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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01329380
First received: March 17, 2011
Last updated: July 13, 2017
Last verified: July 2017
  Purpose

This study of 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

Condition
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: at week 24 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira

  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 12 ]
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ]

Secondary Outcome Measures:
  • Effectiveness evaluation by the investigator [ Time Frame: at week 12 ]
    The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment

  • Effectiveness evaluation by the investigator [ Time Frame: at week 24 ]
    The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment


Estimated Enrollment: 100
Study Start Date: November 29, 2010
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who receive Humira for the treatment of Ankylosing Spondylitis
Criteria

Inclusion Criteria:

  • All patients with Ankylosing Spondylitis who are not responding well to conventional therapy and receive Humira 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329380

  Hide Study Locations
Locations
Japan
Asano Orthopedic Clinic /ID# 68725
Aichi, Japan
Nagoya Daini Red Cross Hospital /ID# 59603
Aichi, Japan
Ozone Surgery Clinic /ID# 64970
Aichi, Japan
Yamagiwa Clinic /ID# 59605
Aichi, Japan
Narushima Internal Medicine Clinic /ID# 133707
Ami-machi, Japan
Asahikawa Kosei General Hospital /ID# 140716
Asahikawa-shi, Japan
Asahikawa Medical College Hospital /ID# 54715
Asahikawa-shi, Japan
Atsugi City Hospital /ID# 126363
Atsugi-shi, Japan
Chiba University Hospital /ID# 134999
Chiba-shi, Japan
Fujieda Municipal General Hospital /ID# 79755
Fujieda, Japan
Nakamura Clinic /ID# 128416
Fukuchiyama-shi, Japan
National Hospital Organization Kyushu Medical Center /ID# 150995
Fukuoka-shi, Fukuoka, Japan
National Hospital Organization Kyushu Medical Center /ID# 150996
Fukuoka-shi, Fukuoka, Japan
Japanese Red Cross Fukuoka Hospital /ID# 80934
Fukuoka-shi, Japan
Kyushu University Hospital /ID# 51114
Fukuoka-shi, Japan
Hamanomachi Hospital /ID# 96506
Fukuoka, Japan
Mutaguchi Orthopedics Clinic /ID# 89985
Fukuoka, Japan
PS Clinic /ID# 51163
Fukuoka, Japan
Fukushima Medical University Hospital /ID# 51086
Fukushima, Japan
Fukushima Red Cross Hospital /ID# 133702
Fukushima, Japan
Minami Tohoku Fukushima Hospital /ID# 129892
Fukushima, Japan
Gifu University Hospital /ID# 54709
Gifu-shi, Japan
Seirei Mikatahara General Hospital /ID# 89988
Hamamatsu, Japan
Yoshida Internal Medicine Clinic /ID# 142012
Hanishina-gun, Japan
Osaka Rehabilitation Hospital /ID# 79773
Hannan, Japan
Matsunami General Hospital /ID# 132031
Hashima-gun, Japan
Kono Orthopedics and Internal Medicine Clinic /ID# 133704
Higashimatsuyama-shi, Japan
Tama-Hokubu Medical Center /ID# 148824
Higashimurayama, Japan
NHO Higashi-Ohmi General Medical Center /ID# 124638
Higashiomi, Japan
Yamaguchi Clinic /ID# 51197
Higashiosaka-shi, Japan
NHO Himeji Medical Center /ID# 112239
Himeji, Japan
Hirosaki Memorial Hospital /ID# 94822
Hirosaki, Japan
Hirosaki University School of Medicine & Hospital /ID# 51147
Hirosaki, Japan
Hiroshima Red Cross Hospital &Atomic-bomb Survivors Hospital /ID# 51162
Hiroshima-shi,Hiroshima, Japan
Hiroshima Clinic /ID# 51155
Hiroshima-shi, Japan
Hiroshima University Hospital /ID# 54983
Hiroshima-shi, Japan
Shigenobu Clinic /ID# 79754
Hiroshima, Japan
Yamana-kai Higashi Hiroshima Kinen Hospital /ID# 51126
