Examination and interview at baseline and follow-up
| Baseline | 4 Months | |
|---|---|---|
| Demographics and disease-related characteristics (interview) | ||
| Sex(M/F) | X | |
| Age (years) | X | |
| Diagnosed with spinal involvement (y/n) | X | |
| Disease duration of psoriatic arthritis (months) | X | |
| Symptom duration prior to diagnosis (months) | X | |
| Disease duration of psoriasis (months) | X | |
| Educational level | X | |
| Smoking (current/previous/never) | X | |
| Alcohol consumption (number per week) | X | |
| Diabetes (y/n) | X | |
| Cardiovascular disease (y/n) | X | |
| Dyslipidaemia (or treatment for this) (y/n) | X | |
| Mental disorder (depression, anxiety) (y/n) | X | |
| Medication (interview) | ||
| Use of mild analgesics, including NSAIDs (dosage) | X | X |
| Use of opioids, antidepressants or anticonvulsants during the study period (dosage) | X | |
| Cumulated dose of oral prednisolone during the last month | X | X |
| Medication history (current and previous cs/bDMARD) | X | |
| Interval (days) between study baseline visit and initiation of new treatment | X | |
| Date for treatment termination of new drug | X | |
| Reason for treatment withdrawal during the study period (lack of effect, adverse events, other) | X | |
| Clinical examination | ||
| VAS physician (0–100) | X | X |
| Height (cm) | X | |
| Weight (kg) | X | |
| Swollen joint count (66)(number) | X | X |
| Tender joint count (68)(number) | X | X |
| Manual tender point examination (number), only scores ≥2 are interpreted as a tender point. | X | X |
| SPARCC | X | X |
| Dactylitis (number) | X | X |
| Psoriatic body surface area (%) | X | X |
| Subtype of psoriasis | X | |
| Psoriatic nail lesions (number) | X | X |
| PASI (if psoriasis vulgaris) | X | X |
| Patient-reported outcomes | ||
| PDQ score | X | X |
| HAQ Disability Index (HAQ, including VAS for pain and global) | X | X |
| Medical Outcomes Study Questionnaire (SF-36, mental and physical) | X | X |
| PsAID | X | X |
| DLQI | X | X |
| VAS fatigue (0–100) | X | X |
| AMPS | X | X |
| WPI | X | X |
| GAD-10 | X | X |
| Trans-Q score | X | |
| BASFI | X | X |
| BASDAI | X | X |
| Imaging | ||
| X-ray hands and feet | X | |
| Ultrasonographic examination | X | X |
| Blood samples (maximum 54 mL at each time point) | ||
| Blood samples will be analysed for: C reactive protein, ALAT, alkaline phosphatase, erythrocytes, erythrocytes volume fraction, erythrocyte MCV, haemoglobin, erythrocyte MCHC, leucocytes and leucocyte types, reticulocytes, thrombocytes, potassium, sodium, creatinine, cobalamin (B12), VitD (P-25(OH)D cholesterol (total), LDL, HDL, glucose, HbA1C, inflammatory biomarkers. | X | X |
ALAT, alanine aminotransferase; AMPS, Assessment of Motor and Process Skills; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; cs/bDMARD, conventional synthetic and/or biologicals disease-modifying antirheumatic drugs; DLQI, Dermatology Life Quality Index; GAD-10, Generalised Anxiety Disorder Self-Assessment Questionnaire; HAQ, Health Assessment Questionnaire; HbA1C, glycated haemoglobin; HDL, high-density lipoprotein; LDL, low-density lipoprotein; M/F, male/female; MCHC, mean corpuscular haemoglobin concentration; MCV, mean cell volume; PASI, Psoriatic Area Severity Index; PDQ, PainDETECT Questionnaire; PsAID, Psoriatic Arthritis Impact of Disease score; SPARCC, Spondyloarthritis Research Consortium of Canada enthesitis score; Trans-Q, Transition Questionnaire; VAS, Visual Analogue Scale; WPI, Widespread Pain Index; y/n, yes/no.