Clinical Trial: The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndrom
Brief Summary: This study will assess the safety, tolerability and efficacy of canakinumab treatment in Canadian patient diagnosed with cryopyrin-associated periodic syndrome over a period of 18 months.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Safety & tolerability of canakinumab by measuring the maintenance of response over time using the Investigators Clinical Assessment of Disease Activity scale and the evaluation of serum inflammation markers CRP (C-Reactive Protein), SAA (Serum Amyloid A. [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in long term maintenance of Health-Related Quality of Life and productivity measured from baseline to end of study. [ Time Frame: Baseline, 18 months ]
- Treatment adherence with canakinumab for the duration of the study. [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: March 25, 2010
Date Started: August 2010
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017
