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Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01412021
First received: August 5, 2011
Last updated: April 7, 2017
Last verified: April 2017
  Purpose

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints 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
Arthritis, Juvenile Rheumatoid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

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

  • Disease Activity Score28 [ Time Frame: at week 4 ]
  • Disease Activity Score28 [ Time Frame: at week 8 ]
  • Disease Activity Score28 [ Time Frame: at week 12 ]
  • Disease Activity Score28 [ Time Frame: at week 16 ]
  • Disease Activity Score28 [ Time Frame: at week 24 ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 4 ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 8 ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 12 ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 16 ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 24 ]
  • Height [ Time Frame: at week 4 ]
  • Height [ Time Frame: at week 8 ]
  • Height [ Time Frame: at week 12 ]
  • Height [ Time Frame: at week 16 ]
  • Height [ Time Frame: at week 24 ]
  • Weight [ Time Frame: at week 4 ]
  • Weight [ Time Frame: at week 8 ]
  • Weight [ Time Frame: at week 12 ]
  • Weight [ Time Frame: at week 16 ]
  • Weight [ Time Frame: at week 24 ]
  • Anti-cyclic citrullinated peptides antibodies [ Time Frame: at baseline ]
  • Anti-cyclic citrullinated peptides antibodies [ Time Frame: at week 24 ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 4 ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 8 ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 12 ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 16 ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 24 ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

Ages Eligible for Study:   up 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 Juvenile idiopathic arthritis
Criteria

Inclusion Criteria:

- All patients with Juvenile idiopathic arthritis 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: NCT01412021

Contacts
Contact: AbbVie_GK Clinical_Trials_Registration_Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Kaori Hozumi

