Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen

Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis)

ClinicalTrials.gov Identifier: NCT04940065

Novartis Reference Number: COMB157G1401

Last Update: Sep 16, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Relapsing-remitting Multiple Sclerosis
Active Secondary Progressive Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jun 30, 2021
Completion date 
Jul 31, 2026
Gender 
All
Age(s)
99 Years and older (Child, Adult, Older Adult)

Interventions

Other
Kesimpta
Prospective observational cohort study. There is no treatment allocation.

Eligibility Criteria

Inclusion Criteria:

Patients must provide written consent to cooperate in this study before the start of treatment with Kesimpta

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:

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

Study Locations

Japan
Novartis Investigative Site
Recruiting
Ichinomiya, 491-0041
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagakute-city, 480-1195
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya-city, 467-8602
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya, 453-0815
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
Recruiting
Tokoname, 479-0868
Aichi
Japan
Novartis Investigative Site
Recruiting
Toyohashi, 441-8570
Aichi
Japan
Novartis Investigative Site
Recruiting
Hachinohe, 031-0011
Aomori
Japan
Novartis Investigative Site
Recruiting
Hachinohe, 039-1104
Aomori
Japan
Novartis Investigative Site
Recruiting
Hirosaki, 036 8563
Aomori
Japan
Novartis Investigative Site
Recruiting
Ichihara-city, 299-0111
Chiba
Japan
Novartis Investigative Site
Recruiting
Ichikawa, 272-8513
Chiba
Japan
Novartis Investigative Site
Recruiting
Narita, 286-8523
Chiba
Japan
Novartis Investigative Site
Recruiting
Yachiyo-city, 276-8524
Chiba
Japan
Novartis Investigative Site
Recruiting
Toon-city, 791-0295
Ehime
Japan
Novartis Investigative Site
Recruiting
Chikushino-city, 818-8516
Fukuka
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Fukuoka-city, 810-0001
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Iizuka-city, 820-8505
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Kitakyushu-city, 802-8555
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Kitakyushu-city, 807-8556
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Kurume city, 830-0011
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Omuta, 836-8566
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Gifu shi, 500 8513
Gifu
Japan
Novartis Investigative Site
Recruiting
Gifu-city, 501-1194
Gifu
Japan
Novartis Investigative Site
Recruiting
Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
Recruiting
Maebashi, 371-0847
Gunma
Japan
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Recruiting
Fukuyama, 720-0825
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Asahikawa, 070-8530
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodate, 041-0821
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 063-0005
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo-city, 060-8543
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo, 060-0807
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo, 063-0802
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo, 065-0021
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sunagawa, 073-0196
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Novartis Investigative Site
Recruiting
Mito-city, 310-0011
Ibaraki
Japan
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Recruiting
Tsukuba, 300-2622
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Ichinoseki, 021-0871
Iwate
Japan
Novartis Investigative Site
Recruiting
Ichinoseki, 029-0192
Iwate
Japan
Novartis Investigative Site
Recruiting
Morioka, 020-8505
Iwate
Japan
Novartis Investigative Site
Recruiting
Kita-gun, 761-0793
Kagawa
Japan
Novartis Investigative Site
Recruiting
Kagoshima city, 890 8520
Kagoshima
Japan
Novartis Investigative Site
Recruiting
Kanoya, 893-0023
Kagoshima
Japan
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Recruiting
Kawasaki-city, 216-8511
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Sagamihara-city, 252-0375
Kanagawa
Japan
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Recruiting
Yokohama city, 232 0024
Kanagawa
Japan
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Recruiting
Yokohama-city, 227-8501
Kanagawa
Japan
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Recruiting
Yokohama-city, 236-0004
Kanagawa
Japan
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Recruiting
Nankoku city, 783 8505
Kochi
Japan
Novartis Investigative Site
Recruiting
Kyoto-city, 600-8558
Kyoto
Japan
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Recruiting
Kyoto-city, 602-8566
Kyoto
Japan
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Recruiting
Kyoto-city, 616-8255
Kyoto
Japan
