Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)

Официальное название

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

Обзор

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.

Первичные конечные точки

• Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis [Срок оценки: up to 13 years]
• Number of exacerbation per year (frequency of exacerbation) [Срок оценки: up to 13 years]
• Percent of pulmonary fibrosis: grade of parenchymal involvement evidenced by high-resolution computed tomography (HRCT) [Срок оценки: up to 13 years]
• Change in 6-minute walk tests (6-MWT) over time [Срок оценки: up to 13 years]
• King's Brief Interstitial Lung Disease Questionnaire (K-BILD) score change over time [Срок оценки: up to 13 years]
• Saint George Respiratory Questionnaire (SGRQ)-I score change over time [Срок оценки: up to 13 years]

Вторичные конечные точки (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) [Срок оценки: up to 13 years]
• Frequency of use of diagnostic tools (laboratory, cabinet) [Срок оценки: up to 13 years]
• Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index [Срок оценки: up to 13 years]

Критерии участия

Критерии включения

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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Мексика · 1 центр

• Colegio Mexicano de Reumatologia — Mexico City

Идентификаторы

NCT: NCT05819385 · 1199-0522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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