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

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

Detailed Description
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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.

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

Conditions
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Relapsing-remitting Multiple Sclerosis, Active Secondary Progressive Multiple Sclerosis

Intervention / Treatment
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* Other: Kesimpta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kesimpta<br>Patients treated with Kesimpta | Other: Kesimpta<br>* Prospective observational cohort study. There is no treatment allocation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kesimpta, multiple sclerosis, Japan