[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561132":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":33,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 (C1; basic cohort)",null,"Participants will be seen every 6 months up until month 24, then every 12 months. The following parameters will be collected: demographic data, disease characteristics incl. EDSS and MRI data, serum samples, and PBMCs. Furthermore, SF-36 and FSMC are documented.",[13],"Drug: Anti-CD20 antibody",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 (C2; in-depth cohort)","In addition to the parameters collected for C1, participants of C2 will receive: clinical evaluation incl. EDSS and sampling of serum and PBMCs at months 1 and 3, MFSC every 6 months, and OCT as well as NPT every 12 months.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Anti-CD20 antibody","Study participants receive an anti-CD20 antibody according to the summary of product characteristics.",[9,15],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Saskia Räuber, MD","CONTACT","+492118117889","SaskiaJanina.Raeuber@med.uni-duesseldorf.de",{"name":31,"role":27,"phone":28,"phoneExt":10,"email":32},"Alice Willison, MD","AliceGrizzel.Willison@med.uni-duesseldorf.de",[34],{"facility":5,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Düsseldorf","40225","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],6.77927,51.22319,{"lat":44,"lon":43},[47,48],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":31,"role":27,"phone":28,"phoneExt":10,"email":32},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Univ.-Prof. Dr. med. Dr rer. nat. Sven Meuth","Chairman",[54],{"name":55,"class":56},"Novartis","INDUSTRY","100561132","understanding-the-durable-effect-concept-of-b-cell-modulating-therapies-100561132",false,"NCT06586177","Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies","REBELLION-MS","Inclusion Criteria:\n\n* Diagnosed relapsing-remitting multiple sclerosis (RRMS) according to 2017 revised McDonald criteria\n* Current treatment with B cell modulating therapies or initiation\u002Ftransition to B cell modulating therapies according to the \"Summary of Product Characteristics (SmPC)\"\n* EDSS score of 0.0 to 7.0\n\nExclusion Criteria:\n\n* Previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation or bone marrow transplantation\n* Medical, psychiatric, cognitive, or other conditions that, in the opinion of the investigator, impair the patient's ability to understand the patient information and give informed consent\n* Patients receiving immunosuppressive treatment for conditions other than MS or long-term corticosteroid treatment\n* Patients with confirmed infection by the Human Immunodeficiency Virus or Hepatitis C Virus","ALL","18 Years","60 Years",{"count":68,"type":69},100,"ESTIMATED","OBSERVATIONAL","This prospective, observational clinical study aims to longitudinally assess peripheral immune cell profiles of patients with relapsing-remitting multiple sclerosis (RRMS) receiving anti-CD20 therapy with ofatumumab (OFA), ocrelizumab (OCR), ublituximab (UBX), and rituximab (RTX). Throughout the study, clinical data - including relapse events, patient scores, and neuropsychological parameters - will be collected, along with results from imaging techniques such as Optical Coherence Tomography (OCT) and Magnetic Resonance Imaging (MRI). This clinical data will be combined with immunological analyses, including multidimensional flow cytometry (mFC), bulk RNA sequencing (bulk-Seq), T and B cell receptor sequencing (TCR\u002FBCR-Seq), proteomics, and immunoglobulin analysis. This approach aims to enable a detailed characterization of changes in the immune cell repertoire and their impact on the clinical disease course.",[73],"Relapsing-remitting Multiple Sclerosis","2025-09-12",{"date":76,"type":77},"2025-09-18","ACTUAL",{"date":79,"type":77},"2021-10-27",{"date":81,"type":69},"2028-12-31",{"name":5,"class":6},1]