Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA) MedDRA version: 19.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg/
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria- Cohort 1: • Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for =18 years of age must be obtained before any study related activity or assessment is performed. • Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for SJIA and have inactive disease at the last visit in Study CACZ885G2301E1 . Inclusion Criteria- Cohort 2: • Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for = 18 years of age must be obtained before any study related activity or assessment is performed. • Male and female patients aged = 2 to 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose, • At least 2 joints with active arthritis (using ACR definition of active joint), • C-reactive protein (CRP) > 30 mg/L (normal range =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria – Cohort 1 and Cohort 2: • 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 hCG laboratory test. • Female patients of child-bearing potential, defined as all females physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods defined in protocol. • History of hypersensitivity to study drug or to biologics. • With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. • History or evidence of tuberculosis (TB) (active or latent) infection or one of the risk factors for tuberculosis (TB) as defined in protocol. • With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and €/ or places the patient at unacceptable risk for participation in an immunomodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome. • With neutropenia (absolute neutrophil count < 1500/mm3) at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able to remain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg every 8 weeks) for at least 24 consecutive weeks is at least 40% in either treatment arm (Part II).;Secondary Objective: To assess the long-term safety and tolerability of canakinumab (Parts I and II).;Primary end point(s): Proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who are able to remain at a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg every 8 weeks) for at least 24 consecutive weeks;Timepoint(s) of evaluation of this end point: 24 weeks from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): long-term safety and tolerability of canakinumab;Timepoint(s) of evaluation of this end point: Duration of trial | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, Hungary, Israel, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, Spain, Sweden, Turkey, United States
Outcome results
None listed