Clinical trial NCT05181397: The Efficacy and Safety of Tocilizumab for Severe RP-ILD Secondary to Systemic Diseases
Official title: A Prospective, Randomized Controlled Study to Compare Efficacy and Safety of Intravenous 8mg/kg Tocilizumab Versus Regular Treatment for Severe Rapid Progressive Interstitial Lung Diseases (RP-ILD) Secondary to Systemic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rapid Progressive Interstitial Lung Diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*
timeFrame: 3 months
Secondary outcomes:
measure: Time to clinical stability
timeFrame: 3 months
measure: Survival rate after 3 months
timeFrame: 3 months
measure: Length of stay in hospital
timeFrame: 3 months
measure: Length of stay in ICU
timeFrame: 3 months
measure: Changes of dyspnea index
timeFrame: 3 months
measure: The occurrence of adverse events within 1, 3, 7, 14, 28 days and 3 months after the first dose
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Computed tomography score
timeFrame: 3 months
measure: Hospitalization cost
timeFrame: 3 months
measure: Re-admission rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xinlun Tian, M.D.
role: STUDY_DIRECTOR
References: