Vasculitis Associated With Anti-neutrophil Cytoplasmic AntibodiesNALVANCANCT07636655
Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
An observational study of Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies, run by Nantes University Hospital at 1 site in France.
Trial summary
ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation. However, identifying patients at high risk of relapse remains a challenge, often leading to unnecessarily long treatments and side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies
- What is being tested?
- systematic collection of additional biological samples (blood volume) and BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Sep 2051
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults treated in Nantes, Saint-Nazaire, or La Roche-sur-Yon for ANCA-associated vasculitis (GPA or MPA). These patients, positive for anti-PR3 or anti-MPO antibodies, are recruited during a flare or relapse and receive Rituximab therapy. Samples are provided by the NALVANCA Biocollection.
Who may be able to join
- Adult patient (age ≥ 18 years).
- Patient affiliated with the French social security system.
- Seropositive ANCA-associated vasculitis (AAV) (positive for anti-PR3 or anti-MPO) meeting the Chapel-Hill classification criteria.
- Patient scheduled to receive rituximab (RTX) maintenance therapy (500 mg every 6 months) following an initial flare or a relapse of the disease.
Who cannot join
- Patient unable to provide informed consent.
- Patient refusing to participate in the study.
- End-stage renal disease.
- Progressive neoplasia (excluding cutaneous carcinomas)
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
CHU de Nantes
Nantes, Loire-atlantique, 44093
Antoine Néel, Pr, +33.2.40.08.33.55, antoine.neel@chu-nantes.fr
About this study
Official title: NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation. However, identifying patients at high risk of relapse remains a challenge, often leading to unnecessarily long treatments and side effects. Recent research suggests that RTX also impacts CD8+ T-cells, which could serve as valuable markers for better disease monitoring.
The main goal of the NALVANCA cohort is to identify biomarkers within these CD8+ T-cells. Researchers aim to find biological signals that respond to treatment and can predict a relapse. By studying these markers at the start of therapy and during the immune recovery phase, the study hopes to personalize treatment duration and management for each patient.
Recruitment targets adult patients diagnosed with ANCA-associated vasculitis. Participants must provide written informed consent for the use and storage of their blood samples in a biocollection. The protocol involves long-term monitoring with regular sampling to track changes in immune cells alongside the patient's clinical health.
- Being tested
- systematic collection of additional biological samples (blood volume), BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)
- Keywords
- ANCA, AAV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic collection of additional biological samples (blood volume)Other
systematic collection of additional biological samples (blood volume)
BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)Diagnostic test
BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index) are standardized clinical assessment tools used in vasculitis studies. BVAS is a physician-reported score that evaluates current disease activity across organ systems, capturing the presence and severity of active vasculitic manifestations. In contrast, VDI measures accumulated and irreversible organ damage resulting from vasculitis and/or its treatment over time, irrespective of current disease activity. Together, these instruments allow comprehensive evaluation of both disease activity and long-term patient outcomes in clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab. | This cohort follows adult patients with ANCA-associated vasculitis, a systemic autoimmune disease. The intervention of interest is Rituximab (RTX) therapy, used to induce B-cell depletion. The study involves longitudinal monitoring with the systematic collection of biological samples at key time points: before treatment induction, during the depletion phase, and upon immune reconstitution (2 years after the last injection or at relapse). The objective is to study the pleiotropic effects of B-cell depletion on CD8+ T-cells to identify biomarkers capable of predicting the risk of relapse. Receives: Other: systematic collection of additional biological samples (blood volume); Diagnostic Test: BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a CD8+ T-cell signature sensitive to B-cell depletion.
Identification of a CD8+ T-cell biomarker demonstrating dual sensitivity: during rituximab-induced depletion (pre- vs. post-RTX comparison) and during immune reconstitution (comparison of samples under treatment vs. 2 years post-treatment or at relapse).
Measured: From diagnosis up to 2 years after the final rituximab infusion
Secondary outcomes (3)
To characterize the relationship between B-cell immune responses and CD8 T-cell responses in patients with ANCA-associated vasculitis.
Measured: From diagnosis up to 2 years post-treatment.
To identify potential immune biomarkers associated with disease phenotype and outcomes, including CD4 T-cell subsets, regulatory T cells (Tregs), innate lymphoid cells, immunoglobulins, and inflammatory markers.
Measured: From diagnosis up to 2 years post-treatment.
To evaluate the association between lymphocyte-related immune biomarkers and the occurrence of intercurrent clinical events, including infectious and cardiovascular complications.
