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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04940065
Collaborator
(none)
330
Enrollment
111
Locations
61
Anticipated Duration (Months)
3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Jun 30, 2021
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Kesimpta

Patients treated with Kesimpta

Other: Kesimpta
Prospective observational cohort study. There is no treatment allocation.

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events (AEs) [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) [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 [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 [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) [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) [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) [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 [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) [month 12, month 24]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Ichinomiya Aichi Japan 491-0041
2 Novartis Investigative Site Nagakute-city Aichi Japan 480-1195
3 Novartis Investigative Site Nagoya-city Aichi Japan 467-8602
4 Novartis Investigative Site Nagoya Aichi Japan 453-0815
5 Novartis Investigative Site Nagoya Aichi Japan 457 8510
6 Novartis Investigative Site Tokoname Aichi Japan 479-0868
7 Novartis Investigative Site Toyohashi Aichi Japan 441-8570
8 Novartis Investigative Site Hachinohe Aomori Japan 031-0011
9 Novartis Investigative Site Hachinohe Aomori Japan 039-1104
10 Novartis Investigative Site Hirosaki Aomori Japan 036 8563
11 Novartis Investigative Site Ichihara-city Chiba Japan 299-0111
12 Novartis Investigative Site Ichikawa Chiba Japan 272-8513
13 Novartis Investigative Site Narita Chiba Japan 286-8523
14 Novartis Investigative Site Yachiyo-city Chiba Japan 276-8524
15 Novartis Investigative Site Toon-city Ehime Japan 791-0295
16 Novartis Investigative Site Chikushino-city Fukuka Japan 818-8516
17 Novartis Investigative Site Fukuoka city Fukuoka Japan 812-8582
18 Novartis Investigative Site Fukuoka-city Fukuoka Japan 810-0001
19 Novartis Investigative Site Iizuka-city Fukuoka Japan 820-8505
20 Novartis Investigative Site Kitakyushu-city Fukuoka Japan 802-8555
21 Novartis Investigative Site Kitakyushu-city Fukuoka Japan 807-8556
22 Novartis Investigative Site Kurume city Fukuoka Japan 830-0011
23 Novartis Investigative Site Omuta Fukuoka Japan 836-8566
24 Novartis Investigative Site Gifu shi Gifu Japan 500 8513
25 Novartis Investigative Site Gifu-city Gifu Japan 501-1194
26 Novartis Investigative Site Maebashi city Gunma Japan 371 8511
27 Novartis Investigative Site Maebashi Gunma Japan 371-0847
28 Novartis Investigative Site Fukuyama Hiroshima Japan 720-0825
29 Novartis Investigative Site Asahikawa Hokkaido Japan 070-8530
30 Novartis Investigative Site Hakodate Hokkaido Japan 041-0821
31 Novartis Investigative Site Sapporo city Hokkaido Japan 063-0005
32 Novartis Investigative Site Sapporo-city Hokkaido Japan 060-8543
33 Novartis Investigative Site Sapporo Hokkaido Japan 060-0807
34 Novartis Investigative Site Sapporo Hokkaido Japan 063-0802
35 Novartis Investigative Site Sapporo Hokkaido Japan 065-0021
36 Novartis Investigative Site Sunagawa Hokkaido Japan 073-0196
37 Novartis Investigative Site Kobe-shi Hyogo Japan 650-0017
38 Novartis Investigative Site Mito-city Ibaraki Japan 310-0011
39 Novartis Investigative Site Tsukuba Ibaraki Japan 300-2622
40 Novartis Investigative Site Ichinoseki Iwate Japan 021-0871
41 Novartis Investigative Site Ichinoseki Iwate Japan 029-0192
42 Novartis Investigative Site Morioka Iwate Japan 020-8505
43 Novartis Investigative Site Kita-gun Kagawa Japan 761-0793
44 Novartis Investigative Site Kagoshima city Kagoshima Japan 890 8520
45 Novartis Investigative Site Kanoya Kagoshima Japan 893-0023
46 Novartis Investigative Site Kawasaki-city Kanagawa Japan 216-8511
47 Novartis Investigative Site Sagamihara-city Kanagawa Japan 252-0375
48 Novartis Investigative Site Yokohama-city Kanagawa Japan 227-8501
49 Novartis Investigative Site Yokohama-city Kanagawa Japan 236-0004
50 Novartis Investigative Site Nankoku city Kochi Japan 783 8505
