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NCT Number: NCT07102030

Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location status: Recruiting

Location contact

Jon Lampa, MD, PhD

CONTACT

[email protected]

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Primary outcomes

  1. Autoantibody defined subgroups

    Time frame: 2024- 2027

    Subgroups will be defined based on presence of autoantibodies

  2. Cardiovascular events

    Time frame: 2024-2027

    Cardiovascular events will be collected during follow up in National Patient Registries

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabet Svenungsson, MD, PhD

CONTACT

[email protected]

+46760069142

Iva Gunnarsson, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet
  • National Institutes of Health (NIH)
  • Reumatikerförbundet
  • The Swedish Research Council

Registry information

Acronym: SLEsubgroups

Important dates

Study start
2015
Primary completion
2029
Study completion
2032
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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