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RECRUITING
NCT06599307
PHASE2

The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to know if rituximab can improve cognitive and hand functions in secondary progressive multiple sclerosis (SPMS) patients with high disability (EDSS 6.5 or more). The main questions it aims to answer are: Can rituximab improve cognitive and hand functions in SPMS patients? Can rituximab improve the quality of life and the Expanded Disability Status Scale (EDSS) in SPMS patients? Researchers will compare patients who receive rituximab to patient who receive placebo to see the effects of rituximab on cognition, hand functions, quality of life and EDSS. Demographic and clinical data as age, gender, disease duration and EDSS will be obtained from each participant. Participants will perform The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), The Nine-Hole Peg Test (9-HPT) and The MS-QLQ27 questionnaire at baseline and after one year of receiving either rituximab or placebo.

Official title: The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-08-01

Completion Date

2026-09

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Rituximab

Rituximab 1gm vial diluted on 500 ml normal saline 0.9%

OTHER

Saline (NaCl 0,9 %) (placebo)

500 ml of normal saline 0.9%

Locations (1)

Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.

Giza, Giza Governorate, Egypt