Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis (NCT02474888) | Clinical Trial Compass
TerminatedNot Applicable
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
Stopped: failure of recruit
France28 participantsStarted 2015-09-15
Plain-language summary
The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.
All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.
Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.
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:
* Age \> 18 years
* Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
* Decision taken to start an induction regimen with rituximab
* Informed and having signed the study consent form
* If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop
* no-breast-feeding during RTX treatment and in the 12 months following RTX treatment stop
Exclusion Criteria:
* Other primary or secondary systemic vasculitis
* Incapacity or refusal to sign the informed consent form
* Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
* Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
* severe active infection
* Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease Pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks
* Patients with active hepatitis B
* Any live vaccine within four weeks prior to the first infusion of RTX
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
serum rituximab levels
Timeframe: 1 month after stop of rituximab induction regimen
Trial details
NCT IDNCT02474888
SponsorCentre Hospitalier Universitaire de Saint Etienne