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

NCT ID: NCT04940065

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2024-12-12

Brief Summary

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

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Detailed Description

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

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

Conditions

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Relapsing-remitting Multiple Sclerosis Active Secondary Progressive Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kesimpta

Patients treated with Kesimpta

Kesimpta

Intervention Type OTHER

Prospective observational cohort study. There was no treatment allocation.

Interventions

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Kesimpta

Prospective observational cohort study. There was no treatment allocation.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Ichinomiya, Aichi-ken, Japan

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Nagakute, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Tokoname, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Hachinohe, Aomori, Japan

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Hachinohe, Aomori, Japan

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Hirosaki, Aomori, Japan

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Chiba, Chiba, Japan

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Ichikawa, Chiba, Japan

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Narita, Chiba, Japan

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Yachiyo, Chiba, Japan

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Tōon, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Iizuka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Omuta, Fukuoka, Japan

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Gifu, Gifu, Japan

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Maebashi, Gunma, Japan

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Maebashi, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sunagawa, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Mito, Ibaraki, Japan

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Tsuchiura, Ibaraki, Japan

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Ichinoseki, Iwate, Japan

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Ichinoseki, Iwate, Japan

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Morioka, Iwate, Japan

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Kagoshima, Kagoshima-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Kanoya, Kagoshima-ken, Japan

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Kawasaki, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Nankoku, Kochi, Japan

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Kyoto, Kyoto, Japan

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Kyoto, Kyoto, Japan

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Kesennuma, Miyagi, Japan

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Sendai, Miyagi, Japan

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Sendai, Miyagi, Japan

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Nagano, Nagano, Japan

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Nagano, Nagano, Japan

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Sasebo, Nagasaki, Japan

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Kashihara, Nara, Japan

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Tenri, Nara, Japan

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Niigata, Niigata, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Fujiidera, Osaka, Japan

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Moriguchi, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai, Osaka, Japan

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Sakai, Osaka, Japan

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Suita, Osaka, Japan

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Kawagoe, Saitama, Japan

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Koshigaya, Saitama, Japan

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Saitama, Saitama, Japan

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Wako, Saitama, Japan

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Ohtsu, Shiga, Japan

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Ōmihachiman, Shiga, Japan

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Izumo, Shimane, Japan

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Hamamatsu, Shizuoka, Japan

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Oyama, Tochigi, Japan

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Shimotsuga Gun, Tochigi, Japan

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Shimotsuke, Tochigi, Japan

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Bunkyo Ku, Tokyo, Japan

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Bunkyo Ku, Tokyo, Japan

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Edogawa City, Tokyo, Japan

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Fuchū, Tokyo, Japan

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Kiyose, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Nakano City, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Toyama, Toyama, Japan

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Wakayama, Wakayama, Japan

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Kudamatsu, Yamaguchi, Japan

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Shūnan, Yamaguchi, Japan

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Ube, Yamaguchi, Japan

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Aomori, , Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Kobe, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Niigata, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18382

Link to study results

Other Identifiers

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COMB157G1401

Identifier Type: -

Identifier Source: org_study_id

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