A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

CompletadoFase 3ClinicalTrials.gov

ID: NCT00889863Tipo: INTERVENTIONALInicio: 1 de jul de 2009Fin estimado: 1 de sept de 2011

Traducción no disponible, mostrando original

Resumen

This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 19 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of systemic juvenile idiopathic arthritis as per International League Against Rheumatism (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 for at least 3 days with accompanying symptoms
Active disease at the time of enrollment defined as follows:
At least 2 joints with active arthritis (using American College of rheumatology) ACR definition of active joint)
Documented spiking, intermittent fever (body temperature \> 38oC) for at least 1 day during the screening period within 1 week before first study drug dose
C-reactive protein \> 30 mg/L (normal range \< 10 mg/L)
No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
Stable dose of steroid treatment \< or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent

Criterios de exclusión

Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months
Risk factors for tuberculosis
Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection

Intervenciones

drug

canakinumab

Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.

drug

placebo

Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

La Plata, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

ColaboradorPediatric Rheumatology International Trials Organization

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