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Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis (NALVANCA)

9. juni 2026 opdateret af: Nantes University Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
    • Loire-atlantique
      • Nantes, Loire-atlantique, Frankrig, 44093

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion criteria :

  • 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.

Exclusion Criteria:

  • Patient unable to provide informed consent.
  • Patient refusing to participate in the study.
  • End-stage renal disease.
  • Progressive neoplasia (excluding cutaneous carcinomas)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: systematic collection of additional biological samples (blood volume)
systematic collection of additional biological samples (blood volume)
Diagnostisk test: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identification of a CD8+ T-cell signature sensitive to B-cell depletion.
Tidsramme: 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).
From diagnosis up to 2 years after the final rituximab infusion

Sekundære resultatmål

Resultatmål
Tidsramme
To characterize the relationship between B-cell immune responses and CD8 T-cell responses in patients with ANCA-associated vasculitis.
Tidsramme: From diagnosis up to 2 years post-treatment.
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.
Tidsramme: From diagnosis up to 2 years post-treatment.
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.
Tidsramme: From diagnosis up to 2 years post-treatment.
From diagnosis up to 2 years post-treatment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Samarbejdspartnere

CR2TI - UMR1064 (INSERM)

Efterforskere

  • Ledende efterforsker: Nicolas Degauque, PhD, CR2TI - UMR1064 (INSERM)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2051

Studieafslutning (Anslået)

1. juni 2051

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC19_0417
  • 2026-A00620-51 (Anden identifikator: ANSM)

Plan for individuelle deltagerdata (IPD)

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