ISRCTN95363507已完成2 期
A phase II trial of tocilizumab in anti-TNF refractory patients with JIA associated uveitis
niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 22 人开始时间: 2015年6月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30886955 protocol (added 20/03/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32280950 results (added 15/04/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children and young people aged at least 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 antiTNF 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:
- •5.1. Etanercept 2 weeks prior to registration
- •5.2. Adalimumab 4 weeks prior to registration
- •5.3. Abatacept 8 weeks prior to registration
- •5.4. Canakinumab 20 weeks prior to registration
- •5.5. Rilonacept 6 weeks prior to registration
- •5.6. 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
- •Target Gender: Male & Female; Upper Age Limit 18 years ; Lower Age Limit 4 years
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 antiVEGF 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. Intraocular pressure = 25mm Hg at time of screening.
- •11. On antiglaucoma 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. Autoimmune, 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, subacute, 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 8 weeks following the last dose of study drug
- •29. Immunization with a live/attenuated vaccine within 4 weeks prior to registration
- •30. Previous treatment with any cell depleting therapies, including investigational agents or approved therapies (e.g.CAMPATH, antiCD4, antiCD5, anti CD3, antiCD19 and antiCD20)
- •31. Treatment with intravenous gamma globulin or plasmapheresis within 24 weeks of registration
- •32. Any previous treatment with alkylating agents such as chlorambuci
研究者
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