51 Novartis Investigative Site Kyoto-city Kyoto Japan 600-8558
52 Novartis Investigative Site Kyoto-city Kyoto Japan 602-8566
53 Novartis Investigative Site Kyoto-city Kyoto Japan 616-8255
54 Novartis Investigative Site Suzuka Mie Japan 513-0802
55 Novartis Investigative Site Kesennuma Miyagi Japan 988-0085
56 Novartis Investigative Site Sendai city Miyagi Japan 980 8574
57 Novartis Investigative Site Sendai city Miyagi Japan 983 8512
58 Novartis Investigative Site Matsumoto-city Nagano Japan 390-8621
59 Novartis Investigative Site Nagano-city Nagano Japan 380-8582
60 Novartis Investigative Site Nagano-city Nagano Japan 381-8551
61 Novartis Investigative Site Sasebo-city Nagasaki Japan 857-1165
62 Novartis Investigative Site Kashihara city Nara Japan 634 8522
63 Novartis Investigative Site Tenri Nara Japan 632-8552
64 Novartis Investigative Site Niigata-city Niigata Japan 950-1197
65 Novartis Investigative Site Kurashiki-city Okayama Japan 710-0826
66 Novartis Investigative Site Okayama-city Okayama Japan 700-8558
67 Novartis Investigative Site Fujiidera Osaka Japan 583-0014
68 Novartis Investigative Site Moriguchi Osaka Japan 570-8507
69 Novartis Investigative Site Osaka Sayama Osaka Japan 589 8511
70 Novartis Investigative Site Osaka-city Osaka Japan 530-8480
71 Novartis Investigative Site Osaka-city Osaka Japan 543-8555
72 Novartis Investigative Site Osaka-city Osaka Japan 558-8558
73 Novartis Investigative Site Sakai Osaka Japan 592-8555
74 Novartis Investigative Site Suita city Osaka Japan 565 0871
75 Novartis Investigative Site Kawagoe Saitama Japan 350 8550
76 Novartis Investigative Site Koshigaya-city Saitama Japan 343-8555
77 Novartis Investigative Site Ohtsu-city Shiga Japan 520-2192
78 Novartis Investigative Site Omihachiman Shiga Japan 523-0082
79 Novartis Investigative Site Izumo-city Shimane Japan 693 8501
80 Novartis Investigative Site Fuji city Shizuoka Japan 416-0955
81 Novartis Investigative Site Hamamatsu-city Shizuoka Japan 431-3192
82 Novartis Investigative Site Oyama Tochigi Japan 323-0827
83 Novartis Investigative Site Sano Tochigi Japan 327-8511
84 Novartis Investigative Site Shimotsuga Gun Tochigi Japan 321-0293
85 Novartis Investigative Site Bunkyo ku Tokyo Japan 113 8655
86 Novartis Investigative Site Bunkyo ku Tokyo Japan 113-8431
87 Novartis Investigative Site Edogawa Tokyo Japan 134-0086
88 Novartis Investigative Site Fuchu Tokyo Japan 183-0042
89 Novartis Investigative Site Hachioji-city Tokyo Japan 193-0944
90 Novartis Investigative Site Kiyose-city Tokyo Japan 204-8585
91 Novartis Investigative Site Minato-ku Tokyo Japan 105-8471
92 Novartis Investigative Site Nakano Tokyo Japan 164-8607
93 Novartis Investigative Site Ota-ku Tokyo Japan 143 8541
94 Novartis Investigative Site Shinjuku-ku Tokyo Japan 160 8582
95 Novartis Investigative Site Shinjuku-ku Tokyo Japan 160-0023
96 Novartis Investigative Site Suginami Tokyo Japan 166-0001
97 Novartis Investigative Site Urayasu Tokyo Japan 279-0021
98 Novartis Investigative Site Toyama-city Toyama Japan 930-0194
99 Novartis Investigative Site Wakayama-city Wakayama Japan 641-8510
100 Novartis Investigative Site Kudamatsu Yamaguchi Japan 744-0075
101 Novartis Investigative Site Shunan-city Yamaguchi Japan 745-8522
102 Novartis Investigative Site Ube Yamaguchi Japan 755-8505
103 Novartis Investigative Site Aomori Japan 030 8553
104 Novartis Investigative Site Chiba Japan 260 8677
105 Novartis Investigative Site Kagoshima Japan 890-8760
106 Novartis Investigative Site Kyoto Japan 606 8507
107 Novartis Investigative Site Niigata Japan 951 8520
108 Novartis Investigative Site Oita Japan 870-8511
109 Novartis Investigative Site Osaka Japan 545-8586
110 Novartis Investigative Site Osaka Japan 556-0015
111 Novartis Investigative Site Saitama Japan 330-8553

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04940065
Other Study ID Numbers:
  • COMB157G1401
First Posted:
Jun 25, 2021
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Novartis Pharmaceuticals
Kesimpta
multiple sclerosis
Japan
Additional relevant MeSH terms:
Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Ofatumumab

Study Results

No Results Posted as of Aug 11, 2022