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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01329380
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

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 or disease
Ankylosing Spondylitis

Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
Actual Study Start Date : November 29, 2010
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Humira
those with an exposure



Primary Outcome Measures :
  1. Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 12 ]
  2. 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

  3. Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ]

Secondary Outcome Measures :
  1. 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

  2. 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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329380


  Hide Study Locations
Locations
Japan
Nagoya City University Hospital
Nagoya-shi, Aichi, Japan, 467-8602
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Gunma University Hospital
Maebashi-shi, Gunma, Japan, 371-8511
Hyogo College of Medicine Hosp
Nishinomiya, Hyogo, Japan, 663-8501
Yokohama City Univ Medical Ctr
Yokohama, Kanagawa, Japan, 232-0024
Nagasaki University Hospital
長崎市, Nagasaki, Japan, 〒852-8102
Okayama University Hospital
Okayama-shi, Okayama, Japan, 700-0914
Osaka City University Hospital
大阪市, Osaka, Japan, 〒545-0051
Saitama Medical Center
Kawagoe, Saitama, Japan, 350-8550
Shiga Univ Med Science Hosp
Otsu, Shiga, Japan, 520-2192
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan, 181-8611
St. Luke's International Hosp
中央区, Tokyo, Japan, 〒104-8560
Teikyo University Hospital
板橋区, Tokyo, Japan, 〒173-8605
Asano Orthopedic Clinic
Aichi, Japan, 465-0097
Nagoya Daini Red Cross Hosp
Aichi, Japan
Ozone Surgery Clinic
Aichi, Japan
Yamagiwa Clinic
Aichi, Japan
Narushima Internal Med Clinic
Ami-machi, Japan, 300-1152
Asahikawa Kosei General Hosp
Asahikawa-shi, Japan
Katayama Orthopedic Rheum Clin
Asahikawa, Japan, 078-8243
Asahikawa Med College Hosp, JP
Asahikawa, Japan, 078-8510
Atsugi City Hospital
Atsugi-shi, Japan
Chiba University Hospital
Chiba, Japan, 260-8677
University of Yamanashi Hosp
Chuo, Japan, 409-3898
Tama Medical Center
Fuchu, Japan, 183-8524
Fujieda Municipal General Hosp
Fujieda, Japan, 426-8677
Nakamura Clinic
Fukuchiyama-shi, Japan
Hamanomachi Hospital
Fukuoka, Japan, 810-8539
NHO Kyushu Medical Center
Fukuoka, Japan, 810-8563
Kyushu University Hospital
Fukuoka, Japan, 812-8582
JP Red Cross Fukuoka Hosp
Fukuoka, Japan, 815-8555
Mutaguchi Orthopedics Clinic
Fukuoka, Japan
PS Clinic
Fukuoka, Japan
Fukushima Med Univ Hosp
Fukushima-shi, Japan, 960-1295
Fukushima Red Cross Hospital
Fukushima, Japan, 960-8530
Minami Tohoku Fukushima Hosp
Fukushima, Japan
Gifu University Hospital
Gifu, Japan, 501-1112
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, 189-8511
NHO Higashi-Ohmi Gen Med Ctr
Higashiomi, Japan
Yamaguchi Clinic
Higashiosaka-shi, Japan
NHO Himeji Medical Center
Himeji, Japan, 670-8520
Hirosaki Uni School Med & Hosp
Hirosaki, Japan, 036-8560
Hirosaki Memorial Hospital
Hirosaki, Japan
Hiroshima Clinic
Hiroshima-shi, Japan
Hiroshima Red Cross Hosp Atomi
Hiroshima, Japan, 730-0052
Hiroshima University Hospital
Hiroshima, Japan, 734-0037
Yamana-kai Higashi Hiroshima
Hiroshima, Japan, 739-0002
Shigenobu Clinic
Hiroshima, Japan
Midori Hospital
Hyogo, Japan, 651-2133
