ANCA-associated VasculitisANCANCT05364892
Biocollection of Patients With ANCA Associated Vasculitis
A study testing Blood samples (80 mL), Fecal samples and Urinary sample (20-40 mL) in people with ANCA-associated Vasculitis, run by University Hospital, Brest at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- ANCA-associated Vasculitis
- What is being tested?
- Blood samples (80 mL), Fecal samples and Urinary sample (20-40 mL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2022to 27 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest - Service de rhumatologie
Brest, Brest, 29200
Divi CORNEC, 02 98 34 72 64, divi.cornec@chu-brest.fr
About this study
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
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.
Read the detailed 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.
- Conditions
- ANCA-associated Vasculitis
- Being tested
- Blood samples (80 mL), Fecal samples, Urinary sample (20-40 mL), Questionnaires
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 samplesOther
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
QuestionnairesOther
Questionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment
| Study group | Role | What they receive |
|---|---|---|
| ANCA-associated vasculitis - patient library | Other | It is a description of ANCA-associated vasculitis patients cohort. All the patients are included in one arm. They will undergo various type of samples. Receives: Other: Blood samples (80 mL); Other: Fecal samples; Other: Urinary sample (20-40 mL); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival of the disease
Relapse-free survival of the disease
Measured: Five years after diagnosis
Secondary outcomes (10)
death
death
Measured: Five years after diagnosis
Age
Age
Measured: Five years after diagnosis
Sex
Sex
Measured: Five years after diagnosis
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.
Measured: Five years after diagnosis
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.
Measured: Five years after diagnosis
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.
Measured: Five years after diagnosis
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.
Measured: Five years after diagnosis
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.
Measured: Five years after diagnosis
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.
Measured: Five years after diagnosis
Glucocorticoid toxicity index - Glucocorticoid toxicity index during follow-up Glucocorticoid toxicity index
Glucocorticoid toxicity index during follow-up
Measured: Five years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start27 Oct 2022
- Primary completion27 Oct 2032 (estimated)
- Study completion27 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnosis and follow up of ANCA-associated vasculitis
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364892
- Sponsor's protocol ID
- 29BRC20.0233
- Acronym
- ANCA
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2020
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05364892
- Acronym / sponsor ID
- ANCA / 29BRC20.0233
- Conditions
- ANCA-associated Vasculitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 27 Oct 2032 (estimated)
- Study completion
- 27 Oct 2032 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnosis and follow up of ANCA-associated vasculitis
| Arm | Type | Receives |
|---|---|---|
| ANCA-associated vasculitis - patient library | Other | Other: Blood samples (80 mL), Other: Fecal samples, Other: Urinary sample (20-40 mL), Other: QuestionnairesIt is a description of ANCA-associated vasculitis patients cohort. All the patients are included in one arm. They will undergo various type of samples. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Minor
- Patients unable to consent.
- Patients refusing to participate in research
- Patient under legal protection (tutelage, curatorship)
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples (80 mL)Blood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment | Other | ANCA-associated vasculitis - patient library |
| Fecal samplesFecal samples at inclusion | Other | ANCA-associated vasculitis - patient library |
| Urinary sample (20-40 mL)Urinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment | Other | ANCA-associated vasculitis - patient library |
| QuestionnairesQuestionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment | Other | ANCA-associated vasculitis - patient library |
Primary outcome
Relapse-free survival of the disease
Time frame: Five years after diagnosis
Relapse-free survival of the disease
10 secondary outcomes
death
Time frame: Five years after diagnosis
Age
Time frame: Five years after diagnosis
Sex
Time frame: Five years after diagnosis
Physician assessment of disease activity
Time frame: Five years after diagnosis
Patient assessment of disease activity
Time frame: Five years after diagnosis
BVAS score - Birmingham Vasculitis Activity Score
Time frame: Five years after diagnosis
VDI score - Vasculitis Damage Index
Time frame: Five years after diagnosis
Number of patients with refractory character of the Vasculitis
Time frame: Five years after diagnosis
HAQ-DI - Health Assessment Questionnaire - Disability Index.
Time frame: Five years after diagnosis
Glucocorticoid toxicity index - Glucocorticoid toxicity index during follow-up Glucocorticoid toxicity index
Time frame: Five years after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for ANCA-associated Vasculitis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 2
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Not yet recruitingPhase 2
Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples (80 mL), Fecal samples and Urinary sample (20-40 mL) in people with ANCA-associated Vasculitis, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Divi CORNEC ((0)2 98 34 72 64 ext. +33, divi.cornec@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival of the disease (time frame: Five years after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.