Clinical trial NCT01329380: Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Official title: Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-04-05
Enrollment: 403
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who receive Humira for the treatment of ankylosing spondylitis

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: 24 weeks
measure: Number of Participants With Adverse Drug Reactions by Baseline Factors
timeFrame: 24 weeks
measure: Number of Participants With Adverse Events
timeFrame: 24 weeks
measure: Number of Participants With Self-injection Errors
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Participants With Markedly Improved or Improved Rating
timeFrame: Weeks 12, 24, and at the last visit
measure: Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
timeFrame: 24 weeks (or last visit if earlier)
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline and weeks 12 and 24
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hosp
state: Hyogo
city: Yokohama
country: Japan
facility: Yokohama City Univ Medical Ctr
state: Kanagawa
city: 長崎市
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: 大阪市
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Otsu
country: Japan
facility: Shiga Univ Med Science Hosp
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Medical Hospital of Tokyo Medical and Dental University
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: 中央区
country: Japan
facility: St. Luke's International Hosp
state: Tokyo
city: 板橋区
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Aichi
country: Japan
facility: Asano Orthopedic Clinic
city: Aichi
country: Japan
facility: Nagoya Daini Red Cross Hosp
city: Aichi
country: Japan
facility: Ozone Surgery Clinic
city: Aichi
country: Japan
facility: Yamagiwa Clinic
city: Ami-machi
country: Japan
facility: Narushima Internal Med Clinic
city: Asahikawa-shi
country: Japan
facility: Asahikawa Kosei General Hosp
city: Asahikawa
country: Japan
facility: Katayama Orthopedic Rheum Clin
city: Asahikawa
country: Japan
facility: Asahikawa Med College Hosp, JP
city: Atsugi-shi
country: Japan
facility: Atsugi City Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chuo
country: Japan
facility: University of Yamanashi Hosp
city: Fuchu
country: Japan
facility: Tama Medical Center
city: Fujieda
country: Japan
facility: Fujieda Municipal General Hosp
city: Fukuchiyama-shi
country: Japan
facility: Nakamura Clinic
city: Fukuoka
country: Japan
facility: Hamanomachi Hospital
city: Fukuoka
country: Japan
facility: NHO Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: JP Red Cross Fukuoka Hosp
city: Fukuoka
country: Japan
facility: Mutaguchi Orthopedics Clinic
city: Fukuoka
country: Japan
facility: PS Clinic
city: Fukushima-shi
country: Japan
facility: Fukushima Med Univ Hosp
city: Fukushima
country: Japan
facility: Fukushima Red Cross Hospital
city: Fukushima
country: Japan
facility: Minami Tohoku Fukushima Hosp
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hamamatsu
country: Japan
facility: Seirei Mikatahara General Hosp
city: Hannan
country: Japan
facility: Osaka Rehabilitation Hospital
city: Hashima-gun
country: Japan
facility: Matsunami General Hospital
city: Higashimatsuyama-shi
country: Japan
facility: Kono Orthop. and Int. Med Clin
city: Higashimurayama
country: Japan
facility: Tama-Hokubu Medical Center
city: Higashiomi
country: Japan
facility: NHO Higashi-Ohmi Gen Med Ctr
city: Higashiosaka-shi
country: Japan
facility: Yamaguchi Clinic
city: Himeji
country: Japan
facility: NHO Himeji Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki Uni School Med & Hosp
city: Hirosaki
country: Japan
facility: Hirosaki Memorial Hospital
city: Hiroshima-shi
country: Japan
facility: Hiroshima Clinic
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hosp Atomi
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hiroshima
country: Japan
facility: Yamana-kai Higashi Hiroshima
city: Hiroshima
country: Japan
facility: Shigenobu Clinic
city: Hyogo
country: Japan
facility: Midori Hospital
city: Ichikawa-shi
country: Japan
facility: Kohnodai Hospital
