Basiliximab Treating Interstitial Pneumonia of CADM
Phase 2
- Conditions
- Lung; Disease, Interstitial, With FibrosisDermatomyositis
- Interventions
- Registration Number
- NCT03192657
- Lead Sponsor
- RenJi Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Basiliximab group Calcineurin Inhibitors 1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. 2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 3. Steroids: 1mg/kg/d, calculated with prednisone. Basiliximab group Steroids 1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. 2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 3. Steroids: 1mg/kg/d, calculated with prednisone. control group Calcineurin Inhibitors 1. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 2. Steroids: 1mg/kg/d, calculated with prednisone. control group Steroids 1. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 2. Steroids: 1mg/kg/d, calculated with prednisone. Basiliximab group Basiliximab 1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. 2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 3. Steroids: 1mg/kg/d, calculated with prednisone.
- Primary Outcome Measures
Name Time Method Survival 52 week
- Secondary Outcome Measures
Name Time Method Forced vital capacity 52 week measured with lung function test equipment
Total lung capacity 52 week measured with lung function test equipment
Diffusing capacity 52 week transfer factor of the lung for carbon monoxide, measured with lung function test equipment.
Lung CT change 52 week Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated.
Serum ferritin 52 week Serum KL-6 52 week A new biomarker of alveolar injury.
Trial Locations
- Locations (1)
RenJi Hospital
🇨🇳Shanghai, Shanghai, China