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

Completed

• Conditions: Secondary Progressive Multiple Sclerosis (SPMS)
• Interventions: Drug: Mayzent

• Registration Number: NCT04593927
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2020-10-28
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 451

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mayzent	Mayzent	Patients administered Mayzent by prescription

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions	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 Outcome Measures

Name	Time	Method
Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS	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.
Physician's Global Assessment (PGA) of disease activity	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
Changes over time in Expanded Disability Status Scale (EDSS) score	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.
Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS	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.
Annual relapse rate	24 months	Annual relapse rate will be calculated

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Tokushima, Japan