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)

ClinicalTrials.gov Identifier: NCT04940065

Novartis Reference Number: COMB157G1401

Last Update: Jan 17, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Condition

Relapsing-remitting Multiple Sclerosis

Active Secondary Progressive Multiple Sclerosis

Phase

Not Given

Overall status

Recruiting

Start date

Jun 30, 2021

Completion date

Jul 31, 2026

Gender

All

Age(s)

99 Years and older (Child, Adult, Older Adult)

Interventions

Other

Kesimpta

Prospective observational cohort study. There is no treatment allocation.

Eligibility Criteria

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