Clinical trial NCT02474888: Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
Official title: Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Granulomatosis, Wegener's
Microscopic Polyangiitis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Theradiag
First posted: 2015-06-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: serum rituximab levels
timeFrame: 1 month after stop of rituximab induction regimen
Secondary outcomes:
measure: serum rituximab levels
timeFrame: 3 months after stop of rituximab induction regimen
measure: serum rituximab levels
timeFrame: 6 months after stop of rituximab induction regimen
measure: serum anti-rituximab antibodies
timeFrame: 1 month after stop of rituximab induction regimen
measure: serum anti-rituximab antibodies
timeFrame: 3 months after stop of rituximab induction regimen
measure: serum anti-rituximab antibodies
timeFrame: 6 months after stop of rituximab induction regimen
measure: Serum B lymphocytes (CD19+ cells) levels
timeFrame: 1 month after stop of rituximab induction regimen
measure: Serum B lymphocytes (CD19+ cells) levels
timeFrame: 3 months after stop of rituximab induction regimen
measure: Serum B lymphocytes (CD19+ cells) levels
timeFrame: 6 months after stop of rituximab induction regimen
measure: patient number with adverse event
timeFrame: from start of induction rituximab regimen until six monthes after stop of induction regimen
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Pierre-Bénite
country: France
facility: CH Lyon Sud
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal CATHEBRAS, PHD
role: PRINCIPAL_INVESTIGATOR
References: