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IRCT20250301064890N1 IRCT 2025-03-12 Hamedan University of Medical Sciences The effect of therapeutic doses of 500 mg of rituximab on the disability process in RRMS patients Comparison of the effects of therapeutic doses of 500 and 1000 mg of Rituximab on the course of disability and radiographic changes in relapsing-remitting multiple sclerosis (RRMS) patients 2025-03-21 anticipated 96 Complete https://irct.ir/trial/82190 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, the balanced block randomization method will be used, and then the four-block randomization method will be used. For this purpose, we will prepare four sheets of paper. On two sheets, we will write the letter I, meaning “Intervention,” and on the other two sheets, the letter C, meaning “Control.” The sheets will be mixed together and placed in a desk drawer. When each eligible patient visits, one of the sheets will be drawn at random and, based on whether the drawn sheet is I or C, they will be assigned to one of the two intervention groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been drawn. After all four sheets have been drawn at random, all the sheets will be returned to the drawer and the above process will be continued for the next four patients until the desired sample size is reached, Blinding description: In the face-to-face visit, patients will be examined by a physician who is unaware of the type of therapeutic intervention, so that judgment can be made in a blinded manner. The patient is also unaware of the treatment regimen received, and therefore the study design will be double-blind. 2-3 Multiple Sclerosis. Intervention group: Taking a reduced dose (500 mg or one vial) of rituximab once every 6 months. 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 We need to determine the initial results first, then make a decision.
public Kimia Etemadi
Hamadan University of Medical Sciences, opposite Mardom Park
Hamadan Iran (Islamic Republic of) 6514845411 +98 81 3264 0064 kimiyaetemady77@yahoo.com Hamedan University of Medical Sciences scientific Kimia Etemadi
Hamadan University of Medical Sciences, opposite Mardom Park
Hamadan Iran (Islamic Republic of) 6514845411 +98 81 3264 0064 kimiyaetemady77@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Confirm diagnosis of RRMS History of rituximab use History of adequate response to rituximab 15 years 90 years Both Rejecting the diagnosis of RRMS The patient's need to change the type of medication taken during the study Urgent need to increase the dose of the drug during the study A sharp increase in the risk of recurrence of symptoms during the period of reducing the dose of the drug used. G35 Multiple sclerosis Treatment - Drugs Intervention group: Taking a reduced dose (500 mg or one vial) of rituximab once every 6 months The human CD19 antigen is a 95 kd transmembrane glycoprotein belonging to the immunoglobulin superfamily. CD19 is classified as a type I transmembrane protein, with a single transmembrane domain, a cytoplasmic C-terminus, and extracellular N-terminus. CD19 is a biomarker for normal and neoplastic B cells, as well as follicular dendritic cells. CD19 is critically involved in establishing intrinsic B cell signaling thresholds through modulating both B cell receptor-dependent and independent signaling. Timepoint: 6 months and 1 year after the start of the therapeutic intervention. Method of measurement: CD19+ Bcell population. Hamedan University of Medical Sciences Approved 2024-10-08 Ethics Committee in Biomedical Research, Hamadan University of Medical Sciences Hamedan facing the people park Hamadan Hamadan Iran (Islamic Republic of)