Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis

NCT05954364 · tracked via the Priya Life Science Canada tracker

Sponsor

Women's College Hospital

Phase

Observational

Started

2023-01-23

Last updated

2023-07-24

Condition(s) studied

Psoriatic Arthritis

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Achievement of the American College of Rheumatology (ACR) 20/50/70 — Within 3-6 months
The proportion of patients who have achieved the ACR 20/50/70 following treatment initiation
Achievement of Minimal Disease Activity (MDA) state — Within 3-6 months
The proportion of patients who have achieved the MDA state following treatment initiation

Trial sites (1)

Facility	City	Region	Status
Women's College Hospital	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05954364 on ClinicalTrials.gov ↗ ← All trials in Canada