EUCTR2015-001323-23-GB进行中（未招募）1 期
A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis. - APTITUDE
niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 21 人开始时间: 2015年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
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
入选标准
- •1)Children and young people aged = 2 and <18 years fulfilling ILAR diagnostic criteria for JIA (all subgroups that have uveitis).
- •2)At the time of trial screening the participant must have active anterior uveitis, defined as a sustained grade of cellular infiltrate in anterior chamber of SUN criteria grade =1+ or more during the preceding 6 weeks treatment.
- •3)Participants must have failed MTX (minimum dose of 10mg/m2, with a maximum dose of 20mg/m2 and not to exceed 25mg/participant) The participant must have been on MTX for at least 12 weeks and have been on a stable dose of MTX for 4 weeks prior to screening visit.
- •4)Participants must have failed an anti TNF agent (including etanercept, infliximab, golimumbab, certolizumab pegol or adalimumab) and have been on at least one anti-TNF agent regardless of dose for at least 12 weeks at any time previously.
- •5)If a patient has received previous treatment with any of the following biologic agents, these must have been discontinued according to the following timelines prior to registration:
- •Infliximab 8 weeks prior to registration.
- •Etanercept 2 weeks prior to registration.
- •Adalimumab 4 weeks prior to registration.
- •Abatacept 8 weeks prior to registration.
- •Canakinumab 20 weeks prior to registration.
- •Rilonacept 6 weeks prior to registration.
- •Anakinra 1 week prior to registration
- •If a patient has been on another biologic agent not listed above then please contact the trial team for appropriate washout period
- •6)Written informed consent of participant or parent/legal guardian, and assent where appropriate.
- •7)Participant and parent/legal guardian willing and able to comply with protocol requirements.
- •8)For participants of reproductive potential (males and females), use of a reliable means of contraception throughout their trial participation (abstinence is an acceptable method of contraception as long as this is the usual and preferred lifestyle of the patient.)
- •9)Post pubertal females must have a negative serum pregnancy test within 10 days prior to registration.
- •10)Able to commence trial treatment within 2 weeks of the screening visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1)Uveitis without a diagnosis of JIA
- •2)Currently on Tocilizumab or has previously received Tocilizumab.
- •3)Participation in another clinical trial of investigational medicinal product within the last 4 weeks or 5 serum half-lives (whichever is longer)
- •4)More than 6 topical steroid eye drops per day per eye at time of screening
- •5)For patients on Prednisone or Prednisone equivalent, change of dose within 30 days prior to registration
- •6)For patients on Prednisone or Prednisone equivalent with a dose >0.2mg/kg per day
- •7)No intraocular injection of disease modification agents including steroids and anti-VEGF within 6 months prior to registration.
- •8)No intraocular surgery for previous 12 weeks or expected/panned for duration of study.
- •9)Lack of recovery from recent surgery or surgery < 6 weeks at the time of registration
- •10)Intra-ocular pressure = 25mm Hg at time of screening.
- •11)On anti-glaucoma medications
- •12)No disease modifying immunosuppressive drugs, other than MTX in the 4 weeks prior to registration
- •13)History of active tuberculosis of less than 6 months treatment or untreated latent TB (a test for latent tuberculosis infection (LTBI) must be performed within twelve weeks prior to registration.
- •14)Latent TB not successfully treated for at least 4 weeks prior to registration
- •15) Auto-immune, rheumatic disease or overlap syndrome other than JIA.
- •16)Females who are pregnant, lactating, or intending to become pregnant during trial
- •17)Known human immunodeficiency virus infection or other condition characterized by a compromised immune system
- •18)Any history of alcohol or drug abuse within 6 months prior to registration
- •19)Any active acute, sub-acute, chronic, or recurrent bacterial, viral, systemic fungal, infection or any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of registration or treatment with oral antibiotics within 2 weeks of registration
- •20)History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months prior to registration
- •21)Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
- •22)History of concurrent serious gastrointestinal disorders
- •23)Evidence of current serious uncontrolled concomitant cardiovascular (including hyperlipidemia), nervous system, pulmonary (including obstructive pulmonary disease), renal and hepatic disease
- •24)History of or current cancer or lymphoma
- •25)Persistently poorly controlled severe hypertension (>95th percentile for height / age)
- •26)Uncontrolled diabetes mellitus
- •27)History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- •28)No live attenuated vaccines (including seasonal nasal flu vaccine, varicella vaccine for shingles or chickenpox, MMR or MMRV, oral polio vaccine and vaccines for yellow fever, measles, mumps or rubella) 4 weeks prior to registration, throughout the duration of the trial and for
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