In a clinical study, 197 adults with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) were given either:
The goal of the trial was to see if Rituxan in combination with glucocorticoids worked as well as cyclophosphamide in bringing on complete remission at 6 months in adults with GPA and MPA. "Complete remission" was defined as no disease activity and the ability to stop taking steroids.
The RAVE Trial showed that Rituxan worked as well as cyclophosphamide (CYC) + azathioprine (AZA) to achieve complete remission at 6 months.
Also in the study, there was no significant difference in the rates of complete remission at 6, 12, or 18 months for patients treated with Rituxan compared with patients who received the other medicines (38% for the Rituxan group and 31% for the other group).
The study also showed that there were no major differences between the overall side effects experienced by each group.
In a different clinical study, 115 adults with GPA or MPA received treatments to achieve disease control. After that, they were given either:
The goal of the study was to compare how well each treatment prevented major relapses from occurring. A major relapse was defined as any disease activity that could lead to organ failure or that could be life threatening. Patients were studied for 28 months.
*Rituximab is the generic name for Rituxan.
†People who were treated with Rituxan (rituximab) were given a version of rituximab approved in the European Union (EU) plus glucocorticoids.
Rituxan can cause serious side effects that can lead to death, including:
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