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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05819385
Other study ID # 1199-0522
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 24, 2024
Est. completion date October 17, 2026

Study information

Verified date June 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 312
Est. completion date October 17, 2026
Est. primary completion date October 17, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Boehringer Ingelheim TIC Social

Outcome

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