Back to resultsBasiliximab Treating Interstitial Pneumonia of CADM
Primary Purpose
Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Basiliximab
Calcineurin Inhibitors
Steroids
Sponsored by
About this trial
This is an interventional treatment trial for Lung; Disease, Interstitial, With Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
- Agreement of contraception.
- Serum creatine Kinase ≤ 1.5 fold of upper normal level.
- Interstitial pneumonia:
(meet at least two in four of following)
- interstitial pneumonia images in high resolution CT;
- DLCO (diffusing capacity)≤ 60% predict in lung function test;
- elevated serum KL-6;
- serum anti-MDA5 (+).
Exclusion Criteria:
- Previous application of immunosuppressives or any target treatment for dermatomyositis.
- Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
- Abnormal renal function at screening (serum creatine>300μmol/L，or eGFR<60mL/min/1.73m2, or end-stage renal disease).
- Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
- History of any malignancy.
Sites / Locations
- RenJi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Basiliximab group
control group
Arm Description
Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. Steroids: 1mg/kg/d, calculated with prednisone.
Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. Steroids: 1mg/kg/d, calculated with prednisone.
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Forced vital capacity
measured with lung function test equipment
Total lung capacity
measured with lung function test equipment
Diffusing capacity
transfer factor of the lung for carbon monoxide, measured with lung function test equipment.
Lung CT change
Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated.
Serum ferritin
Serum KL-6
A new biomarker of alveolar injury.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03192657
Brief Title
Basiliximab Treating Interstitial Pneumonia of CADM
Official Title
Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Basiliximab group
Arm Type
Experimental
Arm Description
Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset.
Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
Steroids: 1mg/kg/d, calculated with prednisone.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
Steroids: 1mg/kg/d, calculated with prednisone.
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Intervention Description
The first administration should be within 8 weeks after disease onset.
Intervention Type
Drug
Intervention Name(s)
Calcineurin Inhibitors
Intervention Description
Researchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient.
Intervention Type
Drug
Intervention Name(s)
Steroids
Intervention Description
Dosage of steroid can be adjusted according to personal experience of the researcher.
Primary Outcome Measure Information:
Title
Survival
Time Frame
52 week
Secondary Outcome Measure Information:
Title
Forced vital capacity
Description
measured with lung function test equipment
Time Frame
52 week
Title
Total lung capacity
Description
measured with lung function test equipment
Time Frame
52 week
Title
Diffusing capacity
Description
transfer factor of the lung for carbon monoxide, measured with lung function test equipment.
Time Frame
52 week
Title
Lung CT change
Description
Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated.
Time Frame
52 week
Title
Serum ferritin
Time Frame
52 week
Title
Serum KL-6
Description
A new biomarker of alveolar injury.
Time Frame
52 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
Agreement of contraception.
Serum creatine Kinase ≤ 1.5 fold of upper normal level.
Interstitial pneumonia:
(meet at least two in four of following)
interstitial pneumonia images in high resolution CT;
DLCO (diffusing capacity)≤ 60% predict in lung function test;
elevated serum KL-6;
serum anti-MDA5 (+).
Exclusion Criteria:
Previous application of immunosuppressives or any target treatment for dermatomyositis.
Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
Abnormal renal function at screening (serum creatine>300μmol/L，or eGFR<60mL/min/1.73m2, or end-stage renal disease).
Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
History of any malignancy.
Facility Information:
Facility Name
RenJi Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
12. IPD Sharing Statement
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Basiliximab Treating Interstitial Pneumonia of CADM
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