Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

NCT ID: NCT01329380

Last Updated: 2019-04-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-27

Study Completion Date

2017-12-28

Brief Summary

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This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:

* Unknown adverse drug reactions (especially important adverse drug reactions)
* Incidence and conditions of occurrence of adverse reactions in the clinical setting
* Factors that may affect the safety and effectiveness of Humira

Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab

Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey

Exclusion Criteria

* Contraindications according to the Package Insert

* Patients who have serious infections
* Patients who have tuberculosis
* Patients with a history of hypersensitivity to any ingredient of Humira
* Patients who have demyelinating disease or with a history of demyelinating disease
* Patients who have congestive cardiac failure
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Site Status

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status

Hyogo College of Medicine Hosp

Nishinomiya, Hyōgo, Japan

Site Status

Yokohama City Univ Medical Ctr

Yokohama, Kanagawa, Japan

Site Status

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

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Okayama University Hospital

Okayama, Okayama-ken, Japan

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Osaka City University Hospital

Osaka, Osaka, Japan

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Saitama Medical Center

Kawagoe, Saitama, Japan

Site Status

Shiga Univ Med Science Hosp

Ōtsu, Shiga, Japan

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Medical Hospital of Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, Japan

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St. Luke's International Hosp

Chūō, Tokyo, Japan

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Kyorin University Hospital

Mitaka-shi, Tokyo, Japan

Site Status

Teikyo University Hospital

板橋区, Tokyo, Japan

Site Status

Asano Orthopedic Clinic

Aichi, , Japan

Site Status

Nagoya Daini Red Cross Hosp

Aichi, , Japan

Site Status

Ozone Surgery Clinic

Aichi, , Japan

Site Status

Yamagiwa Clinic

Aichi, , Japan

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Narushima Internal Med Clinic

Ami-machi, , Japan

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Katayama Orthopedic Rheum Clin

Asahikawa, , Japan

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Asahikawa Med College Hosp, JP

Asahikawa, , Japan

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Asahikawa Kosei General Hosp

Asahikawa-shi, , Japan

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Atsugi City Hospital

Atsugi-shi, , Japan

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Chiba University Hospital

Chiba, , Japan

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University of Yamanashi Hosp

Chūō, , Japan

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Tama Medical Center

Fuchū, , Japan

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Fujieda Municipal General Hosp

Fujieda, , Japan

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Nakamura Clinic

Fukuchiyama-shi, , Japan

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Hamanomachi Hospital

Fukuoka, , Japan

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NHO Kyushu Medical Center

Fukuoka, , Japan

Site Status

Kyushu University Hospital

Fukuoka, , Japan

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JP Red Cross Fukuoka Hosp

Fukuoka, , Japan

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Mutaguchi Orthopedics Clinic

Fukuoka, , Japan

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PS Clinic

Fukuoka, , Japan

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Fukushima Med Univ Hosp

Fukushima, , Japan

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Fukushima Red Cross Hospital

Fukushima, , Japan

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Minami Tohoku Fukushima Hosp

Fukushima, , Japan

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Gifu University Hospital

Gifu, , Japan

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Seirei Mikatahara General Hosp

Hamamatsu, , Japan

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Osaka Rehabilitation Hospital

Hannan, , Japan

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Matsunami General Hospital

Hashima-gun, , Japan

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Kono Orthop. and Int. Med Clin

Higashimatsuyama-shi, , Japan

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Tama-Hokubu Medical Center

Higashimurayama, , Japan

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Yamaguchi Clinic

Higashiosaka-shi, , Japan

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NHO Higashi-Ohmi Gen Med Ctr

Higashiōmi, , Japan

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NHO Himeji Medical Center

Himeji, , Japan

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Hirosaki Uni School Med & Hosp

Hirosaki, , Japan

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Hirosaki Memorial Hospital

Hirosaki, , Japan

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Hiroshima Red Cross Hosp Atomi

Hiroshima, , Japan

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Hiroshima University Hospital

Hiroshima, , Japan

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Yamana-kai Higashi Hiroshima

Hiroshima, , Japan

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Hiroshima Clinic

Hiroshima, , Japan

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Shigenobu Clinic

Hiroshima, , Japan

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Midori Hospital

Hyōgo, , Japan

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Kohnodai Hospital

Ichikawa-shi, , Japan

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Iwate Prefectural Iwai Hosp

Ichinoseki-shi, , Japan

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Saitama Medical University Hos

Iruma-gun, , Japan

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Suga Orthopedic Hospital

Isahaya, , Japan

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Isahaya Health Ins Genl Hosp

