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

This study is currently recruiting participants.
Verified April 2013 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 22, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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: January 2014
Estimated Primary Completion Date: January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412021

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4588-4621 abvj-pmos@abbvie.com
Contact: Toshiro Maeda, MD toshiro.maeda@abbvie.com

  Hide Study Locations
Locations
Japan
Site Reference ID/Investigator# 80282 Recruiting
Chiba, Japan
Principal Investigator: Site Reference ID/Investigator# 80282            
Site Reference ID/Investigator# 67234 Recruiting
Chiba, Japan
Principal Investigator: Site Reference ID/Investigator# 67234            
Site Reference ID/Investigator# 67235 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 67235            
Site Reference ID/Investigator# 65081 Recruiting
Fukuoka, Japan
Principal Investigator: Site Reference ID/Investigator# 65081            
Site Reference ID/Investigator# 65061 Recruiting
Fukuoka, 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# 84036 Recruiting
Hakodate, Japan
Principal Investigator: Site Reference ID/Investigator# 84036            
Site Reference ID/Investigator# 80278 Recruiting
Himeji, Japan
Principal Investigator: Site Reference ID/Investigator# 80278            
Site Reference ID/Investigator# 65067 Recruiting
Hirakata, 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# 65058 Recruiting
Hiroshima, Japan
Principal Investigator: Site Reference ID/Investigator# 65058            
Site Reference ID/Investigator# 67233 Recruiting
Hokkaido, Japan
Principal Investigator: Site Reference ID/Investigator# 67233            
Site Reference ID/Investigator# 84033 Recruiting
Houfu, Japan
Principal Investigator: Site Reference ID/Investigator# 84033            
Site Reference ID/Investigator# 65070 Recruiting
Hyogo, Japan
Principal Investigator: Site Reference ID/Investigator# 65070            
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# 67236 Recruiting
Izumo, Japan
Principal Investigator: Site Reference ID/Investigator# 67236            
Site Reference ID/Investigator# 67237 Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 67237            
Site Reference ID/Investigator# 65077 Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 65077            
Site Reference ID/Investigator# 65062 Recruiting
Kanazawa, Japan
Principal Investigator: Site Reference ID/Investigator# 65062            
Site Reference ID/Investigator# 80277 Recruiting
Kashiwa, Japan
Principal Investigator: Site Reference ID/Investigator# 80277            
Site Reference ID/Investigator# 80276 Recruiting
Kitakyushu, Japan
Principal Investigator: Site Reference ID/Investigator# 80276            
Site Reference ID/Investigator# 68742 Recruiting
Kitakyushu, Japan
Principal Investigator: Site Reference ID/Investigator# 68742            
Site Reference ID/Investigator# 80280 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 80280            
Site Reference ID/Investigator# 80283 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 80283            
Site Reference ID/Investigator# 80281 Recruiting
Kobe, Japan
Principal Investigator: Site Reference ID/Investigator# 80281            
Site Reference ID/Investigator# 80253 Recruiting
Konan, Japan
Principal Investigator: Site Reference ID/Investigator# 80253            
Site Reference ID/Investigator# 84034 Recruiting
Kumamoto, Japan
Principal Investigator: Site Reference ID/Investigator# 84034            
Site Reference ID/Investigator# 65082 Recruiting
Kurume, Japan
Principal Investigator: Site Reference ID/Investigator# 65082            
Site Reference ID/Investigator# 65075 Recruiting
Kyoto, Japan
Principal Investigator: Site Reference ID/Investigator# 65075            
Site Reference ID/Investigator# 65080 Recruiting
Kyoto, Japan
Principal Investigator: Site Reference ID/Investigator# 65080            
Site Reference ID/Investigator# 68741 Recruiting
Matsumoto, Japan
Principal Investigator: Site Reference ID/Investigator# 68741            
Site Reference ID/Investigator# 65059 Recruiting
Matsuyama, 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# 68740 Recruiting
Morioka, Japan
Principal Investigator: Site Reference ID/Investigator# 68740            
Site Reference ID/Investigator# 65057 Recruiting
Nagakute, 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# 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# 67238 Recruiting
Obihiro, Japan
Principal Investigator: Site Reference ID/Investigator# 67238            
Site Reference ID/Investigator# 65066 Recruiting
Obu, Japan
Principal Investigator: Site Reference ID/Investigator# 65066            
Site Reference ID/Investigator# 81073 Recruiting
Oiso, 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, Japan
Principal Investigator: Site Reference ID/Investigator# 71512            
Site Reference ID/Investigator# 65078 Recruiting
Okinawa, Japan
Principal Investigator: Site Reference ID/Investigator# 65078            
Site Reference ID/Investigator# 80275 Recruiting
Osaka, Japan
Principal Investigator: Site Reference ID/Investigator# 80275            
Site Reference ID/Investigator# 81074 Recruiting
Osakasayama, Japan
Principal Investigator: Site Reference ID/Investigator# 81074            
Site Reference ID/Investigator# 65074 Recruiting
Saga, Japan
Principal Investigator: Site Reference ID/Investigator# 65074            
Site Reference ID/Investigator# 67231 Recruiting
Sagamihara, Japan
Principal Investigator: Site Reference ID/Investigator# 67231            
Site Reference ID/Investigator# 65071 Recruiting
Saitama, Japan
Principal Investigator: Site Reference ID/Investigator# 65071            
Site Reference ID/Investigator# 80273 Recruiting
Sapporo, Japan
Principal Investigator: Site Reference ID/Investigator# 80273            
Site Reference ID/Investigator# 67239 Recruiting
Sapporo, Japan
Principal Investigator: Site Reference ID/Investigator# 67239            
Site Reference ID/Investigator# 65084 Recruiting
Sendai, 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# 67229 Recruiting
Shiga, Japan
Principal Investigator: Site Reference ID/Investigator# 67229            
Site Reference ID/Investigator# 65079 Recruiting
Shimotsuke, Japan
Principal Investigator: Site Reference ID/Investigator# 65079            
Site Reference ID/Investigator# 84038 Recruiting
Shizuoka, 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# 68739 Recruiting
Takamatsu, Japan
Principal Investigator: Site Reference ID/Investigator# 68739            
Site Reference ID/Investigator# 60665 Recruiting
Takatsuki, Japan
Principal Investigator: Site Reference ID/Investigator# 60665            
Site Reference ID/Investigator# 80293 Recruiting
Tokushima, Japan
Principal Investigator: Site Reference ID/Investigator# 80293            
Site Reference ID/Investigator# 65065 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65065            
Site Reference ID/Investigator# 67232 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 67232            
Site Reference ID/Investigator# 65068 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65068            
Site Reference ID/Investigator# 49892 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 49892            
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# 65055 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65055            
Site Reference ID/Investigator# 84037 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 84037            
Site Reference ID/Investigator# 65069 Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 65069            
Site Reference ID/Investigator# 67230 Recruiting
Toyama, Japan
Principal Investigator: Site Reference ID/Investigator# 67230            
Site Reference ID/Investigator# 80256 Recruiting
Wakayama, Japan
Principal Investigator: Site Reference ID/Investigator# 80256            
Site Reference ID/Investigator# 65072 Recruiting
Yokohama, Japan
Principal Investigator: Site Reference ID/Investigator# 65072            
Site Reference ID/Investigator# 68743 Recruiting
Yokohama, Japan
Principal Investigator: Site Reference ID/Investigator# 68743            
Site Reference ID/Investigator# 71511 Recruiting
Yonago, Japan
Principal Investigator: Site Reference ID/Investigator# 71511            
Site Reference ID/Investigator# 65076 Recruiting
Yufu, Japan
Principal Investigator: Site Reference ID/Investigator# 65076            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Yo Hoshino AbbVie GK
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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: April 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Arthritis, Juvenile Rheumatoid

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

ClinicalTrials.gov processed this record on May 19, 2013