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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rapid Progressive Interstitial Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are planned to be separated into two groups. 68 participants with severe RP-ILD secondary to systemic diseases will be randomly assigned to receive intravenous 8mg/kg tocilizumab or regular treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tocilizumab

Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. No Intervention: control, participants in control group will receive regular treatment.

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab.

Control

Participants in control group will receive regular treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tocilizumab

Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No