Prospective Longitudinal Cohort Study of Vasculitis Patients

Vasculitis Clinical Trial

— VASCO  

Official title:

Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413331
• Other study ID #: APHP200109
• Status: Recruiting
• Start date: July 2, 2020
• Est. completion date: July 2032

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Benjamin Terrier, PhD
• Phone: +33 1 58 41 14 61
• Email: benjamin.terrier[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: July 2032
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vasculitis

Intervention

Other:
• Data collection
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
Biological samples at M0, M6, M12, M24 and at each relapse until M60

Locations

Country	Name	City	State
France	Service de médecine interne, Hôpital Cochin, AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View 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. — View 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. — View Citation

Leavitt RY, Fauci AS, Bloch DA, Michel BA, Hunder GG, Arend WP, Calabrese LH, Fries JF, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Wegener's granulomatosis. Arthritis Rheum. 1990 Aug;33(8):1101-7. doi: 10.1002/art.1780330807. — View 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. — View Citation

Masi AT, Hunder GG, Lie JT, Michel BA, Bloch DA, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, et al. The American College of Rheumatology 1990 criteria for the classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis). Arthritis Rheum. 1990 Aug;33(8):1094-100. doi: 10.1002/art.1780330806. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Primary	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.	5 years
Secondary	Identification of patterns of vasculitis	To identify possible relationships between clinical patterns of vasculitis and response to treatment, risk of glucocorticoids dependence, survival, etc.	5 years
Secondary	Identification of comorbidities	To identify comorbidities and the impact on therapeutic management and patient outcomes	5 years
Secondary	Identification of predictive and prognostic factors	To identify radiological, histological, pharmacological, genetic, molecular and immunological predictive and prognostic markers.	5 years
Secondary	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)	5 years
Secondary	Monitoring of the results reported by patients	Monitor the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)	5 years

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