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NCT05701423
A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
Conditions: Multiple Sclerosis
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Biogen
Summary
The primary objective of this study is to better understand the pathophysiological background of end-of-dose symptoms (EOD) and thereby determine the percentage of participants who develop EOD under natalizumab (NTZ) as an example of interval therapy in MS and to detect specific changes through multimodal analyses, including radiological, blood and digital health measurements, that may be used as potential biomarkers in the future to map EOD.
Eligibility Criteria
Key Inclusion Criteria:Diagnosed Relapsing-Remitting Multiple Sclerosis (RRMS) according to 2017 revised McDonald criteriaInitiation of treatment with SC NTZ according to summary of product characteristic (SmPC) and in accordance to national guidelines orContinuing treatment with IV NTZOwns and be able to handle a smartphoneKey Exclusion Criteria:Participants with an acute MS relapse and/or a history of intravenous corticosteroid treatment within past six weeksAny comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementiaDiagnosis of primary or secondary progressive MSAdditional immunosuppression except of natalizumabNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05701423). StuddyBuddy aggregates publicly available trial information.