Phase 3
Completed N=182
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
Systemic Juvenile Idiopathic Arthritis (SJIA)
Source: ClinicalTrials.gov NCT02296424 ↗
Enrolled (actual)
182
Serious AEs
15.8%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. — 27; 31; 11; 6 particiapants — p=0.0001
◆ Published Evidence
Established
36citations · ~7 / year
Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study.
Summary
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
Linked Publications
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Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. |
27; 31; 11; 6 | 0.0001 sig |
| SECONDARY Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 |
57; 91; 0; 0; 10; 23 | — |
| SECONDARY Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2 |
38; 34; 0; 0; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
Cohort 1:
- Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1
Cohort 2:
- Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with an onset of disease 38°C) for at least 1 day within 1 week before first canakinumab dose;
- At least 2 joints with active arthritis
- C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
- Rash due to SJIA
- Serositis
- Lymphadenopathy
- Hepatosplenomegaly
- Negative TB screen (QuantiFERON or, if required by local guidelines, Purified Protein Derivative).
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.
- 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 (NCT02296424) 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.