Effect of discontinuing immune-modulating drugs versus control group on prognosis in patients with relapsing-remitting multiple sclerosis: a single-blind randomized clinical trial
To assess the effect of discontinuing immune-modulating drugs versus control group on prognosis in patients with relapsing—remitting multiple sclerosis
Design
This is a Phase III single-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 178 eligible patients with relapsing-remitting multiple sclerosis. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single -blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 55 to 80 years
Relapsing-remitting multiple sclerosis
Taking drugs that modulate the immune system
Exclusion criteria:
Disease attack in the last 5 years
Taking Tysabri or Fingolimod drugs
Intervention groups
Intervention group:
Routine treatment of multiple sclerosis with the same dose that the patient has already received, plus stopping any immunosuppressive drugs (including dimethyl fumarate, triflunomide, interferons, glatiramer acetate, rituximab, ocrelizumab) and replacing them with an oral placebo for 24 months.
Control group:
Routine treatment of multiple sclerosis as well as the continuation of the use of immune system modulating drugs with the same dose as the patient has received before.
Main outcome variables
Primary outcome:
Average disease severity, mean number of gadolinium-enhancing lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N516
Registration date:2024-06-17, 1403/03/28
Registration timing:prospective
Last update:2024-06-17, 1403/03/28
Update count:0
Registration date
2024-06-17, 1403/03/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of discontinuing immune-modulating drugs versus control group on prognosis in patients with relapsing-remitting multiple sclerosis: a single-blind randomized clinical trial
Public title
Effect of discontinuing immune-modulating drugs versus control group on prognosis in patients with relapsing-remitting multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 55 to 80 years
Relapsing-remitting multiple sclerosis
Taking drugs that modulate the immune system
Exclusion criteria:
Disease attack in the last 5 years
Taking Tysabri or Fingolimod drugs
Age
From 55 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
178
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a single-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-06-08, 1403/03/19
Ethics committee reference number
IR.UMSHA.REC.1403.166
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
Average disease severity
Timepoint
Before the intervention and 24 months later
Method of measurement
Based on the Extended Disability Status Scale (EDSS)
2
Description
Mean number of gadolinium-enhancing lesions
Timepoint
Before intervention and 24 months after
Method of measurement
Using MRI imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of multiple sclerosis with the same dose that the patient has already received, plus stopping any immunosuppressive drugs (including dimethyl fumarate, triflunomide, interferons, glatiramer acetate, rituximab, ocrelizumab) and replacing them with an oral placebo for 24 months.
Category
Placebo
2
Description
Control group: Routine treatment of multiple sclerosis as well as the continuation of the use of immune system modulating drugs with the same dose as the patient has received before.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Sajad Daneshyar
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
s.danshyar72@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sajad Daneshyar
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
s.danshyar72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Masoud Ghiasian
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
masoud_ghiasian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available