2022-502021-18-00招募中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
- 招募中
- 入组人数
- 182
- 试验地点
- 12
- 主要终点
- The primary endpoint of the study will be a binary outcome of treatment responder/nonresponder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks.
研究概览
简要总结
This study will test the utility of synovial tissue biomarkers (=drug target signatures) to enrich for treatment response in RA patients failing csDMARD therapy and starting on a biologic therapy (e.g. anti-TNF, IL6 inhibitor). The specific aim of the sub-study is to discover if a biopsy at presentation prior to any RA treatment (collected as part of the 3TR-PARTNER-RA study) can be used to determine treatment response even after the patient has received cDMARDs.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •2010 ACR / EULAR classification criteria for a diagnosis of Rheumatoid Arthritis
- •Patients with csDMARD failure and eligible for anti-TNF therapy according to EULAR recommendations: treatment for ≥3months with ≥ 1 csDMARDs
- •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
- •Selected joint for biopsy must be minimum grade 2 synovial thickening, as assessed at the biopsy visit
- •18 years of age or over
- •Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
- •Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
排除标准
- •Women who are pregnant or breast-feeding
- •Septic arthritis of a native joint within the last 12 months
- •Septic arthritis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ
- •Latent TB infection unless they have completed adequate antibiotic prophylaxis
- •Malignancy (other than basal cell carcinoma) within the last 10 years
- •New York Heart Association (NYHA) grade III or IV congestive heart failure
- •Demyelinating disease
- •Known allergy to latex, or known hypersensitivity to the study medication active substance or to any of the excipients of the IMP
- •Any other contra-indication to the study medications as detailed in the applicable SmPC
- •Receipt of live vaccine <4 weeks prior to first dose of study medication
- •Major surgery in 3 months prior to first dose of study medication
- •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
- •Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
- •Known recent substance abuse (drug or alcohol)
- •Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
- •Patients unable to tolerate synovial biopsy or in whom this is contraindicated including patients on anti-coagulants (e.g. warfarin). Patients on short-acting direct oral anticoagulant agents can be considered when anti-coagulant can be temporarily stopped, in line with local guidelines for procedures with a low risk of bleeding, taking into account the individual thromboembolic risk. Oral anti-platelet agents are permitted
- •Patients currently recruited to other clinical trials
- •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. This should include assessment of risk factors for known clinically important risks associated with a study drug
- •Patients with severe hepatic impairment (Child Pugh C classification)
- •Patients that are immunocompromised
- •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)
- •Prior exposure to any biologic/targeted DMARDs for RA
- •Treatment with any investigational agent ≤ 4 weeks prior to baseline or < 5 half-lives of the investigational drug (whichever is the longer)
- •Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to screening visit
- •Oral prednisolone more than 10mg/d or equivalent ≤ 4 weeks prior to baseline synovial biopsy
- •Active infection
- •Known HIV, active Hepatitis B/C infection. Hepatitis B screening test must be performed at or in the preceding 3 months of screening visit or in line with clinical practice
结局指标
主要结局
The primary endpoint of the study will be a binary outcome of treatment responder/nonresponder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks.
The primary endpoint of the study will be a binary outcome of treatment responder/nonresponder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks.
次要结局
- Percentage of patients with DAS28(ESR)<3.2 (LDA) at 12 weeks
- Percentage of patients with CDAI ≤10 (LDA) at 12 weeks
- Percentage of patients with CDAI remission at 12 weeks
- Change in HAQ-DI at 12 weeks from baseline
- Change in SF-36 at 12 weeks from baseline
研究者
Joanna Peel
Scientific
Queen Mary University Of London
研究点 (12)
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