Systemic Lupus ErythematosusSLEsubgroupsNCT07102030
Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment
An observational study of Systemic Lupus Erythematosus, run by Region Stockholm at 1 site in Sweden.
Trial summary
The goal of this observational study is to investigate different phenotypes among patients with SLE and to compare with matched general population controls. The main questions we aim to answer are: A To investigate if subgroups of patients with systemic lupus erythematosus (SLE) defined by autoantibodies, genetic… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 900 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2015to 31 Dec 2032
- How long will I take part?
- 10 Years
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SLE patients as described above who are cared for at karolinska University Hospital, Danderyds Hospital or Center forRheumathology (CFR) in Stockholm and matched general population controls
Who may be able to join
- SLE according to criteria (ACR82 or SLICC 2012) and consenting to participate
Who cannot join
- Not possible to read and understand patient information due to language barriers or psychological/psychiatric disorders Not consenting
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iva Gunnarsson, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Jon Lampa, MD, PhD, jon.lampa@regionstockholm.se
About this study
The goal of this observational study is to investigate different phenotypes among patients with SLE and to compare with matched general population controls. The main questions we aim to answer are:
A To investigate if subgroups of patients with systemic lupus erythematosus (SLE) defined by autoantibodies, genetic predisposition or biomarkers, rather than the present diagnostic entities account for the high risk of premature vascular disease.
Read more
B To perform in depth studies of selected patient groups to shed light on the autoimmune mechanisms behind antiphospholipid (aPL) antibodies and nephritis and their association to vascular disease in SLE and APS Participants will be investigated in person by a nurse and a rheumatologist. Data on previous and present disease characteristics, anthropometric measurements and health related quality of life (according to selfreported questionnaires) will be entered into a data base. Blood samples (plasma serum and DNA), urine and saliva is stored in a corresponding biobank.
Researchers will compare identified subgroups of SLE patients to each other and to matched population controls.
Read the detailed description
The clinical base for this application is a series of cross-sectional studies, performed every 10 years, including all consenting SLE patients at Rheumatology Karolinska. The first studies were initiated 1995-99, with second follow-up 2004-14. Since 2015, a third follow-up of prevalent and new cases is ongoing (presently comprising 400 patients, inclusions have been temporarily slowed by the Covid-19 pandemic). Very detailed clinical characterization, lifestyle questionnaires, together with results from carotid ultrasound and bone mineral density measures have been tabulated. General disease activity as well as features of lupus nephritis, and detailed autoantibody profiles are recorded at inclusion. Samples (plasma, serum, DNA, urine and saliva) are stored. We have a common database for the three cross-sectional studies. The total number of well-characterized SLE patients in these studies is today 867 SLE patients and >250 APS patients.
Population based controls identified in the national population registry (NPR), individually matched for age, sex, and residency have been investigated in person according to the same structured protocol (n=320). New controls will be included to match the "2015+ study".
- Conditions
- Systemic Lupus Erythematosus
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | Patients fulfilling ACR 1982 or SLICC 2012 criteria for SLE. No interventions | |
| Controls | General population controls matched from the National Patient Registries for age, gender and area of living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoantibody defined subgroups
Subgroups will be defined based on presence of autoantibodies
Measured: 2024- 2027
Cardiovascular events
Cardiovascular events will be collected during follow up in National Patient Registries
Measured: 2024-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Feb 2015
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, National Institutes of Health (NIH), The Swedish Research Council, Reumatikerförbundet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102030
- Sponsor's protocol ID
- VR 2022-00783
- Acronym
- SLEsubgroups
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and autoantibody data collected at inclusion
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment
- ClinicalTrials.gov ID
- NCT07102030
- Acronym / sponsor ID
- SLEsubgroups / VR 2022-00783
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet, National Institutes of Health (NIH), The Swedish Research Council, Reumatikerförbundet
- Study start
- 15 Feb 2015 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 3 Aug 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.
The goal of this observational study is to investigate different phenotypes among patients with SLE and to compare with matched general population controls. The main questions we aim to answer are:
A To investigate if subgroups of patients with systemic lupus erythematosus (SLE) defined by autoantibodies, genetic predisposition or biomarkers, rather than the present diagnostic entities account for the high risk of premature vascular disease.
B To perform in depth studies of selected patient groups to shed light on the autoimmune mechanisms behind antiphospholipid (aPL) antibodies and nephritis and their association to vascular disease in SLE and APS Participants will be investigated in person by a nurse and a rheumatologist. Data on previous and present disease characteristics, anthropometric measurements and health related quality of life (according to selfreported questionnaires) will be entered into a data base. Blood samples (plasma serum and DNA), urine and saliva is stored in a corresponding biobank.
Researchers will compare identified subgroups of SLE patients to each other and to matched population controls.
Detailed description
The clinical base for this application is a series of cross-sectional studies, performed every 10 years, including all consenting SLE patients at Rheumatology Karolinska. The first studies were initiated 1995-99, with second follow-up 2004-14. Since 2015, a third follow-up of prevalent and new cases is ongoing (presently comprising 400 patients, inclusions have been temporarily slowed by the Covid-19 pandemic). Very detailed clinical characterization, lifestyle questionnaires, together with results from carotid ultrasound and bone mineral density measures have been tabulated. General disease activity as well as features of lupus nephritis, and detailed autoantibody profiles are recorded at inclusion. Samples (plasma, serum, DNA, urine and saliva) are stored. We have a common database for the three cross-sectional studies. The total number of well-characterized SLE patients in these studies is today 867 SLE patients and >250 APS patients.
Population based controls identified in the national population registry (NPR), individually matched for age, sex, and residency have been investigated in person according to the same structured protocol (n=320). New controls will be included to match the "2015+ study".
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | –Patients fulfilling ACR 1982 or SLICC 2012 criteria for SLE. No interventions |
| Controls | – | –General population controls matched from the National Patient Registries for age, gender and area of living |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SLE patients as described above who are cared for at karolinska University Hospital, Danderyds Hospital or Center forRheumathology (CFR) in Stockholm and matched general population controls
Key inclusion criteria (1 listed)
- SLE according to criteria (ACR82 or SLICC 2012) and consenting to participate
Key exclusion criteria (2 listed)
- Not possible to read and understand patient information due to language barriers or psychological/psychiatric disorders Not consenting
- -
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
Autoantibody defined subgroups
Time frame: 2024- 2027
Subgroups will be defined based on presence of autoantibodies
Cardiovascular events
Time frame: 2024-2027
Cardiovascular events will be collected during follow up in National Patient Registries
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 3 Aug 2025.
- Individual participant dataSharing planned: Yes. Clinical and autoantibody data collected at inclusion
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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.
Iva Gunnarsson, MD, PhD contact
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 Systemic Lupus Erythematosus, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 2 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 3 Aug 2025. 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 Sweden. 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 Elisabet Svenungsson, MD, PhD (+46760069142, elisabet.svenungsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autoantibody defined subgroups (time frame: 2024- 2027). 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 3 Aug 2025.