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Prospective Longitudinal Cohort Study of Vasculitis Patients

ConditionVasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

VASCO is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

The VASCO study population includes adult patients (no age upper-limit) with vasculitis as defined in the 2012 revised Chapel Hill International Nomenclature, at an active phase of the disease, either the initial flare or a relapse. Patients will be informed by the study investigator during a visit as part of their medical follow-up.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Data collection

    Other intervention

    Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse

  • Biological samples and data collection

    Other intervention

    Biological samples at M0, M6, M12, M24 and at each relapse until M60

Treatment groups

670 Participants
are divided into 2 treatment groups
Group A: Vasculitis2 interventions
Group B: EGPA vasculitis2 interventions

Trial outcomes

Primary outcomes

1

Creation of a prospective cohort of vasculitis

Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management, comorbidities and outcomes, based on the analysis of clinical, biological and immunological data

Time frame
5 years
2

Creation of a prospective cohort of EGPA-vasculitis

EGPA -Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management and his efficacity, comorbidities and outcomes of EGPA, based on the analysis of clinical, biological and immunological data. The evaluation of the response to the treatment will be based, for all the different treatments, on the ability or not to reach a prednisone dose of 4.0 mg or less, at any time (binary criterion)). The treatments will be used at the discretion of the referring physician in charge of the pathology, according to what is recommended in the National Diagnostic and Care Protocol (PNDS) in force.

Time frame
5 years

Secondary outcomes

1

Identification of patterns of vasculitis

To identify possible relationships between clinical patterns of vasculitis and response to treatment, risk of glucocorticoids dependence, survival, etc.

Time frame
5 years
2

Identification of comorbidities

To identify comorbidities and the impact on therapeutic management and patient outcomes

Time frame
5 years
3

Identification of predictive and prognostic factors

To identify radiological, histological, pharmacological, genetic, molecular and immunological predictive and prognostic markers.

Time frame
5 years
4

Evaluation of results reported by patients

Evaluate the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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