Longitudinal study of patients with vasculitis
Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage
This study is trying to learn more about vasculitis by following patients over time to see how their disease affects them and what treatments work best.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 670 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04413331 on ClinicalTrials.gov |
What this trial studies
This study aims to collect and analyze clinical, biological, and immunological data from patients diagnosed with vasculitis. It will follow patients over time to describe their disease presentation, management strategies, comorbidities, and outcomes. By utilizing a prospective observational approach, the study seeks to enhance understanding of the various forms of vasculitis as classified by the Chapel Hill nomenclature. The data collected will help identify potential associations with immunological, genetic, and molecular parameters.
Who should consider this trial
Good fit: Ideal candidates include adult patients over 18 years old who are currently experiencing an active phase of vasculitis.
Not a fit: Patients who are unable to provide informed consent or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for patients with vasculitis.
How similar studies have performed: Other studies have successfully utilized similar observational cohort approaches to enhance understanding of complex diseases like vasculitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age over 18 years), * Patients with vasculitis, as defined in the Chapel Hill International Nomenclature as revised in 2012, * Patients included at an active phase of the disease, either the initial flare or a relapse, * Patients who have been informed and have signed the consent * Pregnant and breastfeeding women may be included in the study, * Affiliated to a social security system (beneficiary or entitled person). Exclusion Criteria: * Refusal of consent or inability to obtain consent, * A patient who is insane or not entitled, for psychiatric reasons or intellectual impairment, to receive information about the protocol and to give informed consent, * Patient under guardianship / curators * Patient on state medical assistance (AME) * Hemoglobin less than 7 g/dl at the time of sampling, * Hemoglobin level less than 9 g/dl at the time of sampling if the patient has respiratory or cardiovascular disease, * Patient weighs less than 18 kg. * Parallel participation in an interventional protocol is permitted.
Where this trial is running
Paris
- Service de médecine interne, Hôpital Cochin, AP-HP — Paris, France (Recruiting)
Study contacts
- Study coordinator: Benjamin Terrier, PhD
- Email: benjamin.terrier@aphp.fr
- Phone: +33 1 58 41 14 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.