Hiroshima, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 133708
Hokkaido, Japan
Midori Hospital /ID# 54822
Hyogo, Japan
Midori Hospital /ID# 64968
Hyogo, Japan
Kohnodai Hospital /ID# 54720
Ichikawa-shi, Japan
Iwate Prefectural Iwai Hospital /ID# 79758
Ichinoseki-shi, Japan
Nara City Hospital /ID# 64934
Ikoma, Japan
Suga Orthopedic Hospital /ID# 132038
Isahaya-shi, Japan
Isahaya Health Insurance General Hospital /ID# 59607
Isahaya, Japan
Teikyo University Hospital /ID# 121226
Itabashi-Ku,Tokyo, Japan
National Hospital Organization Iwakuni Clinical Center /ID# 133710
Iwakuni-shi, Japan
Juntendo University Shizuoka Hospital /ID# 51190
Izunokuni-shi, Japan
Kaga City Hospital /ID# 79759
Kaga-shi, Ishikawa, Japan
Kagoshima Red Cross Hospital /ID# 67172
Kagoshima, Japan
Kagoshima University Medical and Dental Hospital /ID# 55020
Kagoshima, Japan
Kameda Medical Center /ID# 51096
Kamogawa, Japan
St. Marianna University School of Medicine Hospital /ID# 51188
Kanagawa, Japan
Kanazawa University Hospital /ID# 55008
Kanazawa-shi, Japan
Kanazawa University Hospital /ID# 55009
Kanazawa-shi, Japan
Saiseikai Kanazawa Hospital /ID# 64936
Kanazawa, Japan
Asahi Hospital /ID# 75096
Kasugai, Japan
Kasugai Orthopaedic Clinic /ID# 75099
Kasugai, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 51125
Kawachinagano-shi, Osaka, Japan
Nagasawa Clinic /ID# 138472
Kawagoe-shi, Japan
Saitama Medical Center /ID# 54997
Kawagoe-shi, Japan
Saitama Medical University Hospital /ID# 51117
Kawagoe, Japan
Saitama Medical University Hospital /ID# 51152
Kawagoe, Japan
Edakuni Orthopedic Clinic /ID# 124557
Kiryu, Japan
Kagawa University Hospital /ID# 54710
Kita-gun, Kagawa, Japan
University of Occupational and Environmental Health /ID# 51167
Kitakyushu-shi, Japan
JR Kyushu Hospital /ID# 59588
Kitakyushu, Japan
Kobe University Hospital /ID# 54725
Kobe-shi, Japan
Komaki Daiichi Hospital /ID# 139517
Komaki, Japan
Jusendo General Hospital /ID# 144424
Koriyama-shi, Japan
Juntendo University Koshigaya Hospital /ID# 51120
Koshigaya, Japan
Shunan Memorial Hospital /ID# 51158
Kudamatsu-shi, Japan
Kumamoto Rheumatology Clinic /ID# 137166
Kumamoto-shi, Japan
Kunitachi Rheumatism Collagen Disease Clinic /ID# 138474
Kunitachi, Japan
Kawasaki Medical School Hospital /ID# 51170
Kurashiki-shi, Japan
Kurashiki Central Hospital /ID# 54723
Kurashiki-shi, Japan
Kurume University Hospital /ID# 55017
Kurume-shi, Japan
Kyoto University Hospital /ID# 55011
Kyoto-shi, Kyoto, Japan
Kyoto University Hospital /ID# 64933
Kyoto-shi, Kyoto, Japan
Kyoto Prefectural University of Medicine /ID# 51118
Kyoto-shi, Japan
Kyoto Prefectural University of Medicine /ID# 51119
Kyoto-shi, Japan
Iwasaku Orthopedic Clinic /ID# 129893
Kyoto, Japan
Japanese Red Cross Kyoto Daiichi Hospital /ID# 135002
Kyoto, Japan
Jujo Rehabilitation Hospital /ID# 64994
Kyoto, Japan
Gunma University Hospital /ID# 51087
Maebashi-shi, Japan
Gunma University Hospital /ID# 54990
Maebashi-shi, Japan
Tori Clinic /ID# 79753
Maizuru-shi, Japan
Matsuyama Red Cross Hospital /ID# 49884
Matsuyama-shi, Japan
Mino Municipal Hospital /ID# 129889
Mino, Japan
Kyorin University Hospital /ID# 51146
Mitaka, Japan
Suzuki Orthopedic Clinic /ID# 128417
Miyashiro-machi, Japan
Miyazaki Prefectural Miyazaki Hospital /ID# 67173
Miyazaki-shi, Japan
Kansai Medical University Takii Hospital /ID# 64932
Moriguchi, Japan
Iwate Medical University Hospital /ID# 132034
Morioka-shi, Japan
Noguchi Seikeigeka Naika Iin /ID# 133705
Motosu-shi, Japan
Munakata Medical Association Hospital /ID# 136150
Munakata-shi, Japan
Japanese Red Cross Musashino Hospital /ID# 112241
Musashino-shi, Japan
Aichi Medical University Hospital /ID# 51169
Nagakute-shi, Japan
Aichi Medical University Hospital /ID# 59591
Nagakute-shi, Japan
Aichi Medical University Hospital /ID# 64967
Nagakute-shi, Japan
Saiseikai Kyoto Hospital /ID# 64931
Nagaokakyo, Japan
Nagasaki University Hospital /ID# 51123
Nagasaki-shi, Japan
Nagoya University Hospital /ID# 54819
Nagoya-shi, Aichi, Japan
Nagoya University Hospital /ID# 89980
Nagoya-shi, Aichi, Japan
Chukyo Social Insurance Hospital /ID# 54821
Nagoya-shi, Japan
Chukyo Social Insurance Hospital /ID# 54985
Nagoya-shi, Japan
NHO Nagoya Medical Center /ID# 59584
Nagoya-shi, Japan
East Medical Center Higashi Municipal Hosp City of Nagoya /ID# 59600
Nagoya, Japan
Kakinuma Orthopedics Clinic /ID# 94823
Nagoya, Japan
Shinseikai Daiichi Hospital /ID# 121228
Nagoya, Japan
Ohama Daiichi Hospital /ID# 129891
Naha, Japan
Oura Clinic /ID# 139518
Naha, Japan
Kochi Medical School Hospital /ID# 139516
Nankoku-shi, Japan
Mitsuka Rheumatism Clinic /ID# 133703
Narashino-shi, Japan
Asahigaoka Hospital /ID# 51186
Nara, Japan
Niigata City General Hospital /ID# 135734
Niigata-shi, Japan
Nirasaki City Hospital /ID# 84020
Nirasaki, Japan
Hyogo College of Medicine Hospital /ID# 55004
Nishinomiya-shi, Hyogo, Japan
Nisshin Orido Hospital /ID# 84194
Nisshin, Japan
Yamachika Memorial General Hospital /ID# 132032
Odawara-shi, Japan
Oita Red Cross Hospital /ID# 148822
Oita-shi, Japan
Saiseikai Hita Hospital /ID# 59598
Oita, Japan
Sunrise Sakai Hospital /ID# 55019
Oita, Japan
Okayama University Hospital /ID# 55013
Okayama-shi, Japan
Ome Municipal General Hospital /ID# 51091
Ome, Japan
Yuri Plastic Surgery /ID# 84022
Ono, Japan
Osaka Red Cross Hospital /ID# 51191
Osaka-shi, Osaka, Japan
Osaka City University Hospital /ID# 51149
Osaka-shi, Japan
Osaka City University Hospital /ID# 51150
Osaka-shi, Japan
Osaka City University Hospital /ID# 51173
Osaka-shi, Japan
Osaka Rheumatology Clinic /ID# 112240
Osaka-shi, Japan
Ushio Clinic /ID# 51196
Osaka-shi, Japan
Yodogawa Christian Hospital /ID# 126748
Osaka-shi, Japan
Kojima Orthopedic Clinic /ID# 51185
Osaka, Japan
Murakami Orthopaedics Clinic /ID# 59602
Osaka, Japan
NTT West Japan Osaka Hospital /ID# 64935
Osaka, Japan
Osaka Saiseikai Noe Hospital /ID# 114300
Osaka, Japan
Yukioka Hospital /ID# 54716
Osaka, Japan
Osaki Citizen Hospital /ID# 51083
Osaki, Japan
Ota Memorial Hospital /ID# 112242
Ota, Japan
Shiga University of Medical Science Hospital /ID# 55012
Otsu-Shiga, Japan
Saga University Hospital /ID# 55018
Saga-shi, Japan
Osaka Rosai Hospital /ID# 94821
Sakai-shi, Japan
Sapporo Medical University Hospital /ID# 51084
Sapporo-shi, Japan
Kin-ikyo Chuo Hospital /ID# 112243
Sapporo, Japan
KKR Sapporo Medical Center Tonan Hospital /ID# 51085
Sapporo, Japan
Teine Internal Medicine Rheumatology Clinic /ID# 51122
Sapporo, Japan
Teine Keijinkai Clinic /ID# 148823
Sapporo, Japan
Sasebo Chuo Hospital /ID# 135001
Sasebo-shi, Japan
Sasebo City General Hospital /ID# 133709
Sasebo-shi, Japan
Tohoku University Hospital /ID# 51148
Sendai-shi, Japan
NHO Nishitaga National Hospital /ID# 144982
Sendai, Japan
Tohoku Pharmaceutical University Hospital /ID# 142017
Sendai, Japan
Jyunshinkai Inoue Hospital /ID# 89993
Seto, Japan
Niigata Rheumatic Center /ID# 142016
Shibata-shi, Japan
Saiseikai Suita Hospital /ID# 54984
Suita-shi, Osaka, Japan
Osaka University Graduate School of Medicine /ID# 89983
Suita-shi, Japan
Osaka University Hospital /ID# 55001
Suita, Japan
Osaka University Hospital /ID# 55002
Suita, Japan
Kotesashi Orthopedic Clinic /ID# 128935
Tokorozawa-shi, Japan
Hirose Clinic /ID# 54986
Tokorozawa, Japan
Toyo Hospital /ID# 136151
Tokushima-shi, Japan
Hishita-Hiasa Neurosurgery and Internal Medicine Clinic /ID# 144425
Tokushima, Japan
Akasaka Chuo Clinic /ID# 124558
Tokyo, Japan
Edogawa Hospital /ID# 114301
Tokyo, Japan
Ishigaki Orthopedic Clinic /ID# 139469
Tokyo, Japan
Juntendo University Hospital /ID# 51089
Tokyo, Japan
Juntendo University Nerima Hospital /ID# 68726
Tokyo, Japan
Kanamecho Hospital /ID# 137169
Tokyo, Japan
Kawakita General Hospital /ID# 132033
Tokyo, Japan
Kawakita General Hospital /ID# 59587
Tokyo, Japan
Keiyo Hospital /ID# 51093
Tokyo, Japan
Kyoundo Hospital /ID# 136148
Tokyo, Japan
Matsuda Orthopedic Rheumatology Clinic /ID# 135732
Tokyo, Japan
Medical Hospital of Tokyo Medical and Dental University /ID# 51115
Tokyo, Japan
Mitsui Memorial Hospital /ID# 54815
Tokyo, Japan
National Center for Global Health and Medicine Hospital /ID# 89981
Tokyo, Japan
NHO Disaster Medical Center /ID# 54995
Tokyo, Japan
Nihon University School of Medicine Itabashi Hospital /ID# 89984
Tokyo, Japan
Showa University Hospital /ID# 54718
Tokyo, Japan
St. Luke's International Hospital /ID# 51090
Tokyo, Japan
The Jikei University School of Medicine /ID# 51151
Tokyo, Japan
The University of Tokyo /ID# 54711
Tokyo, Japan
The University of Tokyo /ID# 54717
Tokyo, Japan
Toho University Medical Center Omori Hospital /ID# 54721
Tokyo, Japan
Tokyo Medical University Hospital /ID# 54994
Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital /ID# 54993
Tokyo, Japan
Tokyo Metropolitan Tama Medical Center /ID# 54996
Tokyo, Japan
Tokyo Womens Medical University Hospital /ID# 51172
Tokyo, Japan
Toranomon Hospital /ID# 71476
Tokyo, Japan
Yoshida Internal Medicine Clinic /ID# 51094
Tokyo, Japan
Toyama Prefectural Central Hospital /ID# 51128
Toyama-shi, Japan
Matsuno Clinic for Rheumatic Diseases /ID# 59589
Toyama, Japan
Toyama University Hospital /ID# 55006
Toyama, Japan
Toyama University Hospital /ID# 55007
Toyama, Japan
Fujita Health University Hospital /ID# 64995
Toyoake-shi, Japan
Fujita Health University Hospital /ID# 89986
Toyoake, Japan
Toyooka Hospital /ID# 96505
Toyooka, Japan
Kishi Orthopedics Medical Clinic /ID# 133713
Tsuchiura-shi, Japan
Tsukuba University Hospital /ID# 59594
Tsukuba-shi, Japan
Tsuyama Chuo Memorial Hospital /ID# 71475
Tsuyama, Japan
Daini Okamoto General Hospital /ID# 89989
Uji, Japan
Wakayama Medical University Hospital /ID# 54817
Wakayama-shi, Japan
Yamagata University Hospital /ID# 139520
Yamagata-shi, Japan
Yamagata City Hospital Saiseikai /ID# 96502
Yamagata, Japan
Yamaguchi Red Cross Hospital /ID# 54823
Yamaguchi-shi, Japan
Yamaguchi Red Cross Hospital /ID# 64969
Yamaguchi-shi, Japan
University of Yamanashi Hospital /ID# 144981
Yamanashi, Japan
Shuto General Hospital /ID# 133712
Yanai-shi, Japan
Kumamoto Rosai Hospital /ID# 135000
Yatsushiro-shi, Japan
Yokohama City University Medical Center /ID# 75098
Yokohama-shi, Kanagawa, Japan
Yokohama City University Medical Center /ID# 94824
Yokohama-shi, Kanagawa, Japan
Showa University Northern Yokohama Hospital /ID# 80933
Yokohama-shi, Japan
Tottori University Hospital /ID# 55014
Yonago-shi, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sarina Kurimoto, MD AbbVie GK
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01329380     History of Changes
Other Study ID Numbers: P12-764
Study First Received: March 17, 2011
Last Updated: July 13, 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on July 25, 2017