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Completed

NCT Number: NCT04593927

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

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Key information

Conditions

Secondary Progressive Multiple Sclerosis (SPMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Anjo, Aichi-ken, Japan

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About this study

This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis

Exclusion criteria

-

Treatment and study plan

Mayzent

Drug

There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.

Primary outcomes

  1. Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions

    Time frame: 24 months

    A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

    An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Mayzent or whose causality is not recorded

Secondary outcomes

  1. Physician's Global Assessment (PGA) of disease activity

    Time frame: month 12 and month 24

    Secondary Progressive Multiple Sclerosis (SPMS) symptom changes will be assessed an rated as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of Mayzent administration

  2. Changes over time in Expanded Disability Status Scale (EDSS) score

    Time frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24

    EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated.

  3. Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS

    Time frame: 24 months

    Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.

  4. Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS

    Time frame: 24 months

    Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.

  5. Annual relapse rate

    Time frame: 24 months

    Annual relapse rate will be calculated

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2020
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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