About
Study Design
A longitudinal observational study of an early RA inception cohort
Working Hypothesis
Our working hypothesis is that a suite of immunological assays (“the immunological toolkit”) can be used to accurately predict clinical responses to therapy at a molecular and cellular level. We also propose that immune based assays can be adapted to define an immune signature associated with a state of sustained clinical remission in patients with early RA. This study protocol seeks to recruit a large cohort of patients with early RA. Biological samples will be acquired from study subjects and used to develop the immunological toolkit, through the identification of baseline biomarker signatures (prior to starting therapy), and by documenting the changes in the immune system in response to therapeutic intervention.
Key Inclusion Criteria
- Diagnosis of early RA using either 1987 ACR or the 2010 ACR/EULAR criteria
- Positive for serum rheumatoid factor and anti-citrullinated protein autoantibodies (ACPA)
- Within 12 months of symptom onset
- Able and willing to give informed consent to provide clinical data and blood samples at defined time points for the duration of the study
- Aged over 18 years
Key Exclusion Criteria
- Previous treatment with DMARDS or biologics
- Corticosteroid treatment for the current episode of inflammatory arthritis within the last 12 months
- Pregnant
- Significant co-morbidities
Study treatment
The study is observational, meaning that we are just looking at how arthritis responds to standard therapy in patients, rather than testing the effects of new treatments. Patients who have been diagnosed with early RA, within 12 months of symptom onset, will receive treatment according to NICE guidelines.
Sample Size
410 Patients.
Study duration
Patients will be in the study for 18 months
Assessments:
Visits will comprise a detailed assessment of disease activity (including standard blood monitoring for DMARDs, TNF inhibitors or other biological agents, as appropriate) along with completion of a number of questionnaires and the provision of additional blood and urine samples for immunoanalysis.
X-rays of the hands and feet will be taken at Baseline, 12 and 18 months.
Where Ultrasound scanning is offered as part of routine care participants may have high resolution ultrasound scanning (HRUS) of affected joints performed at Baseline, 6, 12 and 18 (optional) months.