NCT05954364 Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis
| NCT ID | NCT05954364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women's College Hospital |
| Condition | Psoriatic Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 540 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 540 participants in total. It began in 2023-01-23 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Lihi Eder, MD, PhD
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT05954364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05954364 currently recruiting?
Yes, NCT05954364 is actively recruiting participants. Contact the research team at fahmeen.afgani@wchospital.ca for enrollment information.
Where is the NCT05954364 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05954364 clinical trial?
NCT05954364 is sponsored by Women's College Hospital. The principal investigator is Lihi Eder, MD, PhD at University of Toronto. The trial plans to enroll 540 participants.