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RecruitingPhase 2NCT06599307

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

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

Sponsor

Cairo University

Enrollment

46 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Secondary-progressive Multiple Sclerosis (SPMS)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Diagnosis of secondary progressive multiple sclerosis by Lorscheider et al's criteria (disability progression by 1 EDSS step in patients with EDSS ≤ 5.5 or 0.5 EDSS step in patients with EDSS ≥ 6 in the absence of a relapse, a minimum EDSS score of 4 and pyramidal functional system (FS) score of 2 and confirmed progression over ≥3 months, including confirmation within the leading FS).
  • Baseline EDSS ≥ 6.5.

Exclusion Criteria4

  • Patients received disease modifying therapy for SPMS other than rituximab.
  • Clinical relapse in the last 3 months before recruitment.
  • Patients with documented hypersensitivity or contraindication to rituximab.
  • Patients with concomitant neurologic conditions that may affect cognitive or hand functions.

Interventions

DRUGRituximab

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

OTHERSaline (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

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NCT06599307

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