EUCTR2017-004079-30-BE进行中（未招募）1 期
Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-E
Joint Research & Development Office (QMUL)0 个研究点目标入组 223 人开始时间: 2018年2月19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
- 223
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
- 性别
- All
入选标准
- •Patients will be recruited with active RA:
- •1. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of RA *
- •2. Patient with DMARD failure eligible for anti-TNF-a therapy as per UK NICE guidelines **
- •3. 18 years of age and over
- •4. Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
- •*The ACR/EULAR classification for a diagnosis of RA could have been at any time in the patient’s disease history; the score does not need to be 6 or more at screening.
- •** According to the National Institute for Health and Care Excellence (NICE) guidelines (TA 130), the TNF-a inhibitors are recommended as options for the treatment of adults who have both of the following characteristics:
- •1. Active RA as measured by DAS28>5.1 confirmed on at least two occasions, 1 month apart.
- •2. Have undergone trials of two DMARDs, including MTX (unless contraindicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at standard dose, unless significant toxicity has limited the dose or duration of treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients will be excluded if they have any contraindication to Etanercept, Rituximab or Tocilizumab therapy:
- •1.Women who are pregnant or breast-feeding
- •2.Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling to use an effective method of contraception (recommend double contraception) throughout the trial and beyond the end of trial treatment for the duration as defined in the relevant SmPC or IB; 12 months for Rituximab, at least 3 weeks for Etanercept, and at least 3 months for Tocilizumab.
- •3.History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than RA (if secondary to RA, then the patient is still eligible).
- •4.Prior exposure to Rituximab, any anti-TNF, Tocilizumab, or any biologic for treatment of RA
- •5.Treatment with any investigational agent = 4 weeks prior to baseline or < 5 half-lives of the investigational drug (whichever is the longer)
- •6.Intra-articular or parenteral corticosteroids = 4 weeks prior to baseline synovial biopsy.
- •7.Oral prednisolone more than 10mg/d or equivalent = 4 weeks prior to baseline synovial biopsy.
- •8.Active infection
- •9.Known HIV, active Hepatitis B/C. Hepatitis B screening test must be performed at or in the preceding 3 months of screening visit.
- •10.Septic arthritis of a native joint within the last 12 months
- •11.Septic arthritis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
- •12.Latent TB infection unless they have completed adequate antibiotic prophylaxis
- •13.Malignancy (other than basal cell carcinoma) within the last 10 years
- •14.New York Heart Association (NYHA) grade III or IV congestive heart failure
- •15.Demyelinating disease
- •16.Known latex allergy; known allergy to Rituximab, Tocilizumab or Etanercept
- •17.Any other contra-indication to the study medications as detailed in their SmPC, including low IgG levels, at physician’s discretion
- •18.Receipt of live vaccine <4 weeks prior to first infusion
- •19.Major surgery in 3 months prior to first infusion
- •20.Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
- •21.Known recent substance abuse (drug or alcohol)
- •22.Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
- •23.Patients unable to tolerate synovial biopsy or in whom this is contraindicated (e.g. patients on anti-coagulants may not be suitable). However, assessment of suitability for the biopsy procedure will be a local clinical decision.
- •24.Patients currently recruited to other clinical trials
- •25.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •The PI reserves the right to exclude patients at his centre, if they have concerns regarding compliance with the study procedures or any other aspect of the study eligibility not necessarily limited to the above exclusion criteria.
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