Grouping people with SLE by antibodies, genes, and biomarkers to better understand causes and guide treatment
Official title: Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment
Run by Region Stockholm · NCT07102030 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | February 15, 2015 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2032 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT07102030 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Karolinska University Hospital
Stockholm, Sweden Recruiting
Study contacts
- Study coordinator: Elisabet Svenungsson, MD, PhD
- Email: elisabet.svenungsson@ki.se
- Phone: +46760069142
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effects of anifrolumab on arterial inflammation in SLE patients
This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.
-
Home urine testing for people with lupus
Participants with lupus will try weekly home urine tests in addition to usual care to see if this helps monitor kidney health over a year.
-
CR-402 treatment for refractory autoimmune disease
This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.
-
ATG-201 in adults with autoimmune diseases
This early, open-label study tests ATG-201 in adults with autoimmune diseases to see if it is safe and tolerable, and to get initial clues about how the body handles the drug and its effects.
-
Biomarker tests in adults with lupus to see how kidney disease changes over time
Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.
-
Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia
This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.