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

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ClinicalTrials.gov Identifier: NCT04940065
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment
Relapsing-remitting Multiple Sclerosis Active Secondary Progressive Multiple Sclerosis Other: Kesimpta

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.

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Kesimpta
Patients treated with Kesimpta
Other: Kesimpta
Prospective observational cohort study. There is no treatment allocation.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Physician's Global Assessment [ Time Frame: 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).

  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 will record, 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese patients whose registration form is accepted and registration is confirmed.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04940065


Contacts
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Contact: Novartis Pharmaceuticals +81337978748 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Japan
Novartis Investigative Site Recruiting
Nagakute-city, Aichi, Japan, 480-1195
Novartis Investigative Site Recruiting
Nagoya, Aichi, Japan, 453-0815
Novartis Investigative Site Recruiting
Tokoname, Aichi, Japan, 479-0868
Novartis Investigative Site Recruiting
Hachinohe, Aomori, Japan, 039-1104
Novartis Investigative Site Recruiting
Ichikawa, Chiba, Japan, 272-8513
Novartis Investigative Site Recruiting
Toon-city, Ehime, Japan, 791-0295
Novartis Investigative Site Recruiting
Iizuka-city, Fukuoka, Japan, 820-8505
Novartis Investigative Site Recruiting
Kitakyushu-city, Fukuoka, Japan, 802-8555
Novartis Investigative Site Recruiting
Kitakyushu-city, Fukuoka, Japan, 807-8556
Novartis Investigative Site Recruiting
Kurume city, Fukuoka, Japan, 830-0011
Novartis Investigative Site Recruiting
Sapporo city, Hokkaido, Japan, 063-0005
Novartis Investigative Site Recruiting
Sapporo-city, Hokkaido, Japan, 060-8543
Novartis Investigative Site Recruiting
Sapporo, Hokkaido, Japan, 065-0021
Novartis Investigative Site Recruiting
Kobe-shi, Hyogo, Japan, 650-0017
Novartis Investigative Site Recruiting
Ichinoseki, Iwate, Japan, 021-0871
Novartis Investigative Site Recruiting
Ichinoseki, Iwate, Japan, 029-0192
Novartis Investigative Site Recruiting
Morioka, Iwate, Japan, 020-8505
Novartis Investigative Site Recruiting
Yokohama-city, Kanagawa, Japan, 227-8501
Novartis Investigative Site Recruiting
Kyoto-city, Kyoto, Japan, 602-8566
Novartis Investigative Site Recruiting
Kyoto-city, Kyoto, Japan, 616-8255
Novartis Investigative Site Recruiting
Sendai city, Miyagi, Japan, 983 8512
Novartis Investigative Site Recruiting
Kashihara city, Nara, Japan, 634 8522
Novartis Investigative Site Recruiting
Kurashiki-city, Okayama, Japan, 710-0826
Novartis Investigative Site Recruiting
Okayama-city, Okayama, Japan, 700-8558
Novartis Investigative Site Recruiting
Fujiidera, Osaka, Japan, 583-0014
Novartis Investigative Site Recruiting
Moriguchi, Osaka, Japan, 570-8507
Novartis Investigative Site Recruiting
Osaka Sayama, Osaka, Japan, 589 8511
Novartis Investigative Site Recruiting
Osaka-city, Osaka, Japan, 558-8558
Novartis Investigative Site Recruiting
Suita city, Osaka, Japan, 565 0871
Novartis Investigative Site Recruiting
Omihachiman, Shiga, Japan, 523-0082
Novartis Investigative Site Recruiting
Fuchu, Tokyo, Japan, 183-0042
Novartis Investigative Site Recruiting
Toyama-city, Toyama, Japan, 930-0194
Novartis Investigative Site Recruiting
Kudamatsu, Yamaguchi, Japan, 744-0075
Novartis Investigative Site Recruiting
Shunan-city, Yamaguchi, Japan, 745-8522
Novartis Investigative Site Recruiting
Chiba, Japan, 260 8677
Novartis Investigative Site Recruiting
Kagoshima, Japan, 892-8580
Novartis Investigative Site Recruiting
Osaka, Japan, 545-8586
Novartis Investigative Site Recruiting
Osaka, Japan, 556-0015
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04940065    
Other Study ID Numbers: COMB157G1401
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kesimpta
multiple sclerosis
Japan
Additional relevant MeSH terms:
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Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms
Ofatumumab
Antineoplastic Agents