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

NCT04593927 | Completed

• 1 other identifier: CBAF312A1401
• Study Type: observational
• Target: 451
• Locations: 1 country
• Sites: 174

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.

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Keywords

Secondary Progressive Multiple Sclerosis; SPMS; Mayzent; Siponimod; Japan

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions

  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 Outcomes (5)

• Physician's Global Assessment (PGA) of disease activity

  month 12 and month 24

• 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

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

  24 months

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

  24 months

• Annual relapse rate

  24 months

Study Arms (1)

Mayzent

Patients administered Mayzent by prescription

Drug: Mayzent

Interventions

Mayzent DRUG

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

Mayzent

Eligibility Criteria

• Age: Up to 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

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.

You may qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (174)

Novartis Investigative Site

Anjo, Aichi-ken, 446-8602, Japan

Location

Novartis Investigative Site

Hekinan, Aichi-ken, 447-0084, Japan

Location

Novartis Investigative Site

Ichinomiya, Aichi-ken, 491-0041, Japan

Location

Novartis Investigative Site

Kariya, Aichi-ken, 448-0852, Japan

Location

Novartis Investigative Site

Kasugai, Aichi-ken, 487-0031, Japan

Location

Novartis Investigative Site

Nagakute, Aichi-ken, 480-1195, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 451-8511, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 453-0815, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 454-0012, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 455-8530, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 466 8560, Japan

Location

Novartis Investigative Site

Seto, Aichi-ken, 489-8642, Japan

Location

Novartis Investigative Site

Hachinohe, Aomori, 039-1104, Japan

Location

Novartis Investigative Site

Hirosaki, Aomori, 036 8563, Japan

Location

Novartis Investigative Site

Ichihara, Chiba, 299-0111, Japan

Location

Novartis Investigative Site

Ichikawa, Chiba, 272-8513, Japan

Location

Novartis Investigative Site

Yachiyo, Chiba, 276-8524, Japan

Location

Novartis Investigative Site

Tōon, Ehime, 791-0295, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 802-8517, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 806-8501, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

Location

Novartis Investigative Site

Gifu, Gifu, 500 8513, Japan

Location

Novartis Investigative Site

Gifu, Gifu, 501-1194, Japan

Location

Novartis Investigative Site

Isesaki, Gunma, 372-0817, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371-0847, Japan

Location

Novartis Investigative Site

Ōta, Gunma, 373-8585, Japan

Location

Novartis Investigative Site

Fukuyama, Hiroshima, 720-0825, Japan

Location

Novartis Investigative Site

Kure, Hiroshima, 737-0023, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 070-8530, Japan

Location

Novartis Investigative Site

Hakodate, Hokkaido, 041-0821, Japan

Location

Novartis Investigative Site

Iwamizawa, Hokkaido, 068-0007, Japan

Location

Novartis Investigative Site

Kitami, Hokkaido, 090-0837, Japan

Location

Novartis Investigative Site

Kushiro, Hokkaido, 085-0052, Japan

Location

Novartis Investigative Site

Muroran, Hokkaido, 050-0082, Japan

Location

Novartis Investigative Site

Rumoi, Hokkaido, 077-0007, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-0807, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8543, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 063-0005, Japan

Location

Novartis Investigative Site

Ako, Hyōgo, 678-0239, Japan

Location

Novartis Investigative Site

Awaji, Hyōgo, 672-8501, Japan

Location

Novartis Investigative Site

Itami, Hyōgo, 664-8533, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0044, Japan

Location

Novartis Investigative Site

Nishinomiya, Hyōgo, 663 8501, Japan

Location

Novartis Investigative Site

Hitachi, Ibaraki, 317-0077, Japan

Location

Novartis Investigative Site

Hitachi-Naka, Ibaraki, 312-0057, Japan

Location

Novartis Investigative Site

Toride, Ibaraki, 302-0022, Japan

Location

Novartis Investigative Site

Tsuchiura, Ibaraki, 300-0028, Japan

Location

Novartis Investigative Site

Tsukuba, Ibaraki, 305-8558, Japan

Location

Novartis Investigative Site

Tsukuba, Ibaraki, 305-8576, Japan

Location

Novartis Investigative Site

Kanazawa, Ishikawa-ken, 920-0853, Japan

Location

Novartis Investigative Site

Hanamaki, Iwate, 025-0082, Japan

Location

Novartis Investigative Site

Ichinoseki, Iwate, 021-0871, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Kagoshima, Kagoshima-ken, 890 8520, Japan