  Hide Study Locations
Locations
Japan
Akita City Hospital /ID# 124555 Not yet recruiting
Akita, Japan
Akita City Hospital /ID# 161713 Not yet recruiting
Akita, Japan
Anan Kyoei Hospital /ID# 120079 Recruiting
Anan, Japan
National Hospital Organization Aomori National Hospital /ID# 96499 Not yet recruiting
Aomori, Japan
Chiba Children's Hospital /ID# 80282 Recruiting
Chiba-shi, Japan
Chiba University Hospital /ID# 67234 Recruiting
Chiba-shi, Japan
Ehime University Hospital /ID# 126361 Not yet recruiting
Ehime, Japan
New-Ooe Hospital /ID# 124552 Not yet recruiting
Fukuchiyama, Japan
Fukui Prefectural Hospital /ID# 148853 Not yet recruiting
Fukui, Japan
Kyushu University Hospital /ID# 65061 Recruiting
Fukuoka-shi, Japan
Kirigaoka Tsuda Hospital /ID# 141967 Not yet recruiting
Fukuoka, Japan
National Hospital Organization Kokura Medical Center /ID# 67235 Recruiting
Fukuoka, Japan
Showa Hospital /ID# 65081 Recruiting
Fukuoka, Japan
Fukushima Medical University Hospital /ID# 65056 Recruiting
Fukushima, Japan
Hachinohe Red Cross Hospital /ID# 89895 Recruiting
Hachinohe-shi, Japan
Hakodate Central General Hospital /ID# 84036 Recruiting
Hakodate-shi, Japan
Hamamatsu Medical Center /ID# 132028 Not yet recruiting
Hamamatsu-shi, Japan
Hamamatsu University School of Medicine, University Hospital /ID# 98358 Not yet recruiting
Hamamatsu-shi, Japan
Seirei Hamamatsu General Hospital /ID# 148863 Not yet recruiting
Hamamatsu-shi, Japan
Seirei Hamamatsu General Hospital /ID# 96498 Not yet recruiting
Hamamatsu-shi, Japan
Seirei Mikatahara General Hospital /ID# 89904 Not yet recruiting
Hamamatsu, Japan
Kansai Medical University Hospital /ID# 65067 Recruiting
Hirakata-shi, Japan
Hiroshima Clinic /ID# 126745 Not yet recruiting
Hiroshima-shi, Japan
Hiroshima University Hospital /ID# 65058 Recruiting
Hiroshima-shi, Japan
Nojima Internal Medicine /ID# 133699 Not yet recruiting
Hiroshima-shi, Japan
Hiroshima Prefecture Hospital /ID# 65060 Recruiting
Hiroshima, Japan
Yamaguchi Grand Medical Center /ID# 84033 Recruiting
Hofu, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 148860 Not yet recruiting
Hokkaido, Japan
Japanese Red Cross Society Himeji Hospital /ID# 80278 Recruiting
Hyogo, Japan
Ina Central Hospital /ID# 112196 Recruiting
Ina, Japan
Nippon Medical School Chiba Hokusoh Hospital Medicine /ID# 65073 Recruiting
Inzai-shi, Japan
Ise Red Cross Hospital /ID# 80255 Recruiting
Ise, Japan
Shimane Prefectural Central Hospital /ID# 98359 Not yet recruiting
Izumo-shi, Japan
Shimane University Hospital /ID# 67236 Recruiting
Izumo, Japan
Kagoshima Red Cross Hospital /ID# 67237 Recruiting
Kagoshima, Japan
Kagoshima University Medical and Dental Hospital /ID# 65077 Recruiting
Kagoshima, Japan
Kanazawa University Hospital /ID# 65062 Recruiting
Kanazawa-shi, Japan
Nara Medical University Hospital /ID# 89899 Not yet recruiting
Kashihara-shi, Japan
The Jikei University Kashiwa Hospital /ID# 80277 Recruiting
Kashiwa, Japan
Matsubara Mayflower Hospital /ID# 126362 Not yet recruiting
Kato-shi, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 140700 Not yet recruiting
Kawachinagano-shi, Osaka, Japan
Saitama Medical Center /ID# 157760 Not yet recruiting
Kawagoe, Japan
Kitakami Saiseikai Hospital /ID# 129895 Not yet recruiting
Kitakami, Japan
University of Occupational and Environmental Health /ID# 68742 Recruiting
Kitakyushu-shi, Japan
University of Occupational and Environmental Health /ID# 80276 Recruiting
Kitakyushu-shi, Japan
Hyogo Prefectural Kobe Childrens Hospital /ID# 65070 Recruiting
Kobe-shi, Japan
Kobe City Medical Center General Hospital /ID# 80281 Recruiting
Kobe-shi, Japan
Kobe University Hospital /ID# 80283 Recruiting
Kobe-shi, Japan
Ogihara Misaki Hospital /ID# 80280 Recruiting
Kobe, Japan
Daiichi Hospital /ID# 148375 Not yet recruiting
Kochi-shi, Japan
Komatsu Municipal Hospital /ID# 114297 Not yet recruiting
Komatsu, Japan
Konan Kosei Hospital /ID# 80253 Recruiting
Konan-shi, Japan
Dokkyo Medical University Koshigaya Hospital /ID# 137173 Not yet recruiting
Koshigaya-shi, Japan
Iwate Prefectural Kuji Hospital /ID# 94814 Not yet recruiting
Kuji-shi, Japan
Kumamoto University Hospital /ID# 84034 Recruiting
Kumamoto-shi, Kumamoto, Japan
Kawasaki Medical School Hospital /ID# 89898 Not yet recruiting
Kurashiki-shi, Japan
Kurashiki Medical Center /ID# 60666 Recruiting
Kurashiki, Japan
Kurume University Hospital /ID# 65082 Recruiting
Kurume-shi, Japan
Kyoto Prefectural University of Medicine /ID# 65075 Recruiting
Kyoto-shi, Japan
Kyoto University Hospital /ID# 65080 Recruiting
Kyoto-shi, Japan
Gunma University Hospital /ID# 144460 Not yet recruiting
Maebashi-shi, Japan
Matsue Red Cross Hospital /ID# 89903 Not yet recruiting
Matsue-shi, Japan
Matsuyama Red Cross Hospital /ID# 65059 Recruiting
Matsuyama-shi, Japan
Ibaraki Children's Hospital /ID# 89901 Not yet recruiting
Mito, Japan
Mito Saiseikai General Hospital /ID# 84035 Recruiting
Mito, Japan
Iwate Medical University Hospital /ID# 68740 Recruiting
Morioka-shi, Japan
Shiga Medical Center for Children /ID# 67229 Recruiting
Moriyama-shi, Japan
Japanese Red Cross Musashino Hospital /ID# 112197 Not yet recruiting
Musashino-shi, Japan
Aichi Medical University Hospital /ID# 65057 Recruiting
Nagakute-shi, Japan
Shinshu University Hospital /ID# 68741 Recruiting
Nagano, Japan
Saiseikai Kyoto Hospital /ID# 84039 Recruiting
Nagaokakyo, Japan
Nagasaki University Hospital /ID# 94816 Not yet recruiting
Nagasaki-shi, Nagasaki, Japan
Nagasaki Internal Medicine Rheumatology Clinic /ID# 65083 Recruiting
Nagasaki, Japan
Nagoya City West Medical Center /ID# 80279 Recruiting
Nagoya, Japan
University of the Ryukyus Hospital /ID# 65078 Recruiting
Nakagami-gun, Okinawa, Japan
Kochi Medical School Hospital /ID# 135728 Not yet recruiting
Nankoku-shi, Japan
Nayoro City General Hospital /ID# 148857 Not yet recruiting
Nayoro, Japan
Niigata University Medical and Dental Hospital /ID# 68738 Recruiting
Niigata, Japan
Iwate Prefectural Ninohe Hospital /ID# 126746 Not yet recruiting
Ninohe-shi, Japan
Miyazaki Prefectural Nobeoka Hospital /ID# 148856 Not yet recruiting
Nobeoka, Japan
Hokkaido P.W.F.A.C Obihiro-Kosei General Hospital /ID# 67238 Recruiting
Obihiro-shi, Japan
Hokkaido P.W.F.A.C Obihiro-Kosei General Hospital /ID# 152103 Not yet recruiting
Obihiro, Japan
Aichi Children's Health and Medical Center /ID# 65066 Recruiting
Obu-shi, Japan
Tokai University Oiso Hospital /ID# 81073 Recruiting
Oiso-machi, Japan
Oita Prefectural Hospital /ID# 134998 Not yet recruiting
Oita-shi, Japan
Okayama University Hospital /ID# 71512 Recruiting
Okayama-shi, Japan
Nanbu Hospital /ID# 148855 Not yet recruiting
Okinawa, Japan
Kindai University Hospital /ID# 81074 Recruiting
Osaka sayama-shi, Japan
Osaka City University Hospital /ID# 148859 Not yet recruiting
Osaka, Osaka, Japan
Osaka City University Hospital /ID# 96500 Not yet recruiting
Osaka, Osaka, Japan
Osaka Red Cross Hospital /ID# 80275 Recruiting
Osaka-shi, Osaka, Japan
Osaka City General Hospital /ID# 89913 Recruiting
Osaka-shi, Japan
Jurakukai Ohno Memorial Hospital /ID# 148862 Not yet recruiting
Osaka, Japan
Ota Memorial Hospital /ID# 124554 Not yet recruiting
Ota, Japan
Saga University Hospital /ID# 65074 Recruiting
Saga-shi, Japan
Kitasato University Hospital /ID# 67231 Recruiting
Sagamihara-shi, Kanagawa, Japan
Saitama Childrens Medical Center /ID# 65071 Recruiting
Saitama-shi, Japan
Suzuki Kid's Clinic /ID# 141968 Not yet recruiting
Sakurai, Japan
Hokkaido University Hospital /ID# 67233 Recruiting
Sapporo-shi, Hokkaido, Japan
Sapporo Medical Center NTT EC /ID# 80273 Recruiting
Sapporo-shi, Japan
Sapporo Medical University Hospital /ID# 89896 Not yet recruiting
Sapporo-shi, Japan
Sapporo City General Hospital /ID# 89893 Recruiting
Sapporo, Japan
Sapporo Yamanoue Hospital /ID# 148854 Not yet recruiting
Sapporo, Japan
Teine Keijinkai Clinic /ID# 67239 Recruiting
Sapporo, Japan
