Status:
COMPLETED
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Pediatric Rheumatology International Trials Organization
Conditions:
Systemic Juvenile Idiopathic Arthritis With Active Flare
Eligibility:
All Genders
2-19 years
Phase:
PHASE3
Brief 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
- 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 \< 16 years of age.
- Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
- Active disease at the time of enrollment defined as follows:
- At least 2 joints with active arthritis (using American College of rheumatology) ACR definition of active joint)
- Documented spiking, intermittent fever (body temperature \> 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00889863
Start Date
July 1 2009
End Date
September 1 2011
Last Update
October 16 2012
Active Locations (73)
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1
Arkansas Children's Hospital Research Inst
Little Rock, Arkansas, United States, 72202
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
University of Louisville
Louisville, Kentucky, United States, 40202