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

Secondary Progressive Multiple Sclerosis (SPMS) Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593927
• Other study ID #: CBAF312A1401
• Status: Completed
• Start date: October 28, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Neoplasm Metastasis
• Sclerosis
• Secondary Progressive Multiple Sclerosis (SPMS)

Intervention

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

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Adachi	Tokyo
Japan	Novartis Investigative Site	Adachi-ku	Tokyo
Japan	Novartis Investigative Site	Ageo-city	Saitama
Japan	Novartis Investigative Site	Akita
Japan	Novartis Investigative Site	Ako-city	Hyogo
Japan	Novartis Investigative Site	Anjo	Aichi
Japan	Novartis Investigative Site	Aomori
Japan	Novartis Investigative Site	Asahikawa	Hokkaido
Japan	Novartis Investigative Site	Ashigarakami	Kanagawa
Japan	Novartis Investigative Site	Atsugi-city	Kanagawa
Japan	Novartis Investigative Site	Awaji	Hyogo
Japan	Novartis Investigative Site	Beppu	Oita
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Chiisagata	Nagano
Japan	Novartis Investigative Site	Edogawa	Tokyo
Japan	Novartis Investigative Site	Fuchu	Tokyo
Japan	Novartis Investigative Site	Fuchu	Tokyo
Japan	Novartis Investigative Site	Fuji city	Shizuoka
Japan	Novartis Investigative Site	Fujiidera	Osaka
Japan	Novartis Investigative Site	Fukui
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Fukuyama	Hiroshima
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Gifu shi	Gifu
Japan	Novartis Investigative Site	Gifu-city	Gifu
Japan	Novartis Investigative Site	Ginowan	Okinawa
Japan	Novartis Investigative Site	Hachinohe	Aomori
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hakodate	Hokkaido
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hanamaki	Iwate
Japan	Novartis Investigative Site	Hekinan	Aichi
Japan	Novartis Investigative Site	Higashiosaka	Osaka
Japan	Novartis Investigative Site	Hiratsuka	Kanagawa
Japan	Novartis Investigative Site	Hirosaki	Aomori
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hitachi-city	Ibaraki
Japan	Novartis Investigative Site	Hitachinaka	Ibaraki
Japan	Novartis Investigative Site	Ichihara-city	Chiba
Japan	Novartis Investigative Site	Ichikawa	Chiba
Japan	Novartis Investigative Site	Ichinomiya	Aichi
Japan	Novartis Investigative Site	Ichinoseki	Iwate
Japan	Novartis Investigative Site	Iida	Nagano
Japan	Novartis Investigative Site	Ina	Nagano
Japan	Novartis Investigative Site	Iruma-gun	Saitama
Japan	Novartis Investigative Site	Isehara	Kanagawa
Japan	Novartis Investigative Site	Isesaki	Gunma
Japan	Novartis Investigative Site	Itabashi ku	Tokyo
Japan	Novartis Investigative Site	Itami	Hyogo
Japan	Novartis Investigative Site	Iwamizawa-city	Hokkaido
Japan	Novartis Investigative Site	Izumo-city	Shimane
Japan	Novartis Investigative Site	Izunokuni	Shizuoka
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Kagoshima city	Kagoshima
Japan	Novartis Investigative Site	Kanazawa	Ishikawa
Japan	Novartis Investigative Site	Kariya	Aichi
Japan	Novartis Investigative Site	Kashihara city	Nara
Japan	Novartis Investigative Site	Kasugai	Aichi
Japan	Novartis Investigative Site	Kawagoe	Saitama
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kesennuma	Miyagi
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Kitaazumi	Nagano
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitami	Hokkaido
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Japan	Novartis Investigative Site	Kochi
Japan	Novartis Investigative Site	Kodaira	Tokyo
Japan	Novartis Investigative Site	Koshigaya	Saitama
Japan	Novartis Investigative Site	Koshigaya	Saitama
Japan	Novartis Investigative Site	Kumamoto
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kurayoshi	Tottori
Japan	Novartis Investigative Site	Kure-city	Hiroshima
Japan	Novartis Investigative Site	Kurume city	Fukuoka
Japan	Novartis Investigative Site	Kushiro	Hokkaido
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Maebashi	Gunma
