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

NCT ID: NCT06599307

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

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

Control

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

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type: OTHER

500 ml of normal saline 0.9%

Interventions

Rituximab

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

Intervention Type: DRUG

Saline (NaCl 0,9 %) (placebo)

500 ml of normal saline 0.9%

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amgad Mahmoud Elmeligy

Assistant lecturer of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Atef Zaki, MD Neurology

Role: STUDY_CHAIR

Department of Neurology, Faculty of Medicine, Cairo University

Amr Hassan Elsayed, MD Neurology

Role: STUDY_CHAIR

Department of Neurology, Faculty of Medicine, Cairo University

Locations

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

Giza, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amgad Mahmoud Elmeligy, MSc Neurology

Role: CONTACT

amgad.elmeligy92@outlook.com

00201005393868

Amr Mohamed Fouad, MD Neurology

Role: CONTACT

amro.fouad@yahoo.com

00201003598364

Facility Contacts

Vice Dean for graduate studies and research

Role: primary

pg@kasralainy.edu.eg

0020223649281

Amgad Mahmoud Elmeligy, MSc Neurology

Role: backup

References

Carpinella I, Cattaneo D, Ferrarin M. Quantitative assessment of upper limb motor function in Multiple Sclerosis using an instrumented Action Research Arm Test. J Neuroeng Rehabil. 2014 Apr 18;11:67. doi: 10.1186/1743-0003-11-67.

Reference Type: BACKGROUND

PMID: 24745972 (View on PubMed)

Torgauten HM, Myhr KM, Wergeland S, Bo L, Aarseth JH, Torkildsen O. Safety and efficacy of rituximab as first- and second line treatment in multiple sclerosis - A cohort study. Mult Scler J Exp Transl Clin. 2021 Jan 31;7(1):2055217320973049. doi: 10.1177/2055217320973049. eCollection 2021 Jan-Mar.

Reference Type: BACKGROUND

PMID: 33796328 (View on PubMed)

Salehizadeh S, Saeedi R, Sahraian MA, Rezaei Aliabadi H, Hashemi SN, Eskandarieh S, Gheini MR, Shahmirzaei S, Owji M, Naser Moghadasi A. Effect of Rituximab on the cognitive impairment in patients with secondary progressive multiple sclerosis. Caspian J Intern Med. 2022 Summer;13(3):484-489. doi: 10.22088/cjim.13.3.484.

Reference Type: BACKGROUND

PMID: 35974939 (View on PubMed)

Naegelin Y, Naegelin P, von Felten S, Lorscheider J, Sonder J, Uitdehaag BMJ, Scotti B, Zecca C, Gobbi C, Kappos L, Derfuss T. Association of Rituximab Treatment With Disability Progression Among Patients With Secondary Progressive Multiple Sclerosis. JAMA Neurol. 2019 Mar 1;76(3):274-281. doi: 10.1001/jamaneurol.2018.4239.

Reference Type: BACKGROUND

PMID: 30615019 (View on PubMed)

Brochet B, Clavelou P, Defer G, De Seze J, Louapre C, Magnin E, Ruet A, Thomas-Anterion C, Vermersch P. Cognitive Impairment in Secondary Progressive Multiple Sclerosis: Effect of Disease Duration, Age, and Progressive Phenotype. Brain Sci. 2022 Jan 29;12(2):183. doi: 10.3390/brainsci12020183.

Reference Type: BACKGROUND

PMID: 35203948 (View on PubMed)

Other Identifiers

MD-146-2024

Identifier Type: -

Identifier Source: org_study_id