city: Ichinoseki-shi
country: Japan
facility: Iwate Prefectural Iwai Hosp
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hos
city: Isahaya
country: Japan
facility: Suga Orthopedic Hospital
city: Isahaya
country: Japan
facility: Isahaya Health Ins Genl Hosp
city: Iwakuni-shi
country: Japan
facility: NHO Iwakuni Clinical Center
city: Izunokuni-shi
country: Japan
facility: Juntendo Univ Shizuoka Hosp
city: Kaga-shi, Ishikawa
country: Japan
facility: Kaga City Hospital
city: Kagoshima-shi
country: Japan
facility: Kagoshima Univ Medical and Den
city: Kagoshima
country: Japan
facility: Kagoshima Red Cross Hospital
city: Kamogawa
country: Japan
facility: Kameda Medical Center
city: Kanazawa
country: Japan
facility: Saiseikai Kanazawa Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Ho
city: Kasugai
country: Japan
facility: Kasugai Orthopaedic Clinic
city: Kasugai
country: Japan
facility: Asahi Hospital
city: Kawachinagano
country: Japan
facility: NHO Osaka Minami Med Ctr
city: Kawagoe-shi
country: Japan
facility: Nagasawa Clinic
city: Kawasaki
country: Japan
facility: St. Marianna Univ Hospital
city: Kiryu
country: Japan
facility: Edakuni Orthopedic Clinic
city: Kitakyushu
country: Japan
facility: JR Kyushu Hospital
city: Kitakyushu
country: Japan
facility: Univ Occup & Environ Health
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Komaki
country: Japan
facility: Komaki Daiichi Hospital
city: Koriyama-shi
country: Japan
facility: Jusendo General Hospital
city: Koshigaya
country: Japan
facility: Juntendo Univ Koshigaya Hosp
city: Kudamatsu-shi
country: Japan
facility: Shunan Memorial Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Rheumatology Clinic
city: Kunitachi
country: Japan
facility: Kunitachi Clinic
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hosp
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Kyoto
country: Japan
facility: Jujo Rehabilitation Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefect Univ Med
city: Kyoto
country: Japan
facility: JP Red Cross Kyoto Daiichi Hos
city: Kyoto
country: Japan
facility: Kagawa University Hospital
city: Kyoto
country: Japan
facility: Iwasaku Orthopedic Clinic
city: Maizuru-shi
country: Japan
facility: Tori Clinic
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hosp
city: Mino
country: Japan
facility: Mino Municipal Hospital
city: Miyashiro-machi
country: Japan
facility: Suzuki Orthopedic Clinic
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki
city: Morioka
country: Japan
facility: Iwate Medical University Hosp
city: Motosu-shi
country: Japan
facility: Noguchi Seikeigeka Naika Iin
city: Munakata-shi
country: Japan
facility: Munakata Medical Assoc. Hosp.
city: Nagakute
country: Japan
facility: Aichi Medical University Hosp
city: Nagaokakyo
country: Japan
facility: Saiseikai Kyoto Hospital
city: Nagoya-shi
country: Japan
facility: Chukyo Social Insurance Hospit
city: Nagoya
country: Japan
facility: NHO Nagoya Medical Center
city: Nagoya
country: Japan
facility: Shinseikai Daiichi Hospital
city: Nagoya
country: Japan
facility: Higashi Hosp City of Nagoya
city: Nagoya
country: Japan
facility: Kakinuma Orthopedics Clinic
city: Naha
country: Japan
facility: Oura Clinic
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
city: Narashino-shi
country: Japan
facility: Mitsuka Rheumatism Clinic
city: Nara
country: Japan
facility: Nara City Hospital
city: Nara
country: Japan
facility: Asahigaoka Hospital
city: Niigata
country: Japan
facility: Niigata City General Hospital
city: Nirasaki
country: Japan
facility: Nirasaki City Hospital
city: Nisshin
country: Japan
facility: Nisshin Orido Hospital
city: Odawara-shi
country: Japan
facility: Yamachika Memorial Gen Hosp
city: Oita
country: Japan
facility: Oita Red Cross Hospital
city: Oita
country: Japan
facility: Saiseikai Hita Hospital
city: Oita
country: Japan
facility: Sunrise Sakai Hospital
city: Okinawa
country: Japan
facility: Ohama Daiichi Hospital
city: OME
country: Japan
facility: Ome Municipal General Hospital
city: ONO
country: Japan
facility: Yuri Plastic Surgery
city: Osaka-shi
country: Japan
