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NCT Number: NCT05819385

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

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.

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Key information

Conditions

Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colegio Mexicano de Reumatologia

Mexico City, 04318, Mexico

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis

    Time frame: up to 13 years

  2. Number of exacerbation per year (frequency of exacerbation)

    Time frame: up to 13 years

  3. Percent of pulmonary fibrosis: grade of parenchymal involvement evidenced by high-resolution computed tomography (HRCT)

    Time frame: up to 13 years

  4. Change in 6-minute walk tests (6-MWT) over time

    Time frame: up to 13 years

  5. King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time

    Time frame: up to 13 years

  6. Saint George Respiratory Questionnaire (SGRQ)-I score change over time

    Time frame: up to 13 years

Secondary outcomes

  1. Possibility to have an exacerbation and/or progression in pulmonary fibrosis, sorted by rheumatic disease type (rheumatoid arthritis (RA), connective tissue disease (CTD), spondyloarthritis (SpA) and Sarcoidosis)

    Time frame: up to 13 years

  2. Frequency of use of diagnostic tools (laboratory, cabinet)

    Time frame: up to 13 years

  3. Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index

    Time frame: up to 13 years

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • TIC Social Mexico

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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