Basiliximab Treating Interstitial Pneumonia of CADM

NCT03192657 | Unknown Phase 2

• 1 other identifier: ADM01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Survival

  52 week

Secondary Outcomes (6)

• Forced vital capacity

  52 week

• Total lung capacity

  52 week

• Diffusing capacity

  52 week

• Lung CT change

  52 week

• Serum ferritin

  52 week

Study Arms (2)

Basiliximab group

EXPERIMENTAL

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.

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

control group

ACTIVE COMPARATOR

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.

Drug: Calcineurin Inhibitors; Drug: Steroids

Interventions

Basiliximab DRUG

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

Basiliximab group

Calcineurin Inhibitors 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.

Basiliximab group; control group

Steroids DRUG

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

Basiliximab group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• interstitial pneumonia images in high resolution CT;
• DLCO (diffusing capacity)≤ 60% predict in lung function test;
• elevated serum KL-6;
• serum anti-MDA5 (+).

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Disease; Dermatomyositis

Interventions

Basiliximab; Calcineurin Inhibitors; Steroids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 20, 2017
• Study Start: July 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

CN (1)