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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 October 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01412021
First received: August 5, 2011
Last updated: October 24, 2014
Last verified: October 2014
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Anti-cyclic citrullinated peptides antibodies [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Anti-cyclic citrullinated peptides antibodies [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

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 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 Japan PMOS Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Yasuhiko Shinmura yasuhiko.shinmura@abbvie.com

  Hide Study Locations
Locations
Japan
Site Reference ID/Investigator# 124555 Not yet recruiting
Akita, Japan
Principal Investigator: Site Reference ID/Investigator# 124555         
Site Reference ID/Investigator# 120079 Recruiting
Anan, Japan
Principal Investigator: Site Reference ID/Investigator# 120079         
Site Reference ID/Investigator# 96499 Not yet recruiting
Aomori, Japan
Principal Investigator: Site Reference ID/Investigator# 96499         
Site Reference ID/Investigator# 67234 Recruiting
Chiba, Japan
Principal Investigator: Site Reference ID/Investigator# 67234         
Site Reference ID/Investigator# 80282 Recruiting
Chiba-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 80282         
Site Reference ID/Investigator# 124552 Not yet recruiting
Fukuchiyama, Japan
Principal Investigator: Site Reference ID/Investigator# 124552         
Site Reference ID/Investigator# 65081 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 65081         
Site Reference ID/Investigator# 67235 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 67235         
Site Reference ID/Investigator# 65061 Recruiting
Fukuoka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65061         
Site Reference ID/Investigator# 65056 Recruiting
Fukushima, Japan
Principal Investigator: Site Reference ID/Investigator# 65056         
Site Reference ID/Investigator# 89895 Recruiting
Hachinohe-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89895         
Site Reference ID/Investigator# 84036 Recruiting
Hakodate, Japan
Principal Investigator: Site Reference ID/Investigator# 84036         
Site Reference ID/Investigator# 96498 Not yet recruiting
Hamamatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 96498         
Site Reference ID/Investigator# 89904 Not yet recruiting
Hamamatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 89904         
Site Reference ID/Investigator# 132028 Not yet recruiting
Hamamatsu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 132028         
Site Reference ID/Investigator# 98358 Not yet recruiting
Hamamatsu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 98358         
Site Reference ID/Investigator# 80278 Recruiting
Himeji, Japan
Principal Investigator: Site Reference ID/Investigator# 80278         
Site Reference ID/Investigator# 65067 Recruiting
Hirakata-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65067         
Site Reference ID/Investigator# 65060 Recruiting
Hiroshima, Japan
Principal Investigator: Site Reference ID/Investigator# 65060         
Site Reference ID/Investigator# 126745 Not yet recruiting
Hiroshima-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126745         
Site Reference ID/Investigator# 65058 Recruiting
Hiroshima-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65058         
Site Reference ID/Investigator# 84033 Recruiting
Hofu, Japan
Principal Investigator: Site Reference ID/Investigator# 84033         
Site Reference ID/Investigator# 67233 Recruiting
Hokkaido, Japan
Principal Investigator: Site Reference ID/Investigator# 67233         
Site Reference ID/Investigator# 112196 Recruiting
Ina, Japan
Principal Investigator: Site Reference ID/Investigator# 112196         
Site Reference ID/Investigator# 65073 Recruiting
Inzai, Japan
Principal Investigator: Site Reference ID/Investigator# 65073         
Site Reference ID/Investigator# 80255 Recruiting
Ise, Japan
Principal Investigator: Site Reference ID/Investigator# 80255         
Site Reference ID/Investigator# 98359 Not yet recruiting
Izumo, Japan
Principal Investigator: Site Reference ID/Investigator# 98359         
Site Reference ID/Investigator# 67236 Recruiting
Izumo, Japan
Principal Investigator: Site Reference ID/Investigator# 67236         
Site Reference ID/Investigator# 65077 Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 65077         
Site Reference ID/Investigator# 67237 Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 67237         
Site Reference ID/Investigator# 65062 Recruiting
Kanazawa-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65062         
Site Reference ID/Investigator# 89899 Not yet recruiting
Kashihara-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89899         
Site Reference ID/Investigator# 80277 Recruiting
Kashiwa, Japan
Principal Investigator: Site Reference ID/Investigator# 80277         
Site Reference ID/Investigator# 126362 Not yet recruiting
Kato-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126362         
Site Reference ID/Investigator# 129895 Not yet recruiting
Kitakami, Japan
Principal Investigator: Site Reference ID/Investigator# 129895         
Site Reference ID/Investigator# 68742 Recruiting
Kitakyushu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 68742         
Site Reference ID/Investigator# 80276 Recruiting
Kitakyushu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 80276         
Site Reference ID/Investigator# 80283 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 80283         
Site Reference ID/Investigator# 80280 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 80280         
Site Reference ID/Investigator# 65070 Recruiting
Kobe-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65070         
Site Reference ID/Investigator# 80281 Recruiting
Kobe-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 80281         
Site Reference ID/Investigator# 114297 Not yet recruiting
Komatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 114297         
Site Reference ID/Investigator# 80253 Recruiting
Konan, Japan
Principal Investigator: Site Reference ID/Investigator# 80253         
Site Reference ID/Investigator# 94814 Not yet recruiting
Kuji-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 94814         
Site Reference ID/Investigator# 84034 Recruiting
Kumamoto, Japan
Principal Investigator: Site Reference ID/Investigator# 84034         
Site Reference ID/Investigator# 89898 Not yet recruiting
Kurashiki-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89898         
Site Reference ID/Investigator# 65082 Recruiting
Kurume-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65082         
Site Reference ID/Investigator# 65075 Recruiting
Kyoto-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65075         
Site Reference ID/Investigator# 65080 Recruiting
Kyoto-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65080         
Site Reference ID/Investigator# 89903 Not yet recruiting
Matsue-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89903         
Site Reference ID/Investigator# 68741 Recruiting
Matsumoto-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 68741         
Site Reference ID/Investigator# 65059 Recruiting
Matsuyama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65059         
Site Reference ID/Investigator# 84035 Recruiting
Mito, Japan
Principal Investigator: Site Reference ID/Investigator# 84035         
Site Reference ID/Investigator# 89901 Not yet recruiting
Mito, Japan
Principal Investigator: Site Reference ID/Investigator# 89901         
Site Reference ID/Investigator# 68740 Recruiting
Morioka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 68740         
Site Reference ID/Investigator# 67229 Recruiting
Moriyama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 67229         
Site Reference ID/Investigator# 112197 Not yet recruiting
Musashino-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 112197         
Site Reference ID/Investigator# 65057 Recruiting
Nagakute-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65057         
Site Reference ID/Investigator# 84039 Recruiting
Nagaokakyo, Japan
Principal Investigator: Site Reference ID/Investigator# 84039         
Site Reference ID/Investigator# 65083 Recruiting
Nagasaki, Japan
Principal Investigator: Site Reference ID/Investigator# 65083         
Site Reference ID/Investigator# 94816 Not yet recruiting
Nagasaki-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 94816         
Site Reference ID/Investigator# 80279 Recruiting
Nagoya, Japan
Principal Investigator: Site Reference ID/Investigator# 80279         
Site Reference ID/Investigator# 68738 Recruiting
Niigata, Japan
Principal Investigator: Site Reference ID/Investigator# 68738         
Site Reference ID/Investigator# 126746 Not yet recruiting
Ninohe-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126746         
Site Reference ID/Investigator# 65078 Recruiting
Nishihara, Japan
Principal Investigator: Site Reference ID/Investigator# 65078         
Site Reference ID/Investigator# 67238 Recruiting
Obihiro, Japan
Principal Investigator: Site Reference ID/Investigator# 67238         
Site Reference ID/Investigator# 65066 Recruiting
Obu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65066         
Site Reference ID/Investigator# 81073 Recruiting
Oiso-machi, Japan
Principal Investigator: Site Reference ID/Investigator# 81073         
Site Reference ID/Investigator# 60666 Recruiting
Okayama, Japan
Principal Investigator: Site Reference ID/Investigator# 60666         
Site Reference ID/Investigator# 71512 Recruiting
Okayama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 71512         
Site Reference ID/Investigator# 80275 Recruiting
Osaka, Japan
Principal Investigator: Site Reference ID/Investigator# 80275         
Site Reference ID/Investigator# 96500 Not yet recruiting
Osaka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 96500         
Site Reference ID/Investigator# 89913 Recruiting
Osaka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89913         
Site Reference ID/Investigator# 81074 Recruiting
Osakasayama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 81074         
Site Reference ID/Investigator# 124554 Not yet recruiting
Ota, Japan
Principal Investigator: Site Reference ID/Investigator# 124554         
Site Reference ID/Investigator# 65074 Recruiting
Saga, Japan
Principal Investigator: Site Reference ID/Investigator# 65074         
Site Reference ID/Investigator# 67231 Recruiting
Sagamihara-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 67231         
Site Reference ID/Investigator# 65071 Recruiting
Saitama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65071         
Site Reference ID/Investigator# 67239 Recruiting
Sapporo, Japan
Principal Investigator: Site Reference ID/Investigator# 67239         
Site Reference ID/Investigator# 89893 Recruiting
Sapporo-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89893         
Site Reference ID/Investigator# 89896 Not yet recruiting
