CompletedNot Applicable

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

Japan367 participantsStarted 2021-06-30

Plain-language summary

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

Who can participate

Age range0 Years – 99 Years

SexALL

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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

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

What they're measuring

Incidence of adverse events (AEs)

Timeframe: 24 months

Incidence of serious adverse events (SAEs)

Timeframe: 24 months

Incidence of adverse reactions

Timeframe: 24 months

Trial details

NCT IDNCT04940065

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-12

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