Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05954364

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location status: Recruiting

Location contact

Fahmeen Afgani, MBBS

CONTACT

[email protected]

4163236400 ext. 7319

Lihi Eder, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Within 3-6 months

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

  2. Achievement of Minimal Disease Activity (MDA) state

    Time frame: Within 3-6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fahmeen Afgani, MBBS

CONTACT

[email protected]

1-416-323-6400 ext. 7319

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

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

Acronym: SAGE-PsA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.