Rheumatoid ArthritisNCT01850966
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Eisai Co., Ltd. at 453 sites in Japan.
Trial summary
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Iguratimod
- Type of treatment
- Pill or oral medicine
- How many people
- 2,747 participants
- Where
- 453 sitesJapan
- Study dates
- 12 Sep 2012to 13 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitals and clinics in Japan
Who may be able to join
- Participants with rheumatoid arthritis
- Participants who take iguratimod
Who cannot join
- 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
Trial locations and contacts
453 sites in 1 country.
300 sites in 1 country
Japan300 sites
Study site
Abashiri, Hokkaido
Study site
Abiko, Chiba
Study site
Adachi City, Tokyo
Study site
Agatsuma, Gunma
Study site
Agawa, Kochi
Study site
Aisai, Aichi-ken
Study site
Aizu-Wakamatsu, Fukushima
Study site
Aki, Kochi
Study site
Aki-takata, Hiroshima
Study site
Akiruno, Tokyo
Study site
Akishima, Tokyo
Study site
Akita
Study site
Ako, Hyōgo
Study site
Akune, Kagoshima-ken
Study site
Ama, Aichi-ken
Study site
Amagasaki, Hyōgo
Study site
Anan, Tokushima
Study site
Anjo, Aichi-ken
Study site
Annaka, Gunma
Study site
Aomori
Study site
Arakawa City, Tokyo
Study site
Arida, Wakayama
Study site
Asahikawa, Hokkaido
Study site
Asakuchi, Okayama-ken
Study site
Ashikaga, Tochigi
Study site
Ashiya, Hyōgo
Study site
Aso, Kumamoto
Study site
Awa, Chiba
Study site
Ayauta, Kagawa-ken
Study site
Azumino, Nagano
Study site
Beppu, Oita Prefecture
Study site
Bibai, Hokkaido
Study site
Bunkyo, Tokyo
Study site
Chiba
Study site
Chichibu, Saitama
Study site
Chigasaki, Kanagawa
Study site
Chiisagata, Nagano
Study site
Chikusei, Ibaraki
Study site
Chikushi, Fukuoka
Study site
Chita, Aichi-ken
Study site
Chitose, Hokkaido
Study site
Chiyoda City, Tokyo
Study site
Chōfu, Tokyo
Study site
Chūō, Tokyo
Study site
Chūō, Yamanashi
Study site
Daitō, Osaka
Study site
Date, Hokkaido
Study site
Ebetsu, Hokkaido
Study site
Ebina, Kanagawa
Study site
Edogawa City, Tokyo
Study site
Fuchū, Tokyo
Study site
Fuefuki, Yamanashi
Study site
Fuji, Shizuoka
Study site
Fujieda, Shizuoka
Study site
Fujimi, Saitama
Study site
Fujimino, Saitama
Study site
Fujioka, Gunma
Study site
Fujisawa, Kanagawa
Study site
Fukaya, Saitama
Study site
Fukuchiyama, Kyoto
Study site
Fukui
Study site
Fukuoka
Study site
Fukushima
Study site
Fukutsu, Fukuoka
Study site
Fukuyama, Hiroshima
Study site
Funabashi, Chiba
Study site
Furano, Hokkaido
Study site
Gamagōri, Aichi-ken
Study site
Gamo, Shiga
Study site
Gifu
Study site
Gotemba, Shizuoka
Study site
Gyōda, Saitama
Study site
Habikino, Osaka
Study site
Hachinohe, Aomori
Study site
Hachiōji, Tokyo
Study site
Hakodate, Hokkaido
Study site
Hakui, Ishikawa-ken
Study site
Hamamatsu, Shizuoka
Study site
Hanamaki, Iwate
Study site
Handa, Aichi-ken
Study site
Hanishina, Nagano
Study site
Hannan, Osaka
Study site
Hasuda, Saitama
Study site
Hekinan, Aichi-ken
Study site
Hidaka, Saitama
Study site
Higashi-Matsuyama, Saitama
Study site
Higashihiroshima, Hiroshima
Study site
Higashiibaraki, Ibaraki
Study site
Higashikurume, Tokyo
Study site
Higashimatsushima, Miyagi
Study site
Higashimurayama, Yamagata
Study site
Higashiōmi, Shiga
Study site
Higashiosaka, Osaka
Study site
Hiki, Saitama
Study site
Himeji, Hyōgo
Study site
Himi, Toyama
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Hino, Tokyo
Study site
Hirakata, Osaka
Study site
Hiratsuka, Kanagawa
Study site
Hirosaki, Aomori
Study site
Hiroshima
Study site
Hitachi, Ibaraki
Study site
Hitachi-Naka, Ibaraki
Study site
Hitoyoshi, Kumamoto
Study site
Hōfu, Yamaguchi
Study site
Hongō, Chiba
Study site
Honmachi, Hokkaido
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Hyūga, Miyazaki
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Ibaraki, Osaka
Study site
Ibi, Gifu
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Ichihara, Chiba
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Ichikawa, Chiba
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Ichinomiya, Aichi-ken
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Ichinoseki, Iwate
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Iida, Nagano
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Iiyama, Nagano
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Ikeda, Osaka
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Imizu, Toyama
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Ina, Nagano
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Inashiki, Ibaraki
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Iruma, Saitama
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Isehara, Kanagawa
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Isesaki, Gunma
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Ishinomaki, Miyagi
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Isshōchi, Kumamoto
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Itoshima, Fukuoka
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Iwaki, Fukushima
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Iwanuma, Miyagi
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Izumiōtsu, Osaka
Study site
Izumisano, Osaka
Study site
Izumo, Shimane
Study site
Izunokuni, Shizuoka
Study site
Jōetsu, Niigata
Study site
Jōyō, Kyoto
Study site
Kadoma, Osaka
Study site
Kaga, Ishikawa-ken
Study site
Kagoshima
Study site
Kahoku, Ishikawa-ken
Study site
Kai, Yamanashi
Study site
Kaizuka, Osaka
Study site
Kakamigahara, Gifu
Study site
Kako, Hyōgo
Study site
Kameoka, Kyoto
Study site
Kami, Kochi
Study site
Kamikoshikichō-oshima, Kagoshima-ken
Study site
Kamiminochi, Nagano
Study site
Kamo, Gifu
Study site
Kamo, Niigata
Study site
Kamo, Shizuoka
Study site
Kan’onjichō, Kagawa-ken
Study site
Kanazawa, Ishikawa-ken
Study site
Kanoya, Kagoshima-ken
Study site
Kasama, Ibaraki
Study site
Kashiba, Nara
Study site
Kashihara, Nara
Study site
Kashima-shi, Ibaraki
Study site
Kashiwa, Chiba
Study site
Kasuga, Fukuoka
Study site
Kasugai, Aichi-ken
Study site
Kasukabe, Saitama
Study site
Katano, Osaka
Study site
Katō, Hyōgo
Study site
Katori-shi, Chiba
Study site
Katsushika-ku, Tokyo
Study site
Kawagoe, Saitama
Study site
Kawaguchi, Saitama
Study site
Kawanishi, Hyōgo
Study site
Kawasaki, Kanagawa
Study site
Kesennuma, Miyagi
Study site
Kiryū, Gunma
Study site
Kisarazu, Chiba
Study site
Kishiwada, Osaka
Study site
Kita-ku, Tokyo
Study site
Kitakami, Iwate
Study site
Kitakatsuragi, Nara
Study site
Kitakatsushika, Saitama
Study site
Kitakyushu, Fukuoka
Study site
Kitami, Hokkaido
Study site
Kitamoto, Saitama
Study site
Kitanagoya, Aichi-ken
Study site
Kizugawa, Kyoto
Study site
Kobayashi, Miyazaki
Study site
Kobe, Hyōgo
Study site
Kochi
Study site
Kofu, Yamanashi
Study site
Koga, Fukuoka
Study site
Koga, Ibaraki
Study site
Koganei, Tokyo
Study site
Kōka, Shiga
Study site
Kokubunji, Tokyo
Study site
Komatsu, Ishikawa-ken
Study site
Komoro, Nagano
Study site
Kōriyama, Fukushima
Study site
Koshigaya, Saitama
Study site
Kōtari, Kyoto
Study site
Koto, Tokyo
Study site
Kumagaya, Saitama
Study site
Kumamoto
Study site
Kunisaki, Oita Prefecture
Study site
Kurashiki, Okayama-ken
Study site
Kurayoshi, Tottori
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Kure, Hiroshima
Study site
Kurobe-shi, Toyama
Study site
Kurume, Fukuoka
Study site
Kusatsu, Shiga
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Kushima, Miyazaki
Study site
Kushiro, Hokkaido
Study site
Kuwana, Mie-ken
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Kyōtanabe, Kyoto
Study site
Kyoto
Study site
Machida, Tokyo
Study site
Maebashi, Gunma
Study site
Maizuru, Kyoto
Study site
Marugame, Kagawa-ken
Study site
Matsudo, Chiba
Study site
Matsue, Shimane
Study site
Matsumae, Hokkaido
Study site
Matsumoto, Nagano
Study site
Matsusaka, Mie-ken
Study site
Matsuyama, Ehime
Study site
Meguro City, Tokyo
Study site
Mikatakaminaka, Fukui
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Miki, Hyōgo
Study site
Minamata, Kumamoto
Study site
Minamiakita, Akita
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Minamiawaji, Hyōgo
Study site
Minamibōsō, Chiba
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Minamikoma, Yamanashi
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Minamisaitama, Saitama
Study site
Minamitsugaru, Aomori
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Minato, Tokyo
Study site
Mino, Osaka
Study site
Mishima, Osaka
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Mishima, Shizuoka
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Mitaka, Tokyo
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Mito, Ibaraki
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Miyagi
Study site
Miyakonojō, Miyazaki
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Miyazaki
Study site
Miyoshi, Tokushima
Study site
Mobara, Chiba
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Mooka, Tochigi
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Moriguchi, Osaka
Study site
Morioka, Iwate
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Moriya, Ibaraki
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Moriyama, Shiga
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Motosu, Gifu
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Munakata, Fukuoka
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Murata, Miyagi
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Musashimurayama, Tokyo
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Musashino, Tokyo
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Nagahama, Shiga
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Nagakute, Aichi-ken
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Nagano
Study site
Nagasaki
Study site
Nagato, Yamaguchi
Study site
Nagoya, Aichi-ken
Study site
Naha, Okinawa
Study site
Nakama, Fukuoka
Study site
Nakaniikawa, Toyama
Study site
Nakano City, Tokyo
Study site
Nakatsu, Oita Prefecture
Study site
Nakatsugawa, Gifu
Study site
Nankoku, Kochi
Study site
Nantan, Kyoto
Study site
Nanto, Toyama
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Nara
Study site
Narashino, Chiba
Study site
Narita, Chiba
Study site
Nasushiobara, Tochigi
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Nayoro, Hokkaido
Study site
Nerima City, Tokyo
Study site
Neyagawa, Osaka
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Niigata
Study site
Niihama, Ehime
Study site
Niiza, Saitama
Study site
Nikkō, Tochigi
Study site
Nirasaki, Yamanashi
Study site
Nishimuro, Wakayama
Study site
Nishinomiya, Hyōgo
Study site
Nishiokitama, Yamagata
Study site
Noshiro, Akita
Study site
Numazu, Shizuoka
Study site
Obihiro, Hokkaido
Study site
Oda, Shimane
Study site
Ōfunato, Iwate
Study site
Ōgaki, Gifu
Study site
Ogi, Saga-ken
Study site
Ōita
Study site
Okaya, Nagano
Study site
Okayama
Study site
Okazaki, Aichi-ken
Study site
Oki, Shimane
Study site
Okuno, Tokushima
Study site
Ōme, Tokyo
Study site
Ōmiya, Tochigi
Study site
Ōmura, Nagasaki
Study site
Omuta, Fukuoka
Study site
Ono, Hyōgo
Study site
Onomichi, Hiroshima
About this study
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
- Being tested
- Iguratimod
- Keywords
- Arthritis, Rheumatoid, Iguratimod
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod | Not described Receives: Drug: Iguratimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks (0-24 weeks and 25-52 weeks)
Secondary outcomes (1)
Number of Participants with Adverse Events
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study start12 Sep 2012
- Primary completion13 Apr 2014
- Study completion13 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akiko Yoshimura, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850966
- Sponsor's protocol ID
- CRM01T
- Status last verified
- Jan 2017
- First submitted
- 8 May 2013
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27919207Rheumatology. 2018;59: 222-32.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01850966
- Acronym / sponsor ID
- CRM01T
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, Rheumatoid, Iguratimod
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,747 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2012 (actual)
- Primary completion
- 13 Apr 2014 (actual)
- Study completion
- 13 Apr 2014 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iguratimod | – | Drug: Iguratimod |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals and clinics in Japan
Key inclusion criteria (2 listed)
- Participants with rheumatoid arthritis
- Participants who take iguratimod
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IguratimodThe 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. | Drug | Iguratimod |
Primary outcome
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
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Results publication: PubMed 27919207Mimori 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.
- Results publicationRheumatology. 2018;59: 222-32.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akiko Yoshimura study director
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
453 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Eisai Co., Ltd. at 453 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 453 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria) (time frame: 52 weeks (0-24 weeks and 25-52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.