facility: Osaka Rheumatology Clinic
city: Osaka-shi
country: Japan
facility: Ushio Clinic
city: Osaka-shi
country: Japan
facility: Yodogawa Christian Hospital
city: Osaka
country: Japan
facility: Yukioka Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Noe Hospital
city: Osaka
country: Japan
facility: NTT WEST Osaka Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Kansai Medical Univ Takii Hosp
city: Osaka
country: Japan
facility: Kojima Orthopedic Clinic
city: Osaka
country: Japan
facility: Murakami Orthopaedics Clinic
city: Osaki
country: Japan
facility: Osaki Citizen Hospital
city: OTA
country: Japan
facility: Ota Memorial Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Sakai-shi
country: Japan
facility: Osaka Rosai Hospital
city: Sakaki
country: Japan
facility: Yoshida Internal Med Clinic
city: Sakyo-ku
country: Japan
facility: Kyoto University Hospital
city: Sapporo
country: Japan
facility: Teine Internal Med Rheuma Clin
city: Sapporo
country: Japan
facility: Teine Keijinkai Clinic
city: Sapporo
country: Japan
facility: Sapporo Medical Univ Hosp
city: Sapporo
country: Japan
facility: Kin-ikyo Chuo Hospital
city: Sapporo
country: Japan
facility: KKR Sapporo Med Ctr Tonan Hosp
city: Sasebo-shi
country: Japan
facility: Sasebo City General Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Sendai
country: Japan
facility: NHO Nishitaga National Hospita
city: Sendai
country: Japan
facility: Tohoku Pharmaceutical Univ Hos
city: Seto
country: Japan
facility: Jyunshinkai Inoue Hospital
city: Shibata
country: Japan
facility: Niigata Rheumatic Center
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Tokorozawa-shi
country: Japan
facility: Kotesashi Orthopedic Clinic
city: Tokorozawa
country: Japan
facility: Hirose Clinic
city: Tokushima-shi
country: Japan
facility: Toyo Hospital
city: Tokushima
country: Japan
facility: Hishita-Hiasa Neurosurgery and
city: Tokyo
country: Japan
facility: Kyoundo Hospital
city: Tokyo
country: Japan
facility: Mitsui Memorial Hospital
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Bokutoh Hos
city: Tokyo
country: Japan
facility: Keiyo Hospital
city: Tokyo
country: Japan
facility: Toho Univ Med Ctr Omori Hosp
city: Tokyo
country: Japan
facility: Tokyo Medical University Hosp
city: Tokyo
country: Japan
facility: National Ctr Global Health Med
city: Tokyo
country: Japan
facility: Tokyo Womens Med Univ Hosp
city: Tokyo
country: Japan
facility: Kawakita General Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hosp
city: Tokyo
country: Japan
facility: Juntendo Univ Nerima Hosp
city: Tokyo
country: Japan
facility: JP Red Cross Musashino Hosp
city: Tokyo
country: Japan
facility: Akasaka Chuo Clinic
city: Tokyo
country: Japan
facility: Edogawa Hospital
city: Tokyo
country: Japan
facility: Ishigaki Orthopedic Clinic
city: Tokyo
country: Japan
facility: Kanamecho Hospital
city: Tokyo
country: Japan
facility: Matsuda Orthopedic Rheuma Clin
city: Tokyo
country: Japan
facility: NHO Disaster Medical Center
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: Yoshida Internal Med Clinic
city: Toyama
country: Japan
facility: Matsuno Clinic Rheumatic Disea
city: Toyama
country: Japan
facility: Toyama Prefectural Ctr Hosp
city: Toyoake
country: Japan
facility: Fujita Health University Hosp
city: Toyoma
country: Japan
facility: Toyama University Hospital
city: Toyooka
country: Japan
facility: Toyooka Hospital
city: Tsuchiura-shi
country: Japan
facility: Kishi Orthopedics Medical Clin
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
city: Tsuyama
country: Japan
facility: Tsuyama Chuo Memorial Hospital
city: UJI
country: Japan
facility: Daini Okamoto General Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yamagata
country: Japan
facility: Yamagata City Hosp Saiseikai
city: Yamaguchi-shi
country: Japan
facility: Yamaguchi Red Cross Hospital
city: Yanai-shi
country: Japan
facility: Shuto General Hospital
city: Yatsushiro-shi
country: Japan
facility: Kumamoto Rosai Hospital
city: Yokohama-shi
country: Japan
facility: Showa Univ N Yokohama Hosp
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: