Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Condition: Systemic Juvenile Idiopathic Arthritis With Active Flare
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: canakinumab; placebo
Intervention description: Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.; Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 2 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Flare; arthritis; IL-1beta antagonist; systemic juvenile idiopathic arthritis; Juvenile rheumatoid

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 < 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