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European LUpuS Inception-Cohort Developing initiATivE

NCT07209540 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-10-07

No results posted yet for this study

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)

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-12-01
Completion
2033-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209540 on ClinicalTrials.gov