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

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