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

  • End date
    Jul 31, 2026
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 29 June 2022


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


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.

Condition Relapsing-remitting Multiple Sclerosis, Active Secondary Progressive Multiple Sclerosis
Treatment Kesimpta
Clinical Study IdentifierNCT04940065
SponsorNovartis Pharmaceuticals
Last Modified on29 June 2022


Yes No Not Sure

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
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Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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