Clinical trial NCT04593927: Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Progressive Multiple Sclerosis (SPMS)
Keywords: Secondary Progressive Multiple Sclerosis
SPMS
Mayzent
Siponimod
Japan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 451
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients using Mayzent for the following indication for a specified post-marketing period of time

• Indication: prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis By allowing patients who started Mayzent administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Mayzent will be enrolled in this study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions
timeFrame: 24 months
Secondary outcomes:
measure: Physician's Global Assessment (PGA) of disease activity
timeFrame: month 12 and month 24
measure: Changes over time in Expanded Disability Status Scale (EDSS) score
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24
measure: Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS
timeFrame: 24 months
measure: Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS
timeFrame: 24 months
measure: Annual relapse rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Hekinan
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kariya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kasugai
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagakute-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Seto-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Hachinohe
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Hirosaki
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Ichihara-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Ichikawa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yachiyo city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Toon city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Gifu shi
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Gifu-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Isesaki
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Maebashi
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Ota
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Fukuyama
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Kure-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Hakodate
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Iwamizawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kitami
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kushiro
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Muroran
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Rumoi
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Ako-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Awaji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Itami
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Hitachi-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Hitachinaka
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Toride-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsukuba city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Hanamaki
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Ichinoseki
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kagoshima city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Oshima
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Ashigarakami
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Atsugi-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Hiratsuka
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Isehara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Nankoku city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Suzuka
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Tsu-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Kesennuma
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Miyakonojo
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Chiisagata
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Iida
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Ina
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Kitaazumi
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Matsumoto
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Matsumoto
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Saku
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Suwa
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Sasebo
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Nagaoka
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Nagaoka
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Niigata-city
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Tsubame
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Tsubame
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Beppu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Oita-city
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Usa
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Yufu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Ginowan
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Fujiidera
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Higashiosaka
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka Sayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Saga-city
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Ageo-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Iruma-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawagoe
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Koshigaya
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Koshigaya
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Wako-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Ohtsu-city
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Omihachiman
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Izumo-city
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Fuji city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Hamamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Izunokuni
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Oyama
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Shimotsuke
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Adachi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Adachi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fuchu
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fuchu
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kodaira
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nakano
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kurayoshi
country: Japan
facility: Novartis Investigative Site
state: Tottori
city: Toyama-city
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Sakata-city
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Shimonoseki
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Shunan-city
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Ube
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Aomori
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukui
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Gifu
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kochi
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saga
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Tokushima
country: Japan
facility: Novartis Investigative Site
city: Tokushima
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: