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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01412021
First received: August 5, 2011
Last updated: May 16, 2017
Last verified: May 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 ( AbbVie (prior sponsor, Abbott) ):

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 1, 2011
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 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

  Hide Study Locations
Locations
Japan
Akita City Hospital /ID# 124555
Akita, Japan
Akita City Hospital /ID# 161713
Akita, Japan
Anan Kyoei Hospital /ID# 120079
Anan, Japan
National Hospital Organization Aomori National Hospital /ID# 96499
Aomori, Japan
Chiba Children's Hospital /ID# 80282
Chiba-shi, Japan
Chiba University Hospital /ID# 67234
Chiba-shi, Japan
Ehime University Hospital /ID# 126361
Ehime, Japan
New-Ooe Hospital /ID# 124552
Fukuchiyama, Japan
Fukui Prefectural Hospital /ID# 148853
Fukui, Japan
Kyushu University Hospital /ID# 65061
Fukuoka-shi, Japan
Kirigaoka Tsuda Hospital /ID# 141967
Fukuoka, Japan
National Hospital Organization Kokura Medical Center /ID# 67235
Fukuoka, Japan
Showa Hospital /ID# 65081
Fukuoka, Japan
Fukushima Medical University Hospital /ID# 65056
Fukushima, Japan
Hachinohe Red Cross Hospital /ID# 89895
Hachinohe-shi, Japan
Hakodate Central General Hospital /ID# 84036
Hakodate-shi, Japan
Hamamatsu Medical Center /ID# 132028
Hamamatsu-shi, Japan
Hamamatsu University School of Medicine, University Hospital /ID# 98358
Hamamatsu-shi, Japan
Seirei Hamamatsu General Hospital /ID# 148863
Hamamatsu-shi, Japan
Seirei Hamamatsu General Hospital /ID# 96498
Hamamatsu-shi, Japan
Seirei Mikatahara General Hospital /ID# 89904
Hamamatsu, Japan
Kansai Medical University Hospital /ID# 65067
Hirakata-shi, Japan
Hiroshima Clinic /ID# 126745
Hiroshima-shi, Japan
Hiroshima University Hospital /ID# 65058
Hiroshima-shi, Japan
Nojima Internal Medicine /ID# 133699
Hiroshima-shi, Japan
Hiroshima Prefecture Hospital /ID# 65060
Hiroshima, Japan
Yamaguchi Grand Medical Center /ID# 84033
Hofu, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 148860
Hokkaido, Japan
Japanese Red Cross Society Himeji Hospital /ID# 80278
Hyogo, Japan
Ina Central Hospital /ID# 112196
Ina, Japan
Nippon Medical School Chiba Hokusoh Hospital /ID# 65073
Inzai-shi, Japan
Ise Red Cross Hospital /ID# 80255
Ise, Japan
Shimane Prefectural Central Hospital /ID# 98359
Izumo-shi, Japan
Shimane University Hospital /ID# 67236
Izumo, Japan
Kagoshima Red Cross Hospital /ID# 67237
Kagoshima, Japan
Kagoshima University Medical and Dental Hospital /ID# 65077
Kagoshima, Japan
Kanazawa University Hospital /ID# 65062
Kanazawa-shi, Japan
Nara Medical University Hospital /ID# 89899
Kashihara-shi, Japan
The Jikei University Kashiwa Hospital /ID# 80277
Kashiwa, Japan
Matsubara Mayflower Hospital /ID# 126362
Kato-shi, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 140700
Kawachinagano-shi, Osaka, Japan
Saitama Medical Center /ID# 157760
Kawagoe, Japan
Kitakami Saiseikai Hospital /ID# 129895
Kitakami, Japan
University of Occupational and Environmental Health /ID# 68742
Kitakyushu-shi, Japan
University of Occupational and Environmental Health /ID# 80276
Kitakyushu-shi, Japan
Hyogo Prefectural Kobe Childrens Hospital /ID# 65070
