Timepoint | Enrolment | Post-allocation (weeks) | Close-out | |||||||
---|---|---|---|---|---|---|---|---|---|---|
-t1 | Baseline | 4 | 8 | 12 | 16 | 24 | 32 | 42 | 52 | |
Enrolment | ||||||||||
 Eligibility screen | X |  |  |  |  |  |  |  |  |  |
 Informed consent | X |  |  |  |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |  |  |  |
Intervention | ||||||||||
 Methotrexate |  |  |  |  |  |  |  |  |  |  |
 Placebo |  |  |  |  |  |  |  |  |  |  |
Assessments | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Demographics, medical history, medication overview, RF, ACPA, AP |  | X |  |  |  |  |  |  |  |  |
 Disease characteristics, physical examination, PMR-AS, AE monitoring, PROsa |  | X | X |  | X |  | X | X |  | X |
 CRP, ESR, total blood count, creatinine, ALAT, serum for storage |  | X | X | X | X | X | X | X | X | X |
 GTI, including serum glucose, HbA1c, LDL |  | X |  |  | X |  | X |  |  | X |