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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250301064890N1
Enrollment
96
Registered
2025-03-12
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis. Multiple sclerosis

Interventions

Intervention group: Taking a reduced dose (500 mg or one vial) of rituximab once every 6 months.

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 90 Years

Inclusion criteria

Inclusion criteria: Confirm diagnosis of RRMS History of rituximab use History of adequate response to rituximab

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKimia Etemadi

Hamedan University of Medical Sciences

kimiyaetemady77@yahoo.com+98 81 3264 0064

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026