Biocollection of Patients With ANCA Associated Vasculitis

ANCA-associated Vasculitis Clinical Trial

— ANCA  

Official title:

Biocollection of Patients With ANCA Associated Vasculitis Diagnosed Within the CERAINO Autoimmune Disease Reference Center, Part of the Global BRAISE Project (B-dependent Rare AutoImmune DiseaSES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364892
• Other study ID #: 29BRC20.0233
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: October 27, 2032

Study information

• Verified date: October 2022
• Source: University Hospital, Brest
• Contact: Divi CORNEC
• Phone: (0)2 98 34 72 64
• Email: divi.cornec[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.

Description:

Vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA) is a group of rare and severe autoimmune diseases, encompassing several entities: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (PMA), and eosinophilic granulomatosis with polyangiitis (GEPA). When untreated, these diseases are fatal in a matter of months. Currently, thanks to the use of corticosteroids and immunosuppressants, this high mortality has greatly decreased and these are now chronic diseases. On the other hand, these patients are at high risk of morbidity, linked to both relapses (occurring in at least 50% of patients) and side effects of treatments. It is therefore essential to be able to define which patients are at risk of relapse and justify long-term immunosuppressive treatment to avoid recurrence of the disease, and conversely which patients have a low risk of relapse and in whom immunosuppressive treatments can be discontinued to limit the risk of side effects. However, so far no predictor or biomarker can accurately assess this risk of relapse.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 27, 2032
• Est. primary completion date: October 27, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Major patients with no upper age limit.
• Patients assessed as part of the reference centre for rare autoimmune diseases at the CHRU in Brest.
• Patients for whom a diagnosis of ANCA-associated vasculitis is made by the physician in charge of the patient, according to the definitions of the Chapel-Hill Consensus Conference.
• Patient affiliated with Social Security
• Patient who has signed written informed consent

Exclusion Criteria:

• Minor
• Patients unable to consent.
• Patients refusing to participate in research
• Patient under legal protection (tutelage, curatorship)
• Pregnant or lactating women
• Hemoglobin (Hb) < 7g/dL

Related Conditions & MeSH terms

• ANCA-associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Intervention

Other:
• Blood samples (80 mL)
Blood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment
• Fecal samples
Fecal samples at inclusion
• Urinary sample (20-40 mL)
Urinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment
• Questionnaires
Questionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment

Locations

Country	Name	City	State
France	CHRU de Brest - Service de rhumatologie	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival of the disease	Relapse-free survival of the disease	Five years after diagnosis
Secondary	death	death	Five years after diagnosis
Secondary	Age	Age	Five years after diagnosis
Secondary	Sex	Sex	Five years after diagnosis
Secondary	Physician assessment of disease activity	Disease activity will be assessed on a scale from 0 to 100, considering the pain and the impact on daily life. A higher score means a worse outcome.	Five years after diagnosis
Secondary	Patient assessment of disease activity	Disease activity will be assessed on a scale from 0 to 100, considering the pain and the impact on daily life. A higher score means a worse outcome.	Five years after diagnosis
Secondary	BVAS score - Birmingham Vasculitis Activity Score	Questionnaire listing 56 symptoms divided into nine organ/systems classes, plus an "other" section. For each item, the assessor evaluates if it is present and attribuable to the active vasculitis or not. A higher score means a worse outcome.	Five years after diagnosis
Secondary	VDI score - Vasculitis Damage Index	This is for recording organ damage that has occurred in patients since the onset of vasculitis, and over 3 months. Record features of active disease using the Birmingham Vasculitis Activity Score (BVAS).; A new patient should usually have a VDI score of zero, unless: they have had vasculitis for more than three months of onset of disease. and; the damage has developed or become worse since the onset of vasculitis Questionnaire listing 64 symptoms divided into eleven organ/systems classes. For each item, the assessor evaluates if it is present over 3 months and attribuable to the active vasculitis or not. A higher score means a worse outcome.	Five years after diagnosis
Secondary	Number of patients with refractory character of the Vasculitis	Number of patients for whome a secondary decision to intensify immunosupressive treatment in the first year of treatment (increased corticosteroid dosage, introduction of another immunosupressor outside the scheduled at the end of the initial assessment) has been taken.	Five years after diagnosis
Secondary	HAQ-DI - Health Assessment Questionnaire - Disability Index.	Evolution of HAQ-DI during follow-up 8 fields questionnaire (DRESSING & GROOMING, ARISING, EATING, WALKING, HYGENE, REACH, GRIP, Other activites), scaled from 0 to 3, 3 meaning a worse outcome.	Five years after diagnosis
Secondary	Glucocorticoid toxicity index - Glucocorticoid toxicity index during follow-up Glucocorticoid toxicity index	Glucocorticoid toxicity index during follow-up	Five years after diagnosis