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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: October 28, 2016
Last verified: October 2016
  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:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: at week 24 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness evaluation by the investigator [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 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)
Genders Eligible for Study:   Both
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
Site Reference ID/Investigator# 59603
Aichi, Japan
Site Reference ID/Investigator# 59605
Aichi, Japan
Site Reference ID/Investigator# 64970
Aichi, Japan
Site Reference ID/Investigator# 68725
Aichi, Japan
Site Reference ID/Investigator# 133707
Ami-machi, Japan
Site Reference ID/Investigator# 140716
Asahikawa-shi, Japan
Site Reference ID/Investigator# 54715
Asahikawa-shi, Japan
Site Reference ID/Investigator# 126363
Atsugi-shi, Japan
Site Reference ID/Investigator# 134999
Chiba-shi, Japan
Site Reference ID/Investigator# 144981
Chuo, Japan
Site Reference ID/Investigator# 79755
Fujieda, Japan
Site Reference ID/Investigator# 128416
Fukuchiyama-shi, Japan
Site Reference ID/Investigator# 150995
Fukuoka-shi, Fukuoka, Japan
Site Reference ID/Investigator# 150996
Fukuoka-shi, Fukuoka, Japan
Site Reference ID/Investigator# 51114
Fukuoka-shi, Japan
Site Reference ID/Investigator# 80934
Fukuoka-shi, Japan
Site Reference ID/Investigator# 51163
Fukuoka, Japan
Site Reference ID/Investigator# 89985
Fukuoka, Japan
Site Reference ID/Investigator# 96506
Fukuoka, Japan
Site Reference ID/Investigator# 129892
Fukushima, Japan
Site Reference ID/Investigator# 133702
Fukushima, Japan
Site Reference ID/Investigator# 51086
Fukushima, Japan
Site Reference ID/Investigator# 54709
Gifu-shi, Japan
Site Reference ID/Investigator# 89988
Hamamatsu, Japan
Site Reference ID/Investigator# 142012
Hanishina-gun, Japan
Site Reference ID/Investigator# 79773
Hannan, Japan
Site Reference ID/Investigator# 132031
Hashima-gun, Japan
Site Reference ID/Investigator# 133704
Higashimatsuyama-shi, Japan
Site Reference ID/Investigator# 148824
Higashimurayama, Japan
Site Reference ID/Investigator# 124638
Higashiomi, Japan
Site Reference ID/Investigator# 51197
Higashiosaka-shi, Japan
Site Reference ID/Investigator# 112239
Himeji, Japan
Site Reference ID/Investigator# 51147
Hirosaki, Japan
Site Reference ID/Investigator# 94822
Hirosaki, Japan
Site Reference ID/Investigator# 51162
Hiroshima-shi,Hiroshima, Japan
Site Reference ID/Investigator# 51155
Hiroshima-shi, Japan
Site Reference ID/Investigator# 54983
Hiroshima-shi, Japan
Site Reference ID/Investigator# 51126
Hiroshima, Japan
Site Reference ID/Investigator# 79754
Hiroshima, Japan
Site Reference ID/Investigator# 133708
Hokkaido, Japan
Site Reference ID/Investigator# 54822
Hyogo, Japan
Site Reference ID/Investigator# 64968
Hyogo, Japan
Site Reference ID/Investigator# 54720
Ichikawa-shi, Japan
Site Reference ID/Investigator# 79758
Ichinoseki-shi, Japan
Site Reference ID/Investigator# 64934
Ikoma, Japan
Site Reference ID/Investigator# 132038
Isahaya-shi, Japan
