Clinical trial NCT05701423: A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
Official title: End of Dose Phenomena in Subcutaneous Natalizumab Treated MS Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include MS participants under NTZ therapy.

Brief 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.

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

Eligibility criteria: Key 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

Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ
timeFrame: Up to 30 weeks
Secondary outcomes:
measure: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
timeFrame: Baseline up to 30 weeks
measure: Change From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: Baseline up to 30 weeks
measure: Change From Baseline in Fatigue Severity Scale (FSS)
timeFrame: Baseline up to 30 weeks
measure: Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
timeFrame: Baseline up to 30 weeks
measure: Change From Baseline in Brief Fatigue Inventory (BFI) Score
timeFrame: Baseline up to 30 weeks
measure: Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score
timeFrame: Baseline up to 30 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Klinik für Neurologie, Universitätsklinikum Düsseldorf
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: