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

• Sponsor: Jing Liang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04613219
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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	Phase
Clinically Amyopathic Dermatomyisitis(CAMD)	Drug: Tofacitinib 5 MG [Xeljanz]

Study Design

• Study Type: Observational
• Anticipated 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: Oct 1, 2020
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Outcome Measures

Primary Outcome Measures

1. The level of a lymphocyte in a lymphocyte subset correlates with disease activity. [3 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Qianfoshan Hospital	Jinan	Shandong	China	252000

Sponsors and Collaborators

• Jing Liang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jing Liang, dean of orthopedic department, Qianfoshan Hospital
• ClinicalTrials.gov Identifier: NCT04613219
• Other Study ID Numbers: TY017AN
• First Posted: Nov 3, 2020
• Last Update Posted: Nov 3, 2020
• Last Verified: Sep 1, 2020

• 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: Dermatomyositis; Lung Diseases; Lung Diseases, Interstitial; Tofacitinib

Study Results

No Results Posted as of Nov 3, 2020