Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis (NCT07636655) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis
France120 participantsStarted 2026-06-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on studying CD8+ T-cell activity after B-cell depletion — does that mean it's mainly a research and monitoring study, or would it also change how my ANCA-associated vasculitis is actually treated?
2Since this trial is listed as 'not yet recruiting,' how far out do you think it might actually open for enrollment, and should I be making any treatment decisions now that might affect whether I'd be eligible later?
3The trial phase is listed as 'N/A,' which I understand can mean it's not testing a new treatment but rather observing how my immune system responds — can you explain what that means for my personal safety compared to a typical drug trial?
4Because the study is looking at immune system markers like CD8+ T-cells after B-cell depletion therapy, would I need to be receiving or planning to receive B-cell depleting treatment like rituximab anyway, or would the study change the treatment I'd otherwise get?
5Given that this appears to be an observational or mechanistic study rather than a treatment trial, would you recommend I also explore standard-of-care treatment options in parallel, rather than waiting to see if this study opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of a CD8+ T-cell signature sensitive to B-cell depletion.
Timeframe: From diagnosis up to 2 years after the final rituximab infusion