- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01850966
Undersøgelse af sikkerheden og effektiviteten af Iguratimod hos patienter med reumatoid arthritis
2. november 2018 opdateret af: Eisai Co., Ltd.
At undersøge sikkerheden og effekten af administration af Iguratimod (CRM01T) i 52 uger hos patienter med leddegigt i klinisk praksis
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2747
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Hospitaler og klinikker i Japan
Beskrivelse
Inklusionskriterier
- Deltagere med reumatoid arthritis
- Deltagere, der tager iguratimod
Eksklusionskriterier
- Deltagerne har tidligere tilmeldt sig denne undersøgelse
- Gravide kvinder eller kvinder, der mistænkes for at være gravide
- Deltagere med en alvorlig leversygdom
- Deltagere med mavesår
- Deltagere med kendt overfølsomhed over for iguratimod eller et eller flere af dets hjælpestoffer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Iguratimod
|
Den sædvanlige voksendosis til oral brug af 25 mg tablet iguratimod én gang dagligt i 4 uger eller mere, hvorefter dosis skal øges til én 25 mg tablet taget to gange dagligt.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Disease Activity Score (DAS28) for reumatoid arthritis (EULAR-responskriterier)
Tidsramme: 52 uger (0-24 uger og 25-52 uger)
|
DAS28 er et kvantitativt værktøj, der bruges til at måle og overvåge sygdomsaktivitet og behandling af leddegigt. DAS28 bruger en formel, der inkluderer antallet af ømme led og hævede led for maksimalt 28 led. DAS28 bruges til at vurdere, om en individuel deltager har en signifikant forbedring af sygdomsaktiviteten, sammenlignet med baseline.
|
52 uger (0-24 uger og 25-52 uger)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Antal deltagere med uønskede hændelser
Tidsramme: 52 uger
|
52 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Akiko Yoshimura, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. september 2012
Primær færdiggørelse (Faktiske)
13. april 2014
Studieafslutning (Faktiske)
13. april 2014
Datoer for studieregistrering
Først indsendt
8. maj 2013
Først indsendt, der opfyldte QC-kriterier
9. maj 2013
Først opslået (Skøn)
10. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2018
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRM01T
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Kliniske forsøg med Rheumatoid arthritis
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Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
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Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
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Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
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Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
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Richard Burt, MDAfsluttet
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
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Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater
Kliniske forsøg med Iguratimod
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Jiangsu Simcere Pharmaceutical Co., Ltd.UkendtRheumatoid arthritisKina
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Jiangsu Simcere Pharmaceutical Co., Ltd.Afsluttet
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Jiangsu Simcere Pharmaceutical Co., Ltd.Rekruttering
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Xuzhou Medical UniversityRekruttering
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Peking University People's HospitalIkke rekrutterer endnuHåndslidgigt | Inflammatorisk arthritis
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Peking Union Medical College HospitalUkendt
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Peking University People's HospitalIkke rekrutterer endnu
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Nanfang Hospital of Southern Medical UniversityJiangsu Simcere Pharmaceutical Co., Ltd.Ikke rekrutterer endnuRheumatoid arthritis