Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

Conditions

• Systemic Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

2 Years - 19 Years

Healthy Volunteers

Not accepted

Interventions

• Canakinumab — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jul 31, 2009

Status verified

Feb 2017

Primary completion

Dec 31, 2010

Completion

Jan 31, 2011

Study Design

Enrollment

84 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab
  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.
• Placebo Comparator: Placebo
  Patients received a single dose matching placebo of canakinumab on day 1.

Primary Outcome Measure

Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria [ Time Frame: Baseline, Day 15, Day 29 ]

Locations (15)

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