Status:
NOT_YET_RECRUITING
European LUpuS Inception-Cohort Developing initiATivE
Lead Sponsor:
University of Aarhus
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
16+ years
Brief Summary
The goal of this observational study is to learn more about how systemic lupus erythematosus (SLE or lupus) develops in the first years after diagnosis, and how patients respond to different treatment...
Detailed Description
PROTOCOL SYNOPSIS 1. Introduction Systemic lupus erythematosus (SLE) is a complex autoimmune disease with diverse clinical manifestations. Despite recent therapeutic advances, challenges persist, inc...
Eligibility Criteria
Inclusion
- Inclusion at clinical diagnosis of SLE (or strong clinical suspicion hereof) before initiating treatment (if treatment has been initiated, patients can still be included if it is less than six months since diagnosis and the patient has clinically and biochemically active disease (SLEDAI\>6).
- Fulfilling the 2019 ACR/EULAR criteria for Systemic Lupus Erythematosus
- \>18 years of age (adult onset SLE)
- Ability to provide informed voluntary consent.
Exclusion
- Diagnosed with overlapping systemic autoimmune diseases other than secondary Sjögren's syndrome or antiphospholipid syndrome.
- Active treatment for malignancy at the time of enrolment, except for non-melanoma skin cancer or localized carcinoma in situ of the skin.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2033
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT07209540
Start Date
July 1 2026
End Date
July 1 2033
Last Update
October 7 2025
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