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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rapid Progressive Interstitial Lung Diseases
• Intervention / Treatment: Drug: Tocilizumab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xinlun Tian, M.D.; Phone Number: 86-10-69155039; Email: xinlun_t@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Xinlun Tian, M.D.; Phone Number: 86-10-69155039; Email: xinlun_t@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 tocilizumab group will receive intravenous 8mg/kg tocilizumab.
No Intervention: Control; Participants in control group will receive regular treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Survival rate after 3 months		3 months
Length of stay in hospital		3 months
Length of stay in ICU		3 months
Changes of dyspnea index		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	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		3 months
Computed tomography score		3 months
Hospitalization cost		3 months
Re-admission rate		3 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Xinlun Tian, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: December 19, 2021
• First Submitted That Met QC Criteria: December 19, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: JS-2679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol and clinical study report will be shared.
• IPD Sharing Time Frame: Data will be shared between time of completion of the study and time of publication of the study.
• IPD Sharing Access Criteria: contact study director Xinlun Tian, M.D. via xinlun_t@sina.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No