Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

Microscopic Polyangiitis Clinical Trial

— MONITUX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02474888
• Other study ID #: 1508058
• Secondary ID: 2015-001807-29
• Status: Terminated
• Start date: September 15, 2015
• Est. completion date: June 12, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Granulomatosis with Polyangiitis
• Granulomatosis, Wegener's
• Microscopic Polyangiitis
• Vasculitis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon
France	CH Lyon Sud	Pierre-Bénite
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Theradiag

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum rituximab levels	rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0, 6 months after stop of induction regimen	1 month after stop of rituximab induction regimen
Secondary	serum rituximab levels	rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	3 months after stop of rituximab induction regimen
Secondary	serum rituximab levels	rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	6 months after stop of rituximab induction regimen
Secondary	serum anti-rituximab antibodies	serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	1 month after stop of rituximab induction regimen
Secondary	serum anti-rituximab antibodies	serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	3 months after stop of rituximab induction regimen
Secondary	serum anti-rituximab antibodies	serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	6 months after stop of rituximab induction regimen
Secondary	Serum B lymphocytes (CD19+ cells) levels	Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	1 month after stop of rituximab induction regimen
Secondary	Serum B lymphocytes (CD19+ cells) levels	Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	3 months after stop of rituximab induction regimen
Secondary	Serum B lymphocytes (CD19+ cells) levels	Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score > 0 six months after stop of induction regimen	6 months after stop of rituximab induction regimen
Secondary	patient number with adverse event	frequency and nature of rituximab-attributed adverse events	from start of induction rituximab regimen until six monthes after stop of induction regimen