ISRCTN44988547进行中（未招募）4 期
The 3TR Molecular Pathobiology-Driven Precision Therapy in RA (3TR Precis-The-RA) study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •Patients will be recruited with active rheumatoid arthritis:
- •1. 2010 ACR / EULAR classification criteria for a diagnosis of rheumatoid arthritis *
- •2. Patients with csDMARD failure and eligible for anti-TNF therapy according to EULAR recommendations: treatment for = 3 months with = 1 csDMARDs **
- •3. Patients must have a DAS>5.1 and a minimum of 3 swollen joints – where the patient is undergoing a biopsy at visit 2, these should include the joint selected for biopsy and 2 other joints, 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 or over
- •6. Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
- •7. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study 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 EULAR recommendations are available at the following link: https://ard.bmj.com/content/79/6/685
- •***this inclusion criterion is only applicable to patients in the 3TR Precis-The-RA main study
- •The above inclusion criteria apply to patients in the main study. All inclusion criteria apply to the sub-study except inclusion criteria 4. There are 2 additional inclusion criteria for the 3TR Precis-The-RA sub-study, only listed below:
- •3TR-Precis-The-RA sub-study additional inclusion criteria:
- •1. Patients must have previously received a synovial biopsy prior to commencing any treatment for their RA, as part of the 3TR Early RA study, and are not eligible or willing to undergo a further biopsy.
- •2. The patient’s previous synovial biopsy tissue must have sufficient RNA for Nanostring analysis
排除标准
- •The following exclusion criteria apply to the 3TR Precis-The-RA main study. All exclusion criteria but exclusion criteria number 23 apply to the Sub study:
- •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.
- •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 any biologic/targeted DMARDs for 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, or known hypersensitivity to the IMP active substance or to any of the excipients of the IMP
- •17. Any other contra-indication to the study medications as detailed in the applicable SmPC
- •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. Patients with severe hepatic impairment (Child Pugh C classification).
- •27. Patients that are immunocompromised
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