Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

February 9, 2024 updated by: Novartis Pharmaceuticals

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.

Study Type

Observational

Enrollment (Actual)

451

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
      • Akita, Japan, 010-1495
        • Novartis Investigative Site
      • Aomori, Japan, 030 8553
        • Novartis Investigative Site
      • Chiba, Japan, 260 8677
        • Novartis Investigative Site
      • Fukui, Japan, 918-8503
        • Novartis Investigative Site
      • Fukuoka, Japan, 810-0022
        • Novartis Investigative Site
      • Gifu, Japan, 500-8717
        • Novartis Investigative Site
      • Hiroshima, Japan, 734-8551
        • Novartis Investigative Site
      • Hiroshima, Japan, 730-0004
        • Novartis Investigative Site
      • Hiroshima, Japan, 730-8518
        • Novartis Investigative Site
      • Kagoshima, Japan, 890-0008
        • Novartis Investigative Site
      • Kagoshima, Japan, 890-0067
        • Novartis Investigative Site
      • Kochi, Japan, 781-0011
        • Novartis Investigative Site
      • Kumamoto, Japan, 862-0970
        • Novartis Investigative Site
      • Kyoto, Japan, 603-8041
        • Novartis Investigative Site
      • Kyoto, Japan, 616-8144
        • Novartis Investigative Site
      • Nagasaki, Japan, 850-8555
        • Novartis Investigative Site
      • Nagasaki, Japan, 850-0835
        • Novartis Investigative Site
      • Niigata, Japan, 951 8520
        • Novartis Investigative Site
      • Oita, Japan, 870-8511
        • Novartis Investigative Site
      • Osaka, Japan, 545-8586
        • Novartis Investigative Site
      • Saga, Japan, 840-8571
        • Novartis Investigative Site
      • Saitama, Japan, 330 8503
        • Novartis Investigative Site
      • Shizuoka, Japan, 420-0853
        • Novartis Investigative Site
      • Tokushima, Japan, 770-8503
        • Novartis Investigative Site
      • Tokushima, Japan, 770-0852
        • Novartis Investigative Site
    • Aichi
      • Anjo, Aichi, Japan, 446-8602
        • Novartis Investigative Site
      • Hekinan, Aichi, Japan, 447-0084
        • Novartis Investigative Site
      • Ichinomiya, Aichi, Japan, 491-0041
        • Novartis Investigative Site
      • Kariya, Aichi, Japan, 448-0852
        • Novartis Investigative Site
      • Kasugai, Aichi, Japan, 487-0031
        • Novartis Investigative Site
      • Nagakute-city, Aichi, Japan, 480-1195
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 466 8560
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 454-0012
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 455-8530
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 453-0815
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 451-8511
        • Novartis Investigative Site
      • Seto-city, Aichi, Japan, 489-8642
        • Novartis Investigative Site
    • Aomori
      • Hachinohe, Aomori, Japan, 039-1104
        • Novartis Investigative Site
      • Hirosaki, Aomori, Japan, 036 8563
        • Novartis Investigative Site
    • Chiba
      • Ichihara-city, Chiba, Japan, 299-0111
        • Novartis Investigative Site
      • Ichikawa, Chiba, Japan, 272-8513
        • 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
      • Kitakyushu-city, Fukuoka, Japan, 806-8501
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 807-8556
        • Novartis Investigative Site
      • Kitakyushu-city, Fukuoka, Japan, 802-8517
        • Novartis Investigative Site
      • Kurume city, Fukuoka, Japan, 830-0011
        • Novartis Investigative Site
    • Gifu
      • Gifu shi, Gifu, Japan, 500 8513
        • Novartis Investigative Site
      • Gifu-city, Gifu, Japan, 501-1194
        • Novartis Investigative Site
    • Gunma
      • Isesaki, Gunma, Japan, 372-0817
        • Novartis Investigative Site
      • Maebashi, Gunma, Japan, 371-0847
        • Novartis Investigative Site
      • Maebashi city, Gunma, Japan, 371 8511
        • Novartis Investigative Site
      • Ota, Gunma, Japan, 373-8585
        • Novartis Investigative Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0825
        • Novartis Investigative Site
      • Kure-city, Hiroshima, Japan, 737-0023
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8530
        • Novartis Investigative Site
      • Hakodate, Hokkaido, Japan, 041-0821
        • Novartis Investigative Site
      • Iwamizawa-city, Hokkaido, Japan, 068-0007
        • Novartis Investigative Site
      • Kitami, Hokkaido, Japan, 090-0837
        • Novartis Investigative Site
      • Kushiro, Hokkaido, Japan, 085-0052
        • Novartis Investigative Site
      • Muroran, Hokkaido, Japan, 050-0082
        • Novartis Investigative Site
      • Rumoi, Hokkaido, Japan, 077-0007
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-8543
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 060-0807
        • Novartis Investigative Site
      • Sapporo city, Hokkaido, Japan, 063-0005
        • Novartis Investigative Site
    • Hyogo
      • Ako-city, Hyogo, Japan, 678-0239
        • Novartis Investigative Site
      • Awaji, Hyogo, Japan, 672-8501
        • Novartis Investigative Site
      • Itami, Hyogo, Japan, 664-8533
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 650-0044
        • Novartis Investigative Site
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
      • Nishinomiya, Hyogo, Japan, 663 8501
        • Novartis Investigative Site
    • Ibaraki
      • Hitachi-city, Ibaraki, Japan, 317-0077
        • Novartis Investigative Site
      • Hitachinaka, Ibaraki, Japan, 312-0057
        • Novartis Investigative Site
      • Toride-city, Ibaraki, Japan, 302-0022
        • Novartis Investigative Site
      • Tsuchiura, Ibaraki, Japan, 300-0028
        • Novartis Investigative Site
      • Tsukuba, Ibaraki, Japan, 305-8558
        • Novartis Investigative Site
      • Tsukuba city, Ibaraki, Japan, 305-8576
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-0853
        • Novartis Investigative Site
    • Iwate
      • Hanamaki, Iwate, Japan, 025-0082
        • Novartis Investigative Site
      • Ichinoseki, Iwate, Japan, 021-0871
        • Novartis Investigative Site
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Novartis Investigative Site
    • Kagoshima
      • Kagoshima city, Kagoshima, Japan, 890 8520
        • Novartis Investigative Site
      • Oshima, Kagoshima, Japan, 891-7101
        • Novartis Investigative Site
    • Kanagawa
      • Ashigarakami, Kanagawa, Japan, 258-0003
        • Novartis Investigative Site
      • Atsugi-city, Kanagawa, Japan, 243-0121
        • Novartis Investigative Site
      • Hiratsuka, Kanagawa, Japan, 254-0065
        • Novartis Investigative Site
      • Isehara, Kanagawa, Japan, 259-1193
        • Novartis Investigative Site
      • Kawasaki-city, Kanagawa, Japan, 216-8511
        • Novartis Investigative Site
      • Sagamihara, Kanagawa, Japan, 252-0375
        • 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
      • Yokosuka-city, Kanagawa, Japan, 238-8558
        • Novartis Investigative Site
    • Kochi
      • Nankoku city, Kochi, Japan, 783 8505
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto City, Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 616-8255
        • Novartis Investigative Site
    • Mie
      • Suzuka, Mie, Japan, 513-8505
        • Novartis Investigative Site
      • Tsu-city, Mie, Japan, 514-8507
        • Novartis Investigative Site
    • Miyagi
      • Kesennuma, Miyagi, Japan, 988-0085
        • Novartis Investigative Site
      • Sendai city, Miyagi, Japan, 980 8574
        • Novartis Investigative Site
    • Miyazaki
      • Miyakonojo, Miyazaki, Japan, 885-0055
        • Novartis Investigative Site
    • Nagano
      • Chiisagata, Nagano, Japan, 386-0603
        • Novartis Investigative Site
      • Iida, Nagano, Japan, 395-8502
        • Novartis Investigative Site
      • Ina, Nagano, Japan, 396-0033
        • Novartis Investigative Site
      • Kitaazumi, Nagano, Japan, 399-8601
        • Novartis Investigative Site
      • Matsumoto, Nagano, Japan, 390-8621
        • Novartis Investigative Site
      • Matsumoto, Nagano, Japan, 390-8648
        • Novartis Investigative Site
      • Nagano-city, Nagano, Japan, 380-8582
        • Novartis Investigative Site
      • Saku, Nagano, Japan, 384-0301
        • Novartis Investigative Site
      • Suwa, Nagano, Japan, 392-8510
        • Novartis Investigative Site
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-8511
        • Novartis Investigative Site
    • Nara
      • Kashihara city, Nara, Japan, 634 8522
        • Novartis Investigative Site
    • Niigata
      • Nagaoka, Niigata, Japan, 940-8653
        • Novartis Investigative Site
      • Nagaoka, Niigata, Japan, 940-2085
        • Novartis Investigative Site
      • Niigata-city, Niigata, Japan, 950-1197
        • Novartis Investigative Site
      • Tsubame, Niigata, Japan, 959-1228
        • Novartis Investigative Site
      • Tsubame, Niigata, Japan, 959-1284
        • Novartis Investigative Site
    • Oita
      • Beppu, Oita, Japan, 874-0011
        • Novartis Investigative Site
      • Oita-city, Oita, Japan, 870-0192
        • Novartis Investigative Site
      • Usa, Oita, Japan, 879-0231
        • Novartis Investigative Site
      • Yufu, Oita, Japan, 879-5593
        • Novartis Investigative Site
    • Okayama
      • Okayama-city, Okayama, Japan, 700-8558
        • Novartis Investigative Site
      • Okayama-city, Okayama, Japan, 700-8607
        • Novartis Investigative Site
    • Okinawa
      • Ginowan, Okinawa, Japan, 901-2214
        • Novartis Investigative Site
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0014
        • Novartis Investigative Site
      • Higashiosaka, Osaka, Japan, 578-8588
        • Novartis Investigative Site
      • Osaka Sayama, Osaka, Japan, 589 8511
        • Novartis Investigative Site
      • Osaka-city, Osaka, Japan, 543-8555
        • Novartis Investigative Site
      • Sakai-city, Osaka, Japan, 593-8304
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565 0871
