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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsing-remitting Multiple Sclerosis; Active Secondary Progressive Multiple Sclerosis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 368

Contacts and Locations

Study Locations

• Japan
  • Aomori, Japan, 030 8553
    • Novartis Investigative Site
  • Chiba, Japan, 2608677
    • Novartis Investigative Site
  • Kagoshima, Japan, 890-8760
    • Novartis Investigative Site
  • Kyoto, Japan, 606 8507
    • Novartis Investigative Site
  • Niigata, Japan, 951 8520
    • Novartis Investigative Site
  • Oita, Japan, 870-8511
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Osaka, Japan, 556-0015
    • Novartis Investigative Site
  • Saitama, Japan, 330-8553
    • Novartis Investigative Site
  • Wakayama, Japan, 641-8510
    • Novartis Investigative Site
  • Aichi
    • Ichinomiya, Aichi, Japan, 491-0041
      • Novartis Investigative Site
    • Nagakute-city, Aichi, Japan, 480-1195
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 457 8510
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 453-0815
      • Novartis Investigative Site
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
    • Tokoname, Aichi, Japan, 479-0868
      • Novartis Investigative Site
    • Toyohashi, Aichi, 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
    • Ichikawa, Chiba, Japan, 272-8513
      • Novartis Investigative Site
    • Narita, Chiba, Japan, 286-8523
      • Novartis Investigative Site
    • Yachiyo city, Chiba, Japan, 276-8524
      • Novartis Investigative Site
  • Ehime
    • Toon city, Ehime, Japan, 791-0295
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka city, Fukuoka, Japan, 812-8582
      • Novartis Investigative Site
    • Fukuoka-city, Fukuoka, Japan, 810-0001
      • Novartis Investigative Site
    • Iizuka-city, Fukuoka, Japan, 820-8505
      • Novartis Investigative Site
    • Kitakyushu-city, Fukuoka, Japan, 802-8555
      • Novartis Investigative Site
    • Kurume city, Fukuoka, Japan, 830-0011
      • Novartis Investigative Site
    • Omuta, Fukuoka, Japan, 836-8566
      • Novartis Investigative Site
  • Gifu
    • Gifu-city, Gifu, Japan, 501-1194
      • Novartis Investigative Site
  • Gunma
    • Maebashi, Gunma, Japan, 371-0847
      • Novartis Investigative Site
    • Maebashi city, Gunma, Japan, 371 8511
      • Novartis Investigative Site
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 720-0825
      • Novartis Investigative Site
    • Hiroshima-city, Hiroshima, Japan, 734-8530
      • 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 city, Hokkaido, Japan, 060 8648
      • Novartis Investigative Site
    • Sapporo city, Hokkaido, Japan, 063-0005
      • Novartis Investigative Site
    • Sunagawa, Hokkaido, Japan, 073-0196
      • Novartis Investigative Site
  • Hyogo
    • Kobe-city, Hyogo, Japan, 650-0047
      • Novartis Investigative Site
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Novartis Investigative Site
  • Ibaraki
    • Mito-city, 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
    • Kagoshima city, Kagoshima, Japan, 890 8520
      • Novartis Investigative Site
    • Kanoya, Kagoshima, Japan, 893-0023
      • Novartis Investigative Site
  • Kanagawa
    • Kawasaki-city, Kanagawa, Japan, 216-8511
      • Novartis Investigative Site
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 247-8581
      • Novartis Investigative Site
    • Yokohama city, Kanagawa, Japan, 232 0024
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 236-0004
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 227-8501
      • Novartis Investigative Site
  • Kochi
    • Nankoku city, Kochi, Japan, 783 8505
      • Novartis Investigative Site
  • Kyoto
    • Kyoto-city, Kyoto, Japan, 602-8566
      • Novartis Investigative Site
    • Kyoto-city, Kyoto, Japan, 600-8558
      • Novartis Investigative Site
    • Kyoto-city, Kyoto, Japan, 616-8255
      • Novartis Investigative Site
  • Miyagi
    • Kesennuma, Miyagi, Japan, 988-0085
      • Novartis Investigative Site
    • Sendai city, Miyagi, Japan, 980 8574
      • Novartis Investigative Site
    • Sendai city, Miyagi, Japan, 983 8512
      • Novartis Investigative Site
  • Nagano
    • Nagano-city, Nagano, Japan, 380-8582
      • Novartis Investigative Site
    • Nagano-city, Nagano, Japan, 381-8551
      • Novartis Investigative Site
  • Nagasaki
    • Sasebo-city, Nagasaki, Japan, 857-1165
      • Novartis Investigative Site
  • Nara
    • Kashihara city, Nara, Japan, 634 8522
      • Novartis Investigative Site
    • Tenri, Nara, Japan, 632-8552
      • Novartis Investigative Site
  • Niigata
    • Niigata-city, Niigata, Japan, 950-1197
      • Novartis Investigative Site
  • Okayama
    • Kurashiki-city, Okayama, Japan, 710-0826
      • Novartis Investigative Site
    • Okayama-city, Okayama, Japan, 700-8558
      • Novartis Investigative Site
  • Osaka
    • Fujiidera, Osaka, Japan, 583-0014
      • Novartis Investigative Site
    • Moriguchi, Osaka, Japan, 570-8507
      • Novartis Investigative Site
    • Osaka Sayama, Osaka, Japan, 589 8511
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 530-8480
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 543-8555
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 558-8558
      • Novartis Investigative Site
    • Sakai, Osaka, Japan, 592-8555
      • 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
    • Wako-city, Saitama, Japan, 351-0102
      • Novartis Investigative Site
  • Shiga
    • Ohtsu-city, Shiga, Japan, 520-2192
      • Novartis Investigative Site
    • Omihachiman, Shiga, Japan, 523-0082
      • Novartis Investigative Site
  • Shimane
    • Izumo-city, Shimane, Japan, 693 8501
      • Novartis Investigative Site
  • Shizuoka
    • Hamamatsu-city, 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, Tokyo, Japan, 134-0086
      • Novartis Investigative Site
    • Fuchu, Tokyo, Japan, 183-0042
      • Novartis Investigative Site
    • Kiyose-city, Tokyo, Japan, 204-8585
      • Novartis Investigative Site
    • Minato-ku, Tokyo, Japan, 105-8471
      • Novartis Investigative Site
    • Nakano, 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-city, Toyama, Japan, 930-0194
      • Novartis Investigative Site
  • Yamaguchi
    • Kudamatsu, Yamaguchi, Japan, 744-0075
      • Novartis Investigative Site
    • Shunan-city, Yamaguchi, Japan, 745-8522
      • Novartis Investigative Site
    • Ube, Yamaguchi, Japan, 755-8505
      • Novartis Investigative Site

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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 conditionElective 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 KesimptaSocial 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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): October 27, 2025
• Study Completion (Estimated): October 27, 2025

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): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: multiple sclerosis; Kesimpta; Japan
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Neoplastic Processes; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Neoplasm Metastasis; Antineoplastic Agents; Ofatumumab
• Other Study ID Numbers: COMB157G1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO