Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis

• Status: Recruiting
• Trial end date: 2024-12-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Petersburg State Pavlov Medical University
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Age 18-65;

• 1.0-7.5 points on the EDSS scale (for MS);

• Length of illness - any;

• Disease progression during the last 6 months while taking drugs of 1st and 2nd lines;

• An established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment;

• Ineffectiveness, inaccessibility or intolerance of Disease-Modifying Therapies;

• Relapse after AHSCT.

• Absence of severe concomitant somatic pathology;

• Left ventricular injection fraction > 50%;

• Karnofsky Performance Score (KPS) > 30%;

• The ability to take oral medications;

• Life expectancy is more than 1 month;

• Signed informed consent of the patient or legal representatives.

Exclusion Criteria:

• Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%

• Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted

• Respiratory distress >grade I

• Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits

• Creatinine clearance < 60 mL/min

• Uncontrolled bacterial or fungal infection at the time of enrollment

• Requirement for vasopressor support at the time of enrollment

• Karnofsky performans status <30%

• Pregnancy

• Somatic or psychiatric disorder making the patient unable to sign informed consent