Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Canakinumab; Placebo
Intervention description: Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.; Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
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; Systemic juvenile idiopathic arthritis with active flare

Summary:

      This study assessed the initial efficacy and safety of canakinumab over a 4 week period in
      patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to
      treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30
      criteria at Day 15.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed diagnosis of systemic juvenile idiopathic arthritis as per 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/quotidian for at least 3 days and
                  accompanied by one or more of the following:

               -  evanescent nonfixed erythematous rash,

               -  generalized lymph node enlargement,

               -  hepatomegaly and/ or splenomegaly,

               -  serositis

          2. Parent's or legal guardian's written informed consent and child's assent, if
             appropriate, or patient's informed consent for ≥ 18 years of age

          3. Male and female patients aged ≥ 2 to < 20 years of age

          4. Active disease at the time of enrollment defined as follows:

               -  At least 2 joints with active arthritis

               -  Documented spiking, intermittent fever (body temperature > 38°C) for at least 1
                  day during the screening period within 1 week before first canakinumab/placebo
                  dose

               -  C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)

          5. Naïve to canakinumab

          6. Other protocol defined inclusion criteria may apply

        Exclusion Criteria:

        Patients who fulfilled one or more of the following criteria were not eligible for
        inclusion in this study:

          1. Pregnant or nursing (lactating) female patients

          2. Female patients having reached sexual maturity unless their career, lifestyle, or
             sexual orientation precluded intercourse with a male partner and/or they were using an
             acceptable method of contraception

          3. History of hypersensitivity to study drug or to biologics.

          4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and
             Pistorio 2005) within the last 6 months

          5. With active or recurrent bacterial, fungal or viral infection, including patients with
             evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
             infection

          6. Other protocol defined exclusion criteria may apply