Interstitial Lung Diseases in Primary Sjogren's Syndrome

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04978883
• Collaborator: (none)
• Enrollment: 170
• Actual Duration (Months): 30.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome	Other: No intervention

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 Design

• Study Type: Observational
• Actual Enrollment: 170 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Characteristics of Patients With Primary Sjögren's Syndrome Associated Interstitial Lung Disease and Relevant Features of Disease Progression
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
pSS-ILD diagnosis of pSS-ILD was based on abnormal HRCT and PFTs	Other: No intervention; No intervention
pSS non-ILD pSS patients after exclusion of pSS-ILD and concomitant pulmonary diseases were considered as pSS non-ILD	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. observational study, data analysis to identify the risk factors of pSS-ILD [6 months from baseline]

   ILD progressed in 6 months from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Chair: Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04978883
• Other Study ID Numbers: 20181236FSKXJ
• First Posted: Jul 27, 2021
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sjogren's Syndrome; Lung Diseases; Lung Diseases, Interstitial; Syndrome

Study Results

No Results Posted as of Jul 27, 2021