- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850966
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
November 2, 2018 updated by: Eisai Co., Ltd.
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice
Study Overview
Study Type
Observational
Enrollment (Actual)
2747
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
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Miyagi, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Oita, Japan
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Okayama, Japan
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Osaka, Japan
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Saga, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Yamaguchi, Japan
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Aichi
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Aisai, Aichi, Japan
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Ama, Aichi, Japan
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Anjo, Aichi, Japan
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Chita, Aichi, Japan
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Gamagori, Aichi, Japan
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Handa, Aichi, Japan
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Hekinan, Aichi, Japan
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Ichinomiya, Aichi, Japan
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Kasugai, Aichi, Japan
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Kitanagoya, Aichi, Japan
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Nagakute, Aichi, Japan
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Nagoya, Aichi, Japan
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Okazaki, Aichi, Japan
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Tokoname, Aichi, Japan
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Toyohashi, Aichi, Japan
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Toyokawa, Aichi, Japan
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Toyota, Aichi, Japan
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Tsushima, Aichi, Japan
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Yatomi, Aichi, Japan
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Akita
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Minamiakita, Akita, Japan
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Noshiro, Akita, Japan
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Yurihonjo, Akita, Japan
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Aomori
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Hachinohe, Aomori, Japan
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Hirosaki, Aomori, Japan
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Minamitsugaru, Aomori, Japan
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Sannohe, Aomori, Japan
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Chiba
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Abiko, Chiba, Japan
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Awa, Chiba, Japan
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Chosei, Chiba, Japan
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Funabashi, Chiba, Japan
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Ichihara, Chiba, Japan
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Ichikawa, Chiba, Japan
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Kashiwa, Chiba, Japan
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Katori, Chiba, Japan
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Kisarazu, Chiba, Japan
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Matsudo, Chiba, Japan
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Minamiboso, Chiba, Japan
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Mobara, Chiba, Japan
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Narashino, Chiba, Japan
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Narita, Chiba, Japan
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Sakura, Chiba, Japan
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Sosa, Chiba, Japan
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Tomisato, Chiba, Japan
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Urayasu, Chiba, Japan
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Yachiyo, Chiba, Japan
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Yotsukaido, Chiba, Japan
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Ehime
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Saijo, Ehime, Japan
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Shikokuchuo, Ehime, Japan
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Uwajima, Ehime, Japan
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Fukui
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Mikatakaminaka, Fukui, Japan
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Sabae, Fukui, Japan
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Tsuruga, Fukui, Japan
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Fukuoka
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Chikushi, Fukuoka, Japan
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Fukutsu, Fukuoka, Japan
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Itoshima, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Munakata, Fukuoka, Japan
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Nakama, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Onga, Fukuoka, Japan
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Yame, Fukuoka, Japan
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Fukushima
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Aizuwakamatsu, Fukushima, Japan
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Iwaki, Fukushima, Japan
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Koriyama, Fukushima, Japan
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Shirakawa, Fukushima, Japan
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Gifu
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Ibi, Gifu, Japan
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Kakamigahara, Gifu, Japan
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Kamo, Gifu, Japan
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Motosu, Gifu, Japan
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Nakatsugawa, Gifu, Japan
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Ogaki, Gifu, Japan
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Seki, Gifu, Japan
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Yoro, Gifu, Japan
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Gumma
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Agatsuma, Gumma, Japan
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Annaka, Gumma, Japan
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Fujioka, Gumma, Japan
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Isesaki, Gumma, Japan
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Kiryu, Gumma, Japan
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Maebashi, Gumma, Japan
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Ota, Gumma, Japan
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Shibukawa, Gumma, Japan
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Takasaki, Gumma, Japan
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Hiroshima
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Akitakata, Hiroshima, Japan
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Fukuyama, Hiroshima, Japan
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Higashihiroshima, Hiroshima, Japan
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Kure, Hiroshima, Japan
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Onomichi, Hiroshima, Japan
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Takehara, Hiroshima, Japan
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Yamagata, Hiroshima, Japan
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Hokkaido
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Abashiri, Hokkaido, Japan
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Asahikawa, Hokkaido, Japan
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Bibai, Hokkaido, Japan
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Chitose, Hokkaido, Japan
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Date, Hokkaido, Japan
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Ebetsu, Hokkaido, Japan
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Furano, Hokkaido, Japan
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Hakodate, Hokkaido, Japan
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Kitami, Hokkaido, Japan
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Kushiro, Hokkaido, Japan
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Matsumae, Hokkaido, Japan
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Nayoro, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Shari, Hokkaido, Japan
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Sorachi, Hokkaido, Japan
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Takikawa, Hokkaido, Japan
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Yoichi, Hokkaido, Japan
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Hyogo
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Ako, Hyogo, Japan
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Amagasaki, Hyogo, Japan
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Ashiya, Hyogo, Japan
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Himeji, Hyogo, Japan
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Kako, Hyogo, Japan
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Kato, Hyogo, Japan
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Kawanishi, Hyogo, Japan
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Kobe, Hyogo, Japan
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Miki, Hyogo, Japan
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Minamiawaji, Hyogo, Japan
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Nishinomiya, Hyogo, Japan
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Ono, Hyogo, Japan
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Sayo, Hyogo, Japan
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Sumoto, Hyogo, Japan
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Takarazuka, Hyogo, Japan
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Takasago, Hyogo, Japan
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Tamba, Hyogo, Japan
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Tatsuno, Hyogo, Japan
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Ibaraki
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Chikusei, Ibaraki, Japan
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Higashiibaraki, Ibaraki, Japan
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Hitachi, Ibaraki, Japan
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Hitachinaka, Ibaraki, Japan
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Inashiki, Ibaraki, Japan
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Kasama, Ibaraki, Japan
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Kashima, Ibaraki, Japan
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Koga, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Moriya, Ibaraki, Japan
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Ryugasaki, Ibaraki, Japan
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Toride, Ibaraki, Japan
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Tsuchiura, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Yuki, Ibaraki, Japan
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Ishikawa
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Hakui, Ishikawa, Japan
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Kaga, Ishikawa, Japan
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Kahoku, Ishikawa, Japan
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Kanazawa, Ishikawa, Japan
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Komatsu, Ishikawa, Japan
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Iwate
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Hanamaki, Iwate, Japan
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Ichinoseki, Iwate, Japan
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Kitakami, Iwate, Japan
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Morioka, Iwate, Japan
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Ofunato, Iwate, Japan
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Oshu, Iwate, Japan
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Shimohei, Iwate, Japan
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Kagawa
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Ayauta, Kagawa, Japan
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Kanonji, Kagawa, Japan
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Marugame, Kagawa, Japan
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Sakaide, Kagawa, Japan
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Sanuki, Kagawa, Japan
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Takamatsu, Kagawa, Japan
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Kagoshima
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Akune, Kagoshima, Japan
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Kanoya, Kagoshima, Japan
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Oshima, Kagoshima, Japan
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Soh, Kagoshima, Japan
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Kanagawa
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Chigasaki, Kanagawa, Japan
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Ebina, Kanagawa, Japan
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Fujisawa, Kanagawa, Japan
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Hiratsuka, Kanagawa, Japan
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Isehara, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Zushi, Kanagawa, Japan
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Kochi
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Agawa, Kochi, Japan
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Aki, Kochi, Japan
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Kami, Kochi, Japan
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Nankoku, Kochi, Japan
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Shimanto, Kochi, Japan
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Kumamoto
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Aso, Kumamoto, Japan
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Hitoyoshi, Kumamoto, Japan
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Kuma, Kumamoto, Japan
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Minamata, Kumamoto, Japan
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Tamana, Kumamoto, Japan
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Yamaga, Kumamoto, Japan
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Kyoto
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Fukuchiyama, Kyoto, Japan
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Joyo, Kyoto, Japan
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Kameoka, Kyoto, Japan
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Kizugawa, Kyoto, Japan
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Kyotanabe, Kyoto, Japan
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Maizuru, Kyoto, Japan
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Nagaokakyo, Kyoto, Japan
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Nantan, Kyoto, Japan
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Soraku, Kyoto, Japan
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Uji, Kyoto, Japan
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Yawata, Kyoto, Japan
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Mie
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Kuwana, Mie, Japan
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Matsusaka, Mie, Japan
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Shima, Mie, Japan
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Suzuka, Mie, Japan
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Tsu, Mie, Japan
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Yokkaichi, Mie, Japan
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Miyagi
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Higashimatsushima, Miyagi, Japan
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Ishinomaki, Miyagi, Japan
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Iwanuma, Miyagi, Japan
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Kesennuma, Miyagi, Japan
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Osaki, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shibata, Miyagi, Japan
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Miyazaki
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Hyuga, Miyazaki, Japan
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Kobayashi, Miyazaki, Japan
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Kushima, Miyazaki, Japan
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Miyakonojo, Miyazaki, Japan
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Saito, Miyazaki, Japan
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Nagano
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Azumino, Nagano, Japan
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Chiisagata, Nagano, Japan
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Hanishina, Nagano, Japan
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Iida, Nagano, Japan
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Iiyama, Nagano, Japan
