Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)

Summary

Participation Requirements

Description

The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system fro...

The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Both rituximab and tocilizumab have been given to patients with autoimmune diseases (diseases where the immune system is activated against normal organs). Immune-related side effects appear to closely mirror these autoimmune conditions. Participants in this study have developed an immune-related adverse event while on immunotherapy and require a long course of steroids to manage this side effect. Steroids can cause many side effects with prolonged use including problems with sleep, weight gain, diabetes, muscle loss, high blood pressure, high cholesterol, bone loss, and mood disturbances. Drugs such as rituximab and tocilizumab have been shown to be effective in other diseases involving immune system activation. This study is evaluating the effectiveness of these drugs in patients who have immune-related side effects by their ability to help patients discontinue steroids.

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