Sex and Gender-based Analysis of the Effectiveness of Adv... | NCT05954364

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

NCT05954364

Sponsor

Women's College Hospital

Status

Recruiting

Last Update Posted

Jul 24, 2023Actual

Enrollment

540Estimated

Phase

Not provided

Conditions

Psoriatic Arthritis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2023Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jul 12, 2023

First Submission Date that Met QC Criteria

Jul 12, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2023

Last Update Posted Date

Jul 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lihi Eder, Associate Professor, Department of Medicine, University of TorontoPrincipal Investigator

Lead Sponsor

Women's College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

540Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psoriatic Arthritis		Patients with a rheumatologist-confirmed diagnosis of psoriatic arthritis who are initiating advanced therapy for peripheral musculoskeletal manifestations of psoriatic arthritis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fahmeen Afgani, MBBS	Contact	1-416-323-6400	7319	fahmeen.afgani@wchospital.ca

Overall Officials

Name	Affiliation	Role
Lihi Eder, MD, PhD	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's College Hospital	Recruiting	Toronto	Ontario	M5S 1B2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015535	Arthritis, Psoriatic
D001168	Arthritis
D003075	Coitus

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.