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

November 2, 2018 updated by: Eisai Co., Ltd.
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2747

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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
      • Oita, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Saga, Japan
      • Saitama, Japan
      • Shizuoka, Japan
      • Tochigi, Japan
      • Tokushima, Japan
      • Tottori, Japan
      • Toyama, Japan
      • Wakayama, Japan
      • Yamagata, Japan
      • Yamaguchi, Japan
    • Aichi
      • Aisai, Aichi, Japan
      • Ama, Aichi, Japan
      • Anjo, Aichi, Japan
      • Chita, Aichi, Japan
      • Gamagori, Aichi, Japan
      • Handa, Aichi, Japan
      • Hekinan, Aichi, Japan
      • Ichinomiya, Aichi, Japan
      • Kasugai, Aichi, Japan
      • Kitanagoya, Aichi, Japan
      • Nagakute, Aichi, Japan
      • Nagoya, Aichi, Japan
      • Okazaki, Aichi, Japan
      • Tokoname, Aichi, Japan
      • Toyohashi, Aichi, Japan
      • Toyokawa, Aichi, Japan
      • Toyota, Aichi, Japan
      • Tsushima, Aichi, Japan
      • Yatomi, Aichi, Japan
    • Akita
      • Minamiakita, Akita, Japan
      • Noshiro, Akita, Japan
      • Yurihonjo, Akita, Japan
    • Aomori
      • Hachinohe, Aomori, Japan
      • Hirosaki, Aomori, Japan
      • Minamitsugaru, Aomori, Japan
      • Sannohe, Aomori, Japan
    • Chiba
      • Abiko, Chiba, Japan
      • Awa, Chiba, Japan
      • Chosei, Chiba, Japan
      • Funabashi, Chiba, Japan
      • Ichihara, Chiba, Japan
      • Ichikawa, Chiba, Japan
      • Kashiwa, Chiba, Japan
      • Katori, Chiba, Japan
      • Kisarazu, Chiba, Japan
      • Matsudo, Chiba, Japan
      • Minamiboso, Chiba, Japan
      • Mobara, Chiba, Japan
      • Narashino, Chiba, Japan
      • Narita, Chiba, Japan
      • Sakura, Chiba, Japan
      • Sosa, Chiba, Japan
      • Tomisato, Chiba, Japan
      • Urayasu, Chiba, Japan
      • Yachiyo, Chiba, Japan
      • Yotsukaido, Chiba, Japan
    • Ehime
      • Matsuyama, Ehime, Japan
      • Niihama, Ehime, Japan
      • Saijo, Ehime, Japan
      • Shikokuchuo, Ehime, Japan
      • Uwajima, Ehime, Japan
    • Fukui
      • Mikatakaminaka, Fukui, Japan
      • Sabae, Fukui, Japan
      • Tsuruga, Fukui, Japan
    • Fukuoka
      • Chikushi, Fukuoka, Japan
      • Fukutsu, Fukuoka, Japan
      • Itoshima, Fukuoka, Japan
      • Kasuga, Fukuoka, Japan
      • Kitakyushu, Fukuoka, Japan
      • Kurume, Fukuoka, Japan
      • Munakata, Fukuoka, Japan
      • Nakama, Fukuoka, Japan
      • Omuta, Fukuoka, Japan
      • Onga, Fukuoka, Japan
      • Yame, Fukuoka, Japan
    • Fukushima
      • Aizuwakamatsu, Fukushima, Japan
      • Iwaki, Fukushima, Japan
      • Koriyama, Fukushima, Japan
      • Shirakawa, Fukushima, Japan
    • Gifu
      • Ibi, Gifu, Japan
      • Kakamigahara, Gifu, Japan
      • Kamo, Gifu, Japan
      • Motosu, Gifu, Japan
      • Nakatsugawa, Gifu, Japan
      • Ogaki, Gifu, Japan
      • Seki, Gifu, Japan
      • Yoro, Gifu, Japan
    • Gumma
      • Agatsuma, Gumma, Japan
      • Annaka, Gumma, Japan
      • Fujioka, Gumma, Japan
      • Isesaki, Gumma, Japan
      • Kiryu, Gumma, Japan
      • Maebashi, Gumma, Japan
      • Ota, Gumma, Japan
      • Shibukawa, Gumma, Japan
      • Takasaki, Gumma, Japan
    • Hiroshima
      • Akitakata, Hiroshima, Japan
      • Fukuyama, Hiroshima, Japan
      • Higashihiroshima, Hiroshima, Japan
      • Kure, Hiroshima, Japan
      • Onomichi, Hiroshima, Japan
      • Takehara, Hiroshima, Japan
      • Yamagata, Hiroshima, Japan
    • Hokkaido
      • Abashiri, Hokkaido, Japan
      • Asahikawa, Hokkaido, Japan
      • Bibai, Hokkaido, Japan
      • Chitose, Hokkaido, Japan
      • Date, Hokkaido, Japan
      • Ebetsu, Hokkaido, Japan
      • Furano, Hokkaido, Japan
      • Hakodate, Hokkaido, Japan
      • Kitami, Hokkaido, Japan
      • Kushiro, Hokkaido, Japan
      • Matsumae, Hokkaido, Japan
      • Nayoro, Hokkaido, Japan
      • Obihiro, Hokkaido, Japan
      • Sapporo, Hokkaido, Japan
      • Shari, Hokkaido, Japan
      • Sorachi, Hokkaido, Japan
      • Takikawa, Hokkaido, Japan
      • Yoichi, Hokkaido, Japan
    • Hyogo
      • Ako, Hyogo, Japan
      • Amagasaki, Hyogo, Japan
      • Ashiya, Hyogo, Japan
      • Himeji, Hyogo, Japan
      • Kako, Hyogo, Japan
      • Kato, Hyogo, Japan
      • Kawanishi, Hyogo, Japan
      • Kobe, Hyogo, Japan
      • Miki, Hyogo, Japan
      • Minamiawaji, Hyogo, Japan
      • Nishinomiya, Hyogo, Japan
      • Ono, Hyogo, Japan
      • Sayo, Hyogo, Japan
      • Sumoto, Hyogo, Japan
      • Takarazuka, Hyogo, Japan
      • Takasago, Hyogo, Japan
      • Tamba, Hyogo, Japan
      • Tatsuno, Hyogo, Japan
    • Ibaraki
      • Chikusei, Ibaraki, Japan
      • Higashiibaraki, Ibaraki, Japan
      • Hitachi, Ibaraki, Japan
      • Hitachinaka, Ibaraki, Japan
      • Inashiki, Ibaraki, Japan
      • Kasama, Ibaraki, Japan
      • Kashima, Ibaraki, Japan
      • Koga, Ibaraki, Japan
      • Mito, Ibaraki, Japan
      • Moriya, Ibaraki, Japan
      • Ryugasaki, Ibaraki, Japan
      • Toride, Ibaraki, Japan
      • Tsuchiura, Ibaraki, Japan
      • Tsukuba, Ibaraki, Japan
      • Yuki, Ibaraki, Japan
    • Ishikawa
      • Hakui, Ishikawa, Japan
      • Kaga, Ishikawa, Japan
      • Kahoku, Ishikawa, Japan
      • Kanazawa, Ishikawa, Japan
      • Komatsu, Ishikawa, Japan
    • Iwate
      • Hanamaki, Iwate, Japan
      • Ichinoseki, Iwate, Japan
      • Kitakami, Iwate, Japan
      • Morioka, Iwate, Japan
      • Ofunato, Iwate, Japan
      • Oshu, Iwate, Japan
      • Shimohei, Iwate, Japan
    • Kagawa
      • Ayauta, Kagawa, Japan
      • Kanonji, Kagawa, Japan
      • Marugame, Kagawa, Japan
      • Sakaide, Kagawa, Japan
      • Sanuki, Kagawa, Japan
      • Takamatsu, Kagawa, Japan
    • Kagoshima
      • Akune, Kagoshima, Japan
      • Kanoya, Kagoshima, Japan
      • Oshima, Kagoshima, Japan
      • Soh, Kagoshima, Japan
    • Kanagawa
      • 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
    • Kochi
      • Agawa, Kochi, Japan
      • Aki, Kochi, Japan
      • Kami, Kochi, Japan
      • Nankoku, Kochi, Japan
      • Shimanto, Kochi, Japan
    • Kumamoto
      • Aso, Kumamoto, Japan
      • Hitoyoshi, Kumamoto, Japan
      • Kuma, Kumamoto, Japan
      • Minamata, Kumamoto, Japan
      • Tamana, Kumamoto, Japan
      • Yamaga, Kumamoto, Japan
    • Kyoto
      • Fukuchiyama, Kyoto, Japan
      • Joyo, Kyoto, Japan
      • Kameoka, Kyoto, Japan
      • Kizugawa, Kyoto, Japan
      • Kyotanabe, Kyoto, Japan
      • Maizuru, Kyoto, Japan
      • Nagaokakyo, Kyoto, Japan
      • Nantan, Kyoto, Japan
      • Soraku, Kyoto, Japan
      • Uji, Kyoto, Japan
      • Yawata, Kyoto, Japan
    • Mie
      • Kuwana, Mie, Japan
      • Matsusaka, Mie, Japan
      • Shima, Mie, Japan
      • Suzuka, Mie, Japan
      • Tsu, Mie, Japan
      • Yokkaichi, Mie, Japan
