An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

CompletadoFase 3ClinicalTrials.gov

ID: NCT00891046Tipo: INTERVENTIONALInicio: 1 de sept de 2009Fin estimado: 1 de dic de 2014

Traducción no disponible, mostrando original

Resumen

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 19 YearsSexo: ALL

Criterios de inclusión

Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in Part II.
Treatment-naïve patients need to meet the following criteria:
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
Male and female patients aged ≥ 2 to \< 20 years of age
Active disease at the time of enrollment defined as having 2 or more of the following:
Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose
At least 2 joints with active arthritis
AND C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L) Rash Serositis Lymphadenopathy Hepatosplenomegaly
Naïve to canakinumab

Criterios de exclusión

History of allergy or hypersensitivity to study drug
With active or recurrent bacterial, fungal or viral infections at time of enrollment

Intervenciones

drug

Canakinumab

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

ColaboradorPediatric Rheumatology International Trials Organization

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