Clinical trial NCT01850966: Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
Official title: Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Arthritis, Rheumatoid, Iguratimod
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-10
Enrollment: 2747
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals and clinics in Japan

Brief summary: To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice


Eligibility criteria: Inclusion criteria

* Participants with rheumatoid arthritis
* Participants who take iguratimod

Exclusion criteria

* Participants registered for this survey previously
* Pregnant women or women suspected of being pregnant
* Participants with a serious liver disorder
* Participants with peptic ulcer
* Participants with known hypersensitivity to iguratimod or any of its excipients

Primary outcomes:
measure: Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
timeFrame: 52 weeks (0-24 weeks and 25-52 weeks)
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Aisai
country: Japan
state: Aichi
city: Ama
country: Japan
state: Aichi
city: Anjo
country: Japan
state: Aichi
city: Chita
country: Japan
state: Aichi
city: Gamagori
country: Japan
state: Aichi
city: Handa
country: Japan
state: Aichi
city: Hekinan
country: Japan
state: Aichi
city: Ichinomiya
country: Japan
state: Aichi
city: Kasugai
country: Japan
state: Aichi
city: Kitanagoya
country: Japan
state: Aichi
city: Nagakute
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Okazaki
country: Japan
state: Aichi
city: Tokoname
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Toyokawa
country: Japan
state: Aichi
city: Toyota
country: Japan
state: Aichi
city: Tsushima
country: Japan
state: Aichi
city: Yatomi
country: Japan
state: Aichi
city: Minamiakita
country: Japan
state: Akita
city: Noshiro
country: Japan
state: Akita
city: Yurihonjo
country: Japan
state: Akita
city: Hachinohe
country: Japan
state: Aomori
city: Hirosaki
country: Japan
state: Aomori
city: Minamitsugaru
country: Japan
state: Aomori
city: Sannohe
country: Japan
state: Aomori
city: Abiko
country: Japan
state: Chiba
city: Awa
country: Japan
state: Chiba
city: Chosei
country: Japan
state: Chiba
city: Funabashi
country: Japan
state: Chiba
city: Ichihara
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Katori
country: Japan
state: Chiba
city: Kisarazu
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Minamiboso
country: Japan
state: Chiba
city: Mobara
country: Japan
state: Chiba
city: Narashino
country: Japan
state: Chiba
city: Narita
country: Japan
state: Chiba
city: Sakura
country: Japan
state: Chiba
city: Sosa
country: Japan
state: Chiba
city: Tomisato
country: Japan
state: Chiba
city: Urayasu
country: Japan
state: Chiba
city: Yachiyo
country: Japan
state: Chiba
city: Yotsukaido
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Niihama
country: Japan
state: Ehime
city: Saijo
country: Japan
state: Ehime
city: Shikokuchuo
country: Japan
state: Ehime
city: Uwajima
country: Japan
state: Ehime
city: Mikatakaminaka
country: Japan
state: Fukui
city: Sabae
country: Japan
state: Fukui
city: Tsuruga
country: Japan
state: Fukui
city: Chikushi
country: Japan
state: Fukuoka
city: Fukutsu
country: Japan
state: Fukuoka
city: Itoshima
country: Japan
state: Fukuoka
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
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country: Japan
state: Fukuoka
city: Nakama
country: Japan
state: Fukuoka
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country: Japan
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state: Fukuoka
city: Yame
country: Japan
state: Fukuoka
city: Aizuwakamatsu
country: Japan
state: Fukushima
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city: Shirakawa
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country: Japan
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country: Japan
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city: Nakatsugawa
country: Japan
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country: Japan
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country: Japan
state: Hokkaido
city: Matsumae
country: Japan
state: Hokkaido
city: Nayoro
country: Japan
state: Hokkaido
city: Obihiro
country: Japan
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city: Takikawa
country: Japan
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country: Japan
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city: Ako
country: Japan
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city: Amagasaki
country: Japan
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city: Ashiya
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city: Himeji
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city: Kako
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city: Kato
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city: Kawanishi
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city: Kobe
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city: Miki
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city: Minamiawaji
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city: Sayo
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city: Takarazuka
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city: Chikusei
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state: Ibaraki
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country: Japan
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city: Hitachinaka
country: Japan
state: Ibaraki
city: Hitachi
country: Japan
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city: Inashiki
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city: Kasama
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state: Ibaraki
city: Tsukuba
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city: Yuki
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city: Hakui
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state: Ishikawa
city: Kaga
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city: Kahoku
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city: Kanazawa
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state: Ishikawa
city: Komatsu
country: Japan
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city: Hanamaki
country: Japan
state: Iwate
city: Ichinoseki
country: Japan
state: Iwate
city: Kitakami
country: Japan
state: Iwate
city: Morioka
country: Japan
state: Iwate
city: Ofunato
country: Japan
state: Iwate
city: Oshu
country: Japan
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city: Shimohei
country: Japan
state: Iwate
city: Ayauta
country: Japan
state: Kagawa
city: Kanonji
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state: Kagawa
city: Marugame
country: Japan
state: Kagawa
city: Sakaide
country: Japan
state: Kagawa
city: Sanuki
country: Japan
state: Kagawa
city: Takamatsu
country: Japan
state: Kagawa
city: Akune
country: Japan
state: Kagoshima
city: Kanoya
country: Japan
state: Kagoshima
city: Oshima
country: Japan
state: Kagoshima
city: Soh
country: Japan
state: Kagoshima
city: Chigasaki
country: Japan
state: Kanagawa
city: Ebina
country: Japan
state: Kanagawa
city: Fujisawa
country: Japan
state: Kanagawa
city: Hiratsuka
country: Japan
state: Kanagawa
city: Isehara
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Sagamihara
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state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
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state: Kanagawa
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country: Japan
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city: Aki
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state: Kochi
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state: Kochi
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state: Kochi
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city: Hitoyoshi
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city: Kuma
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state: Kumamoto
city: Minamata
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state: Kumamoto
city: Tamana
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state: Kumamoto
city: Fukuchiyama
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state: Kyoto
city: Joyo
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state: Kyoto
city: Kameoka
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state: Kyoto
city: Kizugawa
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state: Kyoto
city: Kyotanabe
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state: Kyoto
city: Maizuru
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state: Kyoto
city: Nagaokakyo
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state: Kyoto
city: Nantan
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state: Kyoto
city: Soraku
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state: Kyoto
city: Uji
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state: Kyoto
city: Yawata
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state: Kyoto
city: Kuwana
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state: Mie
city: Matsusaka
country: Japan
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city: Shima
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state: Mie
city: Suzuka
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state: Mie
city: Tsu
country: Japan
state: Mie
city: Yokkaichi
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state: Mie
city: Higashimatsushima
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state: Miyagi
city: Ishinomaki
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state: Nagano
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state: Nagano
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state: Nagano
city: Ina
country: Japan
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country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Miyagi
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokushima
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
city: Yamagata
country: Japan
city: Yamaguchi
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Akiko Yoshimura
role: STUDY_DIRECTOR
References:
citation: Mimori T, Harigai M, Atsumi T, Fujii T, Kuwana M, Matsuno H, Momohara S, Takei S, Tamura N, Takasaki Y, Ikeuchi S, Kushimoto S, Koike T. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan. Mod Rheumatol. 2017 Sep;27(5):755-765. doi: 10.1080/14397595.2016.1265695. Epub 2016 Dec 21.
citation: Rheumatology. 2018;59: 222-32.