Measured: From diagnosis up to 2 years post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2051 (estimated)
- Study completion1 Sep 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasculitis Associated With Anti-neutrophil Cytoplasmic AntibodiesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CR2TI - UMR1064 (INSERM)
- Responsible party
- Sponsor
- Investigators
- Nicolas Degauque, PhD, Principal investigator, CR2TI - UMR1064 (INSERM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636655
- Sponsor's protocol ID
- RC19_0417
- Other IDs
- 2026-A00620-51
- Acronym
- NALVANCA
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
- ClinicalTrials.gov ID
- NCT07636655
- Acronym / sponsor ID
- NALVANCA / RC19_0417
- Keywords
- ANCA, AAV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- CR2TI - UMR1064 (INSERM)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2051 (estimated)
- Study completion
- 1 Sep 2051 (estimated)
- First posted
- 9 Jun 2026 (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.
ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation. However, identifying patients at high risk of relapse remains a challenge, often leading to unnecessarily long treatments and side effects. Recent research suggests that RTX also impacts CD8+ T-cells, which could serve as valuable markers for better disease monitoring.
The main goal of the NALVANCA cohort is to identify biomarkers within these CD8+ T-cells. Researchers aim to find biological signals that respond to treatment and can predict a relapse. By studying these markers at the start of therapy and during the immune recovery phase, the study hopes to personalize treatment duration and management for each patient.
Recruitment targets adult patients diagnosed with ANCA-associated vasculitis. Participants must provide written informed consent for the use and storage of their blood samples in a biocollection. The protocol involves long-term monitoring with regular sampling to track changes in immune cells alongside the patient's clinical health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab. | – | Other: systematic collection of additional biological samples (blood volume), Diagnostic Test: BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)This cohort follows adult patients with ANCA-associated vasculitis, a systemic autoimmune disease. The intervention of interest is Rituximab (RTX) therapy, used to induce B-cell depletion. The study involves longitudinal monitoring with the systematic collection of biological samples at key time points: before treatment induction, during the depletion phase, and upon immune reconstitution (2 years after the last injection or at relapse). The objective is to study the pleiotropic effects of B-cell depletion on CD8+ T-cells to identify biomarkers capable of predicting the risk of relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults treated in Nantes, Saint-Nazaire, or La Roche-sur-Yon for ANCA-associated vasculitis (GPA or MPA). These patients, positive for anti-PR3 or anti-MPO antibodies, are recruited during a flare or relapse and receive Rituximab therapy. Samples are provided by the NALVANCA Biocollection.
Key inclusion criteria (4 listed)
- Adult patient (age ≥ 18 years).
- Patient affiliated with the French social security system.
- Seropositive ANCA-associated vasculitis (AAV) (positive for anti-PR3 or anti-MPO) meeting the Chapel-Hill classification criteria.
- Patient scheduled to receive rituximab (RTX) maintenance therapy (500 mg every 6 months) following an initial flare or a relapse of the disease.
Key exclusion criteria (4 listed)
- Patient unable to provide informed consent.
- Patient refusing to participate in the study.
- End-stage renal disease.
- Progressive neoplasia (excluding cutaneous carcinomas)
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 |
|---|---|---|
| systematic collection of additional biological samples (blood volume)systematic collection of additional biological samples (blood volume) | Other | NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab. |
| BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index) are standardized clinical assessment tools used in vasculitis studies. BVAS is a physician-reported score that evaluates current disease activity across organ systems, capturing the presence and severity of active vasculitic manifestations. In contrast, VDI measures accumulated and irreversible organ damage resulting from vasculitis and/or its treatment over time, irrespective of current disease activity. Together, these instruments allow comprehensive evaluation of both disease activity and long-term patient outcomes in clinical trials. | Diagnostic test | NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab. |
Primary outcome
Identification of a CD8+ T-cell signature sensitive to B-cell depletion.
Time frame: From diagnosis up to 2 years after the final rituximab infusion
Identification of a CD8+ T-cell biomarker demonstrating dual sensitivity: during rituximab-induced depletion (pre- vs. post-RTX comparison) and during immune reconstitution (comparison of samples under treatment vs. 2 years post-treatment or at relapse).
3 secondary outcomes
To characterize the relationship between B-cell immune responses and CD8 T-cell responses in patients with ANCA-associated vasculitis.
Time frame: From diagnosis up to 2 years post-treatment.
To identify potential immune biomarkers associated with disease phenotype and outcomes, including CD4 T-cell subsets, regulatory T cells (Tregs), innate lymphoid cells, immunoglobulins, and inflammatory markers.
Time frame: From diagnosis up to 2 years post-treatment.
To evaluate the association between lymphocyte-related immune biomarkers and the occurrence of intercurrent clinical events, including infectious and cardiovascular complications.
Time frame: From diagnosis up to 2 years post-treatment.
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Nicolas Degauque, PhD principal investigator
CR2TI - UMR1064 (INSERM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies, run by Nantes University Hospital 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jul 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 Antoine Néel, Pr (+33.2.40.08.33.55, antoine.neel@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a CD8+ T-cell signature sensitive to B-cell depletion. (time frame: From diagnosis up to 2 years after the final rituximab infusion). 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 7 Jul 2026.