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

NCT06599307 | Recruiting Phase 2

• 1 other identifier: MD-146-2024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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)

Keywords

Rituximab; Cognitive functions; Hand functions; Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test

  The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to identify the digit associated with each symbol as rapidly as possible for 90 seconds. The outcome measure is the number of correct responses over the 90 seconds time span.

  One year

• The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised

  The Brief Visuospatial Memory Test-Revised (BVMT-R) constitutes of six abstract designs presented to the patient for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12. There are three learning trials. The outcome measure is the total number of points earned over the three trials.

  One year

• The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II

  The California Verbal Learning Test-II (CVLT-II) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again followed by a second attempt at recall. Altogether, there are five learning trials. The outcome measure is the total number of recalled items over the five trials.

  One year

• The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test

  The Nine-Hole Peg Test (9-HPT) is a wood or plastic board with 9 holes (10 mm diameter, 15 mm depth) and a container. It is administered by asking the patient to take the pegs from a container, one by one, and place them into the holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The outcome measure is the time taken to complete the activity, recorded in seconds.

  One year

Secondary Outcomes (2)

• The effect of rituximab on quality of life

  One year

• The effect of rituximab on EDSS

  One year

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Drug: Rituximab

Control

PLACEBO COMPARATOR

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

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

Interventions

Saline (NaCl 0,9 %) (placebo) OTHER

500 ml of normal saline 0.9%

Control

Rituximab DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Giza, Giza Governorate, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 24745972 BACKGROUND

• 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.

  PMID: 33796328 BACKGROUND

• 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.

  PMID: 35974939 BACKGROUND

• 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.

  PMID: 30615019 BACKGROUND

• 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.

  PMID: 35203948 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Rituximab; Sodium Chloride

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maha Atef Zaki, MD Neurology

  Department of Neurology, Faculty of Medicine, Cairo University

  STUDY CHAIR

• Amr Hassan Elsayed, MD Neurology

  Department of Neurology, Faculty of Medicine, Cairo University

  STUDY CHAIR

Central Study Contacts

Amgad Mahmoud Elmeligy, MSc Neurology

CONTACT

00201005393868; amgad.elmeligy92@outlook.com

Amr Mohamed Fouad, MD Neurology

CONTACT

00201003598364; amro.fouad@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Neurology

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)