Analyzing how sex and gender affect treatment responses in psoriatic arthritis
Sex Matters: Sex- And Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) - an International Multicentre Study
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 |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05954364 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are unable to read or write, cannot sign informed consent, or are pregnant will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.