NCT04179058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 18, 2019

Last Update Submit

November 25, 2019

Conditions

Idiopathic Interstitial Pneumonia

Keywords

Connective tissue diseaseInterstitial lung diseaseInterstitial pneumonia with autoimmune features

Outcome Measures

Primary Outcomes (1)

  • CTD incidence

    CTD incidence according to classification criteria: rheumatoid arthritis (2010 ACR/EULAR criteria), systemic erythematosus lupus (2019 ACR/EULAR criteria), Sjögren syndrome (2016 ACR/EULAR criteria), systemic sclerosis (2013 ACR/EULAR criteria), idiopathic inflammatory myopathies (2017 ACR/EULAR criteria) and mixed connective tissue disease (modified Sharp criteria or Alarcon-Segovia criteria or Kasukawa criteria)

    After 3 years of follow-up

Secondary Outcomes (5)

  • IPAF clinical domain criteria

    Baseline

  • IPAF serological domain criteria

    Baseline

  • IPAF morphological domain criteria

    Baseline

  • ILD severity

    Baseline, 6 months of follow-up and at the last visit

  • Survival rate

    After 3 years and 5 years of follow-up

Study Arms (2)

IPAF patients

IPAF definition according to 2015 ERS/ATS criteria

Other: Follow-up

non-IPAF patients

Other: Follow-up

Interventions

Follow-upOTHER

Clinical data, radiological data and laboratory tests follow-up

IPAF patientsnon-IPAF patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic interstitial pneumonia classifiable or not as IPAF

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Hospital

Lille, France

Location

Central Hospital

Nancy, France

Location

Related Publications (9)

  • 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.

    PMID: 17329309BACKGROUND

  • 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.

    PMID: 14962966BACKGROUND

  • 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.

    PMID: 15166329BACKGROUND

  • 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.

    PMID: 10639536BACKGROUND

  • 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.

    PMID: 17557770BACKGROUND

  • 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.

    PMID: 17556720BACKGROUND

  • 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.

    PMID: 21565966BACKGROUND

  • 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.

    PMID: 20682528BACKGROUND

  • 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.

    PMID: 26160873BACKGROUND

MeSH Terms

Conditions

Idiopathic Interstitial PneumoniasConnective Tissue DiseasesLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Idiopathic Pulmonary FibrosisPulmonary FibrosisLung DiseasesRespiratory Tract DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Roland JAUSSAUD, Pr

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland JAUSSAUD, Pr

CONTACT

0383154067r.jaussaud@chru-nancy.fr

Paul DECKER, MR

CONTACT

p.decker@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 26, 2019

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)