Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
1 other identifier
observational
2,747
1 country
453
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
453 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2014
CompletedNovember 5, 2018
January 1, 2017
1.6 years
May 8, 2013
November 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
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. * Good response: Baseline DAS28 less than or equal to 3.2 (low disease activity); DAS28 Improvement \>1.2 * Moderate response: Baseline DAS28 less than or equal to 3.2; DAS28 Improvement \>0.6 and less than or equal to 1.2 * or Baseline DAS28 \>3.2 and less than or equal to 5.1; DAS28 Improvement \>0.6 * or Baseline DAS28 \>5.1; DAS28 Improvement \>1.2 * No response: Baseline DAS28 \>5.1 (high disease activity); DAS28 Improvement less than or equal to 1.2 or DAS28 Improvement less than or equal to 0.6
52 weeks (0-24 weeks and 25-52 weeks)
Secondary Outcomes (1)
Number of Participants with Adverse Events
52 weeks
Study Arms (1)
Iguratimod
Interventions
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.
Eligibility Criteria
Hospitals and clinics in Japan
You may qualify if:
- Participants with rheumatoid arthritis
- Participants who take iguratimod
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (453)
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Aisai, Aichi-ken, Japan
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Ama, Aichi-ken, Japan
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Anjo, Aichi-ken, Japan
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Chita, Aichi-ken, Japan
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Gamagōri, Aichi-ken, Japan
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Handa, Aichi-ken, Japan
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Hekinan, Aichi-ken, Japan
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Ichinomiya, Aichi-ken, Japan
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Kasugai, Aichi-ken, Japan
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Kitanagoya, Aichi-ken, Japan
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Nagakute, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Okazaki, Aichi-ken, Japan
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Tokoname, Aichi-ken, Japan
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Toyohashi, Aichi-ken, Japan
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Toyokawa, Aichi-ken, Japan
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Toyota, Aichi-ken, Japan
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Tsushima, Aichi-ken, Japan
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Yatomi, Aichi-ken, Japan
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Minamiakita, Akita, Japan
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Noshiro, Akita, Japan
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Yurihonjō, Akita, Japan
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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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Abiko, Chiba, Japan
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Awa, Chiba, Japan
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Funabashi, Chiba, Japan
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Hongō, 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-shi, Chiba, Japan
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Kisarazu, Chiba, Japan
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Matsudo, Chiba, Japan
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Minamibōsō, 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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Sōsa, 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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Yotsukaidō, Chiba, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Saijō, Ehime, Japan
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Uwajima, Ehime, Japan
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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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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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Koga, 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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Yame, Fukuoka, Japan
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Aizu-Wakamatsu, Fukushima, Japan
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Iwaki, Fukushima, Japan
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Kōriyama, Fukushima, Japan
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Shirakawa, Fukushima, Japan
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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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Ōgaki, Gifu, Japan
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Sekimachi, Gifu, Japan
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Takada, Gifu, Japan
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Agatsuma, Gunma, Japan
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Annaka, Gunma, Japan
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Fujioka, Gunma, Japan
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Isesaki, Gunma, Japan
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Kiryū, Gunma, Japan
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Maebashi, Gunma, Japan
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Ōta, Gunma, Japan
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Shibukawa, Gunma, Japan
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Takasaki, Gunma, Japan
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Aki-takata, 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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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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Honmachi, Hokkaido, Japan
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Kitami, 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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Takikawa, Hokkaido, Japan
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Yoichi, Hokkaido, Japan
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Ako, Hyōgo, Japan
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Ashiya, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Miki, Hyōgo, Japan
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Ono, Hyōgo, Japan
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Sumoto, Hyōgo, Japan
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Takarazuka, Hyōgo, Japan
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Takasago, Hyōgo, Japan
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Tamba, Hyōgo, Japan
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Tatsuno, Hyōgo, Japan
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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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Hitachi-Naka, Ibaraki, Japan
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Inashiki, Ibaraki, Japan
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Kasama, Ibaraki, Japan
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Kashima-shi, 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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Ryūgasaki, 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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Yūki, Ibaraki, Japan
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Hakui, Ishikawa-ken, Japan
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Kaga, Ishikawa-ken, Japan
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Kahoku, Ishikawa-ken, Japan
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Kanazawa, Ishikawa-ken, Japan
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Komatsu, Ishikawa-ken, Japan
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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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Ōfunato, Iwate, Japan
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Ōshū, Iwate, Japan
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Shimohei, Iwate, Japan
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Ayauta, Kagawa-ken, Japan
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Kan’onjichō, Kagawa-ken, Japan
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Marugame, Kagawa-ken, Japan
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Sakaidechō, Kagawa-ken, Japan
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Sanuki, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Akune, Kagoshima-ken, Japan
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Kamikoshikichō-oshima, Kagoshima-ken, Japan
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Kanoya, Kagoshima-ken, Japan
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Soh, Kagoshima-ken, Japan
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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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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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Aso, Kumamoto, Japan
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Hitoyoshi, Kumamoto, Japan
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Isshōchi, 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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Fukuchiyama, Kyoto, Japan
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Jōyō, Kyoto, Japan
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Kameoka, Kyoto, Japan
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Kizugawa, Kyoto, Japan
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Kōtari, Kyoto, Japan
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Kyōtanabe, Kyoto, Japan
