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Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen | Clinical Trials | Clareo Health

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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)

NCT04940065•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

0 - 99 years

Sex

ALL

Healthy Volunteers

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

Locations (103)

Novartis Investigative Site

Ichinomiya, Aichi-ken, Japan

Novartis Investigative Site

Nagakute, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Tokoname, Aichi-ken, Japan

Novartis Investigative Site

Toyohashi, Aichi-ken, Japan

Novartis Investigative Site

Hachinohe, Aomori, Japan

Novartis Investigative Site

Hachinohe, Aomori, Japan

Novartis Investigative Site

Hirosaki, Aomori, Japan

Key Dates

Start Date

June 30, 2021

Primary Completion Date

December 12, 2024

Completion Date

December 12, 2024

Last Updated

November 28, 2025

Enrollment

367

ACTUAL participants

Conditions

Relapsing-remitting Multiple SclerosisActive Secondary Progressive Multiple Sclerosis

Interventions

Kesimpta

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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