Status:
RECRUITING
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
Lead Sponsor:
Cairo University
Conditions:
Secondary Progressive Multiple Sclerosis (SPMS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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). Th...
Eligibility Criteria
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 documented hypersensitivity or contraindication to rituximab.
- Patients with concomitant neurologic conditions that may affect cognitive or hand functions.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06599307
Start Date
August 1 2024
End Date
May 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.
Giza, Giza Governorate, Egypt