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CompletedNCT04978883Updated Jul 27, 2021

Interstitial Lung Diseases in Primary Sjogren's Syndrome

An observational study in Sjogren's Syndrome, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
170
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's enrollment of 170 is above the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eighty-five patients with pSS-ILD were identified, and 85 patients with pSS non-ILD were used for comparison. The average age at disease onset and median disease duration in patients with pSS-ILD were greater when compared with pSS non-ILD patients. There was no difference regarding presenting symptoms at disease onset between pSS-ILD and pSS non-ILD patients.

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

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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
170 participants (actual)
Patient registry
No

Groups and cohorts

  • pSS-ILD

    diagnosis of pSS-ILD was based on abnormal HRCT and PFTs

    Other: 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

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

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

    ILD progressed in 6 months from baseline

    Time frame: 6 months from baseline

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04978883
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jul 27, 2021
Start date
Jan 1, 2016
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018
Last update
Jul 27, 2021

Study contacts

Chen
study chair · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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