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Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT04613219
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jing Liang, Qianfoshan Hospital

Study Description
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Brief Summary:
Acute respiratory distress syndrome (ARDS) occurs in Clinically Amyopathic Dermatomyisitis(CADM) combined with Rapidly Progressive Interstitial Lung Disease(RPILD) within 1-3 months, which leads to death of patients and is difficult to treat. Even if high doses of glucocorticoids are ineffective, there is no recommended treatment for such patients, which is a huge medical challenge.Lymphopenia is an independent risk factor for death in CADM-RPILD, but the cause of lymphopenia is unclear.In this study, the level of lymphocyte subsets in peripheral blood was detected by flow cytometer, in order to further clarify the pathogenesis of the disease, to facilitate clinical guidance of treatment, and to improve the survival rate of patients.In addition, studies have shown that INF-α levels are significantly increased in CADM patients combined with RPILD and are a poor prognostic factor for CADM-RPILD, suggesting that the interferon system plays a role in the pathogenesis of CADM and can be used as an evaluation index of the severity of CADM-RPILD.In this study, the levels of relevant cytokines including INF and IL-2, IL-17, IL-18, IL-6 were detected simultaneously, and the relationship between disease activity and lymphocyte subsets was analyzed, and the changes of lymphocyte subsets after Tofacitinib treatment were determined in order to facilitate clinical guidance of treatment.

Condition or disease Intervention/treatment
Clinically Amyopathic Dermatomyisitis(CAMD) Drug: Tofacitinib 5 MG [Xeljanz]

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Tofacitinib 5 MG [Xeljanz]
    Treatment with Tofacitinib

Outcome Measures
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Primary Outcome Measures :
  1. The level of a lymphocyte in a lymphocyte subset correlates with disease activity. [ Time Frame: 3 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patient with Clinically Amyopathic Dermatomyisitis combined with Rapidly Progressive Interstitial Lung Disease
Criteria

Inclusion Criteria:

  1. Age≥18 years old,≤80years old,no gender limit;
  2. CADM of diagnosis according to Sontheimer diagnostic criteria;
  3. combined with Rapidly Progressive Interstitial Lung Disease

Exclusion Criteria:

  1. Age<18years old，>80years old;
  2. potential malignant tumor
Contacts and Locations
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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): NCT04613219


Contacts
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Contact: Yanfeng Hou +8615168888165 yfhou1016@163.com

Locations
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China, Shandong
Qianfoshan Hospital Recruiting
Jinan, Shandong, China, 252000
Contact: Lili Cao       qykyc309@163.com   
Sponsors and Collaborators
Jing Liang
More Information
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Responsible Party: Jing Liang, dean of orthopedic department, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT04613219    
Other Study ID Numbers: TY017AN
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dermatomyositis
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action