Basiliximab Treating Interstitial Pneumonia of CADM

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

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.

Study Overview

• Status: Unknown
• Conditions: Dermatomyositis; Lung; Disease, Interstitial, With Fibrosis
• Intervention / Treatment: Drug: Basiliximab; Drug: Calcineurin Inhibitors; Drug: Steroids

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

1. interstitial pneumonia images in high resolution CT;
2. DLCO (diffusing capacity)≤ 60% predict in lung function test;
3. elevated serum KL-6;
4. 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 18, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 18, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Polymyositis; Myositis; Lung Diseases; Pneumonia; Lung Diseases, Interstitial; Dermatomyositis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Basiliximab; Calcineurin Inhibitors
• Other Study ID Numbers: ADM01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No