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Recruiting
Suzuka, 513-0802
Mie
Japan
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Recruiting
Kesennuma, 988-0085
Miyagi
Japan
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Sendai city, 980 8574
Miyagi
Japan
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Recruiting
Sendai city, 983 8512
Miyagi
Japan
Novartis Investigative Site
Recruiting
Matsumoto-city, 390-8621
Nagano
Japan
Novartis Investigative Site
Recruiting
Nagano-city, 380-8582
Nagano
Japan
Novartis Investigative Site
Recruiting
Nagano-city, 381-8551
Nagano
Japan
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Recruiting
Sasebo-city, 857-1165
Nagasaki
Japan
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Recruiting
Kashihara city, 634 8522
Nara
Japan
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Recruiting
Tenri, 632-8552
Nara
Japan
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Recruiting
Niigata-city, 950-1197
Niigata
Japan
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Recruiting
Kurashiki-city, 710-0826
Okayama
Japan
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Recruiting
Okayama-city, 700-8558
Okayama
Japan
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Recruiting
Fujiidera, 583-0014
Osaka
Japan
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Recruiting
Moriguchi, 570-8507
Osaka
Japan
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Osaka Sayama, 589 8511
Osaka
Japan
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Recruiting
Osaka-city, 530-8480
Osaka
Japan
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Osaka-city, 543-8555
Osaka
Japan
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Osaka-city, 558-8558
Osaka
Japan
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Recruiting
Sakai, 592-8555
Osaka
Japan
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Recruiting
Suita city, 565 0871
Osaka
Japan
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Recruiting
Kawagoe, 350 8550
Saitama
Japan
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Recruiting
Koshigaya-city, 343-8555
Saitama
Japan
Novartis Investigative Site
Recruiting
Wako-city, 351-0102
Saitama
Japan
Novartis Investigative Site
Recruiting
Ohtsu-city, 520-2192
Shiga
Japan
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Recruiting
Omihachiman, 523-0082
Shiga
Japan
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Recruiting
Izumo-city, 693 8501
Shimane
Japan
Novartis Investigative Site
Recruiting
Fuji city, 416-0955
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Hamamatsu-city, 431-3192
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Oyama, 323-0827
Tochigi
Japan
Novartis Investigative Site
Recruiting
Sano, 327-8511
Tochigi
Japan
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Recruiting
Shimotsuga Gun, 321-0293
Tochigi
Japan
Novartis Investigative Site
Recruiting
Shimotsuke, 329-0403
Tochigi
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8431
Tokyo
Japan
Novartis Investigative Site
Recruiting
Edogawa, 134-0086
Tokyo
Japan
Novartis Investigative Site
Recruiting
Fuchu, 183-0042
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 193-0944
Tokyo
Japan
Novartis Investigative Site
Recruiting
Kiyose-city, 204-8585
Tokyo
Japan
Novartis Investigative Site
Recruiting
Minato-ku, 105-8471
Tokyo
Japan
Novartis Investigative Site
Recruiting
Nakano, 164-8607
Tokyo
Japan
Novartis Investigative Site
Recruiting
Ota-ku, 143 8541
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160-0023
Tokyo
Japan
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Recruiting
Suginami, 166-0001
Tokyo
Japan
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Recruiting
Urayasu, 279-0021
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toyama-city, 930-0194
Toyama
Japan
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Recruiting
Wakayama-city, 641-8510
Wakayama
Japan
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Recruiting
Kudamatsu, 744-0075
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Shunan-city, 745-8522
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Ube, 755-8505
Yamaguchi
Japan
Novartis Investigative Site
Recruiting
Aomori, 030 8553
-
Japan
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Recruiting
Chiba, 260 8677
-
Japan
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Recruiting
Kagoshima, 890-8760
-
Japan
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Kyoto, 606 8507
-
Japan
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Niigata, 951 8520
-
Japan
Novartis Investigative Site
Recruiting
Oita, 870-8511
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 545-8586
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 556-0015
-
Japan
Novartis Investigative Site
Recruiting
Saitama, 330-8553
-
Japan

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