ClinicalTrials.gov record NCT06377462
Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A multicenter, prospective registry that records clinical information and collects biospecimens from adults (≥18) with established or suspected VEXAS syndrome. It follows participants over time (target 5 years) to document disease course, treatments, and outcomes.
What it is studying. The study is gathering real-world data and biological samples to describe how VEXAS presents and progresses, what treatments are used and in what order, and to search for diagnostic signs and biomarkers (including genotype–phenotype links and laboratory signatures). It also collects quality-of-life and other clinical outcome information.
What the researchers hope to learn. Collect epidemiological data on VEXAS (incidence, age/sex distribution); document initial disease manifestations and associations with hematologic conditions; record treatment approaches and sequences; analyze clinical endpoints (remission types, treatment-free remission); identify phenotype clusters and genotype–phenotype associations; establish diagnostic and monitoring laboratory signatures and biomarkers (including molecular characterization of UBA1 and other mutations, HLA correlations, coagulation diagnostics); collect quality-of-life and fatigue data; and support translational research (metabolic, inflammatory, microbiome signatures; potential triggers/risk factors).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients with established or suspected (clinical and hematological criteria) VEXAS Syndrome
- Age ≥18 years
- Signed informed consent form
Exclusion criteria
- patients who are not in a position to understand the nature and scope of participation in this register
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
see brief summary
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants have their medical history, disease course and treatments documented during routine care and may be followed for up to 5 years. They will be asked to provide biospecimens for storage and laboratory research and to complete quality-of-life and fatigue questionnaires. The registry collects epidemiological and clinical data and documents treatment sequences and clinical endpoints. The record lists biospecimen collection but does not specify which sample types or name any specific invasive procedures (for example, bone marrow biopsy or lumbar puncture); the study team would provide those details.
How the study is structured. A prospective, observational registry (cohort) that enrolls adults with established or suspected VEXAS. Participants provide clinical data, treatment histories, questionnaires (including quality-of-life and fatigue), and biospecimens for laboratory and molecular testing. Data and samples are followed and analyzed over a planned period of up to 5 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on VEXAS syndrome
Important dates
- Study start
- Mar 13, 2024
- Primary completion
- Dec 31, 2029 (estimated)
- Study completion
- Dec 31, 2030 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Sep 19, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Technische Universität Dresden
- Collaborators
- Bristol-Myers Squibb
- University Hospital Munich
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Katja Sockel, Dr. med. 📞 +493514585627 ✉ katja.sockel@ukdd.de
- Katharina Goetze, Prof. 📞 +498941404618 ✉ katharina.goetze@tum.de
Participating sites (13)
- Universitätsklinikum AachenRecruiting
Aachen · Germany
- Klinikum Chemnitz gGmbHRecruiting
Chemnitz · Germany
- Universitätsklinikum Carl Gustav CarusRecruiting
Dresden, 01307 · Germany
- Katja Sockel, Dr. med.
- Universitätsklinikum DüsseldorfRecruiting
Düsseldorf · Germany
- Evang. Kliniken Essen-MitteRecruiting
Essen · Germany
- Universitätsklinikum Hamburg-EppendorfRecruiting
Hamburg · Germany
- Universitätsklinikum Leipzig AöRRecruiting
Leipzig · Germany
- Universitätsmedizin MannheimRecruiting
Mannheim · Germany
- Klinikum rechts der Isar TUMRecruiting
München · Germany
- Klinikum Osnabrück GmbHRecruiting
Osnabrück · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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