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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05181397
Phase
PHASE2
Status
Unknown

Conditions

  • Rapid Progressive Interstitial Lung Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab.

Study Details

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.

Key Dates

Start date
Feb 22, 2021
Status verified
Mar 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose* [ Time Frame: 3 months ]

Central Contacts