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Basiliximab Treating Interstitial Pneumonia of CADM

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ClinicalTrials.gov Identifier: NCT03192657
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Lung; Disease, Interstitial, With Fibrosis Dermatomyositis Drug: Basiliximab Drug: Calcineurin Inhibitors Drug: Steroids Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: 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.
Drug: Basiliximab
The first administration should be within 8 weeks after disease onset.

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.

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

Active Comparator: 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.
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.

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




Primary Outcome Measures :
  1. Survival [ Time Frame: 52 week ]

Secondary Outcome Measures :
  1. Forced vital capacity [ Time Frame: 52 week ]
    measured with lung function test equipment

  2. Total lung capacity [ Time Frame: 52 week ]
    measured with lung function test equipment

  3. Diffusing capacity [ Time Frame: 52 week ]
    transfer factor of the lung for carbon monoxide, measured with lung function test equipment.

  4. Lung CT change [ Time Frame: 52 week ]
    Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated.

  5. Serum ferritin [ Time Frame: 52 week ]
  6. Serum KL-6 [ Time Frame: 52 week ]
    A new biomarker of alveolar injury.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192657


Locations
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China, Shanghai
RenJi Hospital
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03192657     History of Changes
Other Study ID Numbers: ADM01
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pneumonia
Dermatomyositis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Tacrolimus
Cyclosporins
Cyclosporine
Basiliximab
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents