An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

ovartis Pharma K.K.0 个研究点目标入组 20 人开始时间: 2015年4月6日最近更新: 2023年10月17日

试验速览

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•Inclusion Criteria
•- Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an onset of disease less than 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: Rash due to SJIA,lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis
•- Active disease at the time of baseline defined as follows:
•-At least 2 joints with active arthritis
•-Documented spiking, intermittent fever (body temperature more than 38 degrees Celsius) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose
•-CRP more than 30 mg/L(3 mg/dL) (normal range less than 10 mg/L(1 mg/dL))
•-Negative TB screen (Chest X-ray and T-SPOT test)

•Exclusion Criteria:
•-With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody).
•-With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
•-With neutropenia (absolute neutrophil count less than 1500/mm3) at screening.

发起方

ovartis Pharma K.K.