Basiliximab Treating Interstitial Pneumonia of CADM

Study Overview
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Brief Summary
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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.

Official Title
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Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients

Conditions
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Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis

Intervention / Treatment
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* Drug: Basiliximab
* Drug: Calcineurin Inhibitors
* Drug: Steroids


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basiliximab group<br>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. | Drug: Basiliximab<br>* The first administration should be within 8 weeks after disease onset.<br>Drug: Calcineurin Inhibitors<br>* 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.<br>Drug: Steroids<br>* Dosage of steroid can be adjusted according to personal experience of the researcher.<br>|
| Active Comparator: control group<br>Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. Steroids: 1mg/kg/d, calculated with prednisone. | Drug: Calcineurin Inhibitors<br>* 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.<br>Drug: Steroids<br>* Dosage of steroid can be adjusted according to personal experience of the researcher.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 52 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity | measured with lung function test equipment | 52 week | 
| Total lung capacity | measured with lung function test equipment | 52 week | 
| Diffusing capacity | transfer factor of the lung for carbon monoxide, measured with lung function test equipment. | 52 week | 
| Lung CT change | Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated. | 52 week | 
| Serum ferritin |  | 52 week | 
| Serum KL-6 | A new biomarker of alveolar injury. | 52 week |