EUCTR2008-005476-27-IT进行中（未招募）不适用
A randomized, double-blind, placebo controlled, singledose 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 - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Parents or legal guardians written informed consent and childs assent, if appropriate, or patients informed consent for ≥ 18 years of age before any study related activity is performed. 2. Male and female patients aged ≥ 2 to < 20 years of age at the time of the screening visit 3. Confirmed diagnosis of SJIA as per ILAR definition (Petty et al, 2004) that must have occurred at least 2 months prior to enrollment with an 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 4. Active disease at the time of enrollment defined as follows: At least 2 joints with active arthritis (using ACR definition of active joint) Documented spiking, intermittent fever (body temperature > 38C) for at least 3 days during the screening period (minimum duration of screening 3 days) before first canakinumab/placebo dose C-reactive protein > 30 mg/L (normal range < 10 mg/L) 5. Na?ve to canakinumab 6. Patients willingness to discontinue anakinra, rilonacept, tocilizumab or other experimental drug under close monitoring (please refer to section 5.2 Exclusion criteria #15 for washout period) 7. 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 (maximum of 20 mg/ m2/ week) for at least 8 weeks prior to the screening visit, and folic/folinic acid supplementation (according to standard medical practice of the center) Stable dose of no more than one non-steroidal anti-inflammatory drug (NSAID) for at least 2 weeks prior to the screening visit PLS SEE PROTOCOL
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria Patients who fulfill one or more of the following criteria will not be eligible for inclusion in this study: 1. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ mL) at screening visit 2. Female patients having reached sexual maturity, i.e. being physiologically capable of becoming pregnant UNLESS they are: female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and/or using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1. Reliable contraception should be maintained throughout the study and for 2 months after study drug discontinuation. 3. History of hypersensitivity to study drug or to biologics. 4. Biologic features of MAS such as hemorrhages, central nervous system dysfunction, hepatomegaly, plasma fibrinogen level < 2.5 g/L, cytopenia, hypertriglyceridemia, decreased platelet count, increased aspartate transaminase, hyperferritinemia (Ravelli, Magni-Manzoni and Pistorio 2005) at screening or a history of recurrent pericarditis, myocarditis, serositis and/ or biologic features of MAS over the last 6 months 5. 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 6. Risk factors for tuberculosis (TB) such as: History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection); health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient, or Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last year 7. 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 in an immunodulatory therapy. PLS SEE PROTOCOL
研究者
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