Visit number | V0 Screening | V1 Baseline | V2 | V3 | V4 | V5 | V6 | V7 | USV |
---|---|---|---|---|---|---|---|---|---|
Month | − 3 to 0 | 0 | 3 | 6 | 9 | 12 | 15 | 18 | … |
Informed consent | X | ||||||||
Eligibility criteria | X | ||||||||
Demographic data | X | ||||||||
Medical history | X | ||||||||
Anti-rheumatic treatment | X | X | X | X | X | X | X | X | X |
Smoking and alcohol use | X | ||||||||
Height, Weight | X | ||||||||
Randomization | X | ||||||||
Clinical disease parameters | |||||||||
28TJC and 28SJC | X | X | X | X | X | X | X | X | X |
Provider VAS GDA | X | X | X | X | X | X | X | X | |
Patient VAS GDA | X | X | X | X | X | X | X | X | X |
Questionnaires | |||||||||
HAQ-DI | X | X | X | X | X | X | X | ||
EQ-5D-5L | X | X | X | X | X | X | X | ||
RA flare questionnairea | X | X | X | X | X | X | X | X* | |
PASS | X | X | X | X | X | X | X | X* | |
Likert transition question | X | X | X | X | X | X | X | X* | |
Health care utilization and work participation | X | X | X | X | X | X | X | ||
Patients satisfaction with care (Dutch SAPS) | X | ||||||||
Physician satisfaction with care (VAS) | X | ||||||||
Laboratory assessments | |||||||||
CRP | X | X | X | X | X | X | X | X | |
Safety/adverse events | |||||||||
(Serious) Adverse events | X | X | X | X | X | X | X | X |