European LUpuS Inception-Cohort Developing initiATivE

NCT07209540 | Not Yet Recruiting

• 1 other identifier: 36-18-2025
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

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 treatments. The main questions the study aims to answer are: How many patients with newly diagnosed lupus reach remission or low disease activity in the first years after starting treatment? Which biological markers (in blood or urine) can help predict treatment response, disease complications, or symptoms such as pain and fatigue? Adults recently diagnosed with lupus (within the past 6 months) will be invited to participate. They will continue with their normal medical care, but in addition, they will take part in study visits over a 5-year period. At these visits, doctors will collect information about symptoms, treatment, and quality of life. Blood and urine samples will also be stored in a biobank for later analysis. Around 720 patients from several European countries are expected to join the study. Because participants are included very soon after diagnosis, researchers can follow the course of lupus from the beginning, before long-term treatment or damage occurs. By combining clinical information and biological samples, researchers hope to identify new ways to understand lupus, improve treatment strategies, and eventually develop personalized medicine approaches. This could help future patients achieve better disease control, fewer complications, and improved quality of life.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

lupus; systemic lupus erythematosus; SLE; treat-to-target; prediction

Outcome Measures

Primary Outcomes (2)

• DORIS remission

  How many patients achieve DORIS remission 1 year after diagnosis

  1 year

• Lupus Low Disease Activity

  How many patients have achieved LLDAS at 1 year after diagnosis

  1 year

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a new diagnosis of systemic lupus erythematosus (SLE) according to the 2019 ACR/EULAR criteria. Patients must be treatment-naïve. If they have started treatment they must have clinically and biochemically active disease. Approximately 700 participants will be enrolled across multiple European centers.

You may qualify if:

• Fulfilling the 2019 ACR/EULAR criteria for Systemic Lupus Erythematosus
• \>18 years of age (adult onset SLE)
• Ability to provide informed voluntary consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Biospecimen

Retention: SAMPLES WITH DNA

EDTA plasma, Serum, PBMCs, PAX gene tubes

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

Anne Troldborg, MD; PhD

CONTACT

+4540789072; annetrol@rm.dk

Silvia Piantoni, MD, PhD

CONTACT

slv.piantoni@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): July 1, 2033
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Protocol and data will be available from completion of inclusion and minimum 5 years after study end.
• Access Criteria: Access will be granted for scientifically sound proposals addressing questions related to lupus, treatment outcomes, or biomarkers. Requests must be submitted to the study steering committee for review and approval. Approved researchers will sign a data access agreement and receive data through a secure, controlled-access platform.