Sasebo City General Hospital /ID# 112215 Not yet recruiting
Sasebo-shi, Japan
Izumi Himawari Clinic /ID# 148858 Not yet recruiting
Sendai-shi, Japan
Miyagi Children's Hospital /ID# 65084 Recruiting
Sendai-shi, Japan
Murata Kids' Clinic /ID# 80254 Recruiting
Settu, Japan
Gunma Children's Medical Center /ID# 80274 Recruiting
Shibukawa-shi, Japan
Jichi Medical University Hospital /ID# 65079 Recruiting
Shimotsuke-shi, Japan
Shizuoka Children's Hospital /ID# 84038 Recruiting
Shizuoka-shi, Japan
Shizuoka Kosei Hospital /ID# 132029 Not yet recruiting
Shizuoka-shi, Japan
Tokuyama Central Hospital /ID# 68744 Recruiting
Shunan-shi, Japan
Osaka University Graduate School of Medicine /ID# 124553 Recruiting
Suita-shi, Japan
Suzuka General Hospital /ID# 144461 Not yet recruiting
Suzuka, Japan
Kagawa University Hospital /ID# 68739 Recruiting
Takamatsu, Japan
Osaka Medical College Hospital /ID# 60665 Recruiting
Takatsuki-shi, Japan
Nippon Medical School Tama Nagayama Hospital /ID# 132030 Not yet recruiting
Tama-shi, Japan
Tenri Hospital /ID# 94812 Not yet recruiting
Tenri-shi, Japan
Medical Corporation Kojyokai Hirose Clinic /ID# 150045 Not yet recruiting
Tokorozawa-shi, Japan
Tokushima University Hospital /ID# 80293 Recruiting
Tokushima-shi, Japan
Fujikawa Clinic /ID# 49892 Recruiting
Tokyo, Japan
Medical Hospital of Tokyo Medical and Dental University /ID# 153592 Not yet recruiting
Tokyo, Japan
National Center for Child Health and Development /ID# 65065 Recruiting
Tokyo, Japan
National Center for Child Health and Development /ID# 65068 Recruiting
Tokyo, Japan
Nihon University Nerima Hikarigaoka Hospital /ID# 65064 Recruiting
Tokyo, Japan
Nihon University School of Medicine Itabashi Hospital /ID# 84037 Recruiting
Tokyo, Japan
Nippon Medical School Hospital /ID# 65055 Recruiting
Tokyo, Japan
Showa University Hospital /ID# 112195 Not yet recruiting
Tokyo, Japan
St. Luke's International Hospital /ID# 65063 Recruiting
Tokyo, Japan
Takinogawa Hospital /ID# 133698 Not yet recruiting
Tokyo, Japan
Tokyo Medical University Hospital /ID# 65069 Recruiting
Tokyo, Japan
Tokyo Womens Medical University Hospital /ID# 67232 Recruiting
Tokyo, Japan
Tokyo Womens Medical University Hospital /ID# 94813 Recruiting
Tokyo, Japan
Takasu Rhumatic Orthpedic Clinic /ID# 89902 Not yet recruiting
Tottori, Japan
Saiseikai Toyama Hospital /ID# 67230 Recruiting
Toyama-shi, Japan
Toyama City Hospital /ID# 89894 Recruiting
Toyama, Japan
Fujita Health University Hospital /ID# 148374 Not yet recruiting
Toyoake-shi, Japan
Toyooka Hospital /ID# 141966 Not yet recruiting
Toyooka, Japan
National Mie Hospital /ID# 133697 Not yet recruiting
Tsu-shi, Japan
Tsukuba University Hospital /ID# 144462 Not yet recruiting
Tsukuba-shi, Japan
Kanazawa Medical University Hospital /ID# 89914 Not yet recruiting
Uchinada-machi, Japan
Wakayama Medical University Hospital /ID# 80256 Recruiting
Wakayama-shi, Japan
Japanese Red Cross Wakayama Medical Center /ID# 112235 Not yet recruiting
Wakayama, Japan
Yao Municipal Hospital /ID# 121224 Recruiting
Yao, Japan
Yokohama City University Medical Center /ID# 68743 Recruiting
Yokohama-shi, Kanagawa, Japan
Kanagawa Children's Medical Center /ID# 114900 Recruiting
Yokohama-shi, Japan
Yokohama Municipal Citizen's Hospital /ID# 65072 Recruiting
Yokohama-shi, Japan
Yokohama Seibu Hospital /ID# 89900 Not yet recruiting
Yokohama, Japan
Tottori University Hospital /ID# 71511 Recruiting
Yonago-shi, Japan
Oita University Hospital /ID# 65076 Recruiting
Yufu-shi, Japan
Kagawa National Children's Hospital /ID# 94815 Not yet recruiting
Zentsuji, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sarina Kurimoto AbbVie GK
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01412021     History of Changes
Other Study ID Numbers: P12-769
Study First Received: August 5, 2011
Last Updated: April 7, 2017

Keywords provided by AbbVie:
Arthritis, Juvenile Rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 27, 2017