    • Miyagi
      • Higashimatsushima, Miyagi, Japan
      • Ishinomaki, Miyagi, Japan
      • Iwanuma, Miyagi, Japan
      • Kesennuma, Miyagi, Japan
      • Osaki, Miyagi, Japan
      • Sendai, Miyagi, Japan
      • Shibata, Miyagi, Japan
    • Miyazaki
      • Hyuga, Miyazaki, Japan
      • Kobayashi, Miyazaki, Japan
      • Kushima, Miyazaki, Japan
      • Miyakonojo, Miyazaki, Japan
      • Saito, Miyazaki, Japan
    • Nagano
      • 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
    • Nagasaki
      • Omura, Nagasaki, Japan
      • Sasebo, Nagasaki, Japan
    • Nara
      • Kashiba, Nara, Japan
      • Kashihara, Nara, Japan
      • Kitakatsuragi, Nara, Japan
      • Shiki, Nara, Japan
      • Uda, Nara, Japan
      • Yamatokoriyama, Nara, Japan
      • Yamatotakada, Nara, Japan
      • Yoshino, Nara, Japan
    • Niigata
      • Joetsu, Niigata, Japan
      • Kamo, Niigata, Japan
      • Sado, Niigata, Japan
      • Sanjo, Niigata, Japan
      • Shibata, Niigata, Japan
    • Oita
      • Beppu, Oita, Japan
      • Kunisaki, Oita, Japan
      • Nakatsu, Oita, Japan
      • Saiki, Oita, Japan
      • Yufu, Oita, Japan
    • Okayama
      • Asakuchi, Okayama, Japan
      • Kurashiki, Okayama, Japan
      • Setouchi, Okayama, Japan
      • Tsukubo, Okayama, Japan
    • Okinawa
      • Naha, Okinawa, Japan
      • Tomigusuku, Okinawa, Japan
      • Urasoe, Okinawa, Japan
    • Osaka
      • Daito, Osaka, Japan
      • Habikino, Osaka, Japan
      • Hannan, Osaka, Japan
      • Higashiosaka, Osaka, Japan
      • Hirakata, Osaka, Japan
      • Ibaraki, Osaka, Japan
      • Ikeda, Osaka, Japan
      • Izumiotsu, 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
      • Osakasayama, Osaka, Japan
      • Sakai, Osaka, Japan
      • Sennan, Osaka, Japan
      • Settsu, Osaka, Japan
      • Shijonawate, Osaka, Japan
      • Suita, Osaka, Japan
      • Takatsuki, Osaka, Japan
      • Toyonaka, Osaka, Japan
    • Saga
      • Ogi, Saga, Japan
      • Takeo, Saga, Japan
      • Taku, Saga, Japan
      • Tosu, Saga, Japan
    • Saitama
      • Chichibu, Saitama, Japan
      • Fujimi, Saitama, Japan
      • Fujimino, Saitama, Japan
      • Fukaya, Saitama, Japan
      • Gyoda, Saitama, Japan
      • Hasuda, Saitama, Japan
      • Hidaka, Saitama, Japan
      • Higashimatsuyama, 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
      • Soka, Saitama, Japan
      • Tokorozawa, Saitama, Japan
      • Tsurugashima, Saitama, Japan
      • Wako, Saitama, Japan
      • Yashio, Saitama, Japan
    • Shiga
      • Gamo, Shiga, Japan
      • Higashiomi, Shiga, Japan
      • Koka, Shiga, Japan
      • Kusatsu, Shiga, Japan
      • Moriyama, Shiga, Japan
      • Nagahama, Shiga, Japan
      • Otsu, Shiga, Japan
    • Shimane
      • Izumo, Shimane, Japan
      • Matsue, Shimane, Japan
      • Oda, Shimane, Japan
      • Oki, Shimane, Japan
      • Yasugi, Shimane, Japan
    • Shizuoka
      • 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
    • Tochigi
      • Ashikaga, Tochigi, Japan
      • Moka, Tochigi, Japan
      • Nasushiobara, Tochigi, Japan
      • Nikko, Tochigi, Japan
      • Oyama, Tochigi, Japan
      • Sano, Tochigi, Japan
      • Shimotsuke, Tochigi, Japan
      • Shioya, Tochigi, Japan
      • Utsunomiya, Tochigi, Japan
    • Tokushima
      • Anan, Tokushima, Japan
      • Itano, Tokushima, Japan
      • Miyoshi, Tokushima, Japan
      • Yoshinogawa, Tokushima, Japan
    • Tokyo
