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Registry of Autoimmune Interstitial Lung Disease

ConditionInterstitial Lung Disease Due to Systemic Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEPIMAR registry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Spirometry performed within the last 6 months before entering the registry.

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Multidisciplinary aproach

    Diagnostic test

    regular tests

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: EPIMAR group1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Number of patients that Survival at end of the study

Time frame
5 years
2

Pulmonary test functionals

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

Time frame
baseline and annual visits
3

Fibrosis in Computed tomography

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

Time frame
baseline and annual visits

Secondary outcomes

1

Safety of the treatments used

number and type of event adverse

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EPIMAR registry

Lead sponsor

Sociedad Argentina de Reumatologia

Collaborator

Source ClinicalTrials.gov
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