A Phase 2 interventional study of Tocilizumab in Rapid Progressive Interstitial Lung Diseases, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-06.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 68 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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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
Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. No Intervention: control, participants in control group will receive regular treatment.
Drug: Tocilizumab
Participants in control group will receive regular treatment.
Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab.
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*
first dose: The tocilizumab group: the tocilizumab administered for the first time; The control group: the maximum dose of glucocorticoid administered for the first time
Time frame: 3 months
Time to clinical stability
clinical stability was defined as on the first day that all of the following criteria are simultaneously achieved: (1) Participants can tolerate walking with or without oxygen therapy; (2) no wheeze; and (3) oxygen saturation \>88% on room air.
Time frame: 3 months
Survival rate after 3 months
Time frame: 3 months
Length of stay in hospital
Time frame: 3 months
Length of stay in ICU
Time frame: 3 months
Changes of dyspnea index
Time frame: 3 months
The occurrence of adverse events within 1, 3, 7, 14, 28 days and 3 months after the first dose
adverse events: sepsis, treatment-related hyperglycemia, gastrointestinal bleeding, hospital infection
Time frame: 3 months
Changes of erythrocyte sedimentation rate, c-reactive protein or ferritin at baseline and on day 3, 7, 14, 28, month 3 after the first dose
Time frame: 3 months
Computed tomography score
Time frame: 3 months
Hospitalization cost
Time frame: 3 months
Re-admission rate
Time frame: 3 months
Plan to share: Yes — The protocol and clinical study report will be shared.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital