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

NCT05701423 | Terminated

• 1 other identifier: DE-TYS-12185
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ

  Up to 30 weeks

Secondary Outcomes (6)

• Change From Baseline in Expanded Disability Status Scale (EDSS) Score

  Baseline up to 30 weeks

• Change From Baseline in Fatigue Scale for Motor and Cognitive Functions (FSMC)

  Baseline up to 30 weeks

• Change From Baseline in Fatigue Severity Scale (FSS)

  Baseline up to 30 weeks

• Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score

  Baseline up to 30 weeks

• Change From Baseline in Brief Fatigue Inventory (BFI) Score

  Baseline up to 30 weeks

Study Arms (1)

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.

Drug: Natalizumab

Interventions

Natalizumab DRUG

Administered as specified in the treatment arm.

Also known as: Tysabri

Natalizumab (NTZ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include MS participants under NTZ therapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Klinik für Neurologie, Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: February 8, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)