ANCA-associated Vasculitis Clinical Trial
— ANCAOfficial 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
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Brest - Service de rhumatologie | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02257866 -
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
|
||
Completed |
NCT02463539 -
Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis
|
N/A | |
Recruiting |
NCT05897684 -
Avacostar - (PASS)
|
||
Terminated |
NCT00482066 -
Abatacept in ANCA Associated Vasculitis
|
Phase 2 | |
Not yet recruiting |
NCT02126098 -
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
|
N/A | |
Recruiting |
NCT05965284 -
Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)
|
Phase 4 | |
Recruiting |
NCT06285279 -
FKC288 in Participants With Autoimmune Kidney Diseases
|
Phase 1 | |
Completed |
NCT02994927 -
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
|
Phase 3 | |
Recruiting |
NCT02463578 -
Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis
|
N/A | |
Active, not recruiting |
NCT05716334 -
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
|
||
Recruiting |
NCT05383573 -
Pediatric ANCA Associated-vasculitis
|
||
Completed |
NCT02222155 -
Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
|
Phase 2 | |
Recruiting |
NCT05197842 -
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
|
Phase 1/Phase 2 | |
Completed |
NCT02954705 -
MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS
|
||
Completed |
NCT04280601 -
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis
|
N/A | |
Active, not recruiting |
NCT02108860 -
Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
|
Phase 3 |