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

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Novartis

Status

Active, not recruiting

Conditions

Active Secondary Progressive Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis

Treatments

Other: Kesimpta

Study type

Observational

Funder types

Industry

Identifiers

NCT04940065
COMB157G1401

Details and patient eligibility

About

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

Full description

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.

Enrollment

367 patients

Sex

All

Ages

Under 99 years old

Volunteers

No 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

Trial design

367 participants in 1 patient group

Kesimpta
Description:
Patients treated with Kesimpta
Treatment:
Other: Kesimpta

Trial contacts and locations

103

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Data sourced from clinicaltrials.gov

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