Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis
Recruiting · NCT05954364 · Observational (researchers observe without assigning treatment) · Lead sponsor: Women's College Hospital
View the official record on ClinicalTrials.gov →What this trial is about
Sex and gender are important factors that influence treatment response in PsA. The goal of this multi-centre observational study is to understand how sex and gender influence response to advanced therapies in psoriatic arthritis (PsA). The investigators hope to discover biological and socio-cultural mechanisms that explain the differences in treatment response between men and women with PsA. The study investigators plan to recruit patients from approximately 30 sites across the world. Men and women with active PsA will be assessed before and after they start advanced therapies and information will be collected about sex- and gender-related factors through questionnaires and physical examination. Physicians will assess the patient response to treatment. The investigators will compare the response to treatment in men and women and assess what biological and socio-cultural factors contribute to differences in treatment response.
Who can take part
Inclusion criteria
- Rheumatologist confirmed diagnosis of PsA according to CASPAR criteria
- Age ≥18 years
- Active PsA with any of the following manifestations detected on physical examination: peripheral arthritis, dactylitis, and enthesitis. The patient may have axial involvement in addition to the peripheral manifestations of PsA
- Plan to start treatment with advanced therapies for peripheral musculoskeletal manifestations of PsA
Exclusion criteria
- Unable to read or write
- Unable to sign informed consent
- Cannot return for a follow up visit
- The drug is given for another indication and not for active PsA (e.g. psoriasis, IBD)
- Pregnant women
Where it is running
1 location listed.
- Women's College Hospital - Toronto, Ontario, Canada