The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01105507
- Phase
- PHASE3
- Status
- Completed
Conditions
- Cryopyrin Associated Periodic Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
Study Details
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.
Key Dates
- First listed
- Apr 16, 2010
- Start date
- Aug 31, 2010
- Status verified
- Mar 2017
- Primary completion
- May 12, 2012
- Completion
- May 12, 2012
Study Design
- Enrollment
- 4 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: canakinumab arm
Primary Outcome Measure
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 ]