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

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:

Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04940065
• Other study ID #: COMB157G1401
• Status: Active, not recruiting
• Start date: June 30, 2021
• Est. completion date: October 27, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 368
• Est. completion date: October 27, 2025
• Est. primary completion date: October 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Neoplasm Metastasis
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Kesimpta
Prospective observational cohort study. There is no treatment allocation.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Aomori
Japan	Novartis Investigative Site	Asahikawa	Hokkaido
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Chiba
Japan	Novartis Investigative Site	Edogawa	Tokyo
Japan	Novartis Investigative Site	Fuchu	Tokyo
Japan	Novartis Investigative Site	Fujiidera	Osaka
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuyama	Hiroshima
Japan	Novartis Investigative Site	Gifu-city	Gifu
Japan	Novartis Investigative Site	Hachinohe	Aomori
Japan	Novartis Investigative Site	Hachinohe	Aomori
Japan	Novartis Investigative Site	Hakodate	Hokkaido
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hirosaki	Aomori
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Ichikawa	Chiba
Japan	Novartis Investigative Site	Ichinomiya	Aichi
Japan	Novartis Investigative Site	Ichinoseki	Iwate
Japan	Novartis Investigative Site	Ichinoseki	Iwate
Japan	Novartis Investigative Site	Iizuka-city	Fukuoka
Japan	Novartis Investigative Site	Izumo-city	Shimane
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Kagoshima city	Kagoshima
Japan	Novartis Investigative Site	Kanoya	Kagoshima
Japan	Novartis Investigative Site	Kashihara city	Nara
Japan	Novartis Investigative Site	Kawagoe	Saitama
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kesennuma	Miyagi
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Japan	Novartis Investigative Site	Koshigaya	Saitama
Japan	Novartis Investigative Site	Kudamatsu	Yamaguchi
Japan	Novartis Investigative Site	Kurashiki-city	Okayama
Japan	Novartis Investigative Site	Kurume city	Fukuoka
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Maebashi	Gunma
Japan	Novartis Investigative Site	Maebashi city	Gunma
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Mito-city	Ibaraki
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Morioka	Iwate
Japan	Novartis Investigative Site	Nagakute-city	Aichi
Japan	Novartis Investigative Site	Nagano-city	Nagano
Japan	Novartis Investigative Site	Nagano-city	Nagano
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nakano	Tokyo
Japan	Novartis Investigative Site	Nankoku city	Kochi
Japan	Novartis Investigative Site	Narita	Chiba
Japan	Novartis Investigative Site	Niigata
Japan	Novartis Investigative Site	Niigata-city	Niigata
Japan	Novartis Investigative Site	Ohtsu-city	Shiga
Japan	Novartis Investigative Site	Oita
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Omihachiman	Shiga
Japan	Novartis Investigative Site	Omuta	Fukuoka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka Sayama	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Oyama	Tochigi
Japan	Novartis Investigative Site	Sagamihara	Kanagawa
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sakai	Osaka
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Sasebo-city	Nagasaki
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Shimotsuga Gun	Tochigi
Japan	Novartis Investigative Site	Shimotsuke	Tochigi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shunan-city	Yamaguchi
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Sunagawa	Hokkaido
Japan	Novartis Investigative Site	Tenri	Nara
Japan	Novartis Investigative Site	Tokoname	Aichi
Japan	Novartis Investigative Site	Toon city	Ehime
Japan	Novartis Investigative Site	Toyama-city	Toyama
Japan	Novartis Investigative Site	Toyohashi	Aichi
Japan	Novartis Investigative Site	Tsuchiura	Ibaraki
Japan	Novartis Investigative Site	Ube	Yamaguchi
Japan	Novartis Investigative Site	Wakayama
Japan	Novartis Investigative Site	Wako-city	Saitama
Japan	Novartis Investigative Site	Yachiyo	Chiba
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	An adverse event (AE) is any untoward medical occurrence experienced by a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not related to the medicinal product(s).	24 months
Primary	Incidence of serious adverse events (SAEs)	A SAE is defined as an adverse event which: Is fatal or life-threatening; Results in persistent or significant disability/incapacity; Constitutes a congenital anomaly/birth defect; Requires inpatient hospitalization or prolongation of existing hospitalization, unless hospitalization is for: Routine treatment or monitoring of the indication under study, not associated with any deterioration in condition; Elective or pre-planned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of treatment with Kesimpta; Social reasons and respite care in the absence of any deterioration in the patient's general condition; Is medically significant, i.e., events that jeopardize the patient or may require medical or surgical intervention to prevent one of the outcomes listed above.	24 months
Primary	Incidence of adverse reactions	An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Kesimpta or whose causality is not recorded.	24 months
Secondary	Physician's Global Assessment	The investigator will comprehensively assess the symptom changes in relapsing-remitting Multiple Sclerosis (MS) and active Secondary Progressive Multiple Sclerosis (SPMS), rating the changes as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of this drug, and record the results in the Case report forms (CRFs).	month 12, month 24 (or at treatment discontinuation)
Secondary	Confirmed disability worsening on Expanded Disability Status Scale (EDSS)	EDSS is a method of quantifying disability in multiple sclerosis (MS) and monitoring changes in the level of disability over time. The scale ranges from 0 (being normal neurological exam and no disability in any functional system) up to 10 (death due to MS). Confirmed disability worsening on EDSS continuing for = 3 months and = 6 months (3mCDW, 6mCDW)	Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
Secondary	Confirmed improvement on Expanded Disability Status Scale (EDSS)	EDSS is a method of quantifying disability in multiple sclerosis (MS) and monitoring changes in the level of disability over time. The scale ranges from 0 (being normal neurological exam and no disability in any functional system) up to 10 (death due to MS). Confirmed improvement on EDSS continuing for = 6 months (6mCDI)	Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
Secondary	Number of gadolinium (Gd)-enhancing lesions on Magnetic Resonance Imaging (MRI)	The investigator will record, in the Case report forms (CRFs), the numbers of gadolinium (Gd)-enhancing lesions on MRI	Baseline, month 6, month 12, month 18, month 24 (or at discontinuation)
Secondary	Annual relapse rate	Relapse: Occurrence of new neurological abnormalities or pre-existing neurological abnormalities in stable state or remission occurring at least 30 days after the occurrence of the previous clinical demyelination event that continues at least for 24 hours without pyrexia and infection.	Up to 24 months
Secondary	No Evidence of Disease Activity (NEDA-3)	NEDA-3 assessments: no relapse, no new/enlarged MRI lesion, no disability progression on EDSS	month 12, month 24