Tests rituximab for thinking and hand function in progressive multiple sclerosis
Tests rituximab against a placebo in adults with advanced progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
Key facts
- Where
- Giza, EgyptSee the site
- Phase
- Phase 2
Where in Egypt
- Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.Giza, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cairo University
- Trial code
- NCT06599307
- Record updated
- 18 March 2026
- Original description
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:Read full original descriptionShow less
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial
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.
Inclusion: 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.
Exclusion: Patients received disease modifying therapy for SPMS other than rituximab; Clinical relapse in the last 3 months before recruitment; Patients with concomitant neurologic conditions that may affect cognitive or hand functions; Patients with documented hypersensitivity or contraindication to rituximab.