Actively Recruiting
Ambispective, Non-Interventional Study to Evaluate the Epidemiology of Interstitial Lung Diseases Associated to Rheumatic Diseases and Progression Risk Factors in the Mexican Population
Led by Boehringer Ingelheim · Updated on 2026-05-07
312
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Boehringer Ingelheim
Lead Sponsor
T
TIC Social Mexico
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the epidemiology of interstitial lung diseases (ILD) linked to connective tissue diseases (CTD) in Mexico. They aim to understand how different comorbidities and treatments affect disease progression, flare-ups, and mortality in these patients. This observational study covers various rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, inflammatory myopathies, systemic lupus erythematosus, and others, focusing on their association with ILD. All participants must have diagnoses of both a connective tissue disease and interstitial lung disease confirmed by clinical evaluation and high-resolution computed tomography. The study collects data from medical records spanning the past ten years (2012 to 2022) and from new patient consultations over the next three years (2023 to 2026). Participant observation time varies depending on whether data is historical, ongoing, or both. Participants' medical records and clinical information will be reviewed, including lung imaging, lung function tests, and patient questionnaires assessing respiratory health and quality of life. Researchers will track the time to first exacerbation, frequency of flare-ups, extent of lung fibrosis, and changes in walking tests and respiratory questionnaires over up to 13 years. The study will also monitor factors influencing disease progression and treatment patterns. Participation duration varies based on data availability and collection period.
CONDITIONS
Brief Title
Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients over 18 years old
- Patients who provide signed informed consent for use of their medical information
- Diagnosis of rheumatoid arthritis, connective tissue disease (such as systemic sclerosis, inflammatory myopathy, lupus, Sjögren syndrome, vasculitis, psoriasis, ankylosing spondylitis, reactive arthritis), spondyloarthritis, or sarcoidosis
- Diagnosis of interstitial lung disease confirmed clinically and by high-resolution computed tomography with an interstitial pattern supervised by an expert radiologist
- For existing data, medical records must include patient initials, date of birth, gender, date of diagnosis, and full diagnosis of CTD and ILD
You will not qualify if you...
- Patients with biopsy-confirmed usual interstitial pneumonitis unrelated to connective tissue disease
- Patients with pneumonitis caused by chemotherapy or radiotherapy
- Medical records lacking complete diagnosis of interstitial lung disease, either clinically or by biopsy or high-resolution computed tomography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 13 years
Participants who have connective tissue disease-associated interstitial lung disease are observed over time through medical record reviews and medical consultations to collect data on disease progression and outcomes.
Data collection from medical records and medical consultations over several years
Trial Site Locations
Total: 1 location
1
Colegio Mexicano de Reumatologia
Mexico City, Mexico, 04318
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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