NCT07209540Not yet recruiting
European LUpuS Inception-Cohort Developing initiATivE
Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 1 Oct 2025
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Dec 2029
- Lead sponsor
- University of Aarhus
- Diseases
- Lupus (SLE)
- NCT number
- NCT07209540
What you commit to
- Study type: Observational
- Planned participants: 700
- From 1 Jul 2026 to the primary completion date, 1 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.