A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

TerminadoFase 3ClinicalTrials.gov

ID: NCT00886769Tipo: INTERVENTIONALInicio: 1 de jul de 2009Fin estimado: 1 de ene de 2011

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 19 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Canakinumab

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.

drug

Placebo

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.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

La Plata, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

ColaboradorInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group

ColaboradorSouthwest Pediatric Nephrology Study Group

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