ISRCTN10618686已完成未知
Stratification of Biologic Therapies for Rheumatoid Arthritis by Pathobiology (STRAP): A randomised, open-labelled biopsy driven stratification trial in DMARD inadequate responder patients randomised to etanercept, tocilizumab or rituximab
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 187
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 08/09/2017:
- •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. Patients must have a minimum of 3 swollen joints – the joint selected for biopsy and a minimum of 2 from 28 joint count set, as assessed at biopsy visit
- •4. Selected joint for biopsy must be minimum grade 2 synovial thickening, as assessed at the biopsy visit
- •5. 18 years of age and over
- •6. 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.
- •** Current NICE guidelines available at the following link: http://www.nice.org.uk/guidance/ta375.
- •Previous inclusion criteria:
- •1. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of RA
- •2. Patient with DMARD failure eligible for antiTNFa therapy as per UK NICE guidelines (those who have both of the following):
- •2.1. Active RA as measured by DAS28>5.1
- •2.2. 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.
- •3. Over 18 years of age
- •4. Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
排除标准
- •Current exclusion criteria as of 08/09/2017:
- •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; 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 other 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 screening visit.
- •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 infection. 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 allergy to latex, Rituximab, Tocilizumab or Etanercept
- •17. Any other contra-indication to the study medications as detailed in the applicable SmPC including low IgG levels, at physician’s discretion
- •18. Receipt of live vaccine <4 weeks prior to first IMP infusion or dose
- •19. Major surgery in 3 months prior to first IMP infusion or dose
- •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 including patients on anti-coagulants. Oral anti-platelet agents are permitted.
- •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
- •26. For patients potentially eligible for MRI any of the following c
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