Location

Novartis Investigative Site

Kamikoshikichō-oshima, Kagoshima-ken, 891-7101, Japan

Location

Novartis Investigative Site

Ashigarakami, Kanagawa, 258-0003, Japan

Location

Novartis Investigative Site

Atsugi, Kanagawa, 243-0121, Japan

Location

Novartis Investigative Site

Hiratsuka, Kanagawa, 254-0065, Japan

Location

Novartis Investigative Site

Isehara, Kanagawa, 259-1193, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 216-8511, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-0375, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 227-8501, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232 0024, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0004, Japan

Location

Novartis Investigative Site

Yokosuka, Kanagawa, 238-8558, Japan

Location

Novartis Investigative Site

Nankoku, Kochi, 783 8505, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 860-8556, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 616-8255, Japan

Location

Novartis Investigative Site

Suzuka, Mie-ken, 513-8505, Japan

Location

Novartis Investigative Site

Tsu, Mie-ken, 514-8507, Japan

Location

Novartis Investigative Site

Kesennuma, Miyagi, 988-0085, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

Location

Novartis Investigative Site

Miyakonojō, Miyazaki, 885-0055, Japan

Location

Novartis Investigative Site

Chiisagata, Nagano, 386-0603, Japan

Location

Novartis Investigative Site

Iida, Nagano, 395-8502, Japan

Location

Novartis Investigative Site

Ina, Nagano, 396-0033, Japan

Location

Novartis Investigative Site

Kitaazumi, Nagano, 399-8601, Japan

Location

Novartis Investigative Site

Matsumoto, Nagano, 390-8621, Japan

Location

Novartis Investigative Site

Matsumoto, Nagano, 390-8648, Japan

Location

Novartis Investigative Site

Nagano, Nagano, 380-8582, Japan

Location

Novartis Investigative Site

Saku, Nagano, 384-0301, Japan

Location

Novartis Investigative Site

Suwa, Nagano, 392-8510, Japan

Location

Novartis Investigative Site

Sasebo, Nagasaki, 857-8511, Japan

Location

Novartis Investigative Site

Kashihara, Nara, 634 8522, Japan

Location

Novartis Investigative Site

Nagaoka, Niigata, 940-2085, Japan

Location

Novartis Investigative Site

Nagaoka, Niigata, 940-8653, Japan

Location

Novartis Investigative Site

Niigata, Niigata, 950-1197, Japan

Location

Novartis Investigative Site

Tsubame, Niigata, 959-1228, Japan

Location

Novartis Investigative Site

Tsubame, Niigata, 959-1284, Japan

Location

Novartis Investigative Site

Beppu, Oita Prefecture, 874-0011, Japan

Location

Novartis Investigative Site

Ōita, Oita Prefecture, 870-0192, Japan

Location

Novartis Investigative Site

Usa, Oita Prefecture, 879-0231, Japan

Location

Novartis Investigative Site

Yufu, Oita Prefecture, 879-5593, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8607, Japan

Location

Novartis Investigative Site

Ginowan, Okinawa, 901-2214, Japan

Location

Novartis Investigative Site

Fujiidera, Osaka, 583-0014, Japan

Location

Novartis Investigative Site

Higashiosaka, Osaka, 578-8588, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 543-8555, Japan

Location

Novartis Investigative Site

Ōsaka-sayama, Osaka, 589 8511, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 593-8304, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-8686, Japan

Location

Novartis Investigative Site

Saga, Saga-ken, 849-8501, Japan

Location

Novartis Investigative Site

Ageo, Saitama, 362-8588, Japan

Location

Novartis Investigative Site

Iruma-gun, Saitama, 350-0495, Japan

Location

Novartis Investigative Site

Kawagoe, Saitama, 350 8550, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-8555, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-8577, Japan

