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

NCT05954364 | Recruiting

• 1 other identifier: 2022-0095-B
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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

Keywords

Psoriatic Arthritis; Inflammatory Arthritis; Sex; Gender; Advanced Therapies

Outcome Measures

Primary Outcomes (2)

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

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

  Within 3-6 months

• Achievement of Minimal Disease Activity (MDA) state

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

  Within 3-6 months

Study Arms (1)

Psoriatic Arthritis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of patients with psoriatic arthritis who have been identified in clinic by their rheumatologist

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples will be collected in selected sites that have a capacity to collect, process and store these samples locally prior to shipment to the coordinating site. These samples will be collected during the baseline and follow-up in person visits.

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis; Coitus

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Sexual Behavior; Behavior

Study Officials

• Lihi Eder, MD, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahmeen Afgani, MBBS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: January 23, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CA (1)