Kobe-shi, Japan
Kobe City Medical Center General Hospital /ID# 80281
Kobe-shi, Japan
Kobe University Hospital /ID# 80283
Kobe-shi, Japan
Ogihara Misaki Hospital /ID# 80280
Kobe, Japan
Daiichi Hospital /ID# 148375
Kochi-shi, Japan
Komatsu Municipal Hospital /ID# 114297
Komatsu, Japan
Konan Kosei Hospital /ID# 80253
Konan-shi, Japan
Dokkyo Medical University Koshigaya Hospital /ID# 137173
Koshigaya-shi, Japan
Iwate Prefectural Kuji Hospital /ID# 94814
Kuji-shi, Japan
Kumamoto University Hospital /ID# 84034
Kumamoto-shi, Kumamoto, Japan
Kawasaki Medical School Hospital /ID# 89898
Kurashiki-shi, Japan
Kurashiki Medical Center /ID# 60666
Kurashiki, Japan
Kurume University Hospital /ID# 65082
Kurume-shi, Japan
Kyoto Prefectural University of Medicine /ID# 65075
Kyoto-shi, Japan
Kyoto University Hospital /ID# 65080
Kyoto-shi, Japan
Gunma University Hospital /ID# 144460
Maebashi-shi, Japan
Matsue Red Cross Hospital /ID# 89903
Matsue-shi, Japan
Matsuyama Red Cross Hospital /ID# 65059
Matsuyama-shi, Japan
Ibaraki Children's Hospital /ID# 89901
Mito, Japan
Mito Saiseikai General Hospital /ID# 84035
Mito, Japan
Iwate Medical University Hospital /ID# 68740
Morioka-shi, Japan
Shiga Medical Center for Children /ID# 67229
Moriyama-shi, Japan
Japanese Red Cross Musashino Hospital /ID# 112197
Musashino-shi, Japan
Aichi Medical University Hospital /ID# 65057
Nagakute-shi, Japan
Shinshu University Hospital /ID# 68741
Nagano, Japan
Saiseikai Kyoto Hospital /ID# 84039
Nagaokakyo, Japan
Nagasaki University Hospital /ID# 94816
Nagasaki-shi, Nagasaki, Japan
Nagasaki Internal Medicine Rheumatology Clinic /ID# 65083
Nagasaki, Japan
Nagoya City West Medical Center /ID# 80279
Nagoya, Japan
University of the Ryukyus Hospital /ID# 65078
Nakagami-gun, Okinawa, Japan
Kochi Medical School Hospital /ID# 135728
Nankoku-shi, Japan
Nayoro City General Hospital /ID# 148857
Nayoro, Japan
Niigata University Medical and Dental Hospital /ID# 68738
Niigata, Japan
Iwate Prefectural Ninohe Hospital /ID# 126746
Ninohe-shi, Japan
Miyazaki Prefectural Nobeoka Hospital /ID# 148856
Nobeoka, Japan
Hokkaido P.W.F.A.C Obihiro-Kosei General Hospital /ID# 67238
Obihiro-shi, Japan
Hokkaido P.W.F.A.C Obihiro-Kosei General Hospital /ID# 152103
Obihiro, Japan
Aichi Children's Health and Medical Center /ID# 65066
Obu-shi, Japan
Tokai University Oiso Hospital /ID# 81073
Oiso-machi, Japan
Oita Prefectural Hospital /ID# 134998
Oita-shi, Japan
Okayama University Hospital /ID# 71512
Okayama-shi, Japan
Nanbu Hospital /ID# 148855
Okinawa, Japan
Kindai University Hospital /ID# 81074
Osaka sayama-shi, Japan
Osaka City University Hospital /ID# 148859
Osaka, Osaka, Japan
Osaka City University Hospital /ID# 96500
Osaka, Osaka, Japan
Osaka Red Cross Hospital /ID# 80275
Osaka-shi, Osaka, Japan
Osaka City General Hospital /ID# 89913
Osaka-shi, Japan
Jurakukai Ohno Memorial Hospital /ID# 148862
Osaka, Japan
Ota Memorial Hospital /ID# 124554
Ota, Japan
Saga University Hospital /ID# 65074
Saga-shi, Japan
Kitasato University Hospital /ID# 67231
Sagamihara-shi, Kanagawa, Japan
Saitama Childrens Medical Center /ID# 65071
Saitama-shi, Japan
Suzuki Kid's Clinic /ID# 141968
Sakurai, Japan
Hokkaido University Hospital /ID# 67233
Sapporo-shi, Hokkaido, Japan
Sapporo Medical Center NTT EC /ID# 80273
Sapporo-shi, Japan
