Status:
COMPLETED
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Systemic Juvenile Idiopathic Arthritis (SJIA)
Eligibility:
All Genders
2-20 years
Phase:
PHASE3
Brief 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.
Detailed Description
This two-part open-label study was to assess 2 different canakinumab taper regimens in patients with clinical remission (inactive disease for at least 24 continuous weeks) on canakinumab treatment wit...
Eligibility Criteria
Inclusion
- 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 \< 16 years of age.
- Active SJIA defined as having 2 or more of the following:
- Documented spiking, intermittent fever (body temperature \> 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
- 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.
Key Trial Info
Start Date :
November 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2017
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT02296424
Start Date
November 17 2014
End Date
September 25 2017
Last Update
July 9 2019
Active Locations (50)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Los Angeles, California, United States, 90027
2
Novartis Investigative Site
Columbus, Ohio, United States, 43205
3
Novartis Investigative Site
Vienna, Austria, A-1090
4
Novartis Investigative Site
Brussels, Belgium, 1200