drugset / Trial / NCT03942887

Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis

NCT03942887 ↗

Phase 3 Unknown 100 enrolled Leiden University Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Most recent insights in the treatment for patients with ANCA-associated vasculitis (AAV) have demonstrated that 'tailored' maintenance treatment with rituximab (RTX) is effective to achieve durable remission of disease. As such, RTX re-treatment can be tailored on the basis of relevant clinical and immunological parameters in AAV patients. Now, the present study intends to evaluate whether combining rituximab with cyclophosphamide is superior to current standard of care with rituximab only to induce a favorable clinical and immunological state in AAV patients and can thereby reduce the number of tailored re-treatments with rituximab.

Timeline

Start
2019-05-03
Primary completion
2025-04-01
Completion
2025-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 500 mg Intravenous
Comparator Rituximab Monoclonal antibody 1000 mg Intravenous
Comparator Methylprednisolone Other / unclassified 500 mg Intravenous
Comparator Prednisolone Other / unclassified 1 mg/kg Oral