Sapporo Medical University Hospital /ID# 89896
Sapporo-shi, Japan
Sapporo City General Hospital /ID# 89893
Sapporo, Japan
Sapporo Yamanoue Hospital /ID# 148854
Sapporo, Japan
Teine Keijinkai Clinic /ID# 67239
Sapporo, Japan
Sasebo City General Hospital /ID# 112215
Sasebo-shi, Japan
Izumi Himawari Clinic /ID# 148858
Sendai-shi, Japan
Miyagi Children's Hospital /ID# 65084
Sendai-shi, Japan
Murata Kids' Clinic /ID# 80254
Settu, Japan
Gunma Children's Medical Center /ID# 80274
Shibukawa-shi, Japan
Jichi Medical University Hospital /ID# 65079
Shimotsuke-shi, Japan
Shizuoka Children's Hospital /ID# 84038
Shizuoka-shi, Japan
Shizuoka Kosei Hospital /ID# 132029
Shizuoka-shi, Japan
Tokuyama Central Hospital /ID# 68744
Shunan-shi, Japan
Osaka University Graduate School of Medicine /ID# 124553
Suita-shi, Japan
Suzuka General Hospital /ID# 144461
Suzuka, Japan
Kagawa University Hospital /ID# 68739
Takamatsu, Japan
Osaka Medical College Hospital /ID# 60665
Takatsuki-shi, Japan
Nippon Medical School Tama Nagayama Hospital /ID# 132030
Tama-shi, Japan
Tenri Hospital /ID# 94812
Tenri-shi, Japan
Medical Corporation Kojyokai Hirose Clinic /ID# 150045
Tokorozawa-shi, Japan
Tokushima University Hospital /ID# 80293
Tokushima-shi, Japan
Fujikawa Clinic /ID# 49892
Tokyo, Japan
Medical Hospital of Tokyo Medical and Dental University /ID# 153592
Tokyo, Japan
National Center for Child Health and Development /ID# 65065
Tokyo, Japan
National Center for Child Health and Development /ID# 65068
Tokyo, Japan
Nihon University Nerima Hikarigaoka Hospital /ID# 65064
Tokyo, Japan
Nihon University School of Medicine Itabashi Hospital /ID# 84037
Tokyo, Japan
Nippon Medical School Hospital /ID# 65055
Tokyo, Japan
Showa University Hospital /ID# 112195
Tokyo, Japan
St. Luke's International Hospital /ID# 65063
Tokyo, Japan
Takinogawa Hospital /ID# 133698
Tokyo, Japan
Tokyo Medical University Hospital /ID# 65069
Tokyo, Japan
Tokyo Womens Medical University Hospital /ID# 67232
Tokyo, Japan
Tokyo Womens Medical University Hospital /ID# 94813
Tokyo, Japan
Takasu Rhumatic Orthpedic Clinic /ID# 89902
Tottori, Japan
Saiseikai Toyama Hospital /ID# 67230
Toyama-shi, Japan
Toyama City Hospital /ID# 89894
Toyama, Japan
Fujita Health University Hospital /ID# 148374
Toyoake-shi, Japan
Toyooka Hospital /ID# 141966
Toyooka, Japan
National Mie Hospital /ID# 133697
Tsu-shi, Japan
Tsukuba University Hospital /ID# 144462
Tsukuba-shi, Japan
Kanazawa Medical University Hospital /ID# 89914
Uchinada-machi, Japan
Wakayama Medical University Hospital /ID# 80256
Wakayama-shi, Japan
Japanese Red Cross Wakayama Medical Center /ID# 112235
Wakayama, Japan
Yao Municipal Hospital /ID# 121224
Yao, Japan
Yokohama City University Medical Center /ID# 68743
Yokohama-shi, Kanagawa, Japan
Kanagawa Children's Medical Center /ID# 114900
Yokohama-shi, Japan
Yokohama Municipal Citizen's Hospital /ID# 65072
Yokohama-shi, Japan
Yokohama Seibu Hospital /ID# 89900
Yokohama, Japan
Tottori University Hospital /ID# 71511
Yonago-shi, Japan
Oita University Hospital /ID# 65076
Yufu-shi, Japan
Kagawa National Children's Hospital /ID# 94815
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: May 16, 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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 June 22, 2017