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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief Summary:

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

Detailed Summary:
Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome:

  • 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 

    Original Primary Outcome:

    • Number of patients with adverse drug reactions [ Time Frame: at week 24 ]
      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 ]
    • 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 ]