Clinical trial NCT04413331: Prospective Longitudinal Cohort Study of Vasculitis Patients
Official title: Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasculitis
Keywords: Prospective vasculitis cohort
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Vasculitis is a group of disorders characterized by the inflammation of blood vessels, leading to an alteration of the vascular wall. The classification of vasculitides has evolved considerably over the last few decades.

In 1990, the American College of Rheumatology established a classification of the main systemic vasculitides based on clinical, biological and histological criteria. In 1994, the Chapel Hill nomenclature has been established as the reference classification system of vasculitides and vasculitides were classified according to the size of the affected vessels. The Chapel Hill nomenclature was revised in 2012, thus enabling to integrate new vasculitides and diagnostic tools.

It is proposed here to conduct a non-interventional cohort study of the different forms of vasculitis, as defined in the Chapel Hill nomenclature. By collecting data from a large number of patients followed prospectively, our objective is to describe the clinical patterns of these diseases, the presentation, management, comorbidities and outcomes, and to evaluate their possible association with some immunological, genetic and molecular parameters.

Eligibility 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.

Primary outcomes:
measure: Creation of a prospective cohort of vasculitis
timeFrame: 5 years
measure: Creation of a prospective cohort of EGPA-vasculitis
timeFrame: 5 years
Secondary outcomes:
measure: Identification of patterns of vasculitis
timeFrame: 5 years
measure: Identification of comorbidities
timeFrame: 5 years
measure: Identification of predictive and prognostic factors
timeFrame: 5 years
measure: Evaluation of results reported by patients
timeFrame: 5 years
measure: Monitoring of the results reported by patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de médecine interne, Hôpital Cochin, AP-HP
Study officials:
References:
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citation: Lightfoot RW Jr, Michel BA, Bloch DA, Hunder GG, Zvaifler NJ, McShane DJ, Arend WP, Calabrese LH, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of polyarteritis nodosa. Arthritis Rheum. 1990 Aug;33(8):1088-93. doi: 10.1002/art.1780330805.
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citation: Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. doi: 10.1002/art.1780370206.
citation: Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available.
citation: van der Woude FJ, Rasmussen N, Lobatto S, Wiik A, Permin H, van Es LA, van der Giessen M, van der Hem GK, The TH. Autoantibodies against neutrophils and monocytes: tool for diagnosis and marker of disease activity in Wegener's granulomatosis. Lancet. 1985 Feb 23;1(8426):425-9. doi: 10.1016/s0140-6736(85)91147-x.
citation: Sable-Fourtassou R, Cohen P, Mahr A, Pagnoux C, Mouthon L, Jayne D, Blockmans D, Cordier JF, Delaval P, Puechal X, Lauque D, Viallard JF, Zoulim A, Guillevin L; French Vasculitis Study Group. Antineutrophil cytoplasmic antibodies and the Churg-Strauss syndrome. Ann Intern Med. 2005 Nov 1;143(9):632-8. doi: 10.7326/0003-4819-143-9-200511010-00006.
citation: Bligny D, Mahr A, Toumelin PL, Mouthon L, Guillevin L. Predicting mortality in systemic Wegener's granulomatosis: a survival analysis based on 93 patients. Arthritis Rheum. 2004 Feb 15;51(1):83-91. doi: 10.1002/art.20082.