Phase 3
Completed N=19
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
Source: ClinicalTrials.gov NCT02396212 ↗Enrolled (actual)
19
Serious AEs
52.6%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria — 100.0 Percentage of Participants
◆ Published Evidence
Established
21citations · ~4 / year
Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients.
Summary
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.
Linked Publications
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Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria |
100.0 | — |
| PRIMARY Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully |
73.7 | — |
| SECONDARY Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time |
94.7; 94.7; 94.7; 84.2; 47.4; 100.0 | — |
| SECONDARY Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity |
-60.2; -62.2; -62.2; -63.9; -63.1; -61.0 | — |
| SECONDARY 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 CHAQ |
-64.4; -73.5; -71.9; -68.6; -68.4; -72.8 | — |
| SECONDARY Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score |
-0.833; -0.912; -0.998; -1.013; -0.951; -1.026 | — |
| SECONDARY Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis |
-5.2; -6.2; -4.4; -4.4; -4.4; -5.2 | — |
| SECONDARY Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion |
-3.9; -4.2; -3.4; -3.5; -3.4; -3.8 | — |
| SECONDARY Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time |
19; 16; 2; 0; 0; 0 | — |
| SECONDARY Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP) |
-89.45; -96.95; -98.19; -97.64; -97.95; -98.58 | — |
| SECONDARY Percentage of Participants Who Had Flares With Canakinumab Treatment Over Time |
5.3; 5.3; 5.3; 5.6; 5.6; 6.3 | — |
| SECONDARY Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over Time |
63.2; 63.2; 75.0; 75.0; 75.0; 80.0 | — |
| SECONDARY Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully Over Time |
87.5; 81.3; 87.5; 100.0; 66.7 | — |
| SECONDARY Absolute Change From Baseline of Corticosteroids Dose Reduction With Canakinumab Treatment Over Time |
-0.133; -0.195; -0.226; -0.296; -0.171 | — |
| SECONDARY Serum Concentration of Canakinumab |
0.01; 15.7; 31.3; 31.1; 30.6; 29.5 | — |
| SECONDARY Pharmacodynamics (PD) Assessment: Total IL-1 Beta |
0.72; 49.8; 85.2; 81.2; 75.3; 74.4 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition (Petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an onset of disease 38°C) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose
- C-Reactive Protein (CRP) > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL))
- Negative TB screen (Chest X-ray and T-SPOT test)
Exclusion Criteria
- 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. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody).
- 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.
- With neutropenia (absolute neutrophil count < 1500/mm3) at screening.
Data sourced from ClinicalTrials.gov (NCT02396212) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.