rheumatoid arthritis, rheuma
Conditions
Interventions
None listed
Sponsors
Humanitas University, Milano
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 or over with a diagnosis of rheumatoid arthritis (2010 ACR/EULAR criteria) and meeting the Difficult-to-treat RA definition* 2. Willing and capable of giving informed consent, and the consent must be obtained prior to any study-specific screening procedures 3. At least one swollen joint, which is amenable to synovial biopsy 4. Patient is judged by the supervising clinician to be a suitable candidate based upon medical history, physical examination, vital signs, and routine laboratory tests 5 Willing and able to comply with scheduled visits, laboratory tests, and other study procedures *Difficult-to-Treat: 1) Treatment according to European League Against Rheumatism (EULAR) recommendation and failure of =2 bDMARDs)/tsDMARDs (with different mechanisms of action) after failing conventional synthetic DMARD therapy (unless contraindicated); (2) presence of at least one of the following: at least moderate disease activity; signs and/or symptoms suggestive of active disease; inability to taper glucocorticoid treatment; rapid radiographic progression; RA symptoms that are causing a reduction in quality of life; and (3) the management of signs and/or symptoms is perceived as problematic by the rheumatologist and/or the patient
Exclusion criteria
Exclusion criteria: 1. Patients in whom synovial biopsy is contra-indicated (e.g., taking anti-coagulants), or in whom this is contraindicated at physician’s discretion (e.g., patients with bleeding disorders). 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. 2. Patients in whom there is no suitable joint for biopsy 3. Patients with a serious underlying medical disorder (e.g., end-stage renal disease, severe respiratory failure) 4. Poor tolerability of venopuncture or lack of adequate venous access for required blood sampling during the study period 5. Intra-articular or parenteral corticosteroids =4 weeks prior to the biopsy/baseline visit and patients taking > 10mg/day prednisone or equivalent.6. Active infection or any other contraindications to start TNFi, IL6Ri, or JAKi, as per local/international guidelines and SmPC 7. Pregnant women 8. Individuals who are unable to give informed consent for any reason (vulnerable groups).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PrOb-MDR-RA will enable the development of a prospective observational MDR-RA patients cohort, with high-quality clinical and imaging data, together with a comprehensive collection of biological samples (blood and synovial tissue), followed-up for an adequate period of time to provide consistent outcomes. | — |
Countries
Austria, Belgium, Denmark, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactJ.M. van Laar
Universitair Medisch Centrum Utrecht
Outcome results
None listed