Procedures | Visits | |||||||
---|---|---|---|---|---|---|---|---|
Baseline cohort | ||||||||
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 72 | Week 96 | Annually (after 96 weeks) | |
Informed consent | X | |||||||
Demographics | X | |||||||
Medical history | X | X | X | X | X | X | X | X |
Medications | X | X | X | X | X | X | X | X |
Physical examination | X | X | X | X | X | X | X | X |
Routine blood tests (FBC, U&Es, LFTs, CRP and eGFR) | X | X | X | X | X | X | X | X |
Immunology (RF, ACPA, ANA) | X | |||||||
Radiographs of hands/feet/spine | X | X | X | X | ||||
Eligibility assessment | X | |||||||
Adherence | X | X | X | X | X | X | X | |
68/66 Joint count | X | X | X | X | X | X | X | X |
Leeds and SPARCC enthesitis index | X | X | X | X | X | X | X | X |
Dactylitis count | X | X | X | X | X | X | X | X |
Psoriasis assessment (PASI and BSA) | X | X | X | X | X | X | X | X |
Physician VAS | X | X | X | X | X | X | X | X |
Metrology with BASMI (if axial involvement) | X | X | X | X | ||||
Patient questionnaires (VAS, HAQ, SF36, PsAID, WPAI, BASDAI, BASFI) | X | X | X | X | X | X | X | X |
TSQM questionnaire | X | X | X | X | X | X | X | |
EQ-5D-5L questionnaire | X | X | X | X | X | X | ||
Healthcare utilisation data | X | X | X | X | X | |||
Adverse event assessments | X | X | X | X | X | X | X | X |