Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

NCT ID: NCT01850966

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2747 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-12
• Study Completion Date: 2014-04-13

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

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Iguratimod

Iguratimod

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants with rheumatoid arthritis
• Participants who take iguratimod

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akiko Yoshimura

Role: STUDY_DIRECTOR

Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Locations

Aisai, Aichi-ken, Japan

Ama, Aichi-ken, Japan

Anjo, Aichi-ken, Japan

Chita, Aichi-ken, Japan

Gamagōri, Aichi-ken, Japan

Handa, Aichi-ken, Japan

Hekinan, Aichi-ken, Japan

Ichinomiya, Aichi-ken, Japan

Kasugai, Aichi-ken, Japan

Kitanagoya, Aichi-ken, Japan

Nagakute, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Okazaki, Aichi-ken, Japan

Tokoname, Aichi-ken, Japan

Toyohashi, Aichi-ken, Japan

Toyokawa, Aichi-ken, Japan

Toyota, Aichi-ken, Japan

Tsushima, Aichi-ken, Japan

Yatomi, Aichi-ken, Japan

Minamiakita, Akita, Japan

Noshiro, Akita, Japan

Yurihonjō, Akita, Japan

Hachinohe, Aomori, Japan

Hirosaki, Aomori, Japan

Minamitsugaru, Aomori, Japan

Sannohe, Aomori, Japan

Abiko, Chiba, Japan

Awa, Chiba, Japan

Funabashi, Chiba, Japan

Hongō, Chiba, Japan

Ichihara, Chiba, Japan

Ichikawa, Chiba, Japan

Kashiwa, Chiba, Japan

Katori-shi, Chiba, Japan

Kisarazu, Chiba, Japan

Matsudo, Chiba, Japan

Minamibōsō, Chiba, Japan

Mobara, Chiba, Japan

Narashino, Chiba, Japan

Narita, Chiba, Japan

Sakura, Chiba, Japan

Sōsa, Chiba, Japan

Tomisato, Chiba, Japan

Urayasu, Chiba, Japan

Yachiyo, Chiba, Japan

Yotsukaidō, Chiba, Japan

Matsuyama, Ehime, Japan

Niihama, Ehime, Japan

Saijō, Ehime, Japan

Shikokuchūō, Ehime, Japan

Uwajima, Ehime, Japan

Mikatakaminaka, Fukui, Japan

Sabae, Fukui, Japan

Tsuruga, Fukui, Japan

Chikushi, Fukuoka, Japan

Fukutsu, Fukuoka, Japan

Itoshima, Fukuoka, Japan

Kasuga, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Koga, Fukuoka, Japan

Kurume, Fukuoka, Japan

Munakata, Fukuoka, Japan

Nakama, Fukuoka, Japan

Omuta, Fukuoka, Japan

Yame, Fukuoka, Japan

Aizu-Wakamatsu, Fukushima, Japan

Iwaki, Fukushima, Japan

Kōriyama, Fukushima, Japan

Shirakawa, Fukushima, Japan

Ibi, Gifu, Japan

Kakamigahara, Gifu, Japan

Kamo, Gifu, Japan

Motosu, Gifu, Japan

Nakatsugawa, Gifu, Japan

Ōgaki, Gifu, Japan

Sekimachi, Gifu, Japan

Takada, Gifu, Japan

Agatsuma, Gunma, Japan

Annaka, Gunma, Japan

Fujioka, Gunma, Japan

Isesaki, Gunma, Japan

Kiryū, Gunma, Japan

Maebashi, Gunma, Japan

Ōta, Gunma, Japan

Shibukawa, Gunma, Japan

Takasaki, Gunma, Japan

Aki-takata, Hiroshima, Japan

Fukuyama, Hiroshima, Japan

Higashihiroshima, Hiroshima, Japan

Kure, Hiroshima, Japan

Onomichi, Hiroshima, Japan

Takehara, Hiroshima, Japan

Yamagata, Hiroshima, Japan

Abashiri, Hokkaido, Japan

Asahikawa, Hokkaido, Japan

Bibai, Hokkaido, Japan

Chitose, Hokkaido, Japan

Date, Hokkaido, Japan

Ebetsu, Hokkaido, Japan

Furano, Hokkaido, Japan

Hakodate, Hokkaido, Japan

Honmachi, Hokkaido, Japan

Kitami, Hokkaido, Japan

Kushiro, Hokkaido, Japan

Matsumae, Hokkaido, Japan

Nayoro, Hokkaido, Japan

Obihiro, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sorachi, Hokkaido, Japan

Takikawa, Hokkaido, Japan

Yoichi, Hokkaido, Japan

Ako, Hyōgo, Japan

Amagasaki, Hyōgo, Japan

Ashiya, Hyōgo, Japan

Himeji, Hyōgo, Japan

Kako, Hyōgo, Japan

Katō, Hyōgo, Japan

Kawanishi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Miki, Hyōgo, Japan

Minamiawaji, Hyōgo, Japan

Nishinomiya, Hyōgo, Japan

Ono, Hyōgo, Japan

Sayō, Hyōgo, Japan

Sumoto, Hyōgo, Japan

Takarazuka, Hyōgo, Japan

Takasago, Hyōgo, Japan

Tamba, Hyōgo, Japan

Tatsuno, Hyōgo, Japan

Chikusei, Ibaraki, Japan

Higashiibaraki, Ibaraki, Japan

Hitachi, Ibaraki, Japan

Hitachi-Naka, Ibaraki, Japan

Inashiki, Ibaraki, Japan

Kasama, Ibaraki, Japan

Kashima-shi, Ibaraki, Japan

Koga, Ibaraki, Japan

Mito, Ibaraki, Japan

Moriya, Ibaraki, Japan

Ryūgasaki, Ibaraki, Japan

Toride, Ibaraki, Japan

Tsuchiura, Ibaraki, Japan

Tsukuba, Ibaraki, Japan

Yūki, Ibaraki, Japan

Hakui, Ishikawa-ken, Japan

Kaga, Ishikawa-ken, Japan

Kahoku, Ishikawa-ken, Japan

Kanazawa, Ishikawa-ken, Japan

Komatsu, Ishikawa-ken, Japan

Hanamaki, Iwate, Japan

Ichinoseki, Iwate, Japan

Kitakami, Iwate, Japan

Morioka, Iwate, Japan

Ōfunato, Iwate, Japan

Ōshū, Iwate, Japan

Shimohei, Iwate, Japan

Ayauta, Kagawa-ken, Japan

Kan’onjichō, Kagawa-ken, Japan

Marugame, Kagawa-ken, Japan

Sakaidechō, Kagawa-ken, Japan

Sanuki, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Akune, Kagoshima-ken, Japan

Kamikoshikichō-oshima, Kagoshima-ken, Japan

Kanoya, Kagoshima-ken, Japan

Soh, Kagoshima-ken, Japan

Chigasaki, Kanagawa, Japan

Ebina, Kanagawa, Japan

Fujisawa, Kanagawa, Japan

Hiratsuka, Kanagawa, Japan

Isehara, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Zushi, Kanagawa, Japan

