Secondary Progressive Multiple Sclerosis (SPMS)Phase 2NCT06599307
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
A Phase 2 study testing Rituximab in people with Secondary Progressive Multiple Sclerosis (SPMS), run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis (SPMS)
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.
Giza, Giza Governorate
Vice Dean for graduate studies and research, 0020223649281, pg@kasralainy.edu.eg
Amgad Mahmoud Elmeligy, MSc Neurology
About this study
Official title: 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?
Read more
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.
- Being tested
- Rituximab, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Rituximab, Cognitive functions, Hand functions, Secondary Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab 1gm vial diluted on 500 ml normal saline 0.9%
Saline (NaCl 0,9 %) (placebo)Other
500 ml of normal saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year
Secondary outcomes (2)
The effect of rituximab on quality of life
Using MS-QLQ27 questionnaire, which contains 27 items covering physical, mental, and treatment-specific impairments as well as items relating to leisure, social, and work life issues. Scaling of items is a 5 point scale ranged from 1: "not at all impaired" to 5: "extremely impaired.
Measured: One year
The effect of rituximab on EDSS
The Expanded Disability Status Scale (EDSS) is a tool used for quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Secondary Progressive Multiple Sclerosis (SPMS)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amgad Mahmoud Elmeligy, Cairo University
- Investigators
- Maha Atef Zaki, MD Neurology, Study chair, Department of Neurology, Faculty of Medicine, Cairo UniversityAmr Hassan Elsayed, MD Neurology, Study chair, Department of Neurology, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599307
- Sponsor's protocol ID
- MD-146-2024
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analyzable IPD used in the results publication
Publications
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.
PubMed 24745972Torgauten 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.
PubMed 33796328Salehizadeh 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.
PubMed 35974939Naegelin 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.
PubMed 30615019Brochet 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.
PubMed 35203948
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06599307
- Acronym / sponsor ID
- MD-146-2024
- Keywords
- Rituximab, Cognitive functions, Hand functions, Secondary Progressive Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: RituximabThis 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. |
| Control | Placebo comparator | Other: Saline (NaCl 0,9 %) (placebo)This group will receive 500 ml normal saline 0.9% as intravenous infusions. Another dose will be given after 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabRituximab 1gm vial diluted on 500 ml normal saline 0.9% | Drug | Intervention |
| Saline (NaCl 0,9 %) (placebo)500 ml of normal saline 0.9% | Other | Control |
Primary outcome
The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test
Time frame: One year
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.
The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised
Time frame: One year
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.
The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II
Time frame: One year
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.
The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test
Time frame: One year
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.
2 secondary outcomes
The effect of rituximab on quality of life
Time frame: One year
The effect of rituximab on EDSS
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 24745972Carpinella 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.
- Background: PubMed 33796328Torgauten 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.
- Background: PubMed 35974939Salehizadeh 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.
- Background: PubMed 30615019Naegelin 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.
- Background: PubMed 35203948Brochet 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.
- Individual participant dataSharing planned: Yes. Analyzable IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maha Atef Zaki, MD Neurology study chair
Department of Neurology, Faculty of Medicine, Cairo University
Amr Hassan Elsayed, MD Neurology study chair
Department of Neurology, Faculty of Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Secondary Progressive Multiple Sclerosis (SPMS), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgad Mahmoud Elmeligy, MSc Neurology (00201005393868, amgad.elmeligy92@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599307, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.