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Trial Title:
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
NCT ID:
NCT06599307
Condition:
Secondary Progressive Multiple Sclerosis (SPMS)
Conditions: Official terms:
Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Rituximab
Conditions: Keywords:
Rituximab
Cognitive functions
Hand functions
Secondary Progressive Multiple Sclerosis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab 1gm vial diluted on 500 ml normal saline 0.9%
Arm group label:
Intervention
Intervention type:
Other
Intervention name:
Saline (NaCl 0,9 %) (placebo)
Description:
500 ml of normal saline 0.9%
Arm group label:
Control
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.
Address:
City:
Giza
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Vice Dean for graduate studies and research
Phone:
0020223649281
Email:
pg@kasralainy.edu.eg
Contact backup:
Last name:
Amgad Mahmoud Elmeligy, MSc Neurology
Start date:
August 1, 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06599307
