Clinical Trial: Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset Multisystem Inflammatory Disease (NOMID) in Japan.

The study will assess the efficacy and safety of canakinumab in Japanese patients with cryopyrin-associated periodic syndromes (CAPS). In previous and currently ongoing CAPS studies (CACZ885A2102, CACZ885D2201, CACZ885D2304, CACZ885D2306), it has been observed that treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse, to improve signs and symptoms and to prevent secondary disease complications. However, no Japanese patients have been included in those studies. This study will allow access for Japanese patients to a new potentially efficacious treatment for CAPS patients with a convenient dosing regimen.


Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of participants without a relapse [ Time Frame: 24 weeks ]

Original Primary Outcome: Number of patients without a relapse [ Time Frame: 24 weeks ]

Current Secondary Outcome:

  • Number of complete responder patients [ Time Frame: 29 days ]
  • Clinical improvement (or resolution) with regards to: central nervous system (CNS) involvement, eye disease, hearing impairment, skin disease, joint disease, fever, and kidney function [ Time Frame: 24 months ]
  • Number of patients experiencing a relapse during the entire study [ Time Frame: 24 months ]
  • How much canakinumab is contained in the patients' blood (pharmacokinetics) and what are the effect of canakinumab on the patients' body (pharmacodynamic) [ Time Frame: 24 months ]
  • Presence of antibody against canakinumab [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: October 6, 2009
Date Started: October 2009
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017