The Efficacy and Safety of Tocilizumab for Severe RP-ILD Secondary to Systemic Diseases

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    68
  • sponsor
    Peking Union Medical College Hospital
Updated on 21 March 2022

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.

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.

Details
Condition Rapid Progressive Interstitial Lung Diseases
Treatment Tocilizumab
Clinical Study IdentifierNCT05181397
SponsorPeking Union Medical College Hospital
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

RP-ILD, previous or concurrent diagnosis of systemic diseases

Exclusion Criteria

pregnancy; uncontrolled pulmonary infections; severe cardiovascular, hepatic and renal
dysfunction; unstable angina or myocardial infarction; thrombocytopenia; neutrophil
reduction; malignant tumor; allergy to tocilizumab
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