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

Recruiting

• Conditions: Psoriatic Arthritis

• Registration Number: NCT05954364
• Lead Sponsor: Women's College Hospital

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.

Study Timeline

• Study Start: 2023-01-23
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada