Basiliximab Treating Interstitial Pneumonia of CADM

NCT ID: NCT03192657

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2020-06-30

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.

Conditions

Lung; Disease, Interstitial, With Fibrosis; Dermatomyositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basiliximab group

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.

Group Type: EXPERIMENTAL

Basiliximab

Intervention Type: DRUG

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

Calcineurin Inhibitors

Intervention Type: DRUG

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

Intervention Type: DRUG

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

control group

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.

Group Type: ACTIVE_COMPARATOR

Calcineurin Inhibitors

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

Basiliximab

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

Intervention Type: 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.

Intervention Type: DRUG

Steroids

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RenJi Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ADM01

Identifier Type: -

Identifier Source: org_study_id