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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05819385
Enrollment
312
Registered
2023-04-19
Start date
2025-06-18
Completion date
2027-12-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Interstitial

Brief 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.

Interventions

None listed

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY
TIC Social Mexico
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frame
Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosisup 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 timeup to 13 years
King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over timeup to 13 years
Saint George Respiratory Questionnaire (SGRQ)-I score change over timeup to 13 years

Secondary

MeasureTime frame
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)up to 13 years
Frequency of use of diagnostic tools (laboratory, cabinet)up to 13 years
Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage indexup to 13 years

Countries

Mexico

Contacts

CONTACTBoehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com1-800-243-0127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026