EUCTR2013-004867-29-SE进行中（未招募）1 期
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and SafetywIth FIrst-line use of CanakinumabAn open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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- Cohort 1:
- •Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for =18 years of age must be obtained before any study related activity or assessment is performed.
- •Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for SJIA and have inactive disease at the last visit in Study CACZ885G2301E1 .
- •Inclusion Criteria- Cohort 2:
- •Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for = 18 years of age must be obtained before any study related activity or assessment is performed.
- •Male and female patients aged = 2 to < 20 years at the time of the screening visit
- •Confirmed diagnosis of SJIA as per ILAR definition 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 non-fixed erythematous rash,
- •Generalized lymph node enlargement,
- •Hepatomegaly and/ or splenomegaly,
- •Serositis
- •Active SJIA at the time of baseline visit 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 (using ACR definition of active joint),
- •C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L),
- •Serositis,
- •Lymphadenopathy,
- •Hepatosplenomegaly
- •Patient’s willingness to discontinue anakinra, rilonacept, tocilizumab, abatacept or other experimental or approved drug under close monitoring (Please refer to Cohort 2 exclusion criteria #16 for washout period.)
- •Negative QuantiFERON (QF) test (or, if required by local guidelines, negative Purified Protein Derivative [PPD] test [< 5 mm induration]) at screening or within 1 month prior to the screening visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 163
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria – Cohort 1 and Cohort 2:
- •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.
- •Female patients of child-bearing potential, defined as all females physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods defined in protocol.
- •History of hypersensitivity to study drug or to biologics.
- •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.
- •History or evidence of tuberculosis (TB) (active or latent) infection or one of the risk factors for tuberculosis (TB) as defined in protocol.
- •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 immunomodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome.
- •With neutropenia (absolute neutrophil count < 1500/mm3) at screening
研究者
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