Clinical Trial: Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients

Brief Summary: The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: To monitor and further explore the overall safey of canakinumab focusing in serious infections [ Time Frame: At least 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness) [ Time Frame: At least 5 years ]
  • Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris [ Time Frame: at least 5 years ]
  • Identify previously unrecognized serious adverse drug reactions in the treated population [ Time Frame: at least 5 years ]
  • Usage and patterns of dosing of Ilaris in routine clinical practice [ Time Frame: at least 5 years ]
  • Incidence of serious infections [ Time Frame: at least 5 years ]
  • Incidence of malignancies [ Time Frame: at least 5 years ]
  • Incidence of hypersensitivity reactions [ Time Frame: at least 5 years ]


Original Secondary Outcome:

  • Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness) [ Time Frame: At least 5 years ]
  • Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris [ Time Frame: at least 5 years ]
  • Identify previously unrecognized serious adverse drug reactions in the treated population [ Time Frame: at least 5 years ]
  • Usage and patterns of dosing of Ilaris in routine clinical practice [ Time Frame: at least 5 years ]
  • Incidence of serious infections [ Time Frame: at least 5 years ]
  • Incidence of malignancies [ Time Frame: at least 5 years ]
  • Incidence of hypersensitivity reactions


Information By: Novartis

Dates:
Date Received: September 30, 2010
Date Started: November 2009
Date Completion:
Last Updated: March 25, 2016
Last Verified: March 2016