Isahaya, , Japan

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NHO Iwakuni Clinical Center

Iwakuni-shi, , Japan

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Juntendo Univ Shizuoka Hosp

Izunokuni-shi, , Japan

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Kaga City Hospital

Kaga-shi, Ishikawa, , Japan

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Kagoshima Red Cross Hospital

Kagoshima, , Japan

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Kagoshima Univ Medical and Den

Kagoshima, , Japan

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Kameda Medical Center

Kamogawa, , Japan

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Saiseikai Kanazawa Hospital

Kanazawa, , Japan

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Kanazawa University Ho

Kanazawa, , Japan

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Kasugai Orthopaedic Clinic

Kasugai, , Japan

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Asahi Hospital

Kasugai, , Japan

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NHO Osaka Minami Med Ctr

Kawachi-Nagano, , Japan

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Nagasawa Clinic

Kawagoe-shi, , Japan

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St. Marianna Univ Hospital

Kawasaki, , Japan

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Edakuni Orthopedic Clinic

Kiryū, , Japan

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JR Kyushu Hospital

Kitakyushu, , Japan

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Univ Occup & Environ Health

Kitakyushu, , Japan

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Kobe University Hospital

Kobe, , Japan

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Komaki Daiichi Hospital

Komaki, , Japan

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Jusendo General Hospital

Koriyama-shi, , Japan

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Juntendo Univ Koshigaya Hosp

Koshigaya, , Japan

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Saiseikai Kyoto Hospital

Kōtari, , Japan

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Shunan Memorial Hospital

Kudamatsu-shi, , Japan

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Kumamoto Rheumatology Clinic

Kumamoto, , Japan

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Kunitachi Clinic

Kunitachi, , Japan

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Kawasaki Medical School Hosp

Kurashiki, , Japan

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Kurashiki Central Hospital

Kurashiki, , Japan

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Jujo Rehabilitation Hospital

Kyoto, , Japan

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Kyoto Prefect Univ Med

Kyoto, , Japan

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JP Red Cross Kyoto Daiichi Hos

Kyoto, , Japan

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Kagawa University Hospital

Kyoto, , Japan

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Iwasaku Orthopedic Clinic

Kyoto, , Japan

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Tori Clinic

Maizuru-shi, , Japan

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Matsuyama Red Cross Hosp

Matsuyama, , Japan

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Mino Municipal Hospital

Mino, , Japan

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Suzuki Orthopedic Clinic

Miyashiro-machi, , Japan

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Miyazaki Prefectural Miyazaki

Miyazaki, , Japan

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Iwate Medical University Hosp

Morioka, , Japan

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Noguchi Seikeigeka Naika Iin

Motosu-shi, , Japan

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Munakata Medical Assoc. Hosp.

Munakata-shi, , Japan

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Aichi Medical University Hosp

Nagakute, , Japan

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Chukyo Social Insurance Hospit

Nagoya, , Japan

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NHO Nagoya Medical Center

Nagoya, , Japan

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Shinseikai Daiichi Hospital

Nagoya, , Japan

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Higashi Hosp City of Nagoya

Nagoya, , Japan

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Kakinuma Orthopedics Clinic

Nagoya, , Japan

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Oura Clinic

Naha, , Japan

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Kochi Medical School Hospital

Nankoku-shi, , Japan

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Nara City Hospital

Nara, , Japan

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Asahigaoka Hospital

Nara, , Japan

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Mitsuka Rheumatism Clinic

Narashino-shi, , Japan

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Niigata City General Hospital

Niigata, , Japan

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Nirasaki City Hospital

Nirasaki, , Japan

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Nisshin Orido Hospital

Nisshin, , Japan

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Yamachika Memorial Gen Hosp

Odawara-shi, , Japan

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Ohama Daiichi Hospital

Okinawa, , Japan

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Yuri Plastic Surgery

Ono, , Japan

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Yukioka Hospital

Osaka, , Japan

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Osaka Saiseikai Noe Hospital

Osaka, , Japan

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NTT WEST Osaka Hospital

Osaka, , Japan

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Osaka Red Cross Hospital

Osaka, , Japan

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Kansai Medical Univ Takii Hosp

Osaka, , Japan

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Kojima Orthopedic Clinic

Osaka, , Japan

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Murakami Orthopaedics Clinic

Osaka, , Japan

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Osaka Rheumatology Clinic

Osaka, , Japan

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Ushio Clinic

Osaka, , Japan

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Yodogawa Christian Hospital

Osaka, , Japan

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Oita Red Cross Hospital

Ōita, , Japan

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Saiseikai Hita Hospital

Ōita, , Japan

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Sunrise Sakai Hospital

Ōita, , Japan

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Ome Municipal General Hospital

Ōme, , Japan

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Osaki Citizen Hospital

Ōsaki, , Japan

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Ota Memorial Hospital

Ōta-ku, , Japan

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Saga University Hospital

Saga, , Japan

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Osaka Rosai Hospital

Sakaishi, , Japan

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Yoshida Internal Med Clinic

Sakaki, , Japan

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Kyoto University Hospital

Sakyo-ku, , Japan

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Teine Internal Med Rheuma Clin

Sapporo, , Japan

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Teine Keijinkai Clinic

Sapporo, , Japan

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Sapporo Medical Univ Hosp

Sapporo, , Japan

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Kin-ikyo Chuo Hospital

Sapporo, , Japan

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KKR Sapporo Med Ctr Tonan Hosp

Sapporo, , Japan

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Sasebo Chuo Hospital

Sasebo, , Japan

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Sasebo City General Hospital

Sasebo-shi, , Japan

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Tohoku University Hospital

Sendai, , Japan

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NHO Nishitaga National Hospita

Sendai, , Japan

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Tohoku Pharmaceutical Univ Hos

Sendai, , Japan

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Jyunshinkai Inoue Hospital

Seto, , Japan

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Niigata Rheumatic Center

Shibata, , Japan

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Saiseikai Suita Hospital

Suita, , Japan

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Osaka University Hospital

Suita, , Japan

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Hirose Clinic

Tokorozawa, , Japan

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Kotesashi Orthopedic Clinic

Tokorozawa-shi, , Japan

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Hishita-Hiasa Neurosurgery and

Tokushima, , Japan

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Toyo Hospital

Tokushima, , Japan

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Kyoundo Hospital

Tokyo, , Japan

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Mitsui Memorial Hospital

Tokyo, , Japan

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The Jikei University Hospital

Tokyo, , Japan

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Toranomon Hospital

Tokyo, , Japan

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The University of Tokyo

Tokyo, , Japan

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Juntendo University Hospital

Tokyo, , Japan

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Tokyo Metropolitan Bokutoh Hos

Tokyo, , Japan

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Keiyo Hospital

Tokyo, , Japan

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Toho Univ Med Ctr Omori Hosp

Tokyo, , Japan

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Tokyo Medical University Hosp

Tokyo, , Japan

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National Ctr Global Health Med

Tokyo, , Japan

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Tokyo Womens Med Univ Hosp

Tokyo, , Japan

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Kawakita General Hospital

Tokyo, , Japan

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Nihon University Itabashi Hosp

Tokyo, , Japan

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Juntendo Univ Nerima Hosp

Tokyo, , Japan

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JP Red Cross Musashino Hosp

Tokyo, , Japan

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Akasaka Chuo Clinic

Tokyo, , Japan

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Edogawa Hospital

Tokyo, , Japan

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Ishigaki Orthopedic Clinic

Tokyo, , Japan

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Kanamecho Hospital

Tokyo, , Japan

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Matsuda Orthopedic Rheuma Clin

Tokyo, , Japan

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NHO Disaster Medical Center

Tokyo, , Japan

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Showa University Hospital

Tokyo, , Japan

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Yoshida Internal Med Clinic

Tokyo, , Japan

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Matsuno Clinic Rheumatic Disea

Toyama, , Japan

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Toyama Prefectural Ctr Hosp

Toyama, , Japan

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Fujita Health University Hosp

Toyoake, , Japan

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Toyama University Hospital

Toyoma, , Japan

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Toyooka Hospital

Toyooka, , Japan

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Kishi Orthopedics Medical Clin

Tsuchiura-shi, , Japan

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Tsukuba University Hospital

Tsukuba, , Japan

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Tsuyama Chuo Memorial Hospital

Tsuyama, , Japan

Site Status

Daini Okamoto General Hospital

Uji, , Japan

Site Status

Wakayama Medical University

Wakayama, , Japan

Site Status

Yamagata University Hospital

Yamagata, , Japan

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Yamagata City Hosp Saiseikai

Yamagata, , Japan

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Yamaguchi Red Cross Hospital

Yamaguchi, , Japan

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Shuto General Hospital

Yanai-shi, , Japan

Site Status

Kumamoto Rosai Hospital

Yatsushiro-shi, , Japan

Site Status

Showa Univ N Yokohama Hosp

Yokohama, , Japan

Site Status

Tottori University Hospital

Yonago-shi, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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P12-764

Identifier Type: -

Identifier Source: org_study_id

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