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Maizuru, 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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Kuwana, Mie-ken, Japan
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Matsusaka, Mie-ken, Japan
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Shima, Mie-ken, Japan
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Suzuka, Mie-ken, Japan
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Tsu, Mie-ken, Japan
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Yokkaichi, Mie-ken, Japan
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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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Murata, Miyagi, Japan
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Ōsaki, Miyagi, Japan
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Sendai, Miyagi, Japan
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Hyūga, Miyazaki, Japan
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Kobayashi, Miyazaki, Japan
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Kushima, Miyazaki, Japan
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Miyakonojō, Miyazaki, Japan
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Saito, Miyazaki, Japan
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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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Ōmura, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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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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Ōuda-yamaguchi, Nara, Japan
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Shiki, Nara, Japan
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Yamatokōriyama, Nara, Japan
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Yamatotakada, Nara, Japan
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Yoshinoyama, Nara, Japan
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Jōetsu, Niigata, Japan
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Kamo, Niigata, Japan
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Sado, Niigata, Japan
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Sanjō, Niigata, Japan
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Shibata, Niigata, Japan
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Beppu, Oita Prefecture, Japan
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Kunisaki, Oita Prefecture, Japan
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Nakatsu, Oita Prefecture, Japan
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Saiki, Oita Prefecture, Japan
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Yufu, Oita Prefecture, Japan
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Asakuchi, Okayama-ken, Japan
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Kurashiki, Okayama-ken, Japan
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Setouchi, Okayama-ken, Japan
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Tsukubo, Okayama-ken, Japan
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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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Daitō, 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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Izumiōtsu, 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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Sakai, Osaka, Japan
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Sayama, Osaka, Japan
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Sennan, Osaka, Japan
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Settsu, Osaka, Japan
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Shijōnawate, 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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Ogi, Saga-ken, Japan
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Takeo, Saga-ken, Japan
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Taku, Saga-ken, Japan
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Tosu, Saga-ken, Japan
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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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Gyōda, Saitama, Japan
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Hasuda, Saitama, Japan
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Hidaka, Saitama, Japan
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Higashi-Matsuyama, 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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Sōka, 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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Gamo, Shiga, Japan
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Higashiōmi, Shiga, Japan
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Kōka, 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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Ōtsu, Shiga, Japan
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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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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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Ashikaga, Tochigi, Japan
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Mooka, Tochigi, Japan
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Nasushiobara, Tochigi, Japan
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Nikkō, Tochigi, Japan
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Oyama, Tochigi, Japan
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Ōmiya, Tochigi, Japan
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Sano, Tochigi, Japan
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Shimotsuke, Tochigi, Japan
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Utsunomiya, Tochigi, Japan
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Anan, Tokushima, Japan
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Miyoshi, Tokushima, Japan
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Okuno, Tokushima, Japan
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Yoshinogawa, Tokushima, Japan
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Adachi City, Tokyo, Japan
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Akiruno, Tokyo, Japan
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Akishima, Tokyo, Japan
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Arakawa City, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chiyoda City, Tokyo, Japan
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Chōfu, Tokyo, Japan
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Chūō, Tokyo, Japan
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Edogawa City, Tokyo, Japan
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Fuchū, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Higashikurume, Tokyo, Japan
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Hino, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Kita-ku, 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 City, 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 City, Tokyo, Japan
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Nerima City, Tokyo, Japan
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Ōme, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shibuya City, 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 City, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Taitō City, Tokyo, Japan
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Tama, Tokyo, Japan
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Toshima City, Tokyo, Japan
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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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Himi, Toyama, Japan
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Imizu, Toyama, Japan
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Kurobe-shi, 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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Arida, Wakayama, Japan
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Nishimuro, Wakayama, Japan
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Tanabe, Wakayama, Japan
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Higashimurayama, Yamagata, Japan
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Nishiokitama, Yamagata, Japan
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Shinjō, Yamagata, Japan
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Tendō, Yamagata, Japan
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Tsuruoka, Yamagata, Japan
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Yonezawa, Yamagata, Japan
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Hōfu, Yamaguchi, Japan
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Nagato, Yamaguchi, Japan
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Shimonoseki, Yamaguchi, Japan
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Shūnan, Yamaguchi, Japan
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Ube, Yamaguchi, Japan
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Chūō, 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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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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Okayama, Japan
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Osaka, Japan
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Ōita, 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
Related Publications (2)
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.
PMID: 27919207RESULTRheumatology. 2018;59: 222-32.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Akiko Yoshimura
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 10, 2013
Study Start
September 12, 2012
Primary Completion
April 13, 2014
Study Completion
April 13, 2014
Last Updated
November 5, 2018
Record last verified: 2017-01