Basiliximab Treating Interstitial Pneumonia of CADM

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03192657

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung; Disease, Interstitial, With Fibrosis Dermatomyositis	Drug: Basiliximab Drug: Calcineurin Inhibitors Drug: Steroids	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Basiliximab group 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 The first administration should be within 8 weeks after disease onset. Drug: Calcineurin Inhibitors 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. Drug: Steroids Dosage of steroid can be adjusted according to personal experience of the researcher.
Active Comparator: control group 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 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. Drug: Steroids Dosage of steroid can be adjusted according to personal experience of the researcher.

Arm

Intervention/Treatment

Experimental: Basiliximab group

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

The first administration should be within 8 weeks after disease onset.

Drug: Calcineurin Inhibitors

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.

Drug: Steroids

Dosage of steroid can be adjusted according to personal experience of the researcher.

Active Comparator: control group

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

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.

Drug: Steroids

Dosage of steroid can be adjusted according to personal experience of the researcher.

Outcome Measures

Primary Outcome Measures

Survival [52 week]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.