CTD-related interstitial lung disease in Mexico: patterns, treatments, and outcomes

Ambispective, Non-Interventional Study to Evaluate the Epidemiology of Interstitial Lung Diseases (ILDs) Associated to Rheumatic Diseases (Rheumatoid Arthritis, Connective Tissue Diseases, Spondylarthritis and Sarcoidosis) and the Progression Risk Factors in the Mexican Population

This project will collect health data to see how interstitial lung disease linked to connective tissue diseases affects adults in Mexico and how other illnesses and treatments relate to progression, flare-ups, or death.

Quick facts

• Study type: Observational
• Enrollment: 312 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Mexico City)
• Trial ID: NCT05819385 on ClinicalTrials.gov

What this trial studies

This non-interventional, observational project will collect new and existing clinical data from adults in Mexico diagnosed with connective tissue disease–associated interstitial lung disease (CTD-ILD). Diagnosis must be supported by clinical assessment and high-resolution CT reviewed by an expert radiologist, and investigators will record comorbidities, treatments, exacerbations, disease progression, and mortality. Researchers will analyze associations between patient characteristics, therapies, and outcomes to characterize epidemiology and identify possible risk factors. The effort is sponsored by Boehringer Ingelheim in collaboration with TIC Social Mexico and will enroll patients through participating Mexican centers including the Colegio Mexicano de Reumatología.

Who should consider this trial

Good fit: Adults (18+) in Mexico with a clinical and high-resolution CT diagnosis of interstitial lung disease associated with a connective tissue disease who can give informed consent are ideal candidates.

Not a fit: People without CTD-associated ILD, those outside the participating geographic area, or those seeking experimental treatments should not expect direct medical benefit from participating.

Why it matters

Potential benefit: If successful, the project could identify risk factors and treatment patterns that help doctors better predict disease course and guide care for CTD-ILD patients in Mexico.

How similar studies have performed: Observational registries and cohort studies of CTD-ILD in other countries have identified risk factors and treatment patterns, but comprehensive epidemiologic data from Mexico remain limited.

Eligibility criteria

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).

Where this trial is running

Mexico City

• Colegio Mexicano de Reumatologia — Mexico City, Mexico (RECRUITING)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions: Lung Diseases, Interstitial