PER-086-09已完成未知
A Randomized, Double-blind, Placebo Controlled, Single-dose 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
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2009年9月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 20（—）
- 性别
- All
入选标准
- •Written informed consent of the parent or legal guardian and consent of the child, if applicable, or informed consent of the patient for 18 years of age before performing any activity related to the study.
- •Male and female patients 2 2 to <20 years of age at the time of the selection visit
- •Confirmed diagnosis of JIA according to the definition of ILAR (Petty et al 2004) that must have been made at least 2 months before enrollment with a disease onset <16 years of age
- •Active disease at the time of enrollment
- •That you have never received Canakinumab
- •8. Will of the patient to discontinue anakinra, rilonacept, tocilizumab or other experimental drug under close monitoring
- •Concomitant use of second-line agents as disease-modifying and / or immunosuppressive drugs will not be allowed.
- •Negative Purified Protein Derivative Test (PPD) (Induration <5 mm) in the selection or within the month prior to selection. Patients with a positive PPD test (Induration s 5 mm) in the selection can only enroll if they have a negative chest x-ray or a negative QuantlFERON test (QFT-TB G In-Tube).
排除标准
- •Patients who are pregnant or breastfeeding women (infants), understanding pregnancy as the status of a woman after conception and until termination of pregnancy, confirmed by a laboratory test of positive hCG (> 5 mlU / mi) at the visit of selection
- •Female patients who have reached sexual maturity, that is, who are physiologically fit to get pregnant
- •History of hypersensitivity to the study drug or biological.
- •Biological features of SAM, 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 Ravelli, Magni -Manzoni and Pistorio 2005) in the selection, or history of recurrent pericarditis, myocarditis, serositis and / or biological features of SAM during the last 6 months.
- •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 infection and Hepatitis C
- •Some of the risk factors for tuberculosis (TE)
- •With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions that, in the opinion of the Researcher, immunocompromise the patient and / or place him at an unacceptable risk by participating in an immunomodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty´s syndrome
- •With significant medical conditions that, in the opinion of the Investigator, would exclude the patient from the study (can be analyzed on a case-by-case basis with Novartis)
- •History of malignant disease of any organic system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis
- •History of autonomic dysfunction (eg history of fainting, orthostatic hypotension, sinus arrhythmia)
- •Poorly controlled hypertension
- •Prolonged QT syndrome or QTc (calculated using the Bazett formula)> 450 msec for men and> 470 msec for women in the selection or baseline evaluation
- •Clinical evidence of liver disease or liver injury Indicated by abnormal liver function tests in the selection such as AST, ALT, GGT, alkaline phosphatase or serum billrublna (should not exceed twice the upper limit of the normal range for age)
- •Presence of moderately or severely impaired renal function, indicated by clinically significant normal values of creatinine (> 1.5 times the upper limit of normal (ULN)) or urea or abnormal urine constituents (eg albuminuria) in the selection. Evidence of urinary obstruction or difficulty in urination, in the selection.
- •Live vaccines within 3 months prior to the start of the study. Dead or inactivated vaccines may be allowed at the investigator´s discretion.
- •Donation or loss of blood (the amount depends on age and weight, 10-20% or more of the volume, see Appendix 3) within 8 weeks prior to the administration of the study drug, or more if so They demand local regulations.
- •Family or social conditions that prevent regular medical evaluation.
- •History of drug or alcohol abuse within 12 months prior to the administration of the study drug.
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