Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPRO

Overview

No summary available.

Registry

who.int

Start Date

January 31, 2019

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Patient (male or female) aged 18 years old and over
•2\. Patient agreement to participate in the study and signed written informed consent
•3\. Patient with MPA according to the CHCC established in 2012
•4\. Absence of any poor prognosis factor (modified five factor score (FFS) 1996\=0\)
•5\. Patient with recent onset or relapse of the disease (\<1 month) defined by BVAS\=3, who did not receive any other treatment than glucocorticoids over the last month. One to 3 initial glucocorticoids pulse(s) are allowed.
•6\. Patient with anti\-MPO antibody measured by ELISA
•7\. Negative pregnancy test (serum ß\-hCG) for women of child\-bearing potential and a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study and 12 months after stopping therapy
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. Small\-sized vessels vasculitis not associated with anti\-MPO antibody or associated with anti\-PR3 positivity.
•2\. Patients with either GPA or EGPA vasculitis according to ACR criteria.
•3\. Patient with a modified FFS 1996 \= 1\.
•4\. Patient with alveolar haemorrhage requiring mechanical ventilation.
•5\. Patient with previous glucocorticoids treatment \>1 month and \>10mg/day either for vasculitis or for any other reason.
•6\. Patient already receiving immunosuppressant or biological agent.
•Prior treatment with any of the following:
•\- azathioprine, methotrexate, mycophenolate mophetil, mycophenolic acid within 4 weeks before inclusion
•\- alkylant agent such as cyclophosphamide within 6 months before inclusion
•\- anti\-TNF? inhibitors : infliximab within 8 weeks, adalimumab and etanercept within 2 weeks before inclusion