Rheumatoid arthritis arthritis
Conditions
Interventions
To create a biomedical resource/biobank for the deep immunophenotyping of synovial biopsies, including at single-cell level, in order to validate the response signatures from previous biopsy-driven st
Sponsors
Queen Mary University of London
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults (18 and over) with a diagnosis of rheumatoid arthritis (2010 ACR/EULAR criteria) Failure of TNF inhibitor, either as monotherapy or in combination with csDMARDs, switching to a different TNFi, an IL6Ri or a JAKi Eligible to start a TNFi, IL6Ri, or JAKi, according to local pathways/guidelines Patients on any csDMARDs at the time of starting their biologic should be on a stable dose in the 4 weeks prior the baseline visit At least one swollen joint amenable to synovial biopsy (minimum grade 2 synovial thickening, as assessed at the biopsy visit) Minimum 3 swollen joints (including the joint selected for biopsy) and a minimum DAS28 (ESR) score of 3.2 at screening. Patient is judged by the supervising clinician to be a suitable candidate based upon medical history, physical examination, vital signs, and routine laboratory tests Willing and capable of giving informed consent, which must be obtained prior to any study-specific screening procedures Willing and able to comply with scheduled visits, laboratory tests, and other study procedures
Exclusion criteria
Exclusion criteria: Patients unable to tolerate synovial biopsy or in whom this is contraindicated including patients on anti-coagulants (e.g. warfarin), or in whom this is contraindicated at physician’s discretion (e.g. patients with bleeding disorders, or patients with liver disease). Patients on short-acting direct oral anticoagulant agents can be considered when anti-coagulant can be continued or temporarily procedures with a low risk of bleeding. Oral anti-platelet agents are permitted. Patients in whom there is no suitable joint for biopsyPatients who are stopping their previously prescribed TNF inhibitor due to toxicity/side-effects, rather than failure to respond. Intra-articular or parenteral corticosteroids =4 weeks prior to the biopsy/baseline visit. Oral prednisolone more than 10mg/d or equivalent =4 weeks prior to the biopsy/baseline visit. If patients are taking oral corticosteroids during this period, they must be on a stable dose (i.e. they must not start or change dose during this period). Patients with a serious underlying medical disorder (e.g. end stage renal disease) Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period Active infection or any other contraindications to start TNFi, IL6Ri, or JAKi, as per local/international guidelines and SmPc (including specific risk assessment for CV events, venous thromboembolism (VTE), cancer, and infections for JAKi) Individuals who are unable to give informed consent for any reason (vulnerable groups).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rheumatoid arthritis disease activity measured in the Clinical Disease Activity Index at 16 weeks from baseline at week 0 in each medication group (Tumor Necrosis Factor, Interleukin 6, & Janus kinase inhibitors) and within the whole population | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of patients with ultrasound-defined remission (ST/PD<=1) vs patients with active synovitis at ultrasound (ST/PD>1) at 16 weeks 2. The percentage of patients with Disease Activity Score-28 for Rheumatoid Arthritis with ESR (DAS28-ESR) below 3.2 at 16 weeks 3. The percentage of patients with a Clinical Disease Activity Index between 2.8 and 10 (Low Disease Activity) at 16 weeks 4. The percentage of patients with a Clinical Disease Activity Index below 2.8 (in remission) at 16 weeks 5. Disability, pain, medication effects, costs of care, and mortality measured using the Health Assessment Questionnaire (HAQ-DI) at 16 weeks from baseline. 6. Health status of particular populations measured using the Short Form Health Survey (SF-36) at 16 weeks from baseline at week 0 | — |
Countries
Germany, Italy, Netherlands, Norway, Sweden, United Kingdom
Contacts
Public ContactR Knevel
Leids Universitair Medisch Centrum
Outcome results
None listed