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NCT Number: NCT05364892

Biocollection of Patients With ANCA Associated Vasculitis

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.

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Key information

Conditions

ANCA-associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest - Service de rhumatologie

Brest, 29200, France

Location status: Recruiting

Location contact

Divi CORNEC

CONTACT

[email protected]

02 98 34 72 64

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples (80 mL)

Other

Blood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment

Fecal samples

Other

Fecal samples at inclusion

Urinary sample (20-40 mL)

Other

Urinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment

questionnaires

Other

Questionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment

Primary outcomes

  1. Relapse-free survival of the disease

    Time frame: Five years after diagnosis

    Relapse-free survival of the disease

Secondary outcomes

  1. death

    Time frame: Five years after diagnosis

    death

  2. Age

    Time frame: Five years after diagnosis

    Age

  3. Sex

    Time frame: Five years after diagnosis

    Sex

  4. Physician assessment of disease activity

    Time frame: Five years after diagnosis

    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.

  5. Patient assessment of disease activity

    Time frame: Five years after diagnosis

    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.

  6. BVAS score - Birmingham Vasculitis Activity Score

    Time frame: Five years after diagnosis

    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.

  7. VDI score - Vasculitis Damage Index

    Time frame: Five years after diagnosis

    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.

  8. Number of patients with refractory character of the Vasculitis

    Time frame: Five years after diagnosis

    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.

  9. HAQ-DI - Health Assessment Questionnaire - Disability Index.

    Time frame: Five years after diagnosis

    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.

  10. Glucocorticoid toxicity index - Glucocorticoid toxicity index during follow-up Glucocorticoid toxicity index

    Time frame: Five years after diagnosis

    Glucocorticoid toxicity index during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Divi CORNEC

CONTACT

[email protected]

(0)2 98 34 72 64 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: ANCA

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
May 6, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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