Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
NCT ID: NCT02474888
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
28 participants
OBSERVATIONAL
2015-09-15
2020-06-12
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rituximab
a classical induction regimen with rituximab (decision taken before inclusion), implying an infusion of 375mg/m² per week, for 4 consecutive weeks (from week -3 until week 0) with blood specimen.
blood specimen
blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment
Interventions
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blood specimen
blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Theradiag
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Pascal CATHEBRAS, PHD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Hôpital Edouard Herriot
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
CH Lyon Sud
Pierre-Bénite, , France
CHU Saint-Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2015-001807-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1508058
Identifier Type: -
Identifier Source: org_study_id