LupusNCT07267091
The Burden of Lupus in Canada From a Patient Perspective: A Canadian Real-World PROxy Study
An observational study of Lupus and Lupus Arthritis, run by PeriPharm at 1 site in Canada.
Trial summary
This study aims to capture the Canadian patient experience, burden, barriers, and treatment preferences. The findings will generate real-world evidence to support patient-centered care and guide healthcare providers, researchers, and decision-makers in improving support and treatment for people living with lupus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus, Lupus Arthritis, Lupus Arthritis, Systemic Lupus Erythematosus
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2025to 23 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with Lupus who are part of Lupus Canada database
Who may be able to join
- 18 years of age or older;
- Part of the Lupus Canada database;
- Self-identified as a patient with Lupus.
- Ability to read and understand English or French;
- Signature of informed consent form.
Who cannot join
- 1. Participation in an interventional clinical trial for Lupus.
Trial locations and contacts
1 site in 1 country.
Canada1 site
PROxy Network, an initiative of PeriPharm Inc.
Montreal, Quebec, H2Y 1V3
About this study
This study aims to capture the Canadian patient experience, burden, barriers, and treatment preferences. The findings will generate real-world evidence to support patient-centered care and guide healthcare providers, researchers, and decision-makers in improving support and treatment for people living with lupus.
Read the detailed description
Lupus Canada will distribute an invitation to participate in the study through their mailing list, website, social networks providing a link to the questionnaire. Their mailing list database comprises about 8,000 individuals, including patients. Lupus Canada will reach out to the lupus community to inform them about their eligibility to participate in the study. Those meeting the eligibility criteria will be invited to sign the informed consent form (ICF) and complete all the study questionnaires on the PROxy web-based platform. For any questions, interested participants will have access to the contact information of the PROxy team, and a designated team member will communicate with participants by phone to answer all questions.
- Conditions
- Lupus, Lupus Arthritis, Lupus Arthritis, Systemic Lupus Erythematosus, Quality of Life (QOL)
- Being tested
- No Intervention: Observational Cohort
- Keywords
- lupus, quality of life, real-world
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No specific intervention is assess in this study. Observational cohort.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lupus | Adult patients with lupus member of Lupus Canada database Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate quality of life of patients with lupus
Using the 36-item Short Form (SF-36) questionnaire, a generic health-related quality of life questionnaire containing 8 domains. Each domains score ranges from 0 to 100, where 0 represents poor health and 100 best possible health.
Measured: At recruitment
Secondary outcomes (2)
To estimate work productivity impairment of patients with lupus.
Using the Work Productivity and Activity Impairment (WPAI) questionnaire.
This questionnaire provides a quantitative measure of impairment over the last 7 days and includes four metrics: absenteeism (work time missed because of health issues during the past 7 days), presenteeism (impairment while working due to health issues during the past 7 days), overall work productivity loss (combination of absenteeism and presenteeism), and activity impairment.
Measured: At recruitment
Indirect Costs and Patients' Preference Questionnaire
Using a self-administered, 19-item questionnaires.
Measured: At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start3 Nov 2025
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies 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
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267091
- Sponsor's protocol ID
- PROxy250918
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Lupus in Canada From a Patient Perspective: A Canadian Real-World PROxy Study
- ClinicalTrials.gov ID
- NCT07267091
- Acronym / sponsor ID
- PROxy250918
- Conditions
- Lupus, Lupus Arthritis, Lupus Arthritis, Systemic Lupus Erythematosus, Quality of Life (QOL)
- Keywords
- lupus, quality of life, real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 5 Dec 2025 (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.
This study aims to capture the Canadian patient experience, burden, barriers, and treatment preferences. The findings will generate real-world evidence to support patient-centered care and guide healthcare providers, researchers, and decision-makers in improving support and treatment for people living with lupus.
Detailed description
Lupus Canada will distribute an invitation to participate in the study through their mailing list, website, social networks providing a link to the questionnaire. Their mailing list database comprises about 8,000 individuals, including patients. Lupus Canada will reach out to the lupus community to inform them about their eligibility to participate in the study. Those meeting the eligibility criteria will be invited to sign the informed consent form (ICF) and complete all the study questionnaires on the PROxy web-based platform. For any questions, interested participants will have access to the contact information of the PROxy team, and a designated team member will communicate with participants by phone to answer all questions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lupus | – | Other: No Intervention: Observational CohortAdult patients with lupus member of Lupus Canada database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Lupus who are part of Lupus Canada database
Key inclusion criteria (5 listed)
- 18 years of age or older;
- Part of the Lupus Canada database;
- Ability to read and understand English or French;
- Signature of informed consent form.
Key exclusion criteria (1 listed)
- 1. Participation in an interventional clinical trial for Lupus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo specific intervention is assess in this study. Observational cohort. | Other | Patients with lupus |
Primary outcome
To estimate quality of life of patients with lupus
Time frame: At recruitment
Using the 36-item Short Form (SF-36) questionnaire, a generic health-related quality of life questionnaire containing 8 domains. Each domains score ranges from 0 to 100, where 0 represents poor health and 100 best possible health.
2 secondary outcomes
To estimate work productivity impairment of patients with lupus.
Time frame: At recruitment
Indirect Costs and Patients' Preference Questionnaire
Time frame: At recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Lupus and Lupus Arthritis, run by PeriPharm 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate quality of life of patients with lupus (time frame: At recruitment). 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 29 Jan 2026.