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Monoclonal Antibodies
The Efficacy and Safety of Tocilizumab for Severe RP-ILD Secondary to Systemic Diseases
Phase 2
Waitlist Available
Research Sponsored by Peking Union Medical College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
RP-ILD, previous or concurrent diagnosis of systemic diseases
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
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.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*
Secondary study objectives
The occurrence of adverse events within 1, 3, 7, 14, 28 days and 3 months after the first dose
Time to clinical stability
Side effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
agranulocytosis
5%
Inpatient admission
5%
fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tocilizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TocilizumabExperimental Treatment1 Intervention
Participants in tocilizumab group will receive intravenous 8mg/kg tocilizumab. No Intervention: control, participants in control group will receive regular treatment.
Group II: ControlActive Control1 Intervention
Participants in control group will receive regular treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved
Find a Location
Who is running the clinical trial?
Peking Union Medical College HospitalLead Sponsor
1,127 Previous Clinical Trials
2,410,808 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
55 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Xinlun Tian, M.D.Study DirectorPeking Union Medical College Hospital