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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Systemic Juvenile Idiopathic Arthritis

In brief

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 facts

Study ID

NCT00886769

Run by

Novartis Pharmaceuticals

People needed

84

Starts

2009-07-01

Expected to finish

2011-01-01

Last updated by the study team

2017-03-29

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 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
• 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
• Male and female patients aged ≥ 2 to < 20 years of age
• 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)
• Naïve to canakinumab
• Other protocol defined inclusion criteria may apply

You may not qualify if…

• Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:
• Pregnant or nursing (lactating) female patients
• 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
• History of hypersensitivity to study drug or to biologics.
• Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
• 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
• Other protocol defined exclusion criteria may apply

Where it is running

• Arkansas Children's Hospital Research Inst — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• 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
• Tufts Medical Center — Boston, Massachusetts, United States
• Tufts New England Medical Center-Dept. of Allergy — 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 — Cinncinati, Ohio, United States
• Nationwide Children's Hospital — Columbus, 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 Janeiro, Brazil
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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