Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Juvenile Idiopathic Arthritis With Active Flare

In brief

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.

Key facts

Study ID

NCT00889863

Run by

Novartis Pharmaceuticals

People needed

177

Starts

2009-07-01

Expected to finish

2011-09-01

Last updated by the study team

2012-10-16

Who can join

Age: 2 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• New England Medical Center - Department of Allergy — Boston, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• St Barnabas Ambulatory Care Center — Livingston, New Jersey, United States
• Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital/Neurology — Cincinnati, Ohio, United States
• Legacy Emanuel Hospital — Portland, Oregon, United States
• Legacy Emanual Research — Portland, Oregon, United States
• Specially For Children — Austin, Texas, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Capital Federal, Argentina
• Novartis Investigative Site — La Plata, Argentina
• Novartis Investigative site — Brussels, Belgium
• Novartis Investigative site — Ghent, Belgium
• Novartis Investigative Site — Laken, Belgium
• Novartis Investigative site — Leuven, Belgium
• Novartis Investigative Site — Curitiba, Brazil
• Novartis Investigative site — Porto Alegre, Brazil
• Novartis Investigative site — Rio de Janiero, Brazil
• Novartis Investigative site — São Paulo, Brazil
• Novartis Investigative site — Vancouver, British Columbia, Canada
• Novartis Investigative site — Halifax, Nova Scotia, Canada
• Arkansas Children's Hospital Research Inst — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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