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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04593927
Collaborator
(none)
330
Enrollment
204
Locations
52
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
330 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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)
Actual Study Start Date :
Oct 28, 2020
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions [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

Secondary Outcome Measures

  1. Physician's Global Assessment (PGA) of disease activity [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

  2. Changes over time in Expanded Disability Status Scale (EDSS) score [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.

  3. Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS [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.

  4. Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS [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.

  5. Annual relapse rate [24 months]

    Annual relapse rate will be calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Anjo Aichi Japan 446-8602
2 Novartis Investigative Site Hekinan Aichi Japan 447-0084
3 Novartis Investigative Site Ichinomiya Aichi Japan 491-0041
4 Novartis Investigative Site Kariya Aichi Japan 448-0852
5 Novartis Investigative Site Kasugai Aichi Japan 487-0031
6 Novartis Investigative Site Nagakute-city Aichi Japan 480-1195
7 Novartis Investigative Site Nagoya Aichi Japan 451-8511
8 Novartis Investigative Site Nagoya Aichi Japan 453-0815
9 Novartis Investigative Site Nagoya Aichi Japan 454-0012
10 Novartis Investigative Site Nagoya Aichi Japan 455-8530
11 Novartis Investigative Site Nagoya Aichi Japan 466 8560
12 Novartis Investigative Site Seto-city Aichi Japan 489-8642
13 Novartis Investigative Site Toyoake city Aichi Japan 470 1192
14 Novartis Investigative Site Toyohashi Aichi Japan 441-8570
15 Novartis Investigative Site Hachinohe Aomori Japan 039-1104
16 Novartis Investigative Site Hirosaki Aomori Japan 036 8563
17 Novartis Investigative Site Ichihara-city Chiba Japan 299-0111
18 Novartis Investigative Site Ichikawa Chiba Japan 272-8513
19 Novartis Investigative Site Matsudo-city Chiba Japan 270-2251
20 Novartis Investigative Site Narita Chiba Japan 286-8523
21 Novartis Investigative Site Yachiyo-city Chiba Japan 276-8524
22 Novartis Investigative Site Niihama Ehime Japan 792-8543
23 Novartis Investigative Site Toon-city Ehime Japan 791-0295
24 Novartis Investigative Site Fukuoka city Fukuoka Japan 812-8582
25 Novartis Investigative Site Kitakyushu-city Fukuoka Japan 802-8517
26 Novartis Investigative Site Kitakyushu-city Fukuoka Japan 806-8501
27 Novartis Investigative Site Kitakyushu-city Fukuoka Japan 807-8556
28 Novartis Investigative Site Kurume city Fukuoka Japan 830-0011
29 Novartis Investigative Site Omuta Fukuoka Japan 836-8566
30 Novartis Investigative Site Tagawa Fukuoka Japan 825-0004
31 Novartis Investigative Site Fukushima city Fukushima Japan 960 1295
32 Novartis Investigative Site Gifu shi Gifu Japan 500 8513
33 Novartis Investigative Site Gifu-city Gifu Japan 501-1194
34 Novartis Investigative Site Isesaki Gunma Japan 372-0817
35 Novartis Investigative Site Maebashi city Gunma Japan 371 8511
36 Novartis Investigative Site Maebashi Gunma Japan 371-0847
37 Novartis Investigative Site Ota Gunma Japan 373-8585
38 Novartis Investigative Site Fukuyama Hiroshima Japan 720-0825
39 Novartis Investigative Site Hiroshima-city Hiroshima Japan 730-8518
40 Novartis Investigative Site Hiroshima-city Hiroshima Japan 734-8530
