Table 1.
Clinical and laboratory assessments during CERTAIN
| |
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 |
Abbreviations: VAS visual analog scale, CRP C-reactive protein, HAQ health assessment questionnaire, DI disability index, HDL high density lipoprotein, LDL low density lipoprotein, RNA ribonucleic acid, AST aspartate aminotransferase, ALT alanine aminotransferase, BUN blood urean nitrogen, CK creatinine kinase, LDH lactate dehydrogenase, DNA deoxyribonucleic acid.
*Collected at baseline, 3 and 6 month follow up visits.