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

NCT04613219 | Unknown

• 1 other identifier: TY017AN
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinically Amyopathic Dermatomyisitis(CAMD)

Outcome Measures

Primary Outcomes (1)

• The level of a lymphocyte in a lymphocyte subset correlates with disease activity.

  3 month

Interventions

Tofacitinib 5 MG [Xeljanz] DRUG

Treatment with Tofacitinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with Clinically Amyopathic Dermatomyisitis combined with Rapidly Progressive Interstitial Lung Disease

You may qualify if:

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

You may not qualify if:

• Age\<18years old，\>80years old;
• potential malignant tumor

Sponsors & Collaborators

• Jing Liang: lead

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 252000, China

RECRUITING

MeSH Terms

Interventions

tofacitinib

Central Study Contacts

Yanfeng Hou

CONTACT

+8615168888165; yfhou1016@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dean of orthopedic department

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: November 3, 2020
• Study Start: October 1, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 3, 2020

Record last verified: 2020-09

Locations

CN (1)