Interstitial Lung Diseases in Primary Sjogren's Syndrome

Completed

• Conditions: Sjogren's Syndrome
• Interventions: Other: No intervention

• Registration Number: NCT04978883
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed.

Detailed Description

Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified. Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary function tests (PFTs) were collected. pSS-ILD patients were further categorized into subgroups according to HRCT patterns or PFTs.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-07-18
• Last Update Submitted: 2021-07-18
• Study First Posted: 2021-07-27
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• All patients with pSS fulfilled the 2002 revised version of the European criteria proposed by the American-European Consensus Group
• Patient with pSS evaluated with pulmonary HRCT and/or PFTs were included in the pSS-ILD group

Exclusion Criteria

• patients with hepatitis C infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, IgG4-related disease
• Patients with other connective tissue diseases (CTD) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pSS-ILD	No intervention	diagnosis of pSS-ILD was based on abnormal HRCT and PFTs
pSS non-ILD	No intervention	pSS patients after exclusion of pSS-ILD and concomitant pulmonary diseases were considered as pSS non-ILD

Primary Outcome Measures

Name	Time	Method
observational study, data analysis to identify the risk factors of pSS-ILD	6 months from baseline	ILD progressed in 6 months from baseline