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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329380
• Other study ID #: P12-764
• Status: Completed
• Start date: October 27, 2010
• Est. completion date: December 28, 2017

Study information

• Verified date: December 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Japan	Nagasaki University Hospital	???	Nagasaki
Japan	Osaka City University Hospital	???	Osaka
Japan	St. Luke's International Hosp	???	Tokyo
Japan	Teikyo University Hospital	???	Tokyo
Japan	Asano Orthopedic Clinic	Aichi
Japan	Nagoya Daini Red Cross Hosp	Aichi
Japan	Ozone Surgery Clinic	Aichi
Japan	Yamagiwa Clinic	Aichi
Japan	Narushima Internal Med Clinic	Ami-machi
Japan	Asahikawa Med College Hosp, JP	Asahikawa
Japan	Katayama Orthopedic Rheum Clin	Asahikawa
Japan	Asahikawa Kosei General Hosp	Asahikawa-shi
Japan	Atsugi City Hospital	Atsugi-shi
Japan	Medical Hospital of Tokyo Medical and Dental University	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital	Chiba
Japan	University of Yamanashi Hosp	Chuo
Japan	Tama Medical Center	Fuchu
Japan	Fujieda Municipal General Hosp	Fujieda
Japan	Nakamura Clinic	Fukuchiyama-shi
Japan	Hamanomachi Hospital	Fukuoka
Japan	JP Red Cross Fukuoka Hosp	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Mutaguchi Orthopedics Clinic	Fukuoka
Japan	NHO Kyushu Medical Center	Fukuoka
Japan	PS Clinic	Fukuoka
Japan	Fukushima Red Cross Hospital	Fukushima
Japan	Minami Tohoku Fukushima Hosp	Fukushima
Japan	Fukushima Med Univ Hosp	Fukushima-shi
Japan	Gifu University Hospital	Gifu
Japan	Seirei Mikatahara General Hosp	Hamamatsu
Japan	Osaka Rehabilitation Hospital	Hannan
Japan	Matsunami General Hospital	Hashima-gun
Japan	Kono Orthop. and Int. Med Clin	Higashimatsuyama-shi
Japan	Tama-Hokubu Medical Center	Higashimurayama
Japan	NHO Higashi-Ohmi Gen Med Ctr	Higashiomi
Japan	Yamaguchi Clinic	Higashiosaka-shi
Japan	NHO Himeji Medical Center	Himeji
Japan	Hirosaki Memorial Hospital	Hirosaki
Japan	Hirosaki Uni School Med & Hosp	Hirosaki
Japan	Hiroshima Red Cross Hosp Atomi	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Shigenobu Clinic	Hiroshima
Japan	Yamana-kai Higashi Hiroshima	Hiroshima
Japan	Hiroshima Clinic	Hiroshima-shi
Japan	Midori Hospital	Hyogo
Japan	Kohnodai Hospital	Ichikawa-shi
Japan	Iwate Prefectural Iwai Hosp	Ichinoseki-shi
Japan	Saitama Medical University Hos	Iruma-gun
Japan	Isahaya Health Ins Genl Hosp	Isahaya
Japan	Suga Orthopedic Hospital	Isahaya
Japan	NHO Iwakuni Clinical Center	Iwakuni-shi
Japan	Juntendo Univ Shizuoka Hosp	Izunokuni-shi
Japan	Kaga City Hospital	Kaga-shi, Ishikawa
Japan	Kagoshima Red Cross Hospital	Kagoshima
Japan	Kagoshima Univ Medical and Den	Kagoshima-shi
Japan	Kameda Medical Center	Kamogawa
Japan	Kanazawa University Ho	Kanazawa
Japan	Saiseikai Kanazawa Hospital	Kanazawa
Japan	Asahi Hospital	Kasugai
Japan	Kasugai Orthopaedic Clinic	Kasugai
Japan	NHO Osaka Minami Med Ctr	Kawachinagano
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	Nagasawa Clinic	Kawagoe-shi
Japan	St. Marianna Univ Hospital	Kawasaki
Japan	Edakuni Orthopedic Clinic	Kiryu
Japan	JR Kyushu Hospital	Kitakyushu
Japan	Univ Occup & Environ Health	Kitakyushu
Japan	Kobe University Hospital	Kobe
Japan	Komaki Daiichi Hospital	Komaki
