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

Cairo University (CU)

Status and phase: Enrolling; Phase 2

Conditions: Secondary Progressive Multiple Sclerosis (SPMS)

Treatments: Drug: Rituximab; Other: Saline (NaCl 0,9 %) (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06599307

MD-146-2024

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Baseline EDSS ≥ 6.5.

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

This group will receive Rituximab as follows: initial 1gm divided into 2 doses (500 mg each) given 2 weeks apart then another 1gm will be given after 6 months. Vials will be diluted on 500 ml normal saline 0.9% and will be given as intravenous infusions.

Treatment:

Drug: Rituximab

Control

Placebo Comparator group

Description:

This group will receive 500 ml normal saline 0.9% as intravenous infusions. Another dose will be given after 6 months

Treatment:

Other: Saline (NaCl 0,9 %) (placebo)