Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis — RITUXGOPRO  

Microscopic Polyangiitis (MPA) Clinical Trial

Official title: Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Microscopic polyangiitis (MPA), is a small-sized vessel necrotizing vasculitis associated with anti-neutrophils cytoplasmic antibody (ANCA). Treatment of ANCA associated vasculitis (AAV) was previously based on glucocorticoids (GC) and cyclophosphamide. It has been demonstrated in two prospective randomized trials that rituximab is as effective as cyclophosphamide in the induction treatment of GPA and severe MPA. In addition, it was shown in GPA and MPA that rituximab is superior to azathioprine as maintenance therapy.

Patients with MPA without poor prognosis factor (Five factor score (FFS)=0) have not been included in the previous studies and GC alone is considered as the reference treatment in these patients. However, as much as 50% of these patients experience relapses after a 24 months follow-up and only 40% of patients have a long lasting remission.

In the group of patients with MPA without any poor prognosis factor (FFS=0), an additional treatment with rituximab might decrease the relapse rate from 40% to 15% after an 18 months' follow-up. The efficacy and safety of this proposal must be tested. ;

Related Conditions & MeSH terms

• Microscopic Polyangiitis
• Microscopic Polyangiitis (MPA)
• Systemic Vasculitis

• NCT number: NCT03920722
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 24, 2020
• Completion date: September 2023