Actively Recruiting
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
Led by Cairo University · Updated on 2026-03-18
46
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with secondary progressive multiple sclerosis by Lorscheider et al's criteria, including confirmed progression over 3 months
- Baseline Expanded Disability Status Scale (EDSS) score of 6.5 or higher
You will not qualify if you...
- Received disease modifying therapy for SPMS other than rituximab
- Experienced a clinical relapse in the last 3 months before recruitment
- Documented hypersensitivity or contraindication to rituximab
- Have other neurologic conditions affecting cognitive or hand functions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.
Giza, Giza Governorate, Egypt
Actively Recruiting
Research Team
A
Amgad Mahmoud Elmeligy, MSc Neurology
CONTACT
A
Amr Mohamed Fouad, MD Neurology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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