Clinical trial NCT05819385: Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: TIC Social Mexico
First posted: 2023-04-19
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All participants must be diagnosed with rheumatic disease (connective tissue disease (CTD)) and intestinal 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).

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.


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.
* 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).

Primary outcomes:
measure: Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis
timeFrame: up to 13 years
measure: Number of exacerbation per year (frequency of exacerbation)
timeFrame: up to 13 years
measure: Percent of pulmonary fibrosis: grade of parenchymal involvement evidenced by high-resolution computed tomography (HRCT)
timeFrame: up to 13 years
measure: Change in 6-minute walk tests (6-MWT) over time
timeFrame: up to 13 years
measure: King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time
timeFrame: up to 13 years
measure: Saint George Respiratory Questionnaire (SGRQ)-I score change over time
timeFrame: up to 13 years
Secondary outcomes:
measure: 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)
timeFrame: up to 13 years
measure: Frequency of use of diagnostic tools (laboratory, cabinet)
timeFrame: up to 13 years
measure: Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index
timeFrame: up to 13 years
Other outcomes:
Locations:
Study officials:
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