Japan	Novartis Investigative Site	Maebashi city	Gunma
Japan	Novartis Investigative Site	Matsumoto	Nagano
Japan	Novartis Investigative Site	Matsumoto	Nagano
Japan	Novartis Investigative Site	Meguro	Tokyo
Japan	Novartis Investigative Site	Miyakonojo	Miyazaki
Japan	Novartis Investigative Site	Muroran	Hokkaido
Japan	Novartis Investigative Site	Nagakute-city	Aichi
Japan	Novartis Investigative Site	Nagano-city	Nagano
Japan	Novartis Investigative Site	Nagaoka	Niigata
Japan	Novartis Investigative Site	Nagaoka	Niigata
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nakano	Tokyo
Japan	Novartis Investigative Site	Nankoku city	Kochi
Japan	Novartis Investigative Site	Niigata
Japan	Novartis Investigative Site	Niigata-city	Niigata
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Ohtsu-city	Shiga
Japan	Novartis Investigative Site	Oita
Japan	Novartis Investigative Site	Oita-city	Oita
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Omihachiman	Shiga
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka Sayama	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Oshima	Kagoshima
Japan	Novartis Investigative Site	Ota	Gunma
Japan	Novartis Investigative Site	Ota	Tokyo
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Oyama	Tochigi
Japan	Novartis Investigative Site	Rumoi	Hokkaido
Japan	Novartis Investigative Site	Saga
Japan	Novartis Investigative Site	Saga-city	Saga
Japan	Novartis Investigative Site	Sagamihara	Kanagawa
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sakai-city	Osaka
Japan	Novartis Investigative Site	Sakata-city	Yamagata
Japan	Novartis Investigative Site	Saku	Nagano
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Sasebo	Nagasaki
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Seto-city	Aichi
Japan	Novartis Investigative Site	Shimonoseki	Yamaguchi
Japan	Novartis Investigative Site	Shimotsuke	Tochigi
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Shunan-city	Yamaguchi
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Suwa	Nagano
Japan	Novartis Investigative Site	Suzuka	Mie
Japan	Novartis Investigative Site	Takatsuki-city	Osaka
Japan	Novartis Investigative Site	Tokushima
Japan	Novartis Investigative Site	Tokushima
Japan	Novartis Investigative Site	Toon city	Ehime
Japan	Novartis Investigative Site	Toride-city	Ibaraki
Japan	Novartis Investigative Site	Toyama-city	Toyama
Japan	Novartis Investigative Site	Tsu-city	Mie
Japan	Novartis Investigative Site	Tsubame	Niigata
Japan	Novartis Investigative Site	Tsubame	Niigata
Japan	Novartis Investigative Site	Tsuchiura	Ibaraki
Japan	Novartis Investigative Site	Tsukuba	Ibaraki
Japan	Novartis Investigative Site	Tsukuba city	Ibaraki
Japan	Novartis Investigative Site	Ube	Yamaguchi
Japan	Novartis Investigative Site	Usa	Oita
Japan	Novartis Investigative Site	Wako-city	Saitama
Japan	Novartis Investigative Site	Yachiyo city	Chiba
Japan	Novartis Investigative Site	Yokohama city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokosuka-city	Kanagawa
Japan	Novartis Investigative Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions	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	24 months
Secondary	Physician's Global Assessment (PGA) of disease activity	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	month 12 and month 24
Secondary	Changes over time in Expanded Disability Status Scale (EDSS) score	EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated.	Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24
Secondary	Time to confirmed disability progression continuing for = 3 months from the start of administration as assessed by the EDSS	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.	24 months
Secondary	Time to confirmed disability progression continuing for = 6 months from the start of administration as assessed by the EDSS	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.	24 months
Secondary	Annual relapse rate	Annual relapse rate will be calculated	24 months