Analyzing how sex and gender affect treatment responses in psoriatic arthritis
Official title: Sex Matters: Sex- And Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) - an International Multicentre Study
Run by Women's College Hospital · NCT05954364 · Data updated 2026-11-12
This study looks at how being male or female affects how well new treatments work for people with psoriatic arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 540 (estimated) |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | January 23, 2023 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 24, 2023 |
| Trial ID | NCT05954364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a rheumatologist-confirmed diagnosis of active psoriatic arthritis who are planning to start advanced therapies.
✕Probably not a fit
Patients who are unable to read or write, cannot sign informed consent, or are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the influence of sex and gender on the effectiveness of advanced therapies in patients with psoriatic arthritis (PsA). Conducted across approximately 30 international sites, the study will enroll 540 patients who have a confirmed diagnosis of PsA and are starting advanced therapy. Participants will undergo assessments before and after treatment initiation, with data collected through questionnaires and physical examinations to identify biological and socio-cultural factors affecting treatment response. The study will compare outcomes between male and female patients to better understand these differences.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for psoriatic arthritis based on sex and gender differences.
How similar studies have gone: While the specific focus on sex and gender in this context may be novel, other studies have explored treatment responses in psoriatic arthritis with varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Women's College Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Lihi Eder, MD, PhD — University of Toronto
- Study coordinator: Fahmeen Afgani, MBBS
- Email: fahmeen.afgani@wchospital.ca
- Phone: 1-416-323-6400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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HLA B Leader in Psoriatic Arthritis
This study tests whether the HLA B leader gene is more common in people with psoriatic arthritis than in healthy individuals.
-
TaVNS for Psoriatic Arthritis in Adults
This study tests whether non-invasive taVNS can help reduce disease activity and improve pain and quality of life in adults with psoriatic arthritis.
-
TQH3906 capsules for active psoriatic arthritis in adults
This trial tests whether TQH3906 capsules help people with active psoriatic arthritis more than a placebo over 12 weeks.
-
Picankibart for people with active psoriatic arthritis
This trial tests whether subcutaneous picankibart can improve joint and skin symptoms in adults with active psoriatic arthritis who have not had enough benefit from NSAIDs or non-biologic DMARDs.
-
Bimekizumab by IV infusion versus subcutaneous injection for adults with psoriatic arthritis or axial spondyloarthritis
This trial tests whether bimekizumab given by intravenous (IV) infusion behaves the same in the body as the usual subcutaneous injection in adults with psoriatic arthritis or axial spondyloarthritis.
-
Continued daily zasocitinib treatment for adults with psoriatic arthritis
This extension will try daily zasocitinib in adults with psoriatic arthritis who completed a year of earlier treatment to see how well it works and how safe it is over about two years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.