Agawa, Kochi, Japan

Aki, Kochi, Japan

Kami, Kochi, Japan

Nankoku, Kochi, Japan

Shimanto, Kochi, Japan

Aso, Kumamoto, Japan

Hitoyoshi, Kumamoto, Japan

Isshōchi, Kumamoto, Japan

Minamata, Kumamoto, Japan

Tamana, Kumamoto, Japan

Yamaga, Kumamoto, Japan

Fukuchiyama, Kyoto, Japan

Jōyō, Kyoto, Japan

Kameoka, Kyoto, Japan

Kizugawa, Kyoto, Japan

Kōtari, Kyoto, Japan

Kyōtanabe, Kyoto, Japan

Maizuru, Kyoto, Japan

Nantan, Kyoto, Japan

Soraku, Kyoto, Japan

Uji, Kyoto, Japan

Yawata, Kyoto, Japan

Kuwana, Mie-ken, Japan

Matsusaka, Mie-ken, Japan

Shima, Mie-ken, Japan

Suzuka, Mie-ken, Japan

Tsu, Mie-ken, Japan

Yokkaichi, Mie-ken, Japan

Higashimatsushima, Miyagi, Japan

Ishinomaki, Miyagi, Japan

Iwanuma, Miyagi, Japan

Kesennuma, Miyagi, Japan

Murata, Miyagi, Japan

Ōsaki, Miyagi, Japan

Sendai, Miyagi, Japan

Hyūga, Miyazaki, Japan

Kobayashi, Miyazaki, Japan

Kushima, Miyazaki, Japan

Miyakonojō, Miyazaki, Japan

Saito, Miyazaki, Japan

Azumino, Nagano, Japan

Chiisagata, Nagano, Japan

Hanishina, Nagano, Japan

Iida, Nagano, Japan

Iiyama, Nagano, Japan

Ina, Nagano, Japan

Kamiminochi, Nagano, Japan

Komoro, Nagano, Japan

Matsumoto, Nagano, Japan

Okaya, Nagano, Japan

Saku, Nagano, Japan

Shimoina, Nagano, Japan

Shiojiri, Nagano, Japan

Suwa, Nagano, Japan

Ueda, Nagano, Japan

Ōmura, Nagasaki, Japan

Sasebo, Nagasaki, Japan

Kashiba, Nara, Japan

Kashihara, Nara, Japan

Kitakatsuragi, Nara, Japan

Ōuda-yamaguchi, Nara, Japan

Shiki, Nara, Japan

Yamatokōriyama, Nara, Japan

Yamatotakada, Nara, Japan

Yoshinoyama, Nara, Japan

Jōetsu, Niigata, Japan

Kamo, Niigata, Japan

Sado, Niigata, Japan

Sanjō, Niigata, Japan

Shibata, Niigata, Japan

Beppu, Oita Prefecture, Japan

Kunisaki, Oita Prefecture, Japan

Nakatsu, Oita Prefecture, Japan

Saiki, Oita Prefecture, Japan

Yufu, Oita Prefecture, Japan

Asakuchi, Okayama-ken, Japan

Kurashiki, Okayama-ken, Japan

Setouchi, Okayama-ken, Japan

Tsukubo, Okayama-ken, Japan

Naha, Okinawa, Japan

Tomigusuku, Okinawa, Japan

Urasoe, Okinawa, Japan

Daitō, Osaka, Japan

Habikino, Osaka, Japan

Hannan, Osaka, Japan

Higashiosaka, Osaka, Japan

Hirakata, Osaka, Japan

Ibaraki, Osaka, Japan

Ikeda, Osaka, Japan

Izumiōtsu, Osaka, Japan

Izumisano, Osaka, Japan

Kadoma, Osaka, Japan

Kaizuka, Osaka, Japan

Katano, Osaka, Japan

Kishiwada, Osaka, Japan

Mino, Osaka, Japan

Mishima, Osaka, Japan

Moriguchi, Osaka, Japan

Neyagawa, Osaka, Japan

Sakai, Osaka, Japan

Sayama, Osaka, Japan

Sennan, Osaka, Japan

Settsu, Osaka, Japan

Shijōnawate, Osaka, Japan

Suita, Osaka, Japan

Takatsuki, Osaka, Japan

Toyonaka, Osaka, Japan

Ogi, Saga-ken, Japan

Takeo, Saga-ken, Japan

Taku, Saga-ken, Japan

Tosu, Saga-ken, Japan

Chichibu, Saitama, Japan

Fujimi, Saitama, Japan

Fujimino, Saitama, Japan

Fukaya, Saitama, Japan

Gyōda, Saitama, Japan

Hasuda, Saitama, Japan

Hidaka, Saitama, Japan

Higashi-Matsuyama, Saitama, Japan

Hiki, Saitama, Japan

Iruma, Saitama, Japan

Kasukabe, Saitama, Japan

Kawagoe, Saitama, Japan

Kawaguchi, Saitama, Japan

Kitakatsushika, Saitama, Japan

Kitamoto, Saitama, Japan

Koshigaya, Saitama, Japan

Kumagaya, Saitama, Japan

Minamisaitama, Saitama, Japan

Niiza, Saitama, Japan

Osato, Saitama, Japan

Satte, Saitama, Japan

Sayama, Saitama, Japan

Sōka, Saitama, Japan

Tokorozawa, Saitama, Japan

Tsurugashima, Saitama, Japan

Wako, Saitama, Japan

Yashio, Saitama, Japan

Gamo, Shiga, Japan

