A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02334748
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.

Key Dates

Start date
Nov 3, 2014
Status verified
May 2020
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: canakinumab
    Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: every 4 weeks up to 1 year ]