CTD-related interstitial lung disease in Mexico: patterns, treatments, and outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-interventional, observational project will collect new and existing clinical data from adults in Mexico diagnosed with connective tissue disease–associated interstitial lung disease (CTD-ILD). Diagnosis must be supported by clinical assessment and high-resolution CT reviewed by an expert radiologist, and investigators will record comorbidities, treatments, exacerbations, disease progression, and mortality. Researchers will analyze associations between patient characteristics, therapies, and outcomes to characterize epidemiology and identify possible risk factors. The effort is sponsored by Boehringer Ingelheim in collaboration with TIC Social Mexico and will enroll patients through participating Mexican centers including the Colegio Mexicano de Reumatología.

Why it matters

Who can join: the full rules

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).

Where it's running

• Colegio Mexicano de Reumatologia
  Mexico City, Mexico Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.