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

canakinumab (company code: ACZ885D) — DRUG

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

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 ]