Study Comparing Longer Versus Shorter Use of Prednisone to Maintain Remission in Granulomatosis With Polyangiitis and Microscopic Polyangiitis Patients Receiving Rituximab

What this Trial Is About

Researchers are investigating the best length of prednisone treatment for patients with granulomatosis with polyangiitis GPA and microscopic polyangiitis MPA, serious autoimmune diseases that can relapse and cause damage despite current treatments. Rituximab is commonly used to maintain remission, but the ideal duration for prednisone therapy remains unclear. This trial is the first prospective study to compare longer versus shorter prednisone use as an add-on to remission maintenance in these conditions. Participants will receive either prednisone 5 mg per day or a placebo for 12 months, with dosing beginning on Day 1. Prednisone dosage will be tapered by 1 mg per week until complete withdrawal after 12 months. The study is randomized, double-blind, and placebo-controlled, evaluating the impact of extended prednisone use alongside rituximab maintenance therapy. During the 30-month study period, participants will be monitored for relapse-free survival, defined by a disease activity score BVAS greater than zero. Researchers will also assess serious adverse events, glucocorticoid-related complications like fractures and weight gain, vasculitis relapse rates, prednisone use, bone density, disease damage, functional disability, quality of life, and healthcare resource use. Assessments include clinical evaluations and standardized questionnaires to track disease status and treatment effects over time.

Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.