PER-004-10已完成未知
A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 11
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 17（—）
入选标准
- •Documented evidence of juvenile idiopathic arthritis of polyarticular course (JIAP): Subgroup of polyarthritis of AU Positive rheumatoid factor or negative rheumatoid factor (JIA) for at least 6 months. Understanding oligoarticular JIA (AlJoe) of active polyarticular course for at least 6 months before admission to the study according to the ILAR Criteria [8]
- •The JIA of polyarticular course requires the presence of active disease with at least five joints with active arthritis (the joints that are inflamed or if they are not inflamed that have limited movement accompanied with pain on palpation or both) both in the selection as in the initial one (with at least three of the active joints with limited movement).
- •Age of 2 years up to and including 17 years of age at the time of enrollment
- •Comply with one of the following: that they have an inadequate response to MTX or cannot tolerate MTX
- •That they comply with one of the following: that they have not received MTX for at least 4 weeks before the initial visit. Have taken MTX for at least 12 weeks immediately before the initial visit and a stable dose> 10 to <20 mg / m ^ for at least 8 weeks before the initial visit, together with folic acid or folinic acid.
- •Complying with one of the following: they are not currently receiving oral corticosteroids - or - they are taking corticosteroids at a stable dose for a minimum of 4 weeks before the initial visit at no more than 10 mg / day or 0.2 mg / kg / day, whichever is less.
- •Fertility: women who are not of childbearing age, or women of reproductive age who are taking effective contraceptive measures, who have a negative urine pregnancy test within three weeks prior to randomization; or sterile men, or non-sterile men who carry out effective contraceptive measures with partners of reproductive age.
- •Comply with one of the following: are not taking NSAIDs -or- they are taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks before the initial visit and is less than or equal to the maximum daily dose recommended;
- •Comply with one of the following: they were never treated with biological products -or- if they were previously treated, they must have suspended anakinra> 1 week before the initial one, etanercept> 2 weeks before the initial one, rilonacept> 5 weeks before the initial one , infliximab or adalimumab> 8 weeks before the initial one, abatacept> 12 weeks before the initial one or canakinumab> 20 weeks before the initial one.
- •Written informed consent to participate in the study obtained from the parents or legal guardian with the corresponding consent of the patient, depending on the patient´s level of understanding.
排除标准
- •Confined to a wheelchair or a bed or have little or no personal care capability;
- •Any other rheumatic autoimmune disease or syndrome that overlaps connective tissue other than that of the JIA subgroups of polyarticular course; Polyarticular JIA Positive rheumatoid factor, Polyarticular JIA Negative rheumatoid factor, and extended oligoarticular JIA. Excluded diseases include, but are not limited to systemic juvenile idiopathic arthritis, Lyme disease, enthesitis-related arthritis; psoriatic arthritis, Reiter´s syndrome, systemic lupus erythematosus, infectious or reactive arthritis or parvovirus infections (See Appendix 1 for definitions)
- •They have not fully recovered from a recent surgery or less than 6 weeks since the surgery, at the time of the selection visit; o surgery planned during the initial 40 weeks of the study;
- •Lack of peripheral venous access or do not wish to undergo multiple venipunctions;
- •Pregnancy, lactation or intention to get pregnant during the study and up to 12 weeks after the last administration of the study medication;
- •Any concurrent medical or surgical condition that jeopardizes the patient´s safety or the ability to complete the study;
- •History of considerable infusion reactions or allergic to previous biological treatment;
- •History or primary or secondary immunodeficiency currently active.
- •History of alcoholism, drug addiction or abuse of chemical substances within 1 year of selection;
- •Evidence of serious uncontrolled concomitant diseases, including but not limited to, cardiovascular, pulmonary, nervous, renal, hepatic or endocrine system.
- •Any acute, subacute, chronic or recurrent bacterial, mycobacterial, viral or fungal systemic infection or opportunistic infection.
- •Active TB that required treatment within 2 years prior to the selection visit or currently active TB;
- •Positive PPD in the selection unless it is confirmed by radiography that it is negative for active tuberculosis in the selection and the patient has been treated with antituberculosis drugs for at least 4 weeks before receiving the study medication;
- •Any major episode of infection that requires hospitalization or treatment during selection or treatment with antibiotics i.v. completed within 4 weeks of the selection visit or oral antibiotics completed within 2 weeks of the selection visit
- •History of known recurrent or current active infectious disease, including, but not limited to chronic kidney infection, chronic lung infections (eg bronchiectasis), an open or drained or infected skin wound, sinusitis, recurrent urinary tract infection ( for example, recurrent pyelonephritis)
- •History of reactivation or new occurrence of a systemic infection such as herpes zoster or Epstein Barr virus within two months of the selection visit;
- •Surface Ag of Hepatitis B or Ab of Hepatitis C positive;
- •Chronic hepatitis
- •Major heart or lung disease [eg, congenital heart disease, valvular heart disease, constrictive pericarditis, myocarditis] (for example, asthma, cystitis, fibrosis)
研究者
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