Study period: | Enrolment | Observation/follow-up | ||||
Visit | Screening | Baseline | 3 months | 6 months | 12 months | 24 months |
Informed consent | X | |||||
Inclusion/exclusion criteria | X | |||||
Sociodemographic data | X | |||||
Medical history | X | |||||
Information treatment | X | X | X | X | X | |
Articular assessment | ||||||
Tender joint count (68) and swollen joint count (66) | X | X | X | X | X | |
Entheseal assessment | X | X | X | X | X | |
Tender dactylitis count | X | X | X | X | X | |
Skin assessment | ||||||
Body surface area | X | X | X | X | X | |
Blood test | ||||||
RF/ACPA/HLA-B27 | X | |||||
ESR/CRP | X | X | X | X | ||
Patient global assessment and pain assessment | ||||||
Pain VAS | X | X | X | X | X | |
Global VAS | X | X | X | X | X | |
Physician’s global assessment | ||||||
Physician’s global VAS | X | X | X | X | ||
Patient spinal assessment | ||||||
BASDAI | X | |||||
Physical function | ||||||
HAQ | X | X | X | X | X | |
Health-related quality of life | ||||||
PsAID-12 | X | X | X | X | ||
Imaging | ||||||
US-score PsA-SIR | X | X | X | X | ||
X-ray (hands–feet) | X | X | X | |||
Adverse events | X | X | X | X |
ACPA, anti-citrullinated protein antibodies; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C reactive protein; ESR, erythocyte sedimentation rate; HAQ, Health Assessment Questionnaire; HLA, Human Leucocyte Antigen; PSAID-12, Psoriatic Arthritis Impact of Disease 12-item; PsA-SIR, psoriatic arthritis-Society of Rheumatology; RF, Rheumatoid Factor; VAS, Visual Analogue Scale.