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Ina, Nagano, Japan
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Kamiminochi, Nagano, Japan
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Komoro, Nagano, Japan
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Matsumoto, Nagano, Japan
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Okaya, Nagano, Japan
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Saku, Nagano, Japan
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Shimoina, Nagano, Japan
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Shiojiri, Nagano, Japan
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Suwa, Nagano, Japan
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Ueda, Nagano, Japan
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Nagasaki
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Omura, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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Nara
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Kashiba, Nara, Japan
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Kashihara, Nara, Japan
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Kitakatsuragi, Nara, Japan
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Shiki, Nara, Japan
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Uda, Nara, Japan
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Yamatokoriyama, Nara, Japan
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Yamatotakada, Nara, Japan
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Yoshino, Nara, Japan
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Niigata
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Joetsu, Niigata, Japan
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Kamo, Niigata, Japan
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Sado, Niigata, Japan
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Sanjo, Niigata, Japan
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Shibata, Niigata, Japan
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Oita
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Beppu, Oita, Japan
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Kunisaki, Oita, Japan
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Nakatsu, Oita, Japan
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Saiki, Oita, Japan
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Yufu, Oita, Japan
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Okayama
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Asakuchi, Okayama, Japan
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Kurashiki, Okayama, Japan
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Setouchi, Okayama, Japan
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Tsukubo, Okayama, Japan
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Okinawa
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Naha, Okinawa, Japan
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Tomigusuku, Okinawa, Japan
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Urasoe, Okinawa, Japan
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Osaka
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Daito, Osaka, Japan
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Habikino, Osaka, Japan
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Hannan, Osaka, Japan
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Higashiosaka, Osaka, Japan
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Hirakata, Osaka, Japan
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Ibaraki, Osaka, Japan
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Ikeda, Osaka, Japan
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Izumiotsu, Osaka, Japan
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Izumisano, Osaka, Japan
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Kadoma, Osaka, Japan
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Kaizuka, Osaka, Japan
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Katano, Osaka, Japan
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Kishiwada, Osaka, Japan
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Mino, Osaka, Japan
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Mishima, Osaka, Japan
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Moriguchi, Osaka, Japan
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Neyagawa, Osaka, Japan
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Osakasayama, Osaka, Japan
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Sakai, Osaka, Japan
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Sennan, Osaka, Japan
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Settsu, Osaka, Japan
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Shijonawate, Osaka, Japan
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Suita, Osaka, Japan
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Takatsuki, Osaka, Japan
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Toyonaka, Osaka, Japan
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Saga
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Ogi, Saga, Japan
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Takeo, Saga, Japan
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Taku, Saga, Japan
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Tosu, Saga, Japan
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Saitama
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Chichibu, Saitama, Japan
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Fujimi, Saitama, Japan
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Fujimino, Saitama, Japan
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Fukaya, Saitama, Japan
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Gyoda, Saitama, Japan
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Hasuda, Saitama, Japan
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Hidaka, Saitama, Japan
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Higashimatsuyama, Saitama, Japan
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Hiki, Saitama, Japan
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Iruma, Saitama, Japan
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Kasukabe, Saitama, Japan
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Kawagoe, Saitama, Japan
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Kawaguchi, Saitama, Japan
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Kitakatsushika, Saitama, Japan
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Kitamoto, Saitama, Japan
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Koshigaya, Saitama, Japan
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Kumagaya, Saitama, Japan
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Minamisaitama, Saitama, Japan
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Niiza, Saitama, Japan
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Osato, Saitama, Japan
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Satte, Saitama, Japan
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Sayama, Saitama, Japan
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Soka, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Tsurugashima, Saitama, Japan
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Wako, Saitama, Japan
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Yashio, Saitama, Japan
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Shiga
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Gamo, Shiga, Japan
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Higashiomi, Shiga, Japan
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Koka, Shiga, Japan
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Kusatsu, Shiga, Japan
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Moriyama, Shiga, Japan
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Nagahama, Shiga, Japan
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Otsu, Shiga, Japan
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Shimane
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Izumo, Shimane, Japan
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Matsue, Shimane, Japan
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Oda, Shimane, Japan
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Oki, Shimane, Japan
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Yasugi, Shimane, Japan
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Shizuoka
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Fuji, Shizuoka, Japan
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Fujieda, Shizuoka, Japan
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Gotemba, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Kamo, Shizuoka, Japan
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Mishima, Shizuoka, Japan
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Numazu, Shizuoka, Japan
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Syuchi, Shizuoka, Japan
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Tagata, Shizuoka, Japan
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Yaizu, Shizuoka, Japan
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Tochigi
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Ashikaga, Tochigi, Japan
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Moka, Tochigi, Japan
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Nasushiobara, Tochigi, Japan
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Nikko, Tochigi, Japan
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Oyama, Tochigi, Japan
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Sano, Tochigi, Japan
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Shimotsuke, Tochigi, Japan
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Shioya, Tochigi, Japan
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Utsunomiya, Tochigi, Japan
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Tokushima
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Anan, Tokushima, Japan
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Itano, Tokushima, Japan
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Miyoshi, Tokushima, Japan
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Yoshinogawa, Tokushima, Japan
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Tokyo
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Adachi, Tokyo, Japan
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Akiruno, Tokyo, Japan
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Akishima, Tokyo, Japan
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Arakawa, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chiyoda, Tokyo, Japan
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Chofu, Tokyo, Japan
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Chuo, Tokyo, Japan
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Edogawa, Tokyo, Japan
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Fuchu, Tokyo, Japan
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Hachioji, Tokyo, Japan
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Higashikurume, Tokyo, Japan
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Hino, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Katsushika, Tokyo, Japan
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Kita, Tokyo, Japan
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Koganei, Tokyo, Japan
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Kokubunji, Tokyo, Japan
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Koto, Tokyo, Japan
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Machida, Tokyo, Japan
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Meguro, Tokyo, Japan
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Minato, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Musashimurayama, Tokyo, Japan
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Musashino, Tokyo, Japan
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Nakano, Tokyo, Japan
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Nerima, Tokyo, Japan
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Ome, Tokyo, Japan
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Ota, Tokyo, Japan
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Setagaya, Tokyo, Japan
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Shibuya, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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Suginami, Tokyo, Japan
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Sumida, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Taito, Tokyo, Japan
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Tama, Tokyo, Japan
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Toshima, Tokyo, Japan
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Tottori
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Kurayoshi, Tottori, Japan
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Sakaiminato, Tottori, Japan
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Tohaku, Tottori, Japan
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Yonago, Tottori, Japan
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Toyama
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Himi, Toyama, Japan
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Imizu, Toyama, Japan
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Kurobe, Toyama, Japan
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Nakaniikawa, Toyama, Japan
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Nanto, Toyama, Japan
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Oyabe, Toyama, Japan
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Shimoniikawa, Toyama, Japan
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Takaoka, Toyama, Japan
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Tonami, Toyama, Japan
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Wakayama
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Arida, Wakayama, Japan
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Nishimuro, Wakayama, Japan
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Tanabe, Wakayama, Japan
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Yamagata
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Higashimurayama, Yamagata, Japan
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Nishiokitama, Yamagata, Japan
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Shinjo, Yamagata, Japan
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Tendo, Yamagata, Japan
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Tsuruoka, Yamagata, Japan
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Yonezawa, Yamagata, Japan
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Yamaguchi
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Hofu, Yamaguchi, Japan
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Nagato, Yamaguchi, Japan
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Shimonoseki, Yamaguchi, Japan
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Shunan, Yamaguchi, Japan
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Ube, Yamaguchi, Japan
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Yamanashi
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Chuo, Yamanashi, Japan
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Fuefuki, Yamanashi, Japan
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Kai, Yamanashi, Japan
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Kofu, Yamanashi, Japan
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Minamikoma, Yamanashi, Japan
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Nirasaki, Yamanashi, Japan
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospitals and clinics in Japan
Description
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
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: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Iguratimod
|
The usual adult dosage for oral use of 25 mg tablet of iguratimod once daily for 4 weeks or more, after which the dosage should be increased to one 25 mg tablet taken twice daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
Time Frame: 52 weeks (0-24 weeks and 25-52 weeks)
|
DAS28 is a quantitative tool used to measure and monitor disease activity and treatment of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline.
|
52 weeks (0-24 weeks and 25-52 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Akiko Yoshimura, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 12, 2012
Primary Completion (Actual)
April 13, 2014
Study Completion (Actual)
April 13, 2014
Study Registration Dates
First Submitted
May 8, 2013
First Submitted That Met QC Criteria
May 9, 2013
First Posted (Estimate)
May 10, 2013
Study Record Updates
Last Update Posted (Actual)
November 5, 2018
Last Update Submitted That Met QC Criteria
November 2, 2018
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRM01T
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 Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
David Grant U.S. Air Force Medical CenterCompleted
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
Clinical Trials on Iguratimod
-
Jiangsu Simcere Pharmaceutical Co., Ltd.UnknownRheumatoid ArthritisChina
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Completed
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Recruiting
-
Xuzhou Medical UniversityRecruiting
-
Peking University People's HospitalNot yet recruitingHand Osteoarthritis | Inflammatory Arthritis
-
Peking Union Medical College HospitalUnknown
-
Peking University People's HospitalNot yet recruitingImmune ThrombocytopeniaChina
-
Nanfang Hospital of Southern Medical UniversityJiangsu Simcere Pharmaceutical Co., Ltd.Not yet recruitingRheumatoid Arthritis