Phase 3
N=270
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
Systemic Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00891046 ↗Enrolled (actual)
270
Serious AEs
32.2%
Results posted
Mar 2017
Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE — 108; 137; 40; 47 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Canakinumab (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE |
108; 137; 40; 47; 14; 18 | — |
| PRIMARY Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Local Injection Site Reactions During the Study |
115; 129; 6; 15; 2; 3 | — |
| PRIMARY Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study |
80.8; 91.7; 100; 95.7; 80.8; 91.7 | — |
| PRIMARY Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study |
92.3; 100; 100; 92.2; 88.5; 100 | — |
| PRIMARY Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study |
96.7; 100; 91.0; 93.3; 50; 91.0 | — |
| SECONDARY Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 |
82.4; 76.5; 83.3; 92.6; 82.4; 70.6 | — |
| SECONDARY Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study |
100; 100; 91.3; 100; 100; 100 | — |
| SECONDARY Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen |
36.4; 55.6; 23.7; 25; 33.8; 27.3 | — |
| SECONDARY Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg |
9; 29; 4; 2; 18 | — |
| SECONDARY Percentage of Participants With Clinical Remission |
42.3; 52.4; 26.8; 42.9; 8.9; 6.8 | — |
| SECONDARY Change From Baseline in Disability, Overall Well-Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study |
-0.375; 0; -0.125; 0; -0.7143; -18 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire- Parent Form (CHQ-PF50) to Last Assessment of Study |
14.0407; 0.6959; 1.3716; 13.9255; 18.8758; 3.8815 | — |
| SECONDARY Change From Baseline in EuroQual 5 -Dimension Health Status Questionnaire (EQ-5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study |
0.204; 0; 0.069; 0.2385; 0.228; 21 | — |
| SECONDARY Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study |
1; 0.5; 0; -4.5 | — |
| SECONDARY Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study |
-0.01; 0 | — |
| SECONDARY Percentage of Participants With Inactive Disease |
39.4; 79.4; 12.5; 36.4; 50.8 | — |
| SECONDARY Change From Baseline in Growth Velocity Parameters to Last Assessment of Study |
0.1; 0 | — |
| SECONDARY Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study |
1.08; -0.77 | — |
Summary
This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.
Eligibility Criteria
Inclusion criteria
- Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in Part II.
- Treatment-naïve patients need to meet the following criteria:
- Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease 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
- AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) Rash Serositis Lymphadenopathy Hepatosplenomegaly
- Naïve to canakinumab
Other protocol-defined inclusion criteria may apply
Exclusion criteria
- History of allergy or hypersensitivity to study drug
- With active or recurrent bacterial, fungal or viral infections at time of enrollment
Other protocol inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00891046). 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.