Sapporo-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 89896         
Site Reference ID/Investigator# 80273 Recruiting
Sapporo-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 80273         
Site Reference ID/Investigator# 112215 Not yet recruiting
Sasebo, Japan
Principal Investigator: Site Reference ID/Investigator# 112215         
Site Reference ID/Investigator# 65084 Recruiting
Sendai-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65084         
Site Reference ID/Investigator# 80254 Recruiting
Settu, Japan
Principal Investigator: Site Reference ID/Investigator# 80254         
Site Reference ID/Investigator# 80274 Recruiting
Shibukawa, Japan
Principal Investigator: Site Reference ID/Investigator# 80274         
Site Reference ID/Investigator# 65079 Recruiting
Shimotsuke-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65079         
Site Reference ID/Investigator# 132029 Not yet recruiting
Shizuoka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 132029         
Site Reference ID/Investigator# 84038 Recruiting
Shizuoka-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 84038         
Site Reference ID/Investigator# 68744 Recruiting
Shunan, Japan
Principal Investigator: Site Reference ID/Investigator# 68744         
Site Reference ID/Investigator# 124553 Recruiting
Suita-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 124553         
Site Reference ID/Investigator# 68739 Recruiting
Takamatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 68739         
Site Reference ID/Investigator# 60665 Recruiting
Takatsuki-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 60665         
Site Reference ID/Investigator# 132030 Not yet recruiting
Tama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 132030         
Site Reference ID/Investigator# 94812 Not yet recruiting
Tenri-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 94812         
Site Reference ID/Investigator# 80293 Recruiting
Tokushima-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 80293         
Site Reference ID/Investigator# 49892 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 49892         
Site Reference ID/Investigator# 65068 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65068         
Site Reference ID/Investigator# 65055 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65055         
Site Reference ID/Investigator# 65063 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65063         
Site Reference ID/Investigator# 65064 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65064         
Site Reference ID/Investigator# 65065 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65065         
Site Reference ID/Investigator# 94813 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 94813         
Site Reference ID/Investigator# 65069 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65069         
Site Reference ID/Investigator# 67232 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 67232         
Site Reference ID/Investigator# 84037 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 84037         
Site Reference ID/Investigator# 112195 Not yet recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 112195         
Site Reference ID/Investigator# 126361 Not yet recruiting
Toon-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 126361         
Site Reference ID/Investigator# 89902 Not yet recruiting
Tottori, Japan
Principal Investigator: Site Reference ID/Investigator# 89902         
Site Reference ID/Investigator# 89894 Recruiting
Toyama, Japan
Principal Investigator: Site Reference ID/Investigator# 89894         
Site Reference ID/Investigator# 67230 Recruiting
Toyama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 67230         
Site Reference ID/Investigator# 89914 Not yet recruiting
Uchinada-machi, Japan
Principal Investigator: Site Reference ID/Investigator# 89914         
Site Reference ID/Investigator# 112235 Not yet recruiting
Wakayama, Japan
Principal Investigator: Site Reference ID/Investigator# 112235         
Site Reference ID/Investigator# 80256 Recruiting
Wakayama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 80256         
Site Reference ID/Investigator# 121224 Recruiting
Yao, Japan
Principal Investigator: Site Reference ID/Investigator# 121224         
Site Reference ID/Investigator# 89900 Not yet recruiting
Yokohama, Japan
Principal Investigator: Site Reference ID/Investigator# 89900         
Site Reference ID/Investigator# 68743 Recruiting
Yokohama, Japan
Principal Investigator: Site Reference ID/Investigator# 68743         
Site Reference ID/Investigator# 114900 Recruiting
Yokohama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 114900         
Site Reference ID/Investigator# 65072 Recruiting
Yokohama-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65072         
Site Reference ID/Investigator# 71511 Recruiting
Yonago, Japan
Principal Investigator: Site Reference ID/Investigator# 71511         
Site Reference ID/Investigator# 65076 Recruiting
Yufu-shi, Japan
Principal Investigator: Site Reference ID/Investigator# 65076         
Site Reference ID/Investigator# 94815 Not yet recruiting
Zentsuji, Japan
Principal Investigator: Site Reference ID/Investigator# 94815         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sarina Kurimoto AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( 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: October 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Arthritis, Juvenile Rheumatoid

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

ClinicalTrials.gov processed this record on November 20, 2014