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

Sponsor

Women's College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05954364

Collaborator

(none)

540

Enrollment

Location

47.2

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis

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 Design

Study Type:

Observational

Anticipated Enrollment :

540 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Sex Matters: Sex- And Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) - an International Multicentre Study

Actual Study Start Date :

Jan 23, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Psoriatic Arthritis Patients with a rheumatologist-confirmed diagnosis of psoriatic arthritis who are initiating advanced therapy for peripheral musculoskeletal manifestations of psoriatic arthritis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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