Table 1.
Summary of milestone assessments
| Assessment | Baseline | Month 6 (midpoint) | Month 12 (final) | Withdrawala | Extension studyb |
|---|---|---|---|---|---|
| DAS28 (ESR) and Extended Joint Count | X | X | X | X | X |
| CRP | X | X | X | X | X |
| Assessor global rating (VAS) | X | X | X | X | X |
| Pain rating (VAS) | X | X | X | X | X |
| Fatigue rating (VAS) | X | X | X | X | X |
| RA medication | X | X | X | X | X |
| Medical history | X | ||||
| Alcohol consumption | X | ||||
| Smoking history/status | X | X | X | X | |
| X-rays (plain, of hands and feet) | X | X | X | ||
| HAQ | X | X | X | X | X |
| CSRI | X | X | X | X | |
| EQ-5D-5 L | X | X | X | X | X |
| PHQ-9 | X | ||||
| GAD-7 | X | ||||
| MARS | X | X | X | X | |
| BIPQ | X | ||||
| BMQ | X | ||||
| Views of RA treatment | X | X | X | ||
| Adverse events | X | X | X | X |
DAS28-ESR will be calculated from joint count, patient global rating (VAS) and ESR during every visit; SDAI will be calculated from joint count, patient global rating (VAS), assessor global rating (VAS) and CRP at baseline, midpoint and final assessments
aTo be completed at any time during the trial if the patient withdraws. bExtension study only
BIPQ Brief Illness Perceptions Questionnaire, BMQ Beliefs about Medicines Questionnaire, CRP C-reactive protein, CSRI Modified Client Service Receipt Inventory, EQ-5D-5 L EuroQol 5-dimensional 5-level score, ESR erythrocyte sedimentation rate, GAD-7 Generalized Anxiety disorder-7, HAQ Health Assessment Questionnaire, MARS Medication Adherence Rating Scale, PHQ-9 Patient Health Questionnaire-9, RA rheumatoid arthritis, SDAI Simplified Disease Activity Index, VAS Visual Analogue Scale