drugset / Trial / NCT03942887
Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |