Baseline | Follow up visits | |
---|---|---|
0 Months | 3, 6, 9, 12 Months | |
Assessments | ||
Demographics (date of birth, sex, address, email) | X | |
Medication exposures (including biologics) | X | X |
Tender & Swollen Joint Count (0–28) | X | X |
Physician Global Disease Activity (100 mm VAS) | X | X |
Patient Global Disease Activity (100 mm VAS) | X | X |
Patient Pain (100 mm VAS) | X | X |
Patient Fatigue (100 mm VAS) | X | X |
EuroQol 5D | X | X |
HAQ DI | X | X |
Laboratory assessments (run at a central laboratory) | ||
Complete blood count (with automated differential) | X | X |
Rheumatoid factor and isotypes | X | |
Anti- cyclic citrullinated peptide antibody | X | |
High-sensitivity C–reactive protein (hsCRP) | X | X |
Immunoglobulin panel (IgM, IgG, IgA) | X | X |
Traditional non fasting lipoprotein analyses (HDL, Total cholesterol, Triglycerides) | X | X |
Direct quantitative LDL (fasting specimens not required) | X | X |
Serum, plasma, whole blood (RNA) | X | X* |
AST ALT, Albumin, Total and direct Bilirubin, BUN, Creatinine, Glucose, Calcium, Serum uric acid, CK, LDH | X | X |
DNA (optional component) | X |