      • Adachi, Tokyo, Japan
      • Akiruno, Tokyo, Japan
      • Akishima, Tokyo, Japan
      • Arakawa, Tokyo, Japan
      • Bunkyo, Tokyo, Japan
      • Chiyoda, Tokyo, Japan
      • Chofu, Tokyo, Japan
      • Chuo, Tokyo, Japan
      • Edogawa, Tokyo, Japan
      • Fuchu, Tokyo, Japan
      • Hachioji, Tokyo, Japan
      • Higashikurume, Tokyo, Japan
      • Hino, Tokyo, Japan
      • Itabashi, Tokyo, Japan
      • Katsushika, Tokyo, Japan
      • Kita, Tokyo, Japan
      • Koganei, Tokyo, Japan
      • Kokubunji, Tokyo, Japan
      • Koto, Tokyo, Japan
      • Machida, Tokyo, Japan
      • Meguro, Tokyo, Japan
      • Minato, Tokyo, Japan
      • Mitaka, Tokyo, Japan
      • Musashimurayama, Tokyo, Japan
      • Musashino, Tokyo, Japan
      • Nakano, Tokyo, Japan
      • Nerima, Tokyo, Japan
      • Ome, Tokyo, Japan
      • Ota, Tokyo, Japan
      • Setagaya, Tokyo, Japan
      • Shibuya, Tokyo, Japan
      • Shinagawa, Tokyo, Japan
      • Shinjuku, Tokyo, Japan
      • Suginami, Tokyo, Japan
      • Sumida, Tokyo, Japan
      • Tachikawa, Tokyo, Japan
      • Taito, Tokyo, Japan
      • Tama, Tokyo, Japan
      • Toshima, Tokyo, Japan
    • Tottori
      • Kurayoshi, Tottori, Japan
      • Sakaiminato, Tottori, Japan
      • Tohaku, Tottori, Japan
      • Yonago, Tottori, Japan
    • Toyama
      • Himi, Toyama, Japan
      • Imizu, Toyama, Japan
      • Kurobe, Toyama, Japan
      • Nakaniikawa, Toyama, Japan
      • Nanto, Toyama, Japan
      • Oyabe, Toyama, Japan
      • Shimoniikawa, Toyama, Japan
      • Takaoka, Toyama, Japan
      • Tonami, Toyama, Japan
    • Wakayama
      • Arida, Wakayama, Japan
      • Nishimuro, Wakayama, Japan
      • Tanabe, Wakayama, Japan
    • Yamagata
      • Higashimurayama, Yamagata, Japan
      • Nishiokitama, Yamagata, Japan
      • Shinjo, Yamagata, Japan
      • Tendo, Yamagata, Japan
      • Tsuruoka, Yamagata, Japan
      • Yonezawa, Yamagata, Japan
    • Yamaguchi
      • Hofu, Yamaguchi, Japan
      • Nagato, Yamaguchi, Japan
      • Shimonoseki, Yamaguchi, Japan
      • Shunan, Yamaguchi, Japan
      • Ube, Yamaguchi, Japan
    • Yamanashi
      • Chuo, Yamanashi, Japan
      • Fuefuki, Yamanashi, Japan
      • Kai, Yamanashi, Japan
      • Kofu, Yamanashi, Japan
      • Minamikoma, Yamanashi, Japan
      • Nirasaki, Yamanashi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitals and clinics in Japan

Description

Inclusion criteria

  • Participants with rheumatoid arthritis
  • Participants who take iguratimod

Exclusion criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Iguratimod
The usual adult dosage for oral use of 25 mg tablet of iguratimod once daily for 4 weeks or more, after which the dosage should be increased to one 25 mg tablet taken twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria)
Time Frame: 52 weeks (0-24 weeks and 25-52 weeks)

DAS28 is a quantitative tool used to measure and monitor disease activity and treatment of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints.

DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline.

  • 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 Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Akiko Yoshimura, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2012

Primary Completion (Actual)

April 13, 2014

Study Completion (Actual)

April 13, 2014

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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