None listed
Conditions
Interventions
Group 1 Type of group
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
Group name:Group 2 Type of group
Patients received a single dose matching placebo of canakinumab on day 1.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
2 Years to 20 Years
Inclusion criteria
Inclusion criteria: • Written informed consent of the parent or legal guardian and consent of the child, if applicable, or informed consent of the patient for 18 years of age before performing any activity related to the study. • Male and female patients 2 2 to <20 years of age at the time of the selection visit • Confirmed diagnosis of JIA according to the definition of ILAR (Petty et al 2004) that must have been made at least 2 months before enrollment with a disease onset <16 years of age • Active disease at the time of enrollment • That you have never received Canakinumab • 8. Will of the patient to discontinue anakinra, rilonacept, tocilizumab or other experimental drug under close monitoring • Concomitant use of second-line agents as disease-modifying and / or immunosuppressive drugs will not be allowed. • Negative Purified Protein Derivative Test (PPD) (Induration <5 mm) in the selection or within the month prior to selection. Patients with a positive PPD test (Induration s 5 mm) in the selection can only enroll if they have a negative chest x-ray or a negative QuantlFERON test (QFT-TB G In-Tube).
Exclusion criteria
Exclusion criteria: • Patients who are pregnant or breastfeeding women (infants), understanding pregnancy as the status of a woman after conception and until termination of pregnancy, confirmed by a laboratory test of positive hCG (> 5 mlU / mi) at the visit of selection • Female patients who have reached sexual maturity, that is, who are physiologically fit to get pregnant • History of hypersensitivity to the study drug or biological. • Biological features of SAM, such as hemorrhages, central nervous system dysfunction, hepatomegaly, plasma fibrinogen level 450 msec for men and> 470 msec for women in the selection or baseline evaluation • Clinical evidence of liver disease or liver injury Indicated by abnormal liver function tests in the selection such as AST, ALT, GGT, alkaline phosphatase or serum billrublna (should not exceed twice the upper limit of the normal range for age) • Presence of moderately or severely impaired renal function, indicated by clinically significant normal values ​​of creatinine (> 1.5 times the upper limit of normal (ULN)) or urea or abnormal urine constituents (eg albuminuria) in the selection. Evidence of urinary obstruction or difficulty in urination, in the selection. • Live vaccines within 3 months prior to the start of the study. Dead or inactivated vaccines may be allowed at the investigator´s discretion. • Donation or loss of blood (the amount depends on age and weight, 10-20% or more of the volume, see Appendix 3) within 8 weeks prior to the administration of the study drug, or more if so They demand local regulations. • Family or social conditions that prevent regular medical evaluation. • History of drug or alcohol abuse within 12 months prior to the administration of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physicians Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patients Global Assessment of Patients overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L) Measure:Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria Timepoints:Baseline, Day 15, Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physicians Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patients Global Assessment of Patients overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L) Measure:Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria Timepoints:Baseline, Day 15, Day 29 ; Outcome name:Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physicians Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patients Global Assessment of Patients overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L) Measure:Percentage of Patients Achieving the Adapted ACR Pediatric 70 Timepoints:Baseline, Day 15, Day 29 ; Outcome name:Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physicians Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patients Global Assessment of Patients overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. | — |
Countries
Belgium, Brazil, Canada, Denmark, France, Greece, Hungaria, Israel, Italy, Netherlands, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, Turkey, United Kindgdom, United States
Contacts
Public ContactPatricia Acosta
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed