Basiliximab Treating Interstitial Pneumonia of CADM

Phase 2UnknownNCT03192657

RenJi Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Lung; Disease, Interstitial, With Fibrosis Dermatomyositis

Interventions

BasiliximabDRUG

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

Calcineurin InhibitorsDRUG

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.

SteroidsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

RenJi Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Survival

Time frame: 52 week

Secondary Outcomes

Forced vital capacity

measured with lung function test equipment

Time frame: 52 week

Total lung capacity

measured with lung function test equipment

Time frame: 52 week

Diffusing capacity

transfer factor of the lung for carbon monoxide, measured with lung function test equipment.

Time frame: 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.

Time frame: 52 week

Serum ferritin

Time frame: 52 week

Serum KL-6

A new biomarker of alveolar injury.

Time frame: 52 week

Data from ClinicalTrials.gov

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