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

Biogen

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Drug: Natalizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05701423

DE-TYS-12185

Details and patient eligibility

About

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.

Full description

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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

34 participants in 1 patient group

Natalizumab (NTZ)

Description:

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.

Treatment:

Drug: Natalizumab