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

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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

Study Locations

Japan
Novartis Investigative Site
Recruiting
Ichihara-city, 299-0111
Chiba
Japan
Novartis Investigative Site
Recruiting
Sapporo, 060-0807
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo, 063-0802
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kita-gun, 761-0793
Kagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 222-0036
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kumamoto-city, 860-0008
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Matsumoto-city, 390-8621
Nagano
Japan
Novartis Investigative Site
Recruiting
Sano, 327-8511
Tochigi
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 193-0944
Tokyo
Japan
Novartis Investigative Site
Recruiting
Suginami, 166-0001
Tokyo
Japan
Novartis Investigative Site
Recruiting
Urayasu, 279-0021
Tokyo
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]