jRCT2011200022进行中（未招募）不适用
An open-label, single-arm, active-treatment study to evaluate efficacy and safety of canakinumab (ACZ885) administered for at least 48 weeks in Japanese patients with Adult Onset Still's Disease (AOSD)
Novartis Pharma. K.K.0 个研究点目标入组 21 人开始时间: 2021年3月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 16age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation in the study. Parent's or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for participants < 20 years of age
- •Japanese male and female participants aged >= 16 years
- •Confirmed diagnosis of AOSD as per Yamaguchi criteria (Yamaguchi M, 1992) with an onset of disease >= 16 years of age. Yamaguchi criteria requires at least five criteria, including two major criteria and no exclusion criteria:
- •Major criteria
- •Fever >= 39 degree lasting 1 week or more
- •Arthralgia lasting 2 weeks or more
- •Typical skin rash: maculopapular, nonpruritic, salmon-pink rash with concomitant fever spikes
- •Leukocytosis >=10,000/mm3 with neutrophil polymorphonuclear proportion >= 80%
- •Minor criteria
- •Pharyngitis or sore throat
- •Lymphadenopathy and/or splenomegaly
- •Liver enzyme abnormalities
- •Negative for RF or antinuclear antibodies
- •Exclusion criteria
- •Infection, especially sepsis and Epstein-Barr viral infection
- •Malignant diseases, especially malignant lymphomas
- •Inflammatory disease, especially polyarteritis nodosa
- •Active disease at the time of baseline defined as follows
- •Fever (body temperature > 38 degree) due to AOSD for at least 1 day within 1 week before baseline
- •At least 2 active joints (tender or swollen)
- •CRP >= 10 mg/L
- •Participants who have history of inadequate response to more than 2 weeks of corticosteroids equivalent to at least 0.4 mg/kg/day of prednisolone
排除标准
- •History/evidence of active MAS or disseminated intravascular coagulation (DIC) prior to 6 months of enrollment.
- •With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator compromises the participant and/ or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
- •Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests at screening such as Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP)(must not exceed 3 times the upper limit value of the normal range for age), or serum bilirubin (must not exceed twice the upper limit value of the normal range for age).
- •With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including participants with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
结局指标
主要结局
-
Proportion of participants who achieve adapted ACR 30 response at Week 8
次要结局
未报告次要终点
研究者
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