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

NCT07102030 | Recruiting

• 1 other identifier: VR 2022-00783
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Autoantibody defined subgroups

  Subgroups will be defined based on presence of autoantibodies

  2024- 2027

• Cardiovascular events

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

  2024-2027

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• SLE according to criteria (ACR82 or SLICC 2012) and consenting to participate

You may not qualify if:

• Not possible to read and understand patient information due to language barriers or psychological/psychiatric disorders Not consenting

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator
• National Institutes of Health (NIH): collaborator
• The Swedish Research Council: collaborator
• Reumatikerförbundet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (serum, plasma, PAx tubes). DNA will be extracted. Urine and saliva

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Elisabet Svenungsson, MD, PhD

CONTACT

+46760069142; elisabet.svenungsson@ki.se

Iva Gunnarsson, MD, PhD

CONTACT

Iva.gunnarsson@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: February 15, 2015
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: July 15 2025 until July 15 2027
• Access Criteria: Selected data will be shared with Christian Lood, University of Washington USA, using Managed File Transfer at Karolinska Institutet.

Locations

SE (1)