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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWomen's College Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

The study population will be comprised of patients with psoriatic arthritis who have been identified in clinic by their rheumatologist

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

540 Participants
are grouped into 1 trial group
Group A: Psoriatic Arthritis

Trial outcomes

Primary outcomes

1

Achievement of the American College of Rheumatology (ACR) 20/50/70

The proportion of patients who have achieved the ACR 20/50/70 following treatment initiation

Time frame
Within 3-6 months
2

Achievement of Minimal Disease Activity (MDA) state

The proportion of patients who have achieved the MDA state following treatment initiation

Time frame
Within 3-6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Women's College Hospital

Lead sponsor

University of Toronto

Sponsor institution