Japan	Jusendo General Hospital	Koriyama-shi
Japan	Juntendo Univ Koshigaya Hosp	Koshigaya
Japan	Shunan Memorial Hospital	Kudamatsu-shi
Japan	Kumamoto Rheumatology Clinic	Kumamoto
Japan	Kunitachi Clinic	Kunitachi
Japan	Kawasaki Medical School Hosp	Kurashiki
Japan	Kurashiki Central Hospital	Kurashiki
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Iwasaku Orthopedic Clinic	Kyoto
Japan	JP Red Cross Kyoto Daiichi Hos	Kyoto
Japan	Jujo Rehabilitation Hospital	Kyoto
Japan	Kagawa University Hospital	Kyoto
Japan	Kyoto Prefect Univ Med	Kyoto
Japan	Gunma University Hospital	Maebashi-shi	Gunma
Japan	Tori Clinic	Maizuru-shi
Japan	Matsuyama Red Cross Hosp	Matsuyama
Japan	Mino Municipal Hospital	Mino
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo
Japan	Suzuki Orthopedic Clinic	Miyashiro-machi
Japan	Miyazaki Prefectural Miyazaki	Miyazaki
Japan	Iwate Medical University Hosp	Morioka
Japan	Noguchi Seikeigeka Naika Iin	Motosu-shi
Japan	Munakata Medical Assoc. Hosp.	Munakata-shi
Japan	Aichi Medical University Hosp	Nagakute
Japan	Saiseikai Kyoto Hospital	Nagaokakyo
Japan	Higashi Hosp City of Nagoya	Nagoya
Japan	Kakinuma Orthopedics Clinic	Nagoya
Japan	NHO Nagoya Medical Center	Nagoya
Japan	Shinseikai Daiichi Hospital	Nagoya
Japan	Chukyo Social Insurance Hospit	Nagoya-shi
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Oura Clinic	Naha
Japan	Kochi Medical School Hospital	Nankoku-shi
Japan	Asahigaoka Hospital	Nara
Japan	Nara City Hospital	Nara
Japan	Mitsuka Rheumatism Clinic	Narashino-shi
Japan	Niigata City General Hospital	Niigata
Japan	Nirasaki City Hospital	Nirasaki
Japan	Hyogo College of Medicine Hosp	Nishinomiya	Hyogo
Japan	Nisshin Orido Hospital	Nisshin
Japan	Yamachika Memorial Gen Hosp	Odawara-shi
Japan	Oita Red Cross Hospital	Oita
Japan	Saiseikai Hita Hospital	Oita
Japan	Sunrise Sakai Hospital	Oita
Japan	Okayama University Hospital	Okayama-shi	Okayama
Japan	Ohama Daiichi Hospital	Okinawa
Japan	Ome Municipal General Hospital	OME
Japan	Yuri Plastic Surgery	ONO
Japan	Kansai Medical Univ Takii Hosp	Osaka
Japan	Kojima Orthopedic Clinic	Osaka
Japan	Murakami Orthopaedics Clinic	Osaka
Japan	NTT WEST Osaka Hospital	Osaka
Japan	Osaka Red Cross Hospital	Osaka
Japan	Osaka Saiseikai Noe Hospital	Osaka
Japan	Yukioka Hospital	Osaka
Japan	Osaka Rheumatology Clinic	Osaka-shi
Japan	Ushio Clinic	Osaka-shi
Japan	Yodogawa Christian Hospital	Osaka-shi
Japan	Osaki Citizen Hospital	Osaki
Japan	Ota Memorial Hospital	OTA
Japan	Shiga Univ Med Science Hosp	Otsu	Shiga
Japan	Saga University Hospital	Saga
Japan	Osaka Rosai Hospital	Sakai-shi
Japan	Yoshida Internal Med Clinic	Sakaki
Japan	Kyoto University Hospital	Sakyo-ku
Japan	Kin-ikyo Chuo Hospital	Sapporo
Japan	KKR Sapporo Med Ctr Tonan Hosp	Sapporo
Japan	Sapporo Medical Univ Hosp	Sapporo
Japan	Teine Internal Med Rheuma Clin	Sapporo
Japan	Teine Keijinkai Clinic	Sapporo
Japan	Sasebo Chuo Hospital	Sasebo
Japan	Sasebo City General Hospital	Sasebo-shi
Japan	NHO Nishitaga National Hospita	Sendai
Japan	Tohoku Pharmaceutical Univ Hos	Sendai
Japan	Tohoku University Hospital	Sendai
Japan	Jyunshinkai Inoue Hospital	Seto
Japan	Niigata Rheumatic Center	Shibata
Japan	Osaka University Hospital	Suita
Japan	Saiseikai Suita Hospital	Suita
Japan	Hirose Clinic	Tokorozawa
