Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis (NCT03920722) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis
France8 participantsStarted 2020-10-24
Plain-language summary
The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient (male or female) over 18 year old
✓. Patient agree to participate in the study and signed written informed consent
✓. Patient with MPA according to the CHCC established in 2012
✓. Absence of any poor prognosis factor (modified five factor score (FFS) 1996 = 0)
✓. Patient with recent onset or relapse of the disease (\<1 month) defined by BVAS \> 0, who did not received any other treatment than glucocorticoids during last month. For patients with a BVAS\<3, activity of vasculitis (either relapse or new onset) has to be confirmed by the coordinating investigator. One to 3 initial glucocorticoids pulse(s) are allowed.
✓. Patient with anti-MPO antibody measured by enzyme - linked immunosorbent assay (ELISA).
✓. Negative pregnancy test (serum β-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
Exclusion criteria
✕. Small-sized vessels vasculitis not associated to anti-MPO antibody or associated with anti-PR3 positivity.
✕. Patients with either GPA or EGPA vasculitis according to ACR criteria
✕. Patient with a modified FFS 1996 ≥ 1
✕. Patient with alveolar hemorrhage requiring mechanical ventilation