A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Participants will additionally be offered to record daily activity and sleep patterns as well as heart rate for the duration of the study.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Natalizumab (NTZ)

Participants who receive NTZ intravenously (IV) or subcutaneously (SC) as standard interval dosing (SID), or as SC extended interval dosing (EID) will be followed prospectively for up to 30 weeks.

Natalizumab

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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Natalizumab

Administered as specified in the treatment arm.

Intervention Type DRUG

Other Intervention Names

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Tysabri

Eligibility Criteria

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Inclusion Criteria

* Diagnosed Relapsing-Remitting Multiple Sclerosis (RRMS) according to 2017 revised McDonald criteria
* Initiation of treatment with SC NTZ according to summary of product characteristic (SmPC) and in accordance to national guidelines or
* Continuing treatment with IV NTZ
* Owns and be able to handle a smartphone

Exclusion Criteria

* Participants with an acute MS relapse and/or a history of intravenous corticosteroid treatment within past six weeks
* Any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia
* Diagnosis of primary or secondary progressive MS
* Additional immunosuppression except of natalizumab

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No