Clinical Trials Directory

Trials / Terminated

TerminatedNCT02474888

Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)

Status
Terminated
Phase
Study type
Observational
Enrollment
28 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2015-09-15
Primary completion
2020-06-12
Completion
2020-06-12
First posted
2015-06-18
Last updated
2020-11-16

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02474888. Inclusion in this directory is not an endorsement.