Patients will be reviewed and samples collected at baseline, six and twelve months. Thereafter the clinical cohort will be followed up bi-annually.
- Demographics – age, gender, ethnicity, Carstairs index, marital status, CHI number.
- Employment – current employment status, including an assessment of absenteeism.
- Referral – date of symptom onset, date of referral and date of diagnosis
- Past medical history, smoking history, alcohol intake, drug therapy
- ACR/EULAR 2010 classification criteria
- Clinical – BMI, swollen joint count, tender joint count, patient global assessment of disease activity (VAS 0-100mm), assessor’s global assessment of disease activity (VAS 0-100mm), pain score (VAS 0-100mm), duration of morning stiffness, disease activity score, Health assessment questionnaire, Hospital Anxiety and Depression questionnaire and EQ5-D questionnaire
- Laboratory and radiographic – urea, creatinine, full blood count, ESR or plasma viscosity, CRP, total cholesterol, HDL-cholesterol, rheumatoid factor and/or anti-CCP antibodies, appearances at musculoskeletal ultrasound (where performed) and plain digital radiographs of hands and feet.
All control subjects will be asked to complete the three questionnaires (HAD, HAQ and EQ5-D). First degree relatives will not require clinical assessment and will be assessed once. TNFi treated controls will receive the same assessments as the SERA patients, and will be assessed twice, at baseline and after 6 months of TNFi therapy (or at the point of discontinuation if this occurs earlier than 6 months).
Data will be entered on an eCRF developed by the Robertson Centre, University of Glasgow who will also co-ordinate data validation checks and query resolution.
Biological Samples for Biobank
Urine and up to 100ml of blood will be collected from patients comprising whole blood, PBMC, serum and plasma and will be taken and stored (or analysed) at baseline, six and twelve months. Similar samples would be collected from control subjects at baseline only.
Biological Sample Collection and storage
|Sample type||Collection Tube||Volume||Lab Analysis||Aliquots||Sample storage|
|Whole Blood||Paxgene RNA||2.5ml x 2||RNA||None as stored in Paxgene tubes||-80°C|
|Serum||SST/Plain||5ml → 2ml||Immunoassay||4 x 500ul||-80°C|
|Plasma||Lithium||5ml → 2ml||Immunoassay||4 x 500ul||-80°C|
|Plasma||EDTA/BDP100||10ml → 5ml||Immunoassay Proteomics Metabolomics||10 x 500ul||-80°C|
|Plasma||EDTA||5ml → 2ml||Metabolomics||4 x 500ul||-80°C|
|Whole blood||EDTA/Citrate/ Heparin||50mls||FACS, lymphocyte studies||None – used immediately||N/A|
|Urine||Universal container||4 mls||Proteomics, metabolomics||4 x 1ml||-80°C|
Samples will be stored in the SAHSC bio-repositories in the academic teaching centres before being centralised in the Greater Glasgow & Clyde NHS Biobank.
Periodically, some patients will attend for scheduled or unscheduled visits at which they require therapeutic or diagnostic aspiration of synovial fluid. After using any fluid required for diagnostic purposes, the residual synovial fluid will be used for analysis and storage in the biobank. Patients will be asked to donate 20mls whole blood collected in EDTA for immediate FACS analysis. Both blood and synovial fluid samples will be transferred directly to the labs in Aberdeen or Glasgow University before onward transfer to the AHSC nodes and biobank.