Phase 3
N=177
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Systemic Juvenile Idiopathic Arthritis With Active Flare
Bottom Line
View on ClinicalTrials.gov: NCT00889863 ↗Enrolled (actual)
177
Serious AEs
9.8%
Results posted
Oct 2012
Primary outcome: Primary: 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 — 44.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- canakinumab (Drug); placebo (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
44.5 | — |
| PRIMARY Part II: Survival Estimate of Time to Flare |
NA; 236.0 | — |
| SECONDARY Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic |
32.8; 18.8 | — |
| SECONDARY Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c |
62.0 | — |
| SECONDARY Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I |
22.9; 77.1; 73.1; 64.6; 51.4; 34.3 | — |
| SECONDARY Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein |
20.4 | — |
| SECONDARY Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein |
24.5 | — |
| SECONDARY Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a |
98.6 | — |
| SECONDARY Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response |
NA; 141.0 | — |
| SECONDARY Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I |
-0.8750 | — |
| SECONDARY Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) |
0.1184; 0.1258 | — |
| SECONDARY Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50) |
21.8050; 8.2223 | — |
| SECONDARY Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50) |
3.9; -0.3; 2.5; -0.5 | — |
Summary
This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of systemic juvenile idiopathic arthritis as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with onset of disease 38oC) for at least 1 day during the screening period within 1 week before first study drug dose
- C-reactive protein > 30 mg/L (normal range < 10 mg/L)
- No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
- Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
- Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
- Stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
Exclusion criteria
- Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months
- Risk factors for tuberculosis
- Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection
Other protocol inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00889863). 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.