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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoehringer Ingelheim

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

All participants must be diagnosed with rheumatic disease (connective tissue disease (CTD)) and interstitial lung disease (ILD) and fulfil all inclusion and no exclusion criteria. Information about participants will be obtained from electronic and physical medical records for existing data collection (over the past ten years, from 2012 to 2022) and/or from medical consultations for newly collected data (for the next three years, from 2023 to 2026). The participants' observation time varies and can be over the whole study duration (from 2012 to 2023), over the past ten years only (existing data) or over the next three years (new data).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

312 Participants
are grouped into 1 trial group
Group A: All participants

Trial outcomes

Primary outcomes

1

Time to first exacerbation: time in months elapsed until the first exacerbation from the diagnosis

Time frame
up to 13 years
2

Number of exacerbation per year (frequency of exacerbation)

Time frame
up to 13 years
3

Percent of pulmonary fibrosis: grade of parenchymal involvement evidenced by high-resolution computed tomography (HRCT)

Time frame
up to 13 years
4

Change in 6-minute walk tests (6-MWT) over time

Time frame
up to 13 years

Secondary outcomes

1

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)

Time frame
up to 13 years
2

Frequency of use of diagnostic tools (laboratory, cabinet)

Time frame
up to 13 years
3

Progression of pulmonary fibrosis by treatment received identified by HRCT patterns, lung function, activity score and damage index

Time frame
up to 13 years

Other outcomes

Sponsors and contacts

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Boehringer Ingelheim

Lead sponsor

TIC Social Mexico

Collaborator