        • Novartis Investigative Site
      • Takatsuki-city, Osaka, Japan, 569-8686
        • Novartis Investigative Site
    • Saga
      • Saga-city, Saga, Japan, 849-8501
        • Novartis Investigative Site
    • Saitama
      • Ageo-city, Saitama, Japan, 362-8588
        • Novartis Investigative Site
      • Iruma-gun, Saitama, Japan, 350-0495
        • Novartis Investigative Site
      • Kawagoe, Saitama, Japan, 350 8550
        • Novartis Investigative Site
      • Koshigaya, Saitama, Japan, 343-8555
        • Novartis Investigative Site
      • Koshigaya, Saitama, Japan, 343-8577
        • 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
      • Fuji city, Shizuoka, Japan, 416-0955
        • Novartis Investigative Site
      • Hamamatsu-city, Shizuoka, Japan, 431-3192
        • Novartis Investigative Site
      • Izunokuni, Shizuoka, Japan, 410-2295
        • Novartis Investigative Site
    • Tochigi
      • Oyama, Tochigi, Japan, 323-0827
        • Novartis Investigative Site
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Novartis Investigative Site
    • Tokyo
      • Adachi, Tokyo, Japan, 123-0864
        • Novartis Investigative Site
      • Adachi-ku, Tokyo, Japan, 121-0061
        • Novartis Investigative Site
      • Bunkyo ku, Tokyo, Japan, 113-8431
        • Novartis Investigative Site
      • Bunkyo ku, Tokyo, Japan, 113 8655
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Novartis Investigative Site
      • Edogawa, Tokyo, Japan, 134-0086
        • Novartis Investigative Site
      • Fuchu, Tokyo, Japan, 183-8524
        • Novartis Investigative Site
      • Fuchu, Tokyo, Japan, 183-0042
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 193-0944
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 192-0032
        • Novartis Investigative Site
      • Itabashi ku, Tokyo, Japan, 173 8606
        • Novartis Investigative Site
      • Kodaira, Tokyo, Japan, 187-8551
        • Novartis Investigative Site
      • Meguro, Tokyo, Japan, 153-8515
        • Novartis Investigative Site
      • Nakano, Tokyo, Japan, 164-8607
        • Novartis Investigative Site
      • Ota, Tokyo, Japan, 146-0092
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143 8541
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 145-0065
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Novartis Investigative Site
      • Shinjuku ku, Tokyo, Japan, 162 8666
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Novartis Investigative Site
    • Tottori
      • Kurayoshi, Tottori, Japan, 682-0863
        • Novartis Investigative Site
    • Toyama
      • Toyama-city, Toyama, Japan, 930-0194
        • Novartis Investigative Site
    • Yamagata
      • Sakata-city, Yamagata, Japan, 998-8501
        • Novartis Investigative Site
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 750-0061
        • Novartis Investigative Site
      • Shunan-city, 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

All patients using Mayzent for the following indication for a specified post-marketing period of time

• Indication: prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis By allowing patients who started Mayzent administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Mayzent will be enrolled in this study.

Description

Inclusion Criteria:

  • Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis

Exclusion Criteria:

-

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
Mayzent
Patients administered Mayzent by prescription
Drug: Mayzent
There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions
Time Frame: 24 months

A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Mayzent or whose causality is not recorded
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician's Global Assessment (PGA) of disease activity
Time Frame: month 12 and month 24
Secondary Progressive Multiple Sclerosis (SPMS) symptom changes will be assessed an rated as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of Mayzent administration
month 12 and month 24
Changes over time in Expanded Disability Status Scale (EDSS) score
Time Frame: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24
EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated.
Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24
Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS
Time Frame: 24 months
Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.
24 months
Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS
Time Frame: 24 months
Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.
24 months
Annual relapse rate
Time Frame: 24 months
Annual relapse rate will be calculated
24 months

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

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)

October 28, 2020

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBAF312A1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Secondary Progressive Multiple Sclerosis (SPMS)

Clinical Trials on Mayzent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe