Psoriatic ArthritisSAGE-PsANCT05954364
Sex and Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Women's College Hospital at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 540 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be comprised of patients with psoriatic arthritis who have been identified in clinic by their rheumatologist
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Fahmeen Afgani, MBBS, 4163236400 ext. 7319, fahmeen.afgani@wchospital.ca
Lihi Eder, MD, PhD
About this study
Official title: Sex Matters: Sex- And Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) - an International Multicentre Study
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.
Read the 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
- Keywords
- Psoriatic Arthritis, Inflammatory Arthritis, Sex, Gender, Advanced Therapies
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Arthritis | Patients with a rheumatologist-confirmed diagnosis of psoriatic arthritis who are initiating advanced therapy for peripheral musculoskeletal manifestations of psoriatic arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 3-6 months
Achievement of Minimal Disease Activity (MDA) state
The proportion of patients who have achieved the MDA state following treatment initiation
Measured: Within 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start23 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lihi Eder, University of Toronto
- Investigators
- Lihi Eder, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954364
- Sponsor's protocol ID
- 2022-0095-B
- Acronym
- SAGE-PsA
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Matters: Sex- And Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) - an International Multicentre Study
- ClinicalTrials.gov ID
- NCT05954364
- Acronym / sponsor ID
- SAGE-PsA / 2022-0095-B
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, Inflammatory Arthritis, Sex, Gender, Advanced Therapies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis | – | –Patients with a rheumatologist-confirmed diagnosis of psoriatic arthritis who are initiating advanced therapy for peripheral musculoskeletal manifestations of psoriatic arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of patients with psoriatic arthritis who have been identified in clinic by their rheumatologist
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achievement of the American College of Rheumatology (ACR) 20/50/70
Time frame: Within 3-6 months
The proportion of patients who have achieved the ACR 20/50/70 following treatment initiation
Achievement of Minimal Disease Activity (MDA) state
Time frame: Within 3-6 months
The proportion of patients who have achieved the MDA state following treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lihi Eder, MD, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahmeen Afgani, MBBS (1-416-323-6400 ext. 7319, fahmeen.afgani@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of the American College of Rheumatology (ACR) 20/50/70 (time frame: Within 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.