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

Launched by BOEHRINGER INGELHEIM · Apr 6, 2023

Keywords

ClinConnect Summary

The Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) study is a research project that aims to understand how interstitial lung diseases (which affect the tissue in the lungs) are related to connective tissue diseases (conditions that affect the body's connective tissues). This study will look at how these lung diseases impact patients in Mexico, including how other health issues (known as comorbidities) and treatments may influence the progression of the lung disease, as well as overall health outcomes like worsening symptoms and mortality.

To participate, individuals must be over 18 years old and have a diagnosis of a connective tissue disease, such as rheumatoid arthritis, lupus, or scleroderma, along with a type of interstitial lung disease confirmed by a special lung scan. The study is currently not recruiting participants, but once it begins, eligible individuals can expect to provide information about their health and treatment as part of the research. This study is important as it aims to gather valuable data that could help improve the understanding and management of lung diseases associated with connective tissue diseases.

Gender

ALL

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).