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Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

NCT02474888 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2020-11-16

No results posted yet for this study

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.

Conditions

  • Granulomatosis, Wegener's
  • Microscopic Polyangiitis

Interventions

OTHER

blood specimen

blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment

Sponsors & Collaborators

  • Theradiag

    collaborator OTHER

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Pascal CATHEBRAS, PHD · CHU SAINT-ETIENNE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02474888 on ClinicalTrials.gov