Location

Novartis Investigative Site

Wako, Saitama, 351-0102, Japan

Location

Novartis Investigative Site

Ohtsu-city, Shiga, 520-2192, Japan

Location

Novartis Investigative Site

Ōmihachiman, Shiga, 523-0082, Japan

Location

Novartis Investigative Site

Izumo, Shimane, 693 8501, Japan

Location

Novartis Investigative Site

Fuji, Shizuoka, 416-0955, Japan

Location

Novartis Investigative Site

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Novartis Investigative Site

Izunokuni, Shizuoka, 410-2295, Japan

Location

Novartis Investigative Site

Oyama, Tochigi, 323-0827, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Adachi City, Tokyo, 123-0864, Japan

Location

Novartis Investigative Site

Adachi-ku, Tokyo, 121-0061, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Novartis Investigative Site

Edogawa City, Tokyo, 134-0086, Japan

Location

Novartis Investigative Site

Fuchū, Tokyo, 183-0042, Japan

Location

Novartis Investigative Site

Fuchū, Tokyo, 183-8524, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0032, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 193-0944, Japan

Location

Novartis Investigative Site

Itabashi Ku, Tokyo, 173 8606, Japan

Location

Novartis Investigative Site

Kodaira, Tokyo, 187-8551, Japan

Location

Novartis Investigative Site

Meguro City, Tokyo, 153-8515, Japan

Location

Novartis Investigative Site

Nakano City, Tokyo, 164-8607, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 143 8541, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 145-0065, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 146-0092, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8666, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160 8582, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Novartis Investigative Site

Kurayoshi, Tottori, 682-0863, Japan

Location

Novartis Investigative Site

Toyama, Toyama, 930-0194, Japan

Location

Novartis Investigative Site

Sakata, Yamagata, 998-8501, Japan

Location

Novartis Investigative Site

Shimonoseki, Yamaguchi, 750-0061, Japan

Location

Novartis Investigative Site

Shūnan, Yamaguchi, 745-8522, Japan

Location

Novartis Investigative Site

Ube, Yamaguchi, 755-8505, Japan

Location

Novartis Investigative Site

Akita, 010-1495, Japan

Location

Novartis Investigative Site

Aomori, 030 8553, Japan

Location

Novartis Investigative Site

Chiba, 260 8677, Japan

Location

Novartis Investigative Site

Fukui, 918-8503, Japan

Location

Novartis Investigative Site

Fukuoka, 810-0022, Japan

Location

Novartis Investigative Site

Gifu, 500-8717, Japan

Location

Novartis Investigative Site

Hiroshima, 730-0004, Japan

Location

Novartis Investigative Site

Hiroshima, 730-8518, Japan

Location

Novartis Investigative Site

Hiroshima, 734-8551, Japan

Location

Novartis Investigative Site

Kagoshima, 890-0008, Japan

Location

Novartis Investigative Site

Kagoshima, 890-0067, Japan

Location

Novartis Investigative Site

Kochi, 781-0011, Japan

Location

Novartis Investigative Site

Kumamoto, 862-0970, Japan

Location

Novartis Investigative Site

Kyoto, 603-8041, Japan

Location

Novartis Investigative Site

Kyoto, 616-8144, Japan

Location

Novartis Investigative Site

Nagasaki, 850-0835, Japan

Location

Novartis Investigative Site

Nagasaki, 850-8555, Japan

Location

Novartis Investigative Site

Niigata, 951 8520, Japan

Location

Novartis Investigative Site

Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Ōita, 870-8511, Japan

Location

Novartis Investigative Site

Saga, 840-8571, Japan

Location

Novartis Investigative Site

Saitama, 330 8503, Japan

Location

Novartis Investigative Site

Shizuoka, 420-0853, Japan

Location

Novartis Investigative Site

Tokushima, 770-0852, Japan

Location

Novartis Investigative Site

Tokushima, 770-8503, Japan

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

siponimod

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: October 14, 2020
• First Posted: October 20, 2020
• Study Start: October 28, 2020
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (174)