Kohnodai Hospital
Ichikawa-shi, Japan, 272-8516
Iwate Prefectural Iwai Hosp
Ichinoseki-shi, Japan
Saitama Medical University Hos
Iruma-gun, Japan, 350-0451
Suga Orthopedic Hospital
Isahaya, Japan, 854-0034
Isahaya Health Ins Genl Hosp
Isahaya, Japan
NHO Iwakuni Clinical Center
Iwakuni-shi, Japan
Juntendo Univ Shizuoka Hosp
Izunokuni-shi, Japan, 410-2295
Kaga City Hospital
Kaga-shi, Ishikawa, Japan, 922-8522
Kagoshima Univ Medical and Den
Kagoshima-shi, Japan
Kagoshima Red Cross Hospital
Kagoshima, Japan
Kameda Medical Center
Kamogawa, Japan, 296-8602
Saiseikai Kanazawa Hospital
Kanazawa, Japan, 920-0353
Kanazawa University Ho
Kanazawa, Japan, 920-8641
Kasugai Orthopaedic Clinic
Kasugai, Japan, 486-0817
Asahi Hospital
Kasugai, Japan
NHO Osaka Minami Med Ctr
Kawachinagano, Japan, 586-0008
Nagasawa Clinic
Kawagoe-shi, Japan
St. Marianna Univ Hospital
Kawasaki, Japan, 216-8511
Edakuni Orthopedic Clinic
Kiryu, Japan
JR Kyushu Hospital
Kitakyushu, Japan, 800-0031
Univ Occup & Environ Health
Kitakyushu, Japan, 807-8556
Kobe University Hospital
Kobe, Japan, 650-0017
Komaki Daiichi Hospital
Komaki, Japan
Jusendo General Hospital
Koriyama-shi, Japan, 963-8585
Juntendo Univ Koshigaya Hosp
Koshigaya, Japan, 343-0032
Shunan Memorial Hospital
Kudamatsu-shi, Japan
Kumamoto Rheumatology Clinic
Kumamoto, Japan, 861-5515
Kunitachi Clinic
Kunitachi, Japan
Kawasaki Medical School Hosp
Kurashiki, Japan, 701-0114
Kurashiki Central Hospital
Kurashiki, Japan, 710-0052
Jujo Rehabilitation Hospital
Kyoto, Japan, 601-8325
Kyoto Prefect Univ Med
Kyoto, Japan, 602-8566
JP Red Cross Kyoto Daiichi Hos
Kyoto, Japan, 605-0981
Kagawa University Hospital
Kyoto, Japan, 615-8256
Iwasaku Orthopedic Clinic
Kyoto, Japan
Tori Clinic
Maizuru-shi, Japan
Matsuyama Red Cross Hosp
Matsuyama, Japan, 790-0826
Mino Municipal Hospital
Mino, Japan
Suzuki Orthopedic Clinic
Miyashiro-machi, Japan
Miyazaki Prefectural Miyazaki
Miyazaki, Japan, 880-8510
Iwate Medical University Hosp
Morioka, Japan, 020-0023
Noguchi Seikeigeka Naika Iin
Motosu-shi, Japan, 501-0446
Munakata Medical Assoc. Hosp.
Munakata-shi, Japan
Aichi Medical University Hosp
Nagakute, Japan, 480-1195
Saiseikai Kyoto Hospital
Nagaokakyo, Japan
Chukyo Social Insurance Hospit
Nagoya-shi, Japan, 457-8510
NHO Nagoya Medical Center
Nagoya, Japan, 460-0001
Shinseikai Daiichi Hospital
Nagoya, Japan, 467-0046
Higashi Hosp City of Nagoya
Nagoya, Japan
Kakinuma Orthopedics Clinic
Nagoya, Japan
Oura Clinic
Naha, Japan, 901-0145
Kochi Medical School Hospital
Nankoku-shi, Japan, 783-8505
Mitsuka Rheumatism Clinic
Narashino-shi, Japan
Nara City Hospital
Nara, Japan, 530-0025
Asahigaoka Hospital
Nara, Japan
Niigata City General Hospital
Niigata, Japan, 950-1197
Nirasaki City Hospital
Nirasaki, Japan
Nisshin Orido Hospital
Nisshin, Japan
Yamachika Memorial Gen Hosp
Odawara-shi, Japan
Oita Red Cross Hospital
Oita, Japan, 870-0033
Saiseikai Hita Hospital
Oita, Japan
Sunrise Sakai Hospital
Oita, Japan
Ohama Daiichi Hospital
Okinawa, Japan
Ome Municipal General Hospital
OME, Japan, 198-0042
Yuri Plastic Surgery
ONO, Japan
Osaka Rheumatology Clinic
Osaka-shi, Japan
Ushio Clinic
Osaka-shi, Japan
Yodogawa Christian Hospital
Osaka-shi, Japan
Yukioka Hospital
Osaka, Japan, 530-0021
Osaka Saiseikai Noe Hospital
Osaka, Japan, 536-0001
NTT WEST Osaka Hospital
Osaka, Japan, 543-0042
Osaka Red Cross Hospital
Osaka, Japan, 543-8555
Kansai Medical Univ Takii Hosp
Osaka, Japan, 570-8507
Kojima Orthopedic Clinic
Osaka, Japan
Murakami Orthopaedics Clinic
Osaka, Japan
Osaki Citizen Hospital
Osaki, Japan
Ota Memorial Hospital
OTA, Japan, 373-8585
Saga University Hospital
Saga, Japan, 849-0937
Osaka Rosai Hospital
Sakai-shi, Japan
Yoshida Internal Med Clinic
Sakaki, Japan, 389-0606
Kyoto University Hospital
Sakyo-ku, Japan, 606-8507
Teine Internal Med Rheuma Clin
Sapporo, Japan, 006-0022
Teine Keijinkai Clinic
Sapporo, Japan, 006-0811
Sapporo Medical Univ Hosp
Sapporo, Japan, 060-8543
Kin-ikyo Chuo Hospital
Sapporo, Japan
KKR Sapporo Med Ctr Tonan Hosp
Sapporo, Japan
Sasebo City General Hospital
Sasebo-shi, Japan
Sasebo Chuo Hospital
Sasebo, Japan, 857-1195
Tohoku University Hospital
Sendai, Japan, 980-0872
NHO Nishitaga National Hospita
Sendai, Japan, 982-8555
Tohoku Pharmaceutical Univ Hos
Sendai, Japan
Jyunshinkai Inoue Hospital
Seto, Japan
Niigata Rheumatic Center
Shibata, Japan, 957-0054
Saiseikai Suita Hospital
Suita, Japan, 564-0013
Osaka University Hospital
Suita, Japan, 565-0871
Kotesashi Orthopedic Clinic
Tokorozawa-shi, Japan
Hirose Clinic
Tokorozawa, Japan, 359-1111
Toyo Hospital
Tokushima-shi, Japan
Hishita-Hiasa Neurosurgery and
Tokushima, Japan
Kyoundo Hospital
Tokyo, Japan, 101-0062
Mitsui Memorial Hospital
Tokyo, Japan, 101-8643
The Jikei University Hospital
Tokyo, Japan, 105-8461
Toranomon Hospital
Tokyo, Japan, 105-8470
The University of Tokyo
Tokyo, Japan, 108-8639
Juntendo University Hospital
Tokyo, Japan, 113-8431
Tokyo Metropolitan Bokutoh Hos
Tokyo, Japan, 130-8575
Keiyo Hospital
Tokyo, Japan, 132-0025
Toho Univ Med Ctr Omori Hosp
Tokyo, Japan, 143-8541
Tokyo Medical University Hosp
Tokyo, Japan, 16000-23
National Ctr Global Health Med
Tokyo, Japan, 162-8655
Tokyo Womens Med Univ Hosp
Tokyo, Japan, 162-8666
Kawakita General Hospital
Tokyo, Japan, 166-8588
Nihon University Itabashi Hosp
Tokyo, Japan, 173-0032
Juntendo Univ Nerima Hosp
Tokyo, Japan, 177-0033
JP Red Cross Musashino Hosp
Tokyo, Japan, 180-8610
Akasaka Chuo Clinic
Tokyo, Japan
Edogawa Hospital
Tokyo, Japan
Ishigaki Orthopedic Clinic
Tokyo, Japan
Kanamecho Hospital
Tokyo, Japan
Matsuda Orthopedic Rheuma Clin
Tokyo, Japan
NHO Disaster Medical Center
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
Yoshida Internal Med Clinic
Tokyo, Japan
Matsuno Clinic Rheumatic Disea
Toyama, Japan, 930-0138
Toyama Prefectural Ctr Hosp
Toyama, Japan, 930-0975
Fujita Health University Hosp
Toyoake, Japan, 470-1192
Toyama University Hospital
Toyoma, Japan, 930-0194
Toyooka Hospital
Toyooka, Japan, 668-8501
Kishi Orthopedics Medical Clin
Tsuchiura-shi, Japan
Tsukuba University Hospital
Tsukuba, Japan, 305-8576
Tsuyama Chuo Memorial Hospital
Tsuyama, Japan, 708-0024
Daini Okamoto General Hospital
UJI, Japan
Wakayama Medical University
Wakayama, Japan, 641-8510
Yamagata University Hospital
Yamagata, Japan, 990-9585
Yamagata City Hosp Saiseikai
Yamagata, Japan
Yamaguchi Red Cross Hospital
Yamaguchi-shi, Japan, 753-8519
Shuto General Hospital
Yanai-shi, Japan, 742-0032
Kumamoto Rosai Hospital
Yatsushiro-shi, Japan
Showa Univ N Yokohama Hosp
Yokohama-shi, Japan, 224-8503
Tottori University Hospital
Yonago-shi, Japan, 683-8504
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01329380     History of Changes
Other Study ID Numbers: P12-764
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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