Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TIC Social Mexico | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | All participants must be diagnosed with rheumatic disease (connective tissue disease (CTD)) and interstitial lung disease (ILD) and fulfil all inclusion and no exclusion criteria. Information about participants will be obtained from electronic and physical medical records for existing data collection (over the past ten years, from 2012 to 2022) and/or from medical consultations for newly collected data (for the next three years, from 2023 to 2026). The participants' observation time varies and can be over the whole study duration (from 2012 to 2023), over the past ten years only (existing data) or over the next three years (new data). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis | up 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 time | up to 13 years | |
| King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time | up to 13 years | |
| Saint George Respiratory Questionnaire (SGRQ)-I score change over time | up to 13 years |
| Measure | Description | Time 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) |
Not provided
Inclusion Criteria:
For newly data collection:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
All participants must be diagnosed with rheumatic disease (connective tissue disease (CTD)) and interstitial lung disease (ILD) and fulfil all inclusion and no exclusion criteria. Information about participants will be obtained from electronic and physical medical records for existing data collection (over the past ten years, from 2012 to 2022) and/or from medical consultations for newly collected data (for the next three years, from 2023 to 2026). The participants' observation time varies and can be over the whole study duration (from 2012 to 2023), over the past ten years only (existing data) or over the next three years (new data).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colegio Mexicano de Reumatologia | Recruiting | Mexico City | 04318 | Mexico |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Once the criteria in section 'time frame frame' are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 13 years |
| Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index | up to 13 years |