Karolinska University Hospital
Stockholm, 17176, Sweden
Location status: Recruiting
NCT Number: NCT07102030
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Stockholm, 17176, Sweden
Location status: Recruiting
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".
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
-
Time frame: 2024- 2027
Subgroups will be defined based on presence of autoantibodies
Time frame: 2024-2027
Cardiovascular events will be collected during follow up in National Patient Registries
Contact information is provided by the study sponsor or research team.
Elisabet Svenungsson, MD, PhD
CONTACT
Iva Gunnarsson, MD, PhD
CONTACT
Region Stockholm
Other Gov
Acronym: SLEsubgroups
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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