Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Diseases, Interstitial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis [Time frame: up to 13 years]
- Number of exacerbation per year (frequency of exacerbation) [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]
- King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change 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 outcome measures (3)
- 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) [Time frame: up to 13 years]
- Frequency of use of diagnostic tools (laboratory, cabinet) [Time frame: up to 13 years]
- Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index [Time frame: up to 13 years]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Mexico · 1 center
- Colegio Mexicano de Reumatologia — Mexico City
Identifiers
NCT: NCT05819385 · 1199-0522