Interstitial Pneumonia With Autoimmune Features: Evaluation of Connective Tissue Disease Incidence During Follow-up

NCT ID: NCT04179058

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Interstitial Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IPAF patients

IPAF definition according to 2015 ERS/ATS criteria

Follow-up

Intervention Type OTHER

Clinical data, radiological data and laboratory tests follow-up

non-IPAF patients

Follow-up

Intervention Type OTHER

Clinical data, radiological data and laboratory tests follow-up

Interventions

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Follow-up

Clinical data, radiological data and laboratory tests follow-up

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland JAUSSAUD, Pr

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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Central Hospital

Lille, , France

Site Status

Central Hospital

Nancy, , France

Site Status

Countries

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France

Central Contacts

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Roland JAUSSAUD, Pr

Role: CONTACT

0383154067

Paul DECKER, MR

Role: CONTACT

Facility Contacts

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Roland JAUSSAUD, Pr

Role: primary

Paul DECKER, MR

Role: backup

References

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Steen VD, Medsger TA. Changes in causes of death in systemic sclerosis, 1972-2002. Ann Rheum Dis. 2007 Jul;66(7):940-4. doi: 10.1136/ard.2006.066068. Epub 2007 Feb 28.

Reference Type BACKGROUND
PMID: 17329309 (View on PubMed)

Fathi M, Dastmalchi M, Rasmussen E, Lundberg IE, Tornling G. Interstitial lung disease, a common manifestation of newly diagnosed polymyositis and dermatomyositis. Ann Rheum Dis. 2004 Mar;63(3):297-301. doi: 10.1136/ard.2003.006122.

Reference Type BACKGROUND
PMID: 14962966 (View on PubMed)

Tanaka N, Kim JS, Newell JD, Brown KK, Cool CD, Meehan R, Emoto T, Matsumoto T, Lynch DA. Rheumatoid arthritis-related lung diseases: CT findings. Radiology. 2004 Jul;232(1):81-91. doi: 10.1148/radiol.2321030174. Epub 2004 May 27.

Reference Type BACKGROUND
PMID: 15166329 (View on PubMed)

Keane MP, Lynch JP 3rd. Pleuropulmonary manifestations of systemic lupus erythematosus. Thorax. 2000 Feb;55(2):159-66. doi: 10.1136/thorax.55.2.159. No abstract available.

Reference Type BACKGROUND
PMID: 10639536 (View on PubMed)

Tillie-Leblond I, Wislez M, Valeyre D, Crestani B, Rabbat A, Israel-Biet D, Humbert M, Couderc LJ, Wallaert B, Cadranel J. Interstitial lung disease and anti-Jo-1 antibodies: difference between acute and gradual onset. Thorax. 2008 Jan;63(1):53-9. doi: 10.1136/thx.2006.069237. Epub 2007 Jun 8.

Reference Type BACKGROUND
PMID: 17557770 (View on PubMed)

Kinder BW, Collard HR, Koth L, Daikh DI, Wolters PJ, Elicker B, Jones KD, King TE Jr. Idiopathic nonspecific interstitial pneumonia: lung manifestation of undifferentiated connective tissue disease? Am J Respir Crit Care Med. 2007 Oct 1;176(7):691-7. doi: 10.1164/rccm.200702-220OC. Epub 2007 Jun 7.

Reference Type BACKGROUND
PMID: 17556720 (View on PubMed)

Vij R, Noth I, Strek ME. Autoimmune-featured interstitial lung disease: a distinct entity. Chest. 2011 Nov;140(5):1292-1299. doi: 10.1378/chest.10-2662. Epub 2011 May 12.

Reference Type BACKGROUND
PMID: 21565966 (View on PubMed)

Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194.

Reference Type BACKGROUND
PMID: 20682528 (View on PubMed)

Fischer A, Antoniou KM, Brown KK, Cadranel J, Corte TJ, du Bois RM, Lee JS, Leslie KO, Lynch DA, Matteson EL, Mosca M, Noth I, Richeldi L, Strek ME, Swigris JJ, Wells AU, West SG, Collard HR, Cottin V; "ERS/ATS Task Force on Undifferentiated Forms of CTD-ILD". An official European Respiratory Society/American Thoracic Society research statement: interstitial pneumonia with autoimmune features. Eur Respir J. 2015 Oct;46(4):976-87. doi: 10.1183/13993003.00150-2015. Epub 2015 Jul 9.

Reference Type BACKGROUND
PMID: 26160873 (View on PubMed)

Other Identifiers

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2019PI251

Identifier Type: -

Identifier Source: org_study_id

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