NCT05819385 Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) Epidemiology Non-interventional Study (NIS)
| NCT ID | NCT05819385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boehringer Ingelheim |
| Condition | Lung Diseases, Interstitial |
| Study Type | OBSERVATIONAL |
| Enrollment | 312 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 312 participants in total. It began in 2025-06-18 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05819385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Diseases, Interstitial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05819385 currently recruiting?
Yes, NCT05819385 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT05819385 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT05819385 clinical trial?
NCT05819385 is sponsored by Boehringer Ingelheim. The trial plans to enroll 312 participants.