Table 2.
Study procedures | Screening | Week 0 | Week 12* | Week 24 | Week 48 | Week 72 | Week 96 |
Informed consent | X | ||||||
Inclusion/exclusion | X | ||||||
Demographics | X | ||||||
Medical history | X | ||||||
Psoriatic disease history | X | ||||||
Medications | X | X | X | X | X | X | X |
Ultrasound | X | X | |||||
Adverse events | X | X | X | X | X | ||
Skin assessments (BSA, IGA) | X | X | X | X | X | X | |
MSK assessments (TJC, SJC, SPARCC enthesitis index, dactylitis count) | X | X | X | X | X | X | |
PEST† | X | X | X | X | X | X | X |
EuroQoL-5D (EQ-5D) | X | X | X | ||||
FACIT-F | X | X | X | X | X | X | X |
Patient pain score | X | X | X | X | X | X | X |
Global health score | X | X | X | X | X | X | X |
IDEOM MSK-Q | X | X | X | X | X | X | X |
Safety labs (CBC, CMP, TB test, serum pregnancy) | X | ||||||
RF/ACPA | X | ||||||
Urine pregnancy‡ | X | ||||||
Biosampling (plasma, PBMCs, skin swabs, stool) | X |
*Arm 3 will not have an in-person visit at week 12. They will also not have to undergo safety labs or record adverse events.
†PEST will also be performed by telephone or electronically every 3 months if there is not an in-person visit.
‡Urine pregnancy test will be done for females of childbearing age the day of the baseline visit, prior to administering the first dose of drug or placebo.
ACPA, anticitrullinated peptide antibodies; BSA, body surface area; CBC, completed blood count; CMP, comprehensive metabolic panel; FACIT-F, functional assessment of chronic illness therapy-fatigue; IDEMO MSK-Q, International Dermatology Outcomes Measures Musculoskeletal-Questionnaire; IGA, investigators global assessment 2011; PAMPA, Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort study; PBMC, peripheral blood mononuclear cell; PEST, psoriasis epidemiology screen tool; RF, rheumatoid factor; SJC, swollen joint count; SPARCC, Spondyloarthritis Research Consortium of Canada Enthesitis Index; TB, tuberculosis; TJC, tender joint count.