Clinical trial NCT06599307: The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
Official title: The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Secondary Progressive Multiple Sclerosis (SPMS)
Keywords: Rituximab
Cognitive functions
Hand functions
Secondary Progressive Multiple Sclerosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test
timeFrame: One year
measure: The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised
timeFrame: One year
measure: The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II
timeFrame: One year
measure: The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test
timeFrame: One year
Secondary outcomes:
measure: The effect of rituximab on quality of life
timeFrame: One year
measure: The effect of rituximab on EDSS
timeFrame: One year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.
Study officials:
affiliation: Department of Neurology, Faculty of Medicine, Cairo University
name: Maha Atef Zaki, MD Neurology
role: STUDY_CHAIR
affiliation: Department of Neurology, Faculty of Medicine, Cairo University
name: Amr Hassan Elsayed, MD Neurology
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.