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

NCT05181397 | Unknown Phase 2

• 1 other identifier: JS-2679
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Rapid Progressive Interstitial Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Time to clinical stability

  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

Study Arms (2)

Tocilizumab

EXPERIMENTAL

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

Drug: Tocilizumab

Control

NO INTERVENTION

Participants in control group will receive regular treatment.

Interventions

Tocilizumab DRUG

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

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RP-ILD, previous or concurrent diagnosis of systemic diseases

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

tocilizumab

Study Officials

• Xinlun Tian, M.D.

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Xinlun Tian, M.D.

CONTACT

86-10-69155039; xinlun_t@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 6, 2022
• Study Start: February 22, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 6, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be shared between time of completion of the study and time of publication of the study.
• Access Criteria: contact study director Xinlun Tian, M.D. via xinlun\ t@sina.com

Locations

CN (1)