This study will be done with aim to study the effectiveness and long-term side effects of biosimilar fingolimod oral forms in 3-year follow-up of patients with RRMS. This is non-blinded clinical trial. The study population will be consisted of all women with RRMS referred to the MS clinic of Imam Reza Hospital.
A total of 50 patients with RRMS according to the recurrence of MS despite treatment with first-line drugs DMT are candidates for treatment with fingolimod by a neurologist; And from the 23/9/2013 received fingolimod and new patients that are candidate to receive fingolimod form 23/9/2015 until 20/9/2016 will be selected in available method. Baseline (at least 6 hours after admission) ECG results, heart rate and blood pressure will be recorded in the checklist.
Patients will receive half-mg biosimilar fingolimod oral capsule daily and for two years, for the symptoms, elevated liver enzymes, and the degree of white blood cells will be examined every three months. At the end treatment satisfaction questionnaire for drugs will be provided for patients and their satisfaction will be measured.
Inclusion criteria: Age 18-45 years; EDSS score between 0 and 5.5; Negative pregnancy test for women of childbearing age.
Exclusion criteria: macular edema at baseline; History of treatment with cyclophosphamide or mitoxantrone at any time; Breastfeeding and pregnancy; Full or direct bilirubin greater than the upper limit of normal; Creatinine more than 1.7 mg per deciliter
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705108323N15
Registration date:2017-06-07, 1396/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness and side effects of fingolimod in 3-year follow-up of patients with relapsing- remitting multiple sclerosis(RRMS)
Public title
Evaluating the efficacy and side effects fingolimod in 3 -year follow-up of patients with recurrent forms of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-45 years; EDSS score between 0 and 5.5; At least one relapse in the previous year despite treatment with a variety of first-line DMT; At least two relapses in the past two years despite treatment with a variety of first-line DMT; No relapse in the 30 days before starting treatment with fingolimod; Negative pregnancy test for women of childbearing age.
Exclusion criteria: macular edema at baseline;
acute or chronic active bacterial infection, fungal or Viral; Treatment with intravenous corticosteroids within 30 days prior to the start fingolimod; History of treatment with cyclophosphamide or mitoxantrone at any time; Breastfeeding and pregnancy;AST and ALT more than double upper limit of normal; Full or direct bilirubin greater than the upper limit of normal; Creatinine more than 1.7 mg per deciliter; White blood cells below 3500 per cubic millimeter; Lymphocyte count below 800 per cubic millimeter; The presence of uveitis
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
kums.rec.1395.753
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Blood pressure
Timepoint
Baseline, every three months for two years
Method of measurement
Blood pressure meter
2
Description
White blood cells
Timepoint
Baseline, every three months for two years
Method of measurement
By blood tests in the laboratory
3
Description
Progressive multifocal leukoencephalophaty
Timepoint
Baseline, every three months for two years
Method of measurement
Using MRI
4
Description
Liver enzymes
Timepoint
Baseline, every three months for two years
Method of measurement
By blood tests in the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group patients will receive half-mg biosimilar fingolimod oral capsule daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Masomeh Moaref
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Masomeh Moaref
Position
Resident of Neurology
Other areas of specialty/work
Street address
Medical School, prstar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 3423
Fax
Email
dr_mmoaref@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nazanin Razazian
Position
Neurologist
Other areas of specialty/work
Street address
Medical School, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 3423
Fax
Email
nrazazian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Masomeh Moaref
Position
Resident Neurology
Other areas of specialty/work
Street address
Medical School, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 3423
Fax
Email
dr_mmoaref@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)