Registry for Autoimmune Interstitial Lung Disease

Characteristics of Patients With Autoimmune Interstitial Lund Disease From Argentina

This study is collecting information from people with autoimmune interstitial lung disease to see how the disease affects them and how different treatments work over five years.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: EPIMAR registry (Research network)
• Locations: 1 site (Buenos Aires)
• Trial ID: NCT05365009 on ClinicalTrials.gov

What this trial studies

This registry aims to collect and analyze data from patients diagnosed with autoimmune interstitial lung disease (Ai-ILD) over a five-year period. It will document various characteristics including sociodemographic, clinical, serological, functional, and radiological data, as well as treatment patterns and outcomes. The study will also investigate the frequency of subclinical Ai-ILD, risk factors for disease progression, and the safety and efficacy of different treatment approaches. By employing a multidisciplinary approach, the registry seeks to enhance understanding and management of Ai-ILD.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who have been diagnosed with interstitial lung disease related to autoimmune conditions within the last five years.

Not a fit: Patients who do not have a confirmed diagnosis of interstitial lung disease or those unable to participate in follow-up assessments may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could lead to improved diagnosis, treatment strategies, and overall management of patients with autoimmune interstitial lung disease.

How similar studies have performed: While there have been studies on interstitial lung diseases, this registry approach focusing specifically on autoimmune-related cases is relatively novel and aims to fill existing gaps in knowledge.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Where this trial is running

Buenos Aires

• Epimar Ii — Buenos Aires, Argentina (Recruiting)

Study contacts

• Principal investigator: Florencia Vivero, MD — Sociedad Argentina Reumatologia
• Study coordinator: Florencia Vivero, MD

Conditions Interstitial Lung Disease Due to Systemic Disease; connective tissue disease; interstitial lung disease; rheumatoid arthritis; systemic sclerosis; interstitial penumonia with autoimmune features