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

NCT04940065 | Completed

• 1 other identifier: COMB157G1401
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 103

Brief Summary

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

Conditions

Relapsing-remitting Multiple Sclerosis; Active Secondary Progressive Multiple Sclerosis

Keywords

Kesimpta; multiple sclerosis; Japan

Outcome Measures

Primary Outcomes (3)

• 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 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

  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 Outcomes (6)

• Physician's Global Assessment

  month 12, month 24 (or at treatment discontinuation)

• Confirmed disability worsening on Expanded Disability Status Scale (EDSS)

  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)

  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)

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

• Annual relapse rate

  Up to 24 months

Study Arms (1)

Kesimpta

Patients treated with Kesimpta

Other: Kesimpta

Interventions

Kesimpta OTHER

Prospective observational cohort study. There was no treatment allocation.

Kesimpta

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (103)

Novartis Investigative Site

Ichinomiya, Aichi-ken, 491-0041, Japan

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Novartis Investigative Site

Nagakute, Aichi-ken, 480-1195, Japan

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Nagoya, Aichi-ken, 453-0815, Japan

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Nagoya, Aichi-ken, 457 8510, Japan

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Nagoya, Aichi-ken, 467-8602, Japan

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Tokoname, Aichi-ken, 479-0868, Japan

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Toyohashi, Aichi-ken, 441-8570, Japan

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Hachinohe, Aomori, 031-0011, Japan

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Hachinohe, Aomori, 039-1104, Japan

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Hirosaki, Aomori, 036 8563, Japan

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Chiba, Chiba, 2608677, Japan

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Ichikawa, Chiba, 272-8513, Japan

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Narita, Chiba, 286-8523, Japan

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Yachiyo, Chiba, 276-8524, Japan

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Tōon, Ehime, 791-0295, Japan

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Fukuoka, Fukuoka, 812-8582, Japan

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Iizuka, Fukuoka, 820-8505, Japan

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Kitakyushu, Fukuoka, 802-8555, Japan

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Kurume, Fukuoka, 830-0011, Japan

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Omuta, Fukuoka, 836-8566, Japan

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Gifu, Gifu, 501-1194, Japan

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Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

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Maebashi, Gunma, 371-0847, Japan

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Fukuyama, Hiroshima, 720-0825, Japan

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Asahikawa, Hokkaido, 070-8530, Japan

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Hakodate, Hokkaido, 041-0821, Japan

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Sapporo, Hokkaido, 060 8648, Japan

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Sapporo, Hokkaido, 060-8543, Japan

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Sapporo, Hokkaido, 063-0005, Japan

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Sapporo, Hokkaido, 065-0021, Japan

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Sunagawa, Hokkaido, 0730196, Japan

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Kobe, Hyōgo, 650-0047, Japan

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Mito, Ibaraki, 310-0011, Japan

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Tsuchiura, Ibaraki, 300-0028, Japan

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Ichinoseki, Iwate, 021-0871, Japan

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Ichinoseki, Iwate, 029-0192, Japan

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Morioka, Iwate, 020-8505, Japan

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Kagoshima, Kagoshima-ken, 890 8520, Japan

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Kagoshima, Kagoshima-ken, 890-8760, Japan

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Kanoya, Kagoshima-ken, 893-0023, Japan

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Kawasaki, Kanagawa, 216-8511, Japan

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Sagamihara, Kanagawa, 252-0375, Japan

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Yokohama, Kanagawa, 227-8501, Japan

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Yokohama, Kanagawa, 232 0024, Japan

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Yokohama, Kanagawa, 236-0004, Japan

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Yokohama, Kanagawa, 247-8581, Japan

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Novartis Investigative Site

Nankoku, Kochi, 783 8505, Japan

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Kyoto, Kyoto, 602-8566, Japan

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Kyoto, Kyoto, 616-8255, Japan

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Kesennuma, Miyagi, 988-0085, Japan

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Sendai, Miyagi, 980 8574, Japan

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Sendai, Miyagi, 983 8512, Japan

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Nagano, Nagano, 380-8582, Japan

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Nagano, Nagano, 381-8551, Japan

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Sasebo, Nagasaki, 857-1195, Japan

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Kashihara, Nara, 634 8522, Japan

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Tenri, Nara, 632-8552, Japan

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Niigata, Niigata, 950-1197, Japan

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Ōita, Oita Prefecture, 870-8511, Japan

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Kurashiki, Okayama-ken, 710-0826, Japan

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Okayama, Okayama-ken, 700-8558, Japan

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Fujiidera, Osaka, 583-0014, Japan

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Moriguchi, Osaka, 570-8507, Japan

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Osaka, Osaka, 556-0015, Japan

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Sakai, Osaka, 590-0197, Japan

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Sakai, Osaka, 5928555, Japan

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Suita, Osaka, 565 0871, Japan

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Kawagoe, Saitama, 350 8550, Japan

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Koshigaya, Saitama, 343-8555, Japan

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Saitama, Saitama, 330-8553, Japan

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Wako, Saitama, 351-0102, Japan

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Ohtsu, Shiga, 520-2192, Japan

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Ōmihachiman, Shiga, 523-0082, Japan

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Izumo, Shimane, 693 8501, Japan

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Hamamatsu, Shizuoka, 431-3192, Japan

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Oyama, Tochigi, 323-0827, Japan

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Shimotsuga Gun, Tochigi, 321-0293, Japan

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Shimotsuke, Tochigi, 329-0403, Japan

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Bunkyo Ku, Tokyo, 113 8655, Japan

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Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

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Edogawa City, Tokyo, 134-0086, Japan

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Fuchū, Tokyo, 183-0042, Japan

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Kiyose, Tokyo, 204-8585, Japan

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Minato-ku, Tokyo, 105-8471, Japan

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Nakano City, Tokyo, 164-8607, Japan

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Shinjuku Ku, Tokyo, 160-0023, Japan

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Shinjuku-ku, Tokyo, 160 8582, Japan

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Toyama, Toyama, 930-0194, Japan

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Wakayama, Wakayama, 641-8510, Japan

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Kudamatsu, Yamaguchi, 744-0075, Japan

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Novartis Investigative Site

Shūnan, Yamaguchi, 745-8522, Japan

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Novartis Investigative Site

Ube, Yamaguchi, 755-8505, Japan

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Aomori, 030 8553, Japan

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Fukuoka, 810-0001, Japan

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Hiroshima, 734 8530, Japan

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Kobe, 650-0017, Japan

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Novartis Investigative Site

Kyoto, 600-8558, Japan

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Novartis Investigative Site

Kyoto, 606 8507, Japan

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Novartis Investigative Site

Niigata, 951 8520, Japan

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Novartis Investigative Site

Osaka, 530-8480, Japan

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Novartis Investigative Site

Osaka, 543-8555, Japan

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Novartis Investigative Site

Osaka, 545-8586, Japan

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Novartis Investigative Site

Osaka, 558-8558, Japan

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 25, 2021
• Study Start: June 30, 2021
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (103)