Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 9.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s informed consent for = 18 years of age before any study related activity is performed. 2. The following patients are eligible to participate in the open label extension study (CACZ885G2301E1): • Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 15 days after their initial dose of canakinumab but experience a flare on or after that timepoint • Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria of 0.5 mg/kg oral prednisone (or equivalent) or were not able to taper their steroids by at least 0.3 mg/kg (please refer to CACZ885G2301 protocol for detailed rules) • Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test 2. Female patients having reached sexual maturity, i.e. being physiologically capable of becoming pregnant UNLESS they are: • Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and/or • Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) 450 msec for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the long-term safety, tolerability, and immunogenicity of canakinumab • To assess efficacy at an exploratory level by investigating disease control defined by maintenance of at least an adapted ACR pediatric 30 during the extension part;Secondary Objective: ;Primary end point(s): - Long-term safety, tolerability, and immunogenicity of canakinumab - Disease control by maintenance of at least an adapted ACR pediatric 30 during the extension study | — |
Countries
Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed