Rheumatoid arthritis Musculoskeletal Diseases
Conditions
Interventions
Patients will be randomised using the online database 1:1 to a control or treatment allocation by a biomarker-driven group. If randomised to the intervention arm (treatment by biomarker), the patient’
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be a binary outcome of treatment responder/non-responder classified using American College of Rheumatology 50 (ACR-50) measure at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment response measured using the percentage of patients with DAS28(ESR)<3.2 (LDA) at 12 weeks 2. Treatment response measured using the percentage of patients with CDAI =10 (LDA) at 12 weeks 3. Treatment response measured using the percentage of patients with CDAI remission at 12 weeks 4. Functional ability and improvement in other aspects of the patient's life measured using the change in HAQ-DI at 12 weeks from baseline 5. Functional ability and improvement in other aspects of the patient's life measured using the change in SF-36 at 12 weeks from baseline | — |
Countries
Belgium, England, Italy, Netherlands, Portugal, Spain, United Kingdom
Contacts
Public ContactLouise Warren
Outcome results
None listed