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

This study is currently recruiting participants.
Verified April 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: April 10, 2014
Last verified: April 2014

August 5, 2011
April 10, 2014
August 2011
October 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event 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 ]
Complete list of historical versions of study NCT01412021 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients who receive Humira for the treatment of Juvenile idiopathic arthritis

Arthritis, Juvenile Rheumatoid
Not Provided
Humira
those with an exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: AbbVie Japan PMOS Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Tadamichi Kubo tadamichi.kubo@abbvie.com
Japan
 
NCT01412021
P12-769
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Yo Hoshino AbbVie GK
AbbVie
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP