Clinical trial NCT04940065: Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen
Official title: Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-remitting Multiple Sclerosis
Active Secondary Progressive Multiple Sclerosis
Keywords: Kesimpta
multiple sclerosis
Japan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 367
Sex: ALL
Minimum age (years): 0
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: Japanese patients whose registration form is accepted and registration is confirmed.

Brief summary: This study is an uncontrolled, central registration system, open-label, multicenter observational study in patients using Kesimpta for the labeled indication.

Detailed description: This is a primary data collection-based special drug-use surveillance to be conducted in accordance with the GPSP ordinance.

Observational period will last 24 months from the start of treatment with Kesimpta.

Eligibility criteria: Inclusion Criteria:

1. Patients must provide written consent to cooperate in this study before the start of treatment with Kesimpta
2. Patients using Kesimpta for the first time for the following indication Indication: prevention of relapses and and prevention of physical disability progression in the following patients

   * Relapsing-remitting MS
   * Active SPMS

Exclusion Criteria:

1. Patients with a history of treatment with a drug containing the same ingredient as Kesimpta (investigational drug or post-marketing clinical study drug)
2. Patients with a history of hypersensitivity to any of the Kesimpta ingredients

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 24 months
measure: Incidence of serious adverse events (SAEs)
timeFrame: 24 months
measure: Incidence of adverse reactions
timeFrame: 24 months
Secondary outcomes:
measure: Physician's Global Assessment
timeFrame: month 12, month 24 (or at treatment discontinuation)
measure: Confirmed disability worsening on Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
measure: Confirmed improvement on Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
measure: Number of gadolinium (Gd)-enhancing lesions on Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, month 6, month 12, month 18, month 24 (or at discontinuation)
measure: Annual relapse rate
timeFrame: Up to 24 months
measure: No Evidence of Disease Activity (NEDA-3)
timeFrame: month 12, month 24
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagakute-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya-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: Tokoname
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Hachinohe
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Hachinohe
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Hirosaki
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Ichikawa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Narita
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yachiyo
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: Iizuka-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: Omuta
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Gifu-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Maebashi
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Fukuyama
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: Sapporo city
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: Sunagawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Mito-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Ichinoseki
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Ichinoseki
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kagoshima city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Kanoya
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Kawasaki
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
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Nankoku city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kesennuma
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Nagano-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Sasebo-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Tenri
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Niigata city
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Kurashiki-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Fujiidera
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
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
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kawagoe
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
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: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Oyama
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Shimotsuga Gun
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Shimotsuke
country: Japan
facility: Novartis Investigative Site
state: Tochigi
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: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nakano
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: Kudamatsu
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: Aomori
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
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: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: