Adults 2 to 19, any sex, with Systemic Juvenile Idiopathic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 CriteriaPrimary· Week 8
Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
100.0
Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids SuccessfullyPrimary· Week 28
To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
73.7
Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over TimeSecondary· Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164)
Adapted ACR Pediatric 30/50/70/90/100 criteria was assessed based on the following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the CHAQ; 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as more than or equal to (≥) 3
Week 4 adapted ACR Pediatric 30
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
94.7
Week 4 adapted ACR Pediatric 50
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
94.7
Week 4 adapted ACR Pediatric 70
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
94.7
Week 4 adapted ACR Pediatric 90
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
84.2
Week 4 adapted ACR Pediatric 100
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
47.4
Week 8 adapted ACR Pediatric 30
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
100.0
Week 8 adapted ACR Pediatric 50
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
100.0
Week 8 adapted ACR Pediatric 70
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
100.0
Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease ActivitySecondary· Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)
ACR component, Physician's Global Assessment of disease activity on a 0 - 100 mm VAS by visit is the first response ACR variable in the ACR pediatric criteria. The VAS scale ranges from no disease activity (0 mm) to very severe disease activity (100 mm). Lower scale indicates decreased disease activity. Change from baseline was calculated by subtracting baseline value from post baseline value.
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-60.2
± 32.27
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-62.2
± 28.23
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-62.2
± 28.61
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-63.9
± 28.81
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-63.1
± 26.99
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-61.0
± 37.24
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-61.4
± 31.05
Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQSecondary· Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164
ACR component, Parent's or Patient's (if appropriate in age)Global Assessment of patient's overall well-being as part of CHAQ on a 0 - 100 mm VAS by visit is the second response variable in the ACR pediatric criteria. The VAS scale ranges from 0-100 mm, from very well (0 mm) to very poor (100 mm). Lower scale indicates improvement of patient's overall well-being. Absolute change is calculated by subtracting baseline value from post baseline value.
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-64.4
± 40.80
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-73.5
± 24.05
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-71.9
± 23.13
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-68.6
± 28.67
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-68.4
± 27.72
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-72.8
± 25.65
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-68.1
± 26.29
Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability ScoreSecondary· Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)
Disability Score as part of CHAQ per functional ability score (range from 0 to 3) is one of the variable in the ACR ped criteria. The CHAQ was used to assess physical ability \& functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activity categories of daily living: dressing \& grooming, arising, eating, walking, reaching, personal hygiene, gripping \& other "activities". Subjects choose from 4 responses, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with muc
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-0.833
± 0.7750
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-0.912
± 0.7338
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-0.998
± 0.7871
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-1.013
± 0.7963
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-0.951
± 0.8381
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-1.026
± 0.9465
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-0.938
± 0.7682
Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active ArthritisSecondary· Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)
ACR component, Number of joints with active arthritis was assessed as the forth response variables of ACR Pediatric Criteria.
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-5.2
± 4.87
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-6.2
± 7.71
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-4.4
± 3.44
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-4.4
± 3.44
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-4.4
± 3.18
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-5.2
± 2.68
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-5.6
± 8.10
Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of MotionSecondary· Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)
ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria.
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-3.9
± 4.02
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-4.2
± 4.30
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-3.4
± 3.79
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-3.5
± 3.78
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-3.4
± 3.59
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-3.8
± 2.86
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-3.7
± 4.81
Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over TimeSecondary· Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164)
ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria.
Baseline
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
19
Day 3
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
16
Week 2
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
2
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
0
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
0
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
0
Week 56
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
1
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
0
Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP)Secondary· Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)
ACR component, Standardized CRP is the sixth response variable in the ACR ped criteria. CRP values were standardized to a normal range of 0 to 10 mg/L.
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-89.45
± 41.431
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-96.95
± 6.915
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-98.19
± 2.567
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-97.64
± 6.333
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-97.95
± 3.730
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-98.58
± 1.330
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
-89.71
± 20.717
Percentage of Participants Who Had Flares With Canakinumab Treatment Over TimeSecondary· > Day3, to <= Week 124
Flare was defined by at least 1 of the following: Reappearance of SJIA-related (e.g., not due to infection) fever (\> 38°C) lasting for at least 2 consecutive days \&/OR Flare according to the JIA pediatric criteria for flare (all criteria must be met): ≥ 30% worsening in at least 3 of the 6 response variables and ≥ 30% improvement in at not more than 1 of the 6 response variables if the physician's or parent's global assessment is 1of 3 response variables used to define flare, worsening of ≥ 20 mm must be present, if the number of active joints or joints with limitation of motion is one of 3
>Day 3 =<Week 2
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
5.3
>Week 2 =<Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
5.3
>Week 4 =<Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
5.3
>Week 8 =<Week 12
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
5.6
>Week 12 =<Week 16
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
5.6
>Week 92 =<Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
6.3
>Week 104 =<Week 108
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
7.7
>Week 120 =<Week 124
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
12.5
Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over TimeSecondary· Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)
Inactive disease was defined as meeting all of the following: No joints with active arthritis; No fever (body temperature ≤ 38°C); No rheumatoid rash, serositis, splenomegaly, hepatomegaly or generalized lymphadenopathy attributable to JIA; Normal CRP; Physician's global assessment of disease activity score ≤ 10 mm
Week 4
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
63.2
Week 8
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
63.2
Week 28
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
75.0
Week 48
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
75.0
Week 96
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
75.0
Week 144
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
80.0
EOS
Group
Value
95% CI
Canakinumab 4 mg/kg Every 4 Weeks
68.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 39 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Canakinumab 4 mg/kg Every 4 Weeks
Serious: 10/19 (53%)
Deaths: 0/19
Serious adverse events (12 terms)
Reaction
System
Canakinumab 4 mg/kg Every …
Still's disease
Musculoskeletal and connective tissue disorders
—
Histiocytosis haematophagic
Blood and lymphatic system disorders
—
Adrenal insufficiency
Endocrine disorders
—
Pyrexia
General disorders
—
Influenza
Infections and infestations
—
Epstein-Barr virus infection
Infections and infestations
—
Gastroenteritis
Infections and infestations
—
Pharyngitis
Infections and infestations
—
Varicella
Infections and infestations
—
Viral infection
Infections and infestations
—
Altered state of consciousness
Nervous system disorders
—
Somatic symptom disorder
Psychiatric disorders
—
Other adverse events (104 terms — click to expand)
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06038526 — Evaluation of Canakinumab in High-Risk Former-Smokers
· Phase 2
· active not recruiting
NCT05984602 — A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclit
· Phase 1
· active not recruiting
NCT05401578 — Canakinumab for the Treatment of Postprandial Hypoglycemia
· Phase 3
· recruiting
NCT05641831 — Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPA
· Phase 2
· recruiting
NCT05535738 — Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
· Phase 2, PHASE3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 13 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02396212.