Recruiting

Observational Study

Sponsor:

Women's College Hospital

Code:

NCT05954364

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Psoriatic Arthritis

Study ID

NCT05954364

Start date

Jan 23, 2023

Status verified date

Jul, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

540 participants

Anticipated

Interventions and Outcome Measures

Arms

Psoriatic Arthritis

Patients with a rheumatologist-confirmed diagnosis of psoriatic arthritis who are initiating advanced therapy for peripheral musculoskeletal manifestations of psoriatic arthritis

Primary outcome measure

  • Achievement of the American College of Rheumatology (ACR) 20/50/70 [ Time Frame: Within 3-6 months ]
  • Achievement of Minimal Disease Activity (MDA) state [ Time Frame: Within 3-6 months ]

Central Contacts and Locations

Central contacts

Fahmeen Afgani, MBBS

1-416-323-6400fahmeen.afgani@wchospital.ca

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Fahmeen Afgani, MBBS

4163236400fahmeen.afgani@wchospital.ca

Principal Investigator:

Lihi Eder, MD, PhD

More Information

Sponsor

Women's College Hospital

Last update posted

Jul 24, 2023

Last verified

Jul, 2023

Keywords

  • Psoriatic Arthritis
  • Inflammatory Arthritis
  • Sex
  • Gender
  • Advanced Therapies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2023-07-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.