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


N/A
N/A
N/A
Open (Enrolling)
Both
Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS), Muckle-wells Syn (MWS), Neonatal Onset Multisystem Inflam Disease (NOMID)

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Trial Information

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


Inclusion Criteria:



- Patients receiving Ilaris (canakinumab) at the time of enrollment as part of medical
care

Exclusion Criteria:

- Local regulations in some locations may exclude patients who receive Ilaris for a
non-approved indication

- Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To monitor and further explore the overall safey of canakinumab focusing in serious infections

Outcome Time Frame:

At least 5 years

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Switzerland: Swissmedic

Study ID:

CACZ885D2401

NCT ID:

NCT01213641

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Cryopyrin-associated Periodic Syndromes (CAPS)
  • Familial Cold Autoinflam Syn (FCAS)
  • Muckle-wells Syn (MWS)
  • Neonatal Onset Multisystem Inflam Disease (NOMID)
  • Cryopyrin-associated periodic syndromes(CAPS)
  • CIAS1 protein
  • NLRP3 protein
  • human cryopyrin protein
  • Familial Cold Autoinflammatory Syndrome(FCAS)
  • Muckle-Wells Syndrome(MWS)
  • Neonatal Onset Multisystem Inflammatory disease(NOMID)
  • NALP3
  • canakinumab
  • Interleukin-1(IL-1)
  • Cryopyrin-Associated Periodic Syndromes

Name

Location
Rush Presbyterian - St. Lukes Medical Center Chicago, Illinois  60612
Little Rock Allergy and Asthma Clinic Little Rock, Arizona  72205
Allergy Center at Brookstone Columbus, Georgia  31904