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Recruiting Observational

Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)

NCT05819385 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2025-06-18
Last updated
2026-05-07

Condition(s) studied

Lung Diseases, Interstitial

Study summary

This study aims to characterize the epidemiology of interstitial lung diseases (ILD) associated to connective tissue disease (CTD) in Mexico, and to study its correlation with the different comorbidities and treatments used, as well as the possible impacts of these factors on the outcome of progression, exacerbations, and mortality in patients with ILD associated to CTD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: For newly data collection: * Male and female Patients. * Patients over 18 years old. * Patient who gives his/her signed informed consent to be able to use information about their condition. * Patient who has the diagnosis of: rheumatoid arthritis, connective tissue disease (CTD) (systemic sclerosis or scleroderma; inflammatory myopathy: antisynthetase, dermatomyositis, polymyositis, mixed connective tissue disease; systemic lupus erythematosus; primary Sjögren syndrome; pulmonary fibrosis associated with non-specific autoimmunity; primary systemic vasculitis; psoriasis, anchylosing spondylitis, reactive arthritis) Spondyloarthritis (SpA) or sarcoidosis, (accordingly with the updated clinical criteria for each pathology). Patient with any interstitial lung diseases (ILD) diagnosed clinically and by a high-resolution computed tomography study with an interstitial pattern (supervised by an expert radiologist). For existing data collection: * Medical Records from patients with whom contact was permanently lost for any reason since 2012 till the study start date. * Medical Records from male and female Patients. * Medical Records from patients over 18 years old. * Medical Records of patients that have at least: patient initials, date of birth, gender, date of diagnosis, full diagnosis of: * Patient who has the diagnosis of: rheumatoid arthritis, CTD (systemic sclerosis or scleroderma; inflammatory myopathy: antisynthetase, dermatomyositis, polymyositis, mixed connective tissue disease; Systemic lupus erythematosus; primary Sjögren syndrome; pulmonary fibrosis associated with non-specific autoimmunity; primary systemic vasculitis; psoriasis, anchylosing spondylitis, reactive arthritis) SpA or Sarcoidosis, (accordingly with the updated clinical criteria for each pathology). * Patient with any ILD diagnosed clinically and by a high-resolution computed tomography study with an interstitial pattern (supervised by an expert radiologist). Exclusion Criteria: * Patient with a biopsy definition of usual interstitial pneumonitis, related to any other non-CTD. * Patient with post-chemotherapy or post-radiotherapy pneumonitis. * Medical Records of patients without full diagnostic of ILD (clinically and by biopsy or high-resolution computed tomography).

Primary outcome measure(s)

  • Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis — up to 13 years
  • Number of exacerbation per year (frequency of exacerbation) — up to 13 years
  • Percent of pulmonary fibrosis: grade of parenchymal involvement evidenced by high-resolution computed tomography (HRCT) — up to 13 years
  • Change in 6-minute walk tests (6-MWT) over time — up to 13 years
  • King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time — up to 13 years
  • Saint George Respiratory Questionnaire (SGRQ)-I score change over time — up to 13 years

Trial sites (1)

FacilityCityRegionStatus
Colegio Mexicano de Reumatologia Mexico City Mexico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05819385 on ClinicalTrials.gov ↗ ← All trials in Mexico