Conditions: Systemic Juvenile Idiopathic Arthritis
Keywords: Flare arthritis IL-1beta antagonist systemic juvenile idiopathic arthritis Juvenile Rheumatoid Systemic juvenile idiopathic arthritis with active flare
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections. arm 2: Patients received a single dose matching placebo of canakinumab on day 1.

Interventions: intervention 1: Canakinumab intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: