None listed
Conditions
Interventions
Group 1 Type of group
In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on
0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤
Group 2 Type of group
Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤
0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
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 to 5 mm Induration) in the selection can only be enrolled if they have a negative chest x-ray or a negative QuantiFERON 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
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein Measure:Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein Timepoints:Baseline, Week 32 ; Outcome name:Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein Measure:Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein Timepoints:Baseline, Week 32 ; Outcome name:The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other activities. Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement. Measure:Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I Timepoints:Baseline, End of Part I (Week 32) ; Outcome name:CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other activities. Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do). Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates. Measure:Part II: Change in Disability Ov | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures. Measure:Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid Timepoints:32 Weeks ; Outcome name:Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following. -Reappearance of fever (>38°C, lasting for at least 2 consecutive days) not due to infections -Flare according to the JIA pediatric criteria for flare (all criteria must have been met): -≥ 30% worsening in at least 3 of the first 6 response variables -≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II. Measure:Part II: Survival Estimate of Time to Flare Timepoints:Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) | — |
Countries
Argentina, Belgium, Brazil, Canada, France, Germany, Hungaria, Israel, Italy, Netherlands, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, Turkey, United States
Contacts
Public ContactPatricia Acosta
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed