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IRCT20120215009014N516 IRCT 2024-06-17 Hamedan University of Medical Sciences Effect of discontinuing immune-modulating drugs versus control group on prognosis in patients with relapsing-remitting multiple sclerosis Effect of discontinuing immune-modulating drugs versus control group on prognosis in patients with relapsing-remitting multiple sclerosis: a single-blind randomized clinical trial 2024-07-05 anticipated 178 Complete https://irct.ir/trial/77370 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Multiple sclerosis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Dr Sajad Daneshyar
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 s.danshyar72@yahoo.com Hamedan University of Medical Sciences scientific Dr. Masoud Ghiasian
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 masoud_ghiasian@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 55 to 80 years Relapsing-remitting multiple sclerosis Taking drugs that modulate the immune system 55 years 80 years Both Disease attack in the last 5 years Taking Tysabri or Fingolimod drugs G35 Multiple sclerosis Placebo Treatment - Drugs 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. Average disease severity. Timepoint: Before the intervention and 24 months later. Method of measurement: Based on the Extended Disability Status Scale (EDSS). Mean number of gadolinium-enhancing lesions. Timepoint: Before intervention and 24 months after. Method of measurement: Using MRI imaging. Hamedan University of Medical Sciences Approved 2024-06-08 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave hamadan Hamadan Iran (Islamic Republic of)