| Screening | Double-blind period | ||||||
---|---|---|---|---|---|---|---|---|
Screening / baseline assessment | Randomization | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
Visit/phone contact | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â |
Clinical visit or telehealth | X | Â | Â | Â | Â | Â | Â | X |
Telephone follow-up | Â | Â | X | X | X | X | X | Â |
Hand x-ray | X | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â |
Medication | X | Â | Â | Â | Â | Â | Â | Â |
Employment and education | X | Â | Â | Â | Â | Â | Â | Â |
Smoking and alcohol | X | Â | Â | Â | Â | Â | Â | Â |
Questionnaires | ||||||||
 Hand VAS | X |  |  |  |  |  |  | X |
 Hand NRS | X |  | X | X | X | X | X | X |
 FIHOA | X |  |  |  |  |  |  | X |
 AUSCAN | X |  |  |  |  |  |  | X |
 MHQ | X |  |  |  |  |  |  | X |
 painDETECT | X |  |  |  |  |  |  | X |
Physical examination | ||||||||
 Height, weight | X |  |  |  |  |  |  |  |
 Tender/swollen joint count | X |  |  |  |  |  |  | X |
Compliance and safety (adverse events) | Â | Â | X | X | X | X | X | X |
Hand photos | X | Â | Â | Â | Â | Â | Â | X |
Dispense medication | Â | X | Â | Â | Â | Â | Â | Â |