PER-088-09已完成未知
An Open-label Extension Study of Canakinumab (ACZ885) 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 3 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
- 入组人数
- 3
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 patients> 18 years of age, before starting any activity related to the study.
- •The following patients are eligible to participate in the open label extension study (CACZ885G2301E1): • Patients of the CACZ885G2305 or CACZ885G2301 studies who achieved a Pediatric ACR 30 adapted 15 days after the initial dose of canakinumab but had an exacerbation in that moment or after it. • Patients of the CACZ885G2301 study who are not eligible to enter Part n (withdrawal part) because they failed to meet the admission criteria for corticosteroids (oral prednisone or equivalent 0.5 mg / kg) or could not gradually decrease corticosteroids at least 0.3 mg / kg (for detailed standards, refer to protocol CACZ885G2301) • Patients who responded in Part I or Part 11 and did not have an exacerbation when the CACZ885G2301 study was discontinued.
排除标准
- •Pregnant or breastfeeding women, with pregnancy defined as the status of the woman after conception and until the end of pregnancy, confirmed by a urinary pregnancy test with a positive result in the selection visit.
- •Women who have reached sexual maturity, that is, physiologically capable of becoming pregnant, UNLESS: • their profession, lifestyle or sexual orientation exclude sexual relations with a male partner and / or • are using an acceptable method of contraception with a failure rate (Pearl Index (PI)) <1. Reliable contraception should be used throughout the study and during the 2 months after discontinuation of the study medication.
- •History of hypersensitivity to study medication or biological products.
- •Biological manifestations 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) or a history of recurrent pericarditis, myocarditis, serositis and / or biological manifestations of MAS during the CACZ885G2305 or CACZ885G2301 studies.
- •Active or recurrent bacterial, fungal or viral infection at the time of recruitment, including patients with signs of Human Immunodeficiency Virus (HIV) infection, Hepatitis B infection and Hepatitis C. If no test was performed during the previous month, In visit 1 an HIV and hepatitis test should be performed as a follow-up test. However, the patient can receive the medication before the result is available, since this has already been confirmed in previous studies. More details on the positive results are given in Section 7.2.1.
- •Risk factors for tuberculosis (TB)
- •Underlying metabolic, renal, hepatic, infectious or gastrointestinal disorders that, in the opinion of the researcher, immunocompromise the patient and / or put him in the face of an unacceptable risk of receiving immunomodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty´s syndrome
- •Important medical conditions that, in the opinion of the researcher, exclude the patient from the study (can be analyzed with Novartis, case by case only)
- •History of malignancy in any functional system (outside localized cutaneous basal cell carcinoma), treated or untreated, within the last 5 years, regardless of whether or not there are signs of local recurrence or metastasis
- •History of autonomic dysfunction (eg, fainting, orthostatic hypotension, sinus arrhythmia).
- •Uncontrolled hypertension
- •Long QT syndrome or QTc (calculated using the Bazett formula)> 450 msec for men and> 470 msec for women) at the time of the PPW of CACZ885G2305 or CACZ885G2301 or at the end of the study CACZ885G2301
- •Live vaccines within 3 months prior to the start of the study. The use of dead or inactivated vaccines is authorized at the discretion of the investigator.
- •Donation or loss of blood (the amount depends on age and weight; for a volume of 10-20% or more, see Annex 3) within 8 weeks before the first administration, or for longer, if so established by local regulations.
- •Family or social situations that prevent periodic medical evaluation
- •History of substance or alcohol abuse within 12 months prior to administration.
研究者
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