Clinical trial NCT05954364: Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Inflammatory Arthritis
Sex
Gender
Advanced Therapies
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be comprised of patients with psoriatic arthritis who have been identified in clinic by their rheumatologist

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.

Detailed description: Study investigators will perform a prospective, multi-center, international cohort study involving approximately 30 sites that specialize in care of patients with PsA. 540 patients with a rheumatologist-confirmed diagnosis of PsA who are initiating advanced therapy for peripheral musculoskeletal manifestations of PsA will be enrolled. The study will include 2 in-person physician visits. Visit 1 (baseline) will take place prior to drug initiation (up to 3 months prior). Visit 2 (follow-up) will occur 3-6 months following drug initiation. In addition, study sites will be asked to report persistence status on the study drug at 1 year.

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

Primary outcomes:
measure: Achievement of the American College of Rheumatology (ACR) 20/50/70
timeFrame: Within 3-6 months
measure: Achievement of Minimal Disease Activity (MDA) state
timeFrame: Within 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Lihi Eder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: