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

Active, not recruiting

• Conditions: Active Secondary Progressive Multiple Sclerosis; Relapsing-remitting Multiple Sclerosis
• Interventions: Other: Kesimpta

• Registration Number: NCT04940065
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-25
• Study Start: 2021-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 367

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kesimpta	Kesimpta	Patients treated with Kesimpta

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	24 months	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.
Incidence of adverse reactions	24 months	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.
Incidence of adverse events (AEs)	24 months	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).

Secondary Outcome Measures

Name	Time	Method
No Evidence of Disease Activity (NEDA-3)	month 12, month 24	NEDA-3 assessments: no relapse, no new/enlarged MRI lesion, no disability progression on EDSS
Physician's Global Assessment	month 12, month 24 (or at treatment discontinuation)	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).
Confirmed disability worsening on Expanded Disability Status Scale (EDSS)	Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)	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)
Number of gadolinium (Gd)-enhancing lesions on Magnetic Resonance Imaging (MRI)	Baseline, month 6, month 12, month 18, month 24 (or at discontinuation)	The investigator will record, in the Case report forms (CRFs), the numbers of gadolinium (Gd)-enhancing lesions on MRI
Confirmed improvement on Expanded Disability Status Scale (EDSS)	Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)	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)
Annual relapse rate	Up to 24 months	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Wakayama, Japan