Clinical trial NCT04179058: Interstitial Pneumonia With Autoimmune Features: Evaluation of Connective Tissue Disease Incidence During Follow-up
Official title: Interstitial Pneumonia With Autoimmune Features: Evaluation of Connective Tissue Disease Incidence During Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Interstitial Pneumonia
Keywords: Connective tissue disease
Interstitial lung disease
Interstitial pneumonia with autoimmune features
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic interstitial pneumonia classifiable or not as IPAF

Brief summary: Interstitial lung diseases (ILD) represent a frequent complication of connective tissue diseases (CTDs), especially systemic sclerosis, idiopathic inflammatory myopathies and rheumatoid arthritis. ILD can either occur during CTD course or be the first manifestation of CTDs. Therefore screening patients with ILD for CTD is crucial. In some cases, ILD are associated with clinical and/or serological autoimmune features but not classifiable for CTDs. Evolution of these forms to defined CTDs has never been study. Recently, the European Respiratory Society/American Thoracic Society experts proposed a new term, "interstitial pneumonia with autoimmune features" or IPAF, to describe these patients according to updated classification criteria. Aims of this study were to compare CTD occurence during follow-up between IPAF and non-IPAF patients in a idiopathic interstitial pneumonia cohort and to identify risk factors of CTD progression in IPAF patients at diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients with a new diagnosis of ILD confirmed by two chest-HRCT 3 months apart
* Patients with a minimal follow-up duration of 3 years after ILD diagnosis

Exclusion Criteria:

* Patients with a defined CTD at ILD diagnosis
* Patients with an other ILD etiology identified at diagnosis (i.e. sarcoidosis, hypersensitivity pneumonitis)

Primary outcomes:
measure: CTD incidence
timeFrame: After 3 years of follow-up
Secondary outcomes:
measure: IPAF clinical domain criteria
timeFrame: Baseline
measure: IPAF serological domain criteria
timeFrame: Baseline
measure: IPAF morphological domain criteria
timeFrame: Baseline
measure: ILD severity
timeFrame: Baseline, 6 months of follow-up and at the last visit
measure: Survival rate
timeFrame: After 3 years and 5 years of follow-up
Other outcomes:
Locations:
city: Lille
country: France
facility: Central Hospital
city: Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Roland JAUSSAUD, Pr
role: PRINCIPAL_INVESTIGATOR
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