Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis (MONITUX)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Granulomatosis, Wegener's; Microscopic Polyangiitis

Treatments: Other: blood specimen

Study type: Observational

Funder types: Other

Identifiers

NCT02474888

2015-001807-29 (EudraCT Number)

1508058

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Rituximab

Description:

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.

Treatment:

Other: blood specimen