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Monoclonal Antibodies
Tocilizumab for Interstitial Lung Disease
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
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
- Interstitial Lung Disease
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The differences of oxygenation index changes between the two groups on day 7, 14, 28 and month 3 after the first dose*
Secondary outcome measures
Changes of dyspnea index
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
Computed tomography score
+7 moreSide effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo
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
1,061 Previous Clinical Trials
2,278,913 Total Patients Enrolled
Xinlun Tian, M.D.Study DirectorPeking Union Medical College Hospital
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