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OpenTrials
Completed

NCT Number: NCT04978883

Interstitial Lung Diseases in Primary Sjogren's Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. observational study, data analysis to identify the risk factors of pSS-ILD

    Time frame: 6 months from baseline

    ILD progressed in 6 months from baseline

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Characteristics of Patients With Primary Sjögren's Syndrome Associated Interstitial Lung Disease and Relevant Features of Disease Progression

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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