[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562141":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":48,"responsibleParty":69,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Rituximab",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","This group will receive 500 ml normal saline 0.9% as intravenous infusions. Another dose will be given after 6 months",[19],"Other: Saline (NaCl 0,9 %) (placebo)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Rituximab","Rituximab 1gm vial diluted on 500 ml normal saline 0.9%",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Saline (NaCl 0,9 %) (placebo)","500 ml of normal saline 0.9%",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Maha Atef Zaki, MD Neurology","Department of Neurology, Faculty of Medicine, Cairo University","STUDY_CHAIR",{"name":37,"affiliation":34,"role":35},"Amr Hassan Elsayed, MD Neurology",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Amgad Mahmoud Elmeligy, MSc Neurology","CONTACT","00201005393868","amgad.elmeligy92@outlook.com",{"name":45,"role":41,"phone":46,"phoneExt":26,"email":47},"Amr Mohamed Fouad, MD Neurology","00201003598364","amro.fouad@yahoo.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":26,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Kasr Alainy Multiple Sclerosis Unit (KAMSU), Cairo University hospitals.","RECRUITING","Giza","Giza Governorate","Egypt","EG",{"type":57,"coordinates":58},"Point",[59,60],31.20861,30.00944,{"lat":60,"lon":59},[63,67],{"name":64,"role":41,"phone":65,"phoneExt":26,"email":66},"Vice Dean for graduate studies and research","0020223649281","pg@kasralainy.edu.eg",{"name":40,"role":68,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Amgad Mahmoud Elmeligy","Assistant lecturer of Neurology","100562141","phase-2-the-effect-of-rituximab-on-cognitive-and-hand-functions-in-secondary-progressive-multiple-sclerosis-100562141",false,"NCT06599307","The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis","The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. 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).\n2. Baseline EDSS ≥ 6.5.\n\nExclusion Criteria:\n\n1. Patients received disease modifying therapy for SPMS other than rituximab.\n2. Clinical relapse in the last 3 months before recruitment.\n3. Patients with documented hypersensitivity or contraindication to rituximab.\n4. Patients with concomitant neurologic conditions that may affect cognitive or hand functions.","ALL","18 Years",{"count":82,"type":83},46,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","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:\n\nCan 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?\n\nResearchers 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.\n\nDemographic 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.",[89],"Secondary Progressive Multiple Sclerosis (SPMS)",[23,91,92,93],"Cognitive functions","Hand functions","Secondary Progressive Multiple Sclerosis","2026-03-16",{"date":96,"type":97},"2026-03-18","ACTUAL",{"date":99,"type":97},"2024-08-01",{"date":101,"type":83},"2026-09",{"name":5,"class":6},1]