Basiliximab Treating Interstitial Pneumonia of CADM

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Dermatomyositis; Lung; Disease, Interstitial, With Fibrosis

Treatments: Drug: Calcineurin Inhibitors; Drug: Basiliximab; Drug: Steroids

Study type: Interventional

Funder types: Other

Identifiers

NCT03192657

ADM01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Basiliximab group

Experimental group

Description:

1. Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. 2. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 3. Steroids: 1mg/kg/d, calculated with prednisone.

Treatment:

Drug: Calcineurin Inhibitors

Drug: Steroids

Drug: Basiliximab

control group

Active Comparator group

Description:

1. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. 2. Steroids: 1mg/kg/d, calculated with prednisone.

Treatment:

Drug: Calcineurin Inhibitors

Drug: Steroids