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

Psoriatic Arthritis Clinical Trial

— SAGE-PsA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954364
• Other study ID #: 2022-0095-B
• Status: Recruiting
• Start date: January 23, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Women's College Hospital
• Contact: Fahmeen Afgani, MBBS
• Phone: 1-416-323-6400
• Email: fahmeen.afgani[@]wchospital.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Achievement of Minimal Disease Activity (MDA) state	The proportion of patients who have achieved the MDA state following treatment initiation	Within 3-6 months