Japan	Kotesashi Orthopedic Clinic	Tokorozawa-shi
Japan	Hishita-Hiasa Neurosurgery and	Tokushima
Japan	Toyo Hospital	Tokushima-shi
Japan	Akasaka Chuo Clinic	Tokyo
Japan	Edogawa Hospital	Tokyo
Japan	Ishigaki Orthopedic Clinic	Tokyo
Japan	JP Red Cross Musashino Hosp	Tokyo
Japan	Juntendo Univ Nerima Hosp	Tokyo
Japan	Juntendo University Hospital	Tokyo
Japan	Kanamecho Hospital	Tokyo
Japan	Kawakita General Hospital	Tokyo
Japan	Keiyo Hospital	Tokyo
Japan	Kyoundo Hospital	Tokyo
Japan	Matsuda Orthopedic Rheuma Clin	Tokyo
Japan	Mitsui Memorial Hospital	Tokyo
Japan	National Ctr Global Health Med	Tokyo
Japan	NHO Disaster Medical Center	Tokyo
Japan	Nihon University Itabashi Hosp	Tokyo
Japan	Showa University Hospital	Tokyo
Japan	The Jikei University Hospital	Tokyo
Japan	The University of Tokyo	Tokyo
Japan	Toho Univ Med Ctr Omori Hosp	Tokyo
Japan	Tokyo Medical University Hosp	Tokyo
Japan	Tokyo Metropolitan Bokutoh Hos	Tokyo
Japan	Tokyo Womens Med Univ Hosp	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	Yoshida Internal Med Clinic	Tokyo
Japan	Matsuno Clinic Rheumatic Disea	Toyama
Japan	Toyama Prefectural Ctr Hosp	Toyama
Japan	Fujita Health University Hosp	Toyoake
Japan	Toyama University Hospital	Toyoma
Japan	Toyooka Hospital	Toyooka
Japan	Kishi Orthopedics Medical Clin	Tsuchiura-shi
Japan	Tsukuba University Hospital	Tsukuba
Japan	Tsuyama Chuo Memorial Hospital	Tsuyama
Japan	Daini Okamoto General Hospital	UJI
Japan	Wakayama Medical University	Wakayama
Japan	Yamagata City Hosp Saiseikai	Yamagata
Japan	Yamagata University Hospital	Yamagata
Japan	Yamaguchi Red Cross Hospital	Yamaguchi-shi
Japan	Shuto General Hospital	Yanai-shi
Japan	Kumamoto Rosai Hospital	Yatsushiro-shi
Japan	Yokohama City Univ Medical Ctr	Yokohama	Kanagawa
Japan	Showa Univ N Yokohama Hosp	Yokohama-shi
Japan	Tottori University Hospital	Yonago-shi

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Drug Reactions	An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown.; A serious adverse drug reaction is any untoward medical occurrence that at any dose; Results in death; Life threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent of significant disability or incapacity	24 weeks
Primary	Number of Participants With Adverse Drug Reactions by Baseline Factors	An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics.; NSAID: non-steroidal anti-inflammatory drug; DMARD: disease-modifying anti-rheumatic drug; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index	24 weeks
Primary	Number of Participants With Adverse Events	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.; A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.	24 weeks
Primary	Number of Participants With Self-injection Errors		24 weeks
Secondary	Number of Participants With Markedly Improved or Improved Rating	Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable	Weeks 12, 24, and at the last visit
Secondary	Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors	Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable	24 weeks (or last visit if earlier)
Secondary	Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (= 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.	Baseline and weeks 12 and 24

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