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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Diseases, Interstitial
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Number of exacerbation per year (frequency of exacerbation)
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
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).
Outcomes
Primary Outcomes
Number of exacerbation per year (frequency of exacerbation)
Time Frame: up to 13 years
King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time
Time Frame: up to 13 years
Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis
Time Frame: up to 13 years
Percent of pulmonary fibrosis: grade of parenchymal involvement evidenced by high-resolution computed tomography (HRCT)
Time Frame: up to 13 years
Change in 6-minute walk tests (6-MWT) over time
Time Frame: up to 13 years
Saint George Respiratory Questionnaire (SGRQ)-I score change over time
Time Frame: up to 13 years
Secondary Outcomes
- 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)