphocyte count less than 800
Taking heart beat reducer drugs
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Tabriz University of Medical Sciences
Street address
No.2,centeral building,university of Medical Sciences,Golgasht ave,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
33364658
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.TBZMED.REC.1395.404
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
Disease disability score,Annualized Relapse rate
Timepoint
Determining of Disease disability score at the beginning of study and after one year,Relapse rate during the past year and one year after starting Fingolimod
Method of measurement
Expanded Disability Status Scale score ,Annualized Relapse rate with negative bi nominal regression
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:capsule Fingolimod 0.5 mg daily for one year