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Completed

NCT Number: NCT04940065

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

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

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Active Secondary Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Ichinomiya, Aichi-ken, Japan

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About this study

This was a primary data collection-based special drug-use surveillance to be conducted in accordance with the GPSP ordinance.

Observational period lasted 24 months from the start of treatment with Kesimpta.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kesimpta

Other

Prospective observational cohort study. There was no treatment allocation.

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 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).

  2. Incidence of serious adverse events (SAEs)

    Time frame: 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.

  3. Incidence of adverse reactions

    Time frame: 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.

Secondary outcomes

  1. Physician's Global Assessment

    Time frame: month 12, month 24 (or at treatment discontinuation)

    The investigator comprehensively assessed 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).

  2. Confirmed disability worsening on Expanded Disability Status Scale (EDSS)

    Time frame: 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)

  3. Confirmed improvement on Expanded Disability Status Scale (EDSS)

    Time frame: 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)

  4. Number of gadolinium (Gd)-enhancing lesions on Magnetic Resonance Imaging (MRI)

    Time frame: Baseline, month 6, month 12, month 18, month 24 (or at discontinuation)

    The investigator recorded, in the Case report forms (CRFs), the numbers of gadolinium (Gd)-enhancing lesions on MRI

  5. Annual relapse rate

    Time frame: 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.

  6. No Evidence of Disease Activity (NEDA-3)

    Time frame: month 12, month 24

    NEDA-3 assessments: no relapse, no new/enlarged MRI lesion, no disability progression on EDSS

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2021
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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