Grouping people with SLE by antibodies, genes, and biomarkers to better understand causes and guide treatment
Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment
This project will see if dividing people with SLE into subgroups by autoantibodies, genetics, or other biomarkers helps explain and predict their risk of blood vessel disease and organ complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07102030 on ClinicalTrials.gov |
What this trial studies
This observational effort uses a long-running series of cross-sectional cohorts from Karolinska with repeated waves since 1995 and currently includes over 800 well-characterized SLE patients and more than 250 APS patients. Participants undergo in-person assessments by a nurse and rheumatologist, complete lifestyle and quality-of-life questionnaires, receive imaging such as carotid ultrasound and bone density measures, and provide biosamples (plasma, serum, DNA, urine, saliva) that are stored in a biobank. The study matches SLE patients to population controls drawn from the national registry and uses detailed clinical, serologic, genetic, and biomarker data to define subgroups and link them to premature vascular disease, antiphospholipid antibody mechanisms, and lupus nephritis. A common database integrates the three cohort waves to enable subgroup analyses and targeted mechanistic follow-up.
Who should consider this trial
Good fit: Adults with confirmed SLE by ACR 1982 or SLICC 2012 criteria who can provide informed consent and attend in-person visits at the Karolinska clinics are ideal candidates.
Not a fit: People without a confirmed SLE diagnosis, those unable to consent or understand study information due to language or psychiatric barriers, or those unwilling/unable to travel to Stockholm are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, this work could improve prediction of vascular risk and enable more personalized treatment strategies for people with SLE.
How similar studies have performed: Previous long-term cohort and cross-sectional studies have linked autoantibodies, antiphospholipid antibodies, and nephritis to vascular risk in SLE, so this subgrouping approach builds on established findings rather than being entirely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: SLE according to criteria (ACR82 or SLICC 2012) and consenting to participate Exclusion Criteria: Not possible to read and understand patient information due to language barriers or psychological/psychiatric disorders Not consenting \-
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Elisabet Svenungsson, MD, PhD
- Email: elisabet.svenungsson@ki.se
- Phone: +46760069142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.