Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)
Recruiting · NCT05819385 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boehringer Ingelheim
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed.
- Colegio Mexicano de Reumatologia - Mexico City, Mexico