Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis

• Register: EUCTR
• Last refreshed on: 3 November 2020
• Main ID: EUCTR2015-001807-29-FR
• Date of registration: 23/07/2015
• Prospective Registration: No
• Primary sponsor: CHU de Saint-Etienne
• Public title: Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis
• Scientific title: Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX
• Date of first enrolment: 09/06/2015
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001807-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France

Contacts

• Name: Chief of project
• Affiliation: CHU de Saint-Etienne

• Name: Chief of project
• Affiliation: CHU de Saint-Etienne

Key inclusion & exclusion 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 to use an effective method of contraception during RTX treatment and in the 12 monthes following RTX treatment stop
- no breast-feeding during RTX treatment and in the 12 monthes following RTX treatment stop
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 of the 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Granulomatosis with polyangiitis Microscopic polyangiitis
MedDRA version: 18.0 Level: PT Classification code 10072579 Term: Granulomatosis with polyangiitis System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders

Intervention(s)

Trade Name: Rituximab
Product Name: Rituximab
Pharmaceutical Form: Concentrate for solution for injection

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 6 month after the stop of induction treatment

Secondary Objective: -To evaluate whether serum rituximab levels at M+3 are predictive of clinical outcome at M+6
-To find out a serum rituximab level threshold predictive of non-response to rituximab
-To evaluate whether the presence of anti-rituximab antibodies in patients is correlated with clinical outcome at M+6
-To evaluate whether ANCA and/or B lymphocytes count (CD19+ cells) increase is correlated with clinical outcome at M+6
-To describe the frequency and nature of rituximab-attributed adverse events in those patients, taking into account their anti-rituximab antibodies status

Primary end point(s): Number of non-responders (Birmingham Vasculitis Activity Score > 0) at M+6

Main Objective: To evaluate whether serum rituximab levels at M+1 are predictive of clinical outcome at M+6

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: at 1, 3 and 6 month after the stop of induction treatment

Secondary end point(s): -Serum ANCA levels (M+1, M+3 and M+6)
-Serum B lymphocytes (CD19+ cells) levels (M+1, M+3 and M+6)
-Frequency and nature of rituximab-attributed adverse events during the 6 month follow-up

Secondary ID(s)

1508058

Source(s) of Monetary Support

THERADIAG

Ethics review

Status: Approved
Approval date: 11/05/2015
Contact: