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

November 21, 2025 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

367

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aomori, Japan, 030 8553
        • Novartis Investigative Site
      • Fukuoka, Japan, 810-0001
        • Novartis Investigative Site
      • Hiroshima, Japan, 734 8530
        • Novartis Investigative Site
      • Kobe, Japan, 650-0017
        • Novartis Investigative Site
      • Kyoto, Japan, 606 8507
        • Novartis Investigative Site
      • Kyoto, Japan, 600-8558
        • Novartis Investigative Site
      • Niigata, Japan, 951 8520
        • Novartis Investigative Site
      • Osaka, Japan, 530-8480
        • Novartis Investigative Site
      • Osaka, Japan, 545-8586
        • Novartis Investigative Site
      • Osaka, Japan, 543-8555
        • Novartis Investigative Site
      • Osaka, Japan, 558-8558
        • Novartis Investigative Site
    • Aichi-ken
      • Ichinomiya, Aichi-ken, Japan, 491-0041
        • Novartis Investigative Site
      • Nagakute, Aichi-ken, Japan, 480-1195
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 457 8510
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 453-0815
        • Novartis Investigative Site
      • Tokoname, Aichi-ken, Japan, 479-0868
        • Novartis Investigative Site
      • Toyohashi, Aichi-ken, Japan, 441-8570
        • Novartis Investigative Site
    • Aomori
      • Hachinohe, Aomori, Japan, 031-0011
        • Novartis Investigative Site
      • Hachinohe, Aomori, Japan, 039-1104
        • Novartis Investigative Site
      • Hirosaki, Aomori, Japan, 036 8563
        • Novartis Investigative Site
    • Chiba
      • Chiba, Chiba, Japan, 2608677
        • Novartis Investigative Site
      • Ichikawa, Chiba, Japan, 272-8513
        • Novartis Investigative Site
      • Narita, Chiba, Japan, 286-8523
        • Novartis Investigative Site
      • Yachiyo, Chiba, Japan, 276-8524
        • Novartis Investigative Site
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
      • Iizuka, Fukuoka, Japan, 820-8505
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 802-8555
        • Novartis Investigative Site
      • Kurume, Fukuoka, Japan, 830-0011
        • Novartis Investigative Site
      • Omuta, Fukuoka, Japan, 836-8566
        • Novartis Investigative Site
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Novartis Investigative Site
    • Gunma
      • Maebashi, Gunma, Japan, 371-0847
        • Novartis Investigative Site
      • Maebashi, Gunma, Japan, 371 8511
        • Novartis Investigative Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0825
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8530
        • Novartis Investigative Site
      • Hakodate, Hokkaido, Japan, 041-0821
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-8543
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 065-0021
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060 8648
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 063-0005
        • Novartis Investigative Site
      • Sunagawa, Hokkaido, Japan, 0730196
        • Novartis Investigative Site
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Novartis Investigative Site
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0011
        • Novartis Investigative Site
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Novartis Investigative Site
    • Iwate
      • Ichinoseki, Iwate, Japan, 021-0871
        • Novartis Investigative Site
      • Ichinoseki, Iwate, Japan, 029-0192
        • Novartis Investigative Site
      • Morioka, Iwate, Japan, 020-8505
        • Novartis Investigative Site
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890 8520
        • Novartis Investigative Site
      • Kagoshima, Kagoshima-ken, Japan, 890-8760
        • Novartis Investigative Site
      • Kanoya, Kagoshima-ken, Japan, 893-0023
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Novartis Investigative Site
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 247-8581
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 227-8501
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 236-0004
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 232 0024
        • Novartis Investigative Site
    • Kochi
      • Nankoku, Kochi, Japan, 783 8505
        • Novartis Investigative Site
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Novartis Investigative Site
      • Kyoto, Kyoto, Japan, 616-8255
        • Novartis Investigative Site
    • Miyagi
      • Kesennuma, Miyagi, Japan, 988-0085
        • Novartis Investigative Site
      • Sendai, Miyagi, Japan, 980 8574
        • Novartis Investigative Site
      • Sendai, Miyagi, Japan, 983 8512
        • Novartis Investigative Site
    • Nagano
      • Nagano, Nagano, Japan, 380-8582
        • Novartis Investigative Site
      • Nagano, Nagano, Japan, 381-8551
        • Novartis Investigative Site
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-1195
        • Novartis Investigative Site
    • Nara
      • Kashihara, Nara, Japan, 634 8522
        • Novartis Investigative Site
      • Tenri, Nara, Japan, 632-8552
        • Novartis Investigative Site
    • Niigata
      • Niigata, Niigata, Japan, 950-1197
        • Novartis Investigative Site
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-8511
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 710-0826
        • Novartis Investigative Site
      • Okayama, Okayama-ken, Japan, 700-8558
        • Novartis Investigative Site
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0014
        • Novartis Investigative Site
      • Moriguchi, Osaka, Japan, 570-8507
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 556-0015
        • Novartis Investigative Site
      • Sakai, Osaka, Japan, 5928555
        • Novartis Investigative Site
      • Sakai, Osaka, Japan, 590-0197
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565 0871
        • Novartis Investigative Site
    • Saitama
      • Kawagoe, Saitama, Japan, 350 8550
        • Novartis Investigative Site
      • Koshigaya, Saitama, Japan, 343-8555
        • Novartis Investigative Site
      • Saitama, Saitama, Japan, 330-8553
        • Novartis Investigative Site
      • Wako, Saitama, Japan, 351-0102
        • Novartis Investigative Site
    • Shiga
      • Ohtsu, Shiga, Japan, 520-2192
        • Novartis Investigative Site
      • Ōmihachiman, Shiga, Japan, 523-0082
        • Novartis Investigative Site
    • Shimane
      • Izumo, Shimane, Japan, 693 8501
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Novartis Investigative Site
    • Tochigi
      • Oyama, Tochigi, Japan, 323-0827
        • Novartis Investigative Site
      • Shimotsuga Gun, Tochigi, Japan, 321-0293
        • Novartis Investigative Site
      • Shimotsuke, Tochigi, Japan, 329-0403
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 113-8431
        • Novartis Investigative Site
      • Bunkyo Ku, Tokyo, Japan, 113 8655
        • Novartis Investigative Site
      • Edogawa City, Tokyo, Japan, 134-0086
        • Novartis Investigative Site
      • Fuchū, Tokyo, Japan, 183-0042
        • Novartis Investigative Site
      • Kiyose, Tokyo, Japan, 204-8585
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japan, 105-8471
        • Novartis Investigative Site
      • Nakano City, Tokyo, Japan, 164-8607
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 160-0023
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Novartis Investigative Site
    • Toyama
      • Toyama, Toyama, Japan, 930-0194
        • Novartis Investigative Site
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Novartis Investigative Site
    • Yamaguchi
      • Kudamatsu, Yamaguchi, Japan, 744-0075
        • Novartis Investigative Site
      • Shūnan, Yamaguchi, Japan, 745-8522
        • Novartis Investigative Site
      • Ube, Yamaguchi, Japan, 755-8505
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Japanese patients whose registration form is accepted and registration is confirmed.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 months
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.
24 months
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)
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.
Up to 24 months
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
month 12, month 24
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).
month 12, month 24 (or at treatment discontinuation)
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
Baseline, month 6, month 12, month 18, month 24 (or at discontinuation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

December 12, 2024

Study Completion (Actual)

December 12, 2024

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB157G1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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