Higashiōmi, Shiga, Japan

Kōka, Shiga, Japan

Kusatsu, Shiga, Japan

Moriyama, Shiga, Japan

Nagahama, Shiga, Japan

Ōtsu, Shiga, Japan

Izumo, Shimane, Japan

Matsue, Shimane, Japan

Oda, Shimane, Japan

Oki, Shimane, Japan

Yasugi, Shimane, Japan

Fuji, Shizuoka, Japan

Fujieda, Shizuoka, Japan

Gotemba, Shizuoka, Japan

Hamamatsu, Shizuoka, Japan

Izunokuni, Shizuoka, Japan

Kamo, Shizuoka, Japan

Mishima, Shizuoka, Japan

Numazu, Shizuoka, Japan

Syuchi, Shizuoka, Japan

Tagata, Shizuoka, Japan

Yaizu, Shizuoka, Japan

Ashikaga, Tochigi, Japan

Mooka, Tochigi, Japan

Nasushiobara, Tochigi, Japan

Nikkō, Tochigi, Japan

Oyama, Tochigi, Japan

Ōmiya, Tochigi, Japan

Sano, Tochigi, Japan

Shimotsuke, Tochigi, Japan

Utsunomiya, Tochigi, Japan

Anan, Tokushima, Japan

Miyoshi, Tokushima, Japan

Okuno, Tokushima, Japan

Yoshinogawa, Tokushima, Japan

Adachi City, Tokyo, Japan

Akiruno, Tokyo, Japan

Akishima, Tokyo, Japan

Arakawa City, Tokyo, Japan

Bunkyo, Tokyo, Japan

Chiyoda City, Tokyo, Japan

Chōfu, Tokyo, Japan

Chūō, Tokyo, Japan

Edogawa City, Tokyo, Japan

Fuchū, Tokyo, Japan

Hachiōji, Tokyo, Japan

Higashikurume, Tokyo, Japan

Hino, Tokyo, Japan

Katsushika-ku, Tokyo, Japan

Kita-ku, Tokyo, Japan

Koganei, Tokyo, Japan

Kokubunji, Tokyo, Japan

Koto, Tokyo, Japan

Machida, Tokyo, Japan

Meguro City, Tokyo, Japan

Minato, Tokyo, Japan

Mitaka, Tokyo, Japan

Musashimurayama, Tokyo, Japan

Musashino, Tokyo, Japan

Nakano City, Tokyo, Japan

Nerima City, Tokyo, Japan

Ōme, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya City, Tokyo, Japan

Shibuya City, Tokyo, Japan

Shinagawa, Tokyo, Japan

Shinjuku, Tokyo, Japan

Suginami, Tokyo, Japan

Sumida City, Tokyo, Japan

tabashi City, Tokyo, Japan

Tachikawa, Tokyo, Japan

Taitō City, Tokyo, Japan

Tama, Tokyo, Japan

Toshima City, Tokyo, Japan

Kurayoshi, Tottori, Japan

Sakaiminato, Tottori, Japan

Tohaku, Tottori, Japan

Yonago, Tottori, Japan

Himi, Toyama, Japan

Imizu, Toyama, Japan

Kurobe-shi, Toyama, Japan

Nakaniikawa, Toyama, Japan

Nanto, Toyama, Japan

Oyabe, Toyama, Japan

Shimoniikawa, Toyama, Japan

Takaoka, Toyama, Japan

Tonami, Toyama, Japan

Arida, Wakayama, Japan

Nishimuro, Wakayama, Japan

Tanabe, Wakayama, Japan

Higashimurayama, Yamagata, Japan

Nishiokitama, Yamagata, Japan

Shinjō, Yamagata, Japan

Tendō, Yamagata, Japan

Tsuruoka, Yamagata, Japan

Yonezawa, Yamagata, Japan

Hōfu, Yamaguchi, Japan

Nagato, Yamaguchi, Japan

Shimonoseki, Yamaguchi, Japan

Shūnan, Yamaguchi, Japan

Ube, Yamaguchi, Japan

Chūō, Yamanashi, Japan

Fuefuki, Yamanashi, Japan

Kai, Yamanashi, Japan

Kofu, Yamanashi, Japan

Minamikoma, Yamanashi, Japan

Nirasaki, Yamanashi, Japan

Akita, , Japan

Aomori, , Japan

Chiba, , Japan

Fukui, , Japan

Fukuoka, , Japan

Fukushima, , Japan

Gifu, , Japan

Hiroshima, , Japan

Kagoshima, , Japan

Kochi, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Miyagi, , Japan

Miyazaki, , Japan

Nagano, , Japan

Nagasaki, , Japan

Nara, , Japan

Niigata, , Japan

Okayama, , Japan

Osaka, , Japan

Ōita, , Japan

Saga, , Japan

Saitama, , Japan

Shizuoka, , Japan

Tochigi, , Japan

Tokushima, , Japan

Tottori, , Japan

Toyama, , Japan

Wakayama, , Japan

Yamagata, , Japan

Yamaguchi, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 27919207 (View on PubMed)

Rheumatology. 2018;59: 222-32.

Reference Type: RESULT

Other Identifiers

CRM01T

Identifier Type: -

Identifier Source: org_study_id