41 Novartis Investigative Site Kure-city Hiroshima Japan 737-0023
42 Novartis Investigative Site Asahikawa Hokkaido Japan 070-8530
43 Novartis Investigative Site Hakodate Hokkaido Japan 041-0821
44 Novartis Investigative Site Iwamizawa-city Hokkaido Japan 068-0007
45 Novartis Investigative Site Kitami Hokkaido Japan 090-0837
46 Novartis Investigative Site Kushiro Hokkaido Japan 085-0052
47 Novartis Investigative Site Muroran Hokkaido Japan 050-0082
48 Novartis Investigative Site Rumoi Hokkaido Japan 077-0007
49 Novartis Investigative Site Sapporo city Hokkaido Japan 060 8648
50 Novartis Investigative Site Sapporo city Hokkaido Japan 063-0005
51 Novartis Investigative Site Sapporo-city Hokkaido Japan 060-8543
52 Novartis Investigative Site Sapporo Hokkaido Japan 060-0807
53 Novartis Investigative Site Sapporo Hokkaido Japan 065-0021
54 Novartis Investigative Site Wakkanai Hokkaido Japan 097-0022
55 Novartis Investigative Site Ako-city Hyogo Japan 678-0239
56 Novartis Investigative Site Awaji Hyogo Japan 672-8501
57 Novartis Investigative Site Itami Hyogo Japan 664-8533
58 Novartis Investigative Site Kakogawa-shi Hyogo Japan 675-8611
59 Novartis Investigative Site Kobe-shi Hyogo Japan 650-0017
60 Novartis Investigative Site Kobe Hyogo Japan 650-0044
61 Novartis Investigative Site Nishinomiya Hyogo Japan 663 8501
62 Novartis Investigative Site Toyooka Hyogo Japan 668-8501
63 Novartis Investigative Site Hitachi-city Ibaraki Japan 317-0077
64 Novartis Investigative Site Hitachinaka Ibaraki Japan 312-0057
65 Novartis Investigative Site Toride-city Ibaraki Japan 302-0022
66 Novartis Investigative Site Tsuchiura Ibaraki Japan 300-0028
67 Novartis Investigative Site Tsukuba city Ibaraki Japan 305-8576
68 Novartis Investigative Site Tsukuba Ibaraki Japan 305-8558
69 Novartis Investigative Site Kanazawa Ishikawa Japan 920-0853
70 Novartis Investigative Site Hanamaki Iwate Japan 025-0082
71 Novartis Investigative Site Ichinoseki Iwate Japan 021-0871
72 Novartis Investigative Site Kita-gun Kagawa Japan 761-0793
73 Novartis Investigative Site Takamatsu city Kagawa Japan 760 8557
74 Novartis Investigative Site Kagoshima city Kagoshima Japan 890 8520
75 Novartis Investigative Site Oshima Kagoshima Japan 891-7101
76 Novartis Investigative Site Satsuma Sendai Kagoshima Japan 895-0061
77 Novartis Investigative Site Ashigarakami Kanagawa Japan 258-0003
78 Novartis Investigative Site Atsugi-city Kanagawa Japan 243-0121
79 Novartis Investigative Site Hiratsuka Kanagawa Japan 254-0065
80 Novartis Investigative Site Isehara Kanagawa Japan 259-1193
81 Novartis Investigative Site Kawasaki-city Kanagawa Japan 216-8511
82 Novartis Investigative Site Naka-gun Kanagawa Japan 259-0198
83 Novartis Investigative Site Sagamihara-city Kanagawa Japan 252-0375
84 Novartis Investigative Site Yokohama city Kanagawa Japan 232 0024
85 Novartis Investigative Site Yokohama-city Kanagawa Japan 227-8501
86 Novartis Investigative Site Yokohama-city Kanagawa Japan 236-0004
87 Novartis Investigative Site Yokohama Kanagawa Japan 245-8575
88 Novartis Investigative Site Yokosuka-city Kanagawa Japan 238-8558
89 Novartis Investigative Site Nankoku city Kochi Japan 783 8505
90 Novartis Investigative Site Kumamoto City Kumamoto Japan 860-8556
91 Novartis Investigative Site Kyoto-city Kyoto Japan 616-8255
92 Novartis Investigative Site Suzuka Mie Japan 513-8505
93 Novartis Investigative Site Kesennuma Miyagi Japan 988-0085
94 Novartis Investigative Site Sendai city Miyagi Japan 980 8574
95 Novartis Investigative Site Miyakonojo Miyazaki Japan 885-0055
96 Novartis Investigative Site Chiisagata Nagano Japan 386-0603
97 Novartis Investigative Site Iida Nagano Japan 395-8502
98 Novartis Investigative Site Ina Nagano Japan 396-0033
99 Novartis Investigative Site Kitaazumi Nagano Japan 399-8601
100 Novartis Investigative Site Matsumoto-city Nagano Japan 390-8621
101 Novartis Investigative Site Matsumoto Nagano Japan 390-8648
102 Novartis Investigative Site Nagano-city Nagano Japan 380-8582
103 Novartis Investigative Site Saku Nagano Japan 384-0301
104 Novartis Investigative Site Suwa Nagano Japan 392-8510
105 Novartis Investigative Site Ueda-city Nagano Japan 386-8610
106 Novartis Investigative Site Iki-city Nagasaki Japan 811-5135
107 Novartis Investigative Site Sasebo Nagasaki Japan 857-8511
108 Novartis Investigative Site Kashihara city Nara Japan 634 8522
109 Novartis Investigative Site Nagaoka Niigata Japan 940-2085
110 Novartis Investigative Site Nagaoka Niigata Japan 940-8653
111 Novartis Investigative Site Niigata-city Niigata Japan 950-1197
112 Novartis Investigative Site Shibata Niigata Japan 957-8588
113 Novartis Investigative Site Tsubame Niigata Japan 959-1228
114 Novartis Investigative Site Tsubame Niigata Japan 959-1284
115 Novartis Investigative Site Beppu-city Oita Japan 874-0011
116 Novartis Investigative Site Oita-city Oita Japan 870-0192
117 Novartis Investigative Site Usa Oita Japan 879-0231
118 Novartis Investigative Site Yufu Oita Japan 879-5593
119 Novartis Investigative Site Okayama-city Okayama Japan 700-8558
120 Novartis Investigative Site Okayama-city Okayama Japan 700-8607
121 Novartis Investigative Site Tsuyama Okayama Japan 708-0841
122 Novartis Investigative Site Ginowan Okinawa Japan 901-2214
123 Novartis Investigative Site Fujiidera Osaka Japan 583-0014
124 Novartis Investigative Site Higashiosaka Osaka Japan 578-8588
125 Novartis Investigative Site Osaka Sayama Osaka Japan 589 8511
126 Novartis Investigative Site Osaka-city Osaka Japan 543-8555
127 Novartis Investigative Site Sakai-city Osaka Japan 593-8304
128 Novartis Investigative Site Suita city Osaka Japan 565 0871
129 Novartis Investigative Site Takatsuki-city Osaka Japan 569-8686
130 Novartis Investigative Site Saga-city Saga Japan 849-8501
131 Novartis Investigative Site Ageo-city Saitama Japan 362-8588
132 Novartis Investigative Site Kawagoe Saitama Japan 350 8550
133 Novartis Investigative Site Koshigaya-city Saitama Japan 343-8555
134 Novartis Investigative Site Koshigaya Saitama Japan 343-8577
135 Novartis Investigative Site Tokorozawa city Saitama Japan 359 8513
136 Novartis Investigative Site Wako-city Saitama Japan 351-0102
137 Novartis Investigative Site Ohtsu-city Shiga Japan 520-2192
138 Novartis Investigative Site Omihachiman Shiga Japan 523-0082
139 Novartis Investigative Site Izumo-city Shimane Japan 693 8501
140 Novartis Investigative Site Fuji city Shizuoka Japan 416-0955
141 Novartis Investigative Site Hamamatsu-city Shizuoka Japan 431-3192
142 Novartis Investigative Site Izunokuni Shizuoka Japan 410-2295
143 Novartis Investigative Site Nasushiobara Tochigi Japan 329-2763
144 Novartis Investigative Site Oyama Tochigi Japan 323-0827
145 Novartis Investigative Site Shimotsuga Gun Tochigi Japan 321-0293
146 Novartis Investigative Site Shimotsuke Tochigi Japan 329-0498
147 Novartis Investigative Site Adachi-ku Tokyo Japan 121-0061
148 Novartis Investigative Site Adachi Tokyo Japan 123-0864
149 Novartis Investigative Site Bunkyo ku Tokyo Japan 113 8655
150 Novartis Investigative Site Bunkyo ku Tokyo Japan 113-8431
151 Novartis Investigative Site Bunkyo-ku Tokyo Japan 113-8519
152 Novartis Investigative Site Edogawa Tokyo Japan 134-0086
153 Novartis Investigative Site Fuchu Tokyo Japan 183-0042
154 Novartis Investigative Site Fuchu Tokyo Japan 183-8524
155 Novartis Investigative Site Hachioji-city Tokyo Japan 192-0032
156 Novartis Investigative Site Hachioji-city Tokyo Japan 193-0944
157 Novartis Investigative Site Itabashi ku Tokyo Japan 173 8606
158 Novartis Investigative Site Kodaira Tokyo Japan 187-8551
159 Novartis Investigative Site Meguro Tokyo Japan 153-8515
160 Novartis Investigative Site Minato-ku Tokyo Japan 108-8329
161 Novartis Investigative Site Nakano Tokyo Japan 164-8607
162 Novartis Investigative Site Ota-ku Tokyo Japan 143 8541
163 Novartis Investigative Site Ota-ku Tokyo Japan 145-0065
164 Novartis Investigative Site Ota Tokyo Japan 146-0092
165 Novartis Investigative Site Shinagawa-ku Tokyo Japan 142-8666
166 Novartis Investigative Site Shinjuku ku Tokyo Japan 162 8666
167 Novartis Investigative Site Shinjuku-ku Tokyo Japan 160 8582
168 Novartis Investigative Site Shinjuku-ku Tokyo Japan 160-0023
169 Novartis Investigative Site Suginami Tokyo Japan 166-0001
170 Novartis Investigative Site Sumida-ku Tokyo Japan 130-8575
171 Novartis Investigative Site Urayasu Tokyo Japan 279-0021
172 Novartis Investigative Site Kurayoshi Tottori Japan 682-0863
173 Novartis Investigative Site Toyama-city Toyama Japan 930-0194
174 Novartis Investigative Site Sakata-city Yamagata Japan 998-8501
175 Novartis Investigative Site Shimonoseki Yamaguchi Japan 750-0061
176 Novartis Investigative Site Shunan-city Yamaguchi Japan 745-8522
177 Novartis Investigative Site Ube Yamaguchi Japan 755-8505
178 Novartis Investigative Site Akita Japan 010-1495
179 Novartis Investigative Site Aomori Japan 030 8553
180 Novartis Investigative Site Chiba Japan 260 8677
181 Novartis Investigative Site Fukui Japan 918-8501
182 Novartis Investigative Site Fukui Japan 918-8503
183 Novartis Investigative Site Fukuoka Japan 810-0022
184 Novartis Investigative Site Gifu Japan 500-8717
185 Novartis Investigative Site Hiroshima Japan 730-8798
186 Novartis Investigative Site Hiroshima Japan 731-3168
187 Novartis Investigative Site Kagoshima Japan 890-0008
188 Novartis Investigative Site Kagoshima Japan 890-0067
189 Novartis Investigative Site Kagoshima Japan 890-8760
190 Novartis Investigative Site Kochi Japan 781-0011
191 Novartis Investigative Site Kumamoto Japan 862-0970
192 Novartis Investigative Site Kyoto Japan 616-8144
193 Novartis Investigative Site Nagasaki Japan 850-0835
194 Novartis Investigative Site Nagasaki Japan 850-8555
195 Novartis Investigative Site Niigata Japan 951 8520
196 Novartis Investigative Site Oita Japan 870-8511
197 Novartis Investigative Site Okayama Japan 700-8557
198 Novartis Investigative Site Osaka Japan 545-8586
199 Novartis Investigative Site Osaka Japan 556-0016
200 Novartis Investigative Site Saga Japan 840-8571
201 Novartis Investigative Site Shizuoka Japan 420-0853
202 Novartis Investigative Site Tokushima Japan 770-0852
203 Novartis Investigative Site Tokushima Japan 770-8503
204 Novartis Investigative Site Yamagata Japan 990 9585

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:
NCT04593927
Other Study ID Numbers:
  • CBAF312A1401
First Posted:
Oct 20, 2020
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Secondary Progressive Multiple Sclerosis
SPMS
Mayzent
Siponimod
Japan
Additional relevant MeSH terms:
Neoplasm Metastasis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Siponimod

Study Results

No Results Posted as of Jul 29, 2022