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Clinical Trial Summary

There is no confirmed drug therapy for RP-ILD. Prognosis is poor of regular treatment. The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.


Clinical Trial Description

RP-ILD, also known as the acute exacerbation of interstitial lung disease, was defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest imaging or histopathology. It is rapidly progressive and life-threatening. Despite aggressive regular treatments with high-dose glucocorticoids in combination with immunosuppressant drugs such as cyclosporine, tacrolimus, or cyclophosphamide, the post-exacerbation mortality rates remain high. There is no confirmed drug therapy for RP-ILD. Recently, the exacerbation of interstitial lung diseases secondary to systemic diseases was proved to involve many inflammatory responses, so patients are more likely to benefit from immune regulation therapy. Tocilizumab is a monoclonal antibody that inhibits the binding of interleukin-6 (IL-6), a multifunctional cytokine that regulates the immune response and inflammation, to its receptor (IL-6R). The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05181397
Study type Interventional
Source Peking Union Medical College Hospital
Contact Xinlun Tian, M.D.
Phone 86-10-69155039
Email [email protected]
Status Recruiting
Phase Phase 2
Start date February 22, 2021
Completion date September 1, 2022