Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)
- Conditions
- Lung Diseases, Interstitial
- Registration Number
- NCT05819385
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 312
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).
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of exacerbation per year (frequency of exacerbation) up to 13 years King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time up to 13 years Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis 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 time up to 13 years Saint George Respiratory Questionnaire (SGRQ)-I score change over time up to 13 years
- Secondary Outcome Measures
Name Time Method Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index up to 13 years 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