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

NCT ID: NCT05954364

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2026-12-31

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.

Conditions

Psoriatic Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Psoriatic Arthritis

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lihi Eder

Associate Professor, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lihi Eder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Women's College Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Fahmeen Afgani, MBBS

Role: CONTACT

fahmeen.afgani@wchospital.ca

1-416-323-6400 ext. 7319

Facility Contacts

Fahmeen Afgani, MBBS

Role: primary

fahmeen.afgani@wchospital.ca

4163236400 ext. 7319

Other Identifiers

2022-0095-B

Identifier Type: -

Identifier Source: org_study_id