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Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis

NCT05078177 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-10-14

No results posted yet for this study

Summary

Considering the accumulated data on the pathogenesis of multiple sclerosis, indicating a significant role of B cells in the progression of the disease, the use of monoclonal antibodies to CD20 antigen, administered intrathecally to achieve adequate B-lymphodepletion in the barrier tissues can increase the duration of the recurrence-free course of autoimmune diseases, suspend their progression, and also prevent clinical relapse when memory B cells are detected.

Conditions

Interventions

DRUG

Rituximab

All patients receive AHSCT with RIC (Cyclophosphamide, Antithymocyte globulin/Rituximab). After resolution of cytopenia (approximately from about D+12 to D+14 AHSCT), patients will receive intrathecal Rituximab.

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Principal Investigators

  • Ivan S Moiseev, MD, Ph.D · Pavlov First Saint Petersburg State Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2022-12-21
Completion
2024-12-21

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078177 on ClinicalTrials.gov