Site Reference ID/Investigator# 59607
Isahaya, Japan
Site Reference ID/Investigator# 121226
Itabashi-Ku,Tokyo, Japan
Site Reference ID/Investigator# 133710
Iwakuni-shi, Japan
Site Reference ID/Investigator# 51190
Izunokuni-shi, Japan
Site Reference ID/Investigator# 79759
Kaga-shi, Ishikawa, Japan
Site Reference ID/Investigator# 55020
Kagoshima, Japan
Site Reference ID/Investigator# 67172
Kagoshima, Japan
Site Reference ID/Investigator# 51096
Kamogawa, Japan
Site Reference ID/Investigator# 55008
Kanazawa-shi, Japan
Site Reference ID/Investigator# 55009
Kanazawa-shi, Japan
Site Reference ID/Investigator# 64936
Kanazawa, Japan
Site Reference ID/Investigator# 75096
Kasugai, Japan
Site Reference ID/Investigator# 75099
Kasugai, Japan
Site Reference ID/Investigator# 51125
Kawachinagano-shi, Osaka, Japan
Site Reference ID/Investigator# 138472
Kawagoe-shi, Japan
Site Reference ID/Investigator# 54997
Kawagoe-shi, Japan
Site Reference ID/Investigator# 51117
Kawagoe, Japan
Site Reference ID/Investigator# 51152
Kawagoe, Japan
Site Reference ID/Investigator# 51188
Kawasaki-shi, Japan
Site Reference ID/Investigator# 124557
Kiryu, Japan
Site Reference ID/Investigator# 54710
Kita-gun, Kagawa, Japan
Site Reference ID/Investigator# 51167
Kitakyushu-shi, Japan
Site Reference ID/Investigator# 59588
Kitakyushu, Japan
Site Reference ID/Investigator# 54725
Kobe-shi, Japan
Site Reference ID/Investigator# 139517
Komaki, Japan
Site Reference ID/Investigator# 144424
Koriyama-shi, Japan
Site Reference ID/Investigator# 51120
Koshigaya, Japan
Site Reference ID/Investigator# 51158
Kudamatsu-shi, Japan
Site Reference ID/Investigator# 137166
Kumamoto-shi, Japan
Site Reference ID/Investigator# 138474
Kunitachi, Japan
Site Reference ID/Investigator# 51170
Kurashiki-shi, Japan
Site Reference ID/Investigator# 54723
Kurashiki-shi, Japan
Site Reference ID/Investigator# 55017
Kurume-shi, Japan
Site Reference ID/Investigator# 55011
Kyoto-shi, Kyoto, Japan
Site Reference ID/Investigator# 64933
Kyoto-shi, Kyoto, Japan
Site Reference ID/Investigator# 51118
Kyoto-shi, Japan
Site Reference ID/Investigator# 51119
Kyoto-shi, Japan
Site Reference ID/Investigator# 129893
Kyoto, Japan
Site Reference ID/Investigator# 135002
Kyoto, Japan
Site Reference ID/Investigator# 64994
Kyoto, Japan
Site Reference ID/Investigator# 51087
Maebashi-shi, Japan
Site Reference ID/Investigator# 54990
Maebashi-shi, Japan
Site Reference ID/Investigator# 79753
Maizuru-shi, Japan
Site Reference ID/Investigator# 49884
Matsuyama-shi, Japan
Site Reference ID/Investigator# 129889
Mino, Japan
Site Reference ID/Investigator# 51146
Mitaka, Japan
Site Reference ID/Investigator# 144982
Miyagi, Japan
Site Reference ID/Investigator# 128417
Miyashiro-machi, Japan
Site Reference ID/Investigator# 67173
Miyazaki-shi, Japan
Site Reference ID/Investigator# 64932
Moriguchi, Japan
Site Reference ID/Investigator# 132034
Morioka-shi, Japan
Site Reference ID/Investigator# 133705
Motosu-shi, Japan
Site Reference ID/Investigator# 136150
Munakata-shi, Japan
Site Reference ID/Investigator# 112241
Musashino-shi, Japan
Site Reference ID/Investigator# 51169
Nagakute-shi, Japan
Site Reference ID/Investigator# 59591
