Basiliximab Treating Interstitial Pneumonia of CADM

Dermatomyositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03192657
• Other study ID #: ADM01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 15, 2017
• Last updated: June 18, 2017
• Start date: July 2017
• Est. completion date: June 2020

Study information

• Verified date: June 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatomyositis
• Lung Diseases
• Lung Diseases, Interstitial
• Lung; Disease, Interstitial, With Fibrosis
• Pneumonia

Intervention

Drug:
• Basiliximab
The first administration should be within 8 weeks after disease onset.
• 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.
• Steroids
Dosage of steroid can be adjusted according to personal experience of the researcher.

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		52 week
Secondary	Forced vital capacity	measured with lung function test equipment	52 week
Secondary	Total lung capacity	measured with lung function test equipment	52 week
Secondary	Diffusing capacity	transfer factor of the lung for carbon monoxide, measured with lung function test equipment.	52 week
Secondary	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
Secondary	Serum ferritin		52 week
Secondary	Serum KL-6	A new biomarker of alveolar injury.	52 week