drugset / Trial / NCT00685373

Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

NCT00685373

Phase 3 Completed 166 enrolled Novartis
NaSingle-groupOpen-labelTreatment

Summary

This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β \[anti-IL-1β\] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease. The duration of this study was 6 months with a maximum duration of 2 years

Timeline

Start
2008-05
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Canakinumab Monoclonal antibody 2 mg/kg Subcutaneous
Subject Canakinumab Monoclonal antibody 150 mg Subcutaneous