Nagakute-shi, Japan
Site Reference ID/Investigator# 64967
Nagakute-shi, Japan
Site Reference ID/Investigator# 64931
Nagaokakyo, Japan
Site Reference ID/Investigator# 51123
Nagasaki-shi, Japan
Site Reference ID/Investigator# 54819
Nagoya-shi, Japan
Site Reference ID/Investigator# 54821
Nagoya-shi, Japan
Site Reference ID/Investigator# 54985
Nagoya-shi, Japan
Site Reference ID/Investigator# 59584
Nagoya-shi, Japan
Site Reference ID/Investigator# 89980
Nagoya-shi, Japan
Site Reference ID/Investigator# 121228
Nagoya, Japan
Site Reference ID/Investigator# 59600
Nagoya, Japan
Site Reference ID/Investigator# 94823
Nagoya, Japan
Site Reference ID/Investigator# 129891
Naha, Japan
Site Reference ID/Investigator# 139518
Naha, Japan
Site Reference ID/Investigator# 139516
Nankoku-shi, Japan
Site Reference ID/Investigator# 133703
Narashino-shi, Japan
Site Reference ID/Investigator# 51186
Nara, Japan
Site Reference ID/Investigator# 135734
Niigata-shi, Japan
Site Reference ID/Investigator# 84020
Nirasaki, Japan
Site Reference ID/Investigator# 55004
Nishinomiya-shi, Japan
Site Reference ID/Investigator# 84194
Nisshin, Japan
Site Reference ID/Investigator# 132032
Odawara-shi, Japan
Site Reference ID/Investigator# 148822
Oita-shi, Japan
Site Reference ID/Investigator# 55019
Oita, Japan
Site Reference ID/Investigator# 59598
Oita, Japan
Site Reference ID/Investigator# 55013
Okayama-shi, Japan
Site Reference ID/Investigator# 51091
Ome, Japan
Site Reference ID/Investigator# 84022
Ono, Japan
Site Reference ID/Investigator# 51149
Osaka, Osaka, Japan
Site Reference ID/Investigator# 51150
Osaka, Osaka, Japan
Site Reference ID/Investigator# 51173
Osaka, Osaka, Japan
Site Reference ID/Investigator# 51191
Osaka-shi, Osaka, Japan
Site Reference ID/Investigator# 112240
Osaka-shi, Japan
Site Reference ID/Investigator# 126748
Osaka-shi, Japan
Site Reference ID/Investigator# 51196
Osaka-shi, Japan
Site Reference ID/Investigator# 114300
Osaka, Japan
Site Reference ID/Investigator# 51185
Osaka, Japan
Site Reference ID/Investigator# 54716
Osaka, Japan
Site Reference ID/Investigator# 59602
Osaka, Japan
Site Reference ID/Investigator# 64935
Osaka, Japan
Site Reference ID/Investigator# 51083
Osaki, Japan
Site Reference ID/Investigator# 112242
Ota, Japan
Site Reference ID/Investigator# 55012
Otsu-Shiga, Japan
Site Reference ID/Investigator# 55018
Saga-shi, Japan
Site Reference ID/Investigator# 94821
Sakai-shi, Japan
Site Reference ID/Investigator# 51084
Sapporo-shi, Japan
Site Reference ID/Investigator# 112243
Sapporo, Japan
Site Reference ID/Investigator# 148823
Sapporo, Japan
Site Reference ID/Investigator# 51085
Sapporo, Japan
Site Reference ID/Investigator# 51122
Sapporo, Japan
Site Reference ID/Investigator# 133709
Sasebo-shi, Japan
Site Reference ID/Investigator# 135001
Sasebo-shi, Japan
Site Reference ID/Investigator# 51148
Sendai-shi, Japan
Site Reference ID/Investigator# 142017
Sendai, Japan
Site Reference ID/Investigator# 89993
Seto, Japan
Site Reference ID/Investigator# 142016
Shibata-shi, Japan
Site Reference ID/Investigator# 54984
Suita-shi, Japan
Site Reference ID/Investigator# 55001
Suita-shi, Japan
Site Reference ID/Investigator# 55002
Suita-shi, Japan
Site Reference ID/Investigator# 89983
Suita-shi, Japan
Site Reference ID/Investigator# 128935
Tokorozawa-shi, Japan
Site Reference ID/Investigator# 54986
Tokorozawa, Japan
Site Reference ID/Investigator# 136151
Tokushima-shi, Japan
Site Reference ID/Investigator# 144425
Tokushima, Japan
Site Reference ID/Investigator# 114301
Tokyo, Japan
Site Reference ID/Investigator# 124558
Tokyo, Japan
Site Reference ID/Investigator# 132033
Tokyo, Japan
Site Reference ID/Investigator# 135732
Tokyo, Japan
Site Reference ID/Investigator# 136148
Tokyo, Japan
Site Reference ID/Investigator# 137169
Tokyo, Japan
Site Reference ID/Investigator# 139469
Tokyo, Japan
Site Reference ID/Investigator# 51089
Tokyo, Japan
Site Reference ID/Investigator# 51090
Tokyo, Japan
Site Reference ID/Investigator# 51093
Tokyo, Japan
Site Reference ID/Investigator# 51094
Tokyo, Japan
Site Reference ID/Investigator# 51115
Tokyo, Japan
Site Reference ID/Investigator# 51151
Tokyo, Japan
Site Reference ID/Investigator# 51172
Tokyo, Japan
Site Reference ID/Investigator# 54711
Tokyo, Japan
Site Reference ID/Investigator# 54717
Tokyo, Japan
Site Reference ID/Investigator# 54718
Tokyo, Japan
Site Reference ID/Investigator# 54721
Tokyo, Japan
Site Reference ID/Investigator# 54815
Tokyo, Japan
Site Reference ID/Investigator# 54993
Tokyo, Japan
Site Reference ID/Investigator# 54994
Tokyo, Japan
Site Reference ID/Investigator# 54995
Tokyo, Japan
Site Reference ID/Investigator# 54996
Tokyo, Japan
Site Reference ID/Investigator# 59587
Tokyo, Japan
Site Reference ID/Investigator# 68726
Tokyo, Japan
Site Reference ID/Investigator# 71476
Tokyo, Japan
Site Reference ID/Investigator# 89981
Tokyo, Japan
Site Reference ID/Investigator# 89984
Tokyo, Japan
Site Reference ID/Investigator# 51128
Toyama-shi, Japan
Site Reference ID/Investigator# 55006
Toyama, Japan
Site Reference ID/Investigator# 55007
Toyama, Japan
Site Reference ID/Investigator# 59589
Toyama, Japan
Site Reference ID/Investigator# 64995
Toyoake-shi, Japan
Site Reference ID/Investigator# 89986
Toyoake, Japan
Site Reference ID/Investigator# 96505
Toyooka, Japan
Site Reference ID/Investigator# 133713
Tsuchiura-shi, Japan
Site Reference ID/Investigator# 59594
Tsukuba-shi, Japan
Site Reference ID/Investigator# 71475
Tsuyama, Japan
Site Reference ID/Investigator# 89989
Uji, Japan
Site Reference ID/Investigator# 54817
Wakayama-shi, Japan
Site Reference ID/Investigator# 139520
Yamagata-shi, Japan
Site Reference ID/Investigator# 96502
Yamagata, Japan
Site Reference ID/Investigator# 54823
Yamaguchi-shi, Japan
Site Reference ID/Investigator# 64969
Yamaguchi-shi, Japan
Site Reference ID/Investigator# 133712
Yanai-shi, Japan
Site Reference ID/Investigator# 135000
Yatsushiro-shi, Japan
Site Reference ID/Investigator# 75098
Yokohama-shi, Japan
Site Reference ID/Investigator# 80933
Yokohama-shi, Japan
Site Reference ID/Investigator# 94824
Yokohama-shi, Japan
Site Reference ID/Investigator# 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: October 28, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
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 December 09, 2016