Registry of Autoimmune Interstitial Lung Disease

NCT05365009 | Recruiting DMC

• 1 other identifier: 2022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial lung diseases (ILD) constitute a group of entities characterized by inflammation and/or fibrosis of the lung parenchyma. In recent years, with the advent of new diagnostic tools and therapeutic options, multidisciplinary evaluation is essential, since it optimizes the interpretation of each case and the quality of care for these pathologies Consensus for the identification and management of ILD associated with SSc (ILD-SSc) is the only guideline published at present. In the others autoimmune ILD (Ai-ILD), screening, diagnosis, treatment and follow-up strategies are usually performed according to the criteria of the treating medical team. Guidelines regarding the follow-up and indication of immunosuppressive and antifibrotic treatment are lacking. Many questions on the horizon of the Ai-ILD should be answered as better quality evidence emerges from studies with a greater number of patients and better methodological design.

Conditions

Interstitial Lung Disease Due to Systemic Disease

Keywords

connective tissue disease; interstitial lung disease; rheumatoid arthritis; systemic sclerosis; interstitial penumonia with autoimmune features

Outcome Measures

Primary Outcomes (3)

• Mortality

  Number of patients that Survival at end of the study

  5 years

• Pulmonary test functionals

  Change in functional tests over time (measurement of FVC and DLCO)

  baseline and annual visits

• Fibrosis in Computed tomography

  Change in Computed tomography in relation to fibrotic involvement, measured by the same operator

  baseline and annual visits

Secondary Outcomes (1)

• Safety of the treatments used

  5 years

Study Arms (1)

EPIMAR group

EPIMAR (ARgentina's Autoimmune Mechanism Interstitial Pulmonary Disease) registry was created in 2016 by a group of multidisciplinary specialists with experience in the management of ILD.

Diagnostic Test: Multidisciplinary aproach

Interventions

Multidisciplinary aproach DIAGNOSTIC_TEST

regular tests

EPIMAR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of ILD-Ai according to the evaluation of a multidisciplinary team. Patients without respiratory symptoms may be included in the registry and will be classified as subclinical ILD.

You may qualify if:

• Age ≥ 18 years old
• Diagnosis of ILD within the last 5 years according to the criteria of the multidisciplinary team composed of at least one pulmonologist and one rheumatologist, with or without respiratory symptoms.
• ILD defined by the presence of ground glass opacities and / or peribronchovascular or airspace consolidations and / or reticulations and / or traction bronchiectasis and / or honeycomb on high-resolution computed tomography (HRCT) within the last 12 months 17 .
• One of the following three criteria (see annex 1):
• Established or early stage CTD 18-30. IPAF according to ATS / ERS 2015 classification criteria 8 ANCA positivity by immunofluorescence confirmed by ELISA, with or without systemic vasculitis 31.
• Spirometry performed within the last 6 months before entering the registry.
• The participant must sign the informed consent voluntarily.

You may not qualify if:

• Not being able to perform the clinical follow-up or the complementary studies required in the protocol.
• Not being able to be evaluated by a multidisciplinary team; at least a rheumatologist plus a pulmonologist.
• ILD associated with another non-autoimmune etiology according to the criteria of the multidisciplinary team (eg, occupational diseases, toxic)

Sponsors & Collaborators

• EPIMAR registry: lead
• Sociedad Argentina de Reumatologia: collaborator

Study Sites (1)

Epimar Ii

Buenos Aires, Argentina

RECRUITING

Related Links

• web site

MeSH Terms

Conditions

Connective Tissue Diseases; Lung Diseases, Interstitial; Arthritis, Rheumatoid; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Lung Diseases; Respiratory Tract Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Study Officials

• Florencia Vivero, MD

  Sociedad Argentina Reumatologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florencia Vivero, MD

CONTACT

542236184381; florenciavivero82@gmail.com

Juan Enghelmayer, MD

CONTACT

542236184381; jiesn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: May 6, 2022
• Study Start: April 10, 2022
• Primary Completion: April 1, 2023
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)