NCT05954364Recruiting
Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies 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
Source: ClinicalTrials.gov · Last updated 24 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 540 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- 23 Jan 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Women's College Hospital
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05954364
What you commit to
- Study type: Observational
- Planned participants: 540
- From 23 Jan 2023 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The drug is given for another indication and not for active PsA (e.g. psoriasis, IBD)
Other
- Unable to read or write
- Unable to sign informed consent
- Cannot return for a follow up visit
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.