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Relapsing-remitting Multiple SclerosisNCT04940065

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

An observational study of Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis, run by Novartis Pharmaceuticals at 103 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 0 to 99 years
What is being tested?
Kesimpta
How many people
367 participants
Where
103 sitesJapan
Study dates
30 Jun 2021to 12 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Japanese patients whose registration form is accepted and registration is confirmed.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

103 sites in 1 country.

103 sites in 1 country

Japan103 sites

  • Novartis Investigative Site

    Aomori, 030 8553

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 070-8530

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113 8655

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Chiba, Chiba, 2608677

  • Novartis Investigative Site

    Edogawa City, Tokyo, 134-0086

  • Novartis Investigative Site

    Fuchū, Tokyo, 183-0042

  • Novartis Investigative Site

    Fujiidera, Osaka, 583-0014

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Fukuoka, 810-0001

  • Novartis Investigative Site

    Fukuyama, Hiroshima, 720-0825

  • Novartis Investigative Site

    Gifu, Gifu, 501-1194

  • Novartis Investigative Site

    Hachinohe, Aomori, 031-0011

  • Novartis Investigative Site

    Hachinohe, Aomori, 039-1104

  • Novartis Investigative Site

    Hakodate, Hokkaido, 041-0821

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 431-3192

  • Novartis Investigative Site

    Hirosaki, Aomori, 036 8563

  • Novartis Investigative Site

    Hiroshima, 734 8530

  • Novartis Investigative Site

    Ichikawa, Chiba, 272-8513

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 491-0041

  • Novartis Investigative Site

    Ichinoseki, Iwate, 021-0871

  • Novartis Investigative Site

    Ichinoseki, Iwate, 029-0192

  • Novartis Investigative Site

    Iizuka, Fukuoka, 820-8505

  • Novartis Investigative Site

    Izumo, Shimane, 693 8501

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 890 8520

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 890-8760

  • Novartis Investigative Site

    Kanoya, Kagoshima-ken, 893-0023

  • Novartis Investigative Site

    Kashihara, Nara, 634 8522

  • Novartis Investigative Site

    Kawagoe, Saitama, 350 8550

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 216-8511

  • Novartis Investigative Site

    Kesennuma, Miyagi, 988-0085

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 802-8555

  • Novartis Investigative Site

    Kiyose, Tokyo, 204-8585

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Kobe, 650-0017

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-8555

  • Novartis Investigative Site

    Kudamatsu, Yamaguchi, 744-0075

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-0826

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566

  • Novartis Investigative Site

    Kyoto, Kyoto, 616-8255

  • Novartis Investigative Site

    Kyoto, 600-8558

  • Novartis Investigative Site

    Kyoto, 606 8507

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Maebashi, Gunma, 371-0847

  • Novartis Investigative Site

    Minato-ku, Tokyo, 105-8471

  • Novartis Investigative Site

    Mito, Ibaraki, 310-0011

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-8507

  • Novartis Investigative Site

    Morioka, Iwate, 020-8505

  • Novartis Investigative Site

    Nagakute, Aichi-ken, 480-1195

  • Novartis Investigative Site

    Nagano, Nagano, 380-8582

  • Novartis Investigative Site

    Nagano, Nagano, 381-8551

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 453-0815

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457 8510

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Nakano City, Tokyo, 164-8607

  • Novartis Investigative Site

    Nankoku, Kochi, 783 8505

  • Novartis Investigative Site

    Narita, Chiba, 286-8523

  • Novartis Investigative Site

    Niigata, Niigata, 950-1197

  • Novartis Investigative Site

    Niigata, 951 8520

  • Novartis Investigative Site

    Ohtsu, Shiga, 520-2192

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-8511

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Ōmihachiman, Shiga, 523-0082

  • Novartis Investigative Site

    Omuta, Fukuoka, 836-8566

  • Novartis Investigative Site

    Osaka, Osaka, 556-0015

  • Novartis Investigative Site

    Osaka, 530-8480

  • Novartis Investigative Site

    Osaka, 543-8555

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Osaka, 558-8558

  • Novartis Investigative Site

    Oyama, Tochigi, 323-0827

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-0375

  • Novartis Investigative Site

    Saitama, Saitama, 330-8553

  • Novartis Investigative Site

    Sakai, Osaka, 590-0197

  • Novartis Investigative Site

    Sakai, Osaka, 5928555

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8543

  • Novartis Investigative Site

    Sapporo, Hokkaido, 063-0005

  • Novartis Investigative Site

    Sapporo, Hokkaido, 065-0021

  • Novartis Investigative Site

    Sasebo, Nagasaki, 857-1195

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574

  • Novartis Investigative Site

    Sendai, Miyagi, 983 8512

  • Novartis Investigative Site

    Shimotsuga Gun, Tochigi, 321-0293

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 329-0403

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 160-0023

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160 8582

  • Novartis Investigative Site

    Shūnan, Yamaguchi, 745-8522

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Sunagawa, Hokkaido, 0730196

  • Novartis Investigative Site

    Tenri, Nara, 632-8552

  • Novartis Investigative Site

    Tokoname, Aichi-ken, 479-0868

  • Novartis Investigative Site

    Tōon, Ehime, 791-0295

  • Novartis Investigative Site

    Toyama, Toyama, 930-0194

  • Novartis Investigative Site

    Toyohashi, Aichi-ken, 441-8570

  • Novartis Investigative Site

    Tsuchiura, Ibaraki, 300-0028

  • Novartis Investigative Site

    Ube, Yamaguchi, 755-8505

  • Novartis Investigative Site

    Wakayama, Wakayama, 641-8510

  • Novartis Investigative Site

    Wako, Saitama, 351-0102

  • Novartis Investigative Site

    Yachiyo, Chiba, 276-8524

  • Novartis Investigative Site

    Yokohama, Kanagawa, 227-8501

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004

  • Novartis Investigative Site

    Yokohama, Kanagawa, 247-8581

Other trials in Japan

About this study

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)

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

Read the 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.

Being tested
Kesimpta
Keywords
Kesimpta, multiple sclerosis, Japan
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KesimptaOther

    Prospective observational cohort study. There was no treatment allocation.

Study groups in NCT04940065
Study groupRoleWhat they receive
KesimptaPatients treated with Kesimpta
Receives: Other: Kesimpta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

Secondary outcomes (6)

  1. Physician's Global Assessment

    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).

    Measured: month 12, month 24 (or at treatment discontinuation)

  2. 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)

    Measured: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)

  3. 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)

    Measured: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 (or at discontinuation)

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

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

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

  5. 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.

    Measured: Up to 24 months

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

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

    Measured: month 12, month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start30 Jun 2021
  3. Primary completion12 Dec 2024
  4. Study completion12 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940065
Sponsor's protocol ID
COMB157G1401
Status last verified
Nov 2025
First submitted
22 Jun 2021
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis, run by Novartis Pharmaceuticals at 103 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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