Active — Not RecruitingNot Applicable

A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis

Switzerland2,000 participantsStarted 2025-06-17

Plain-language summary

This post-approval registry study is planned to generate data to address remaining questions on long-term effectiveness and to better characterize longer term beneficial effects of Nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) in terms of survival, quality of life, pattern of disease progression as well as effectiveness and safety in the subgroup of patients with pulmonary hypertension.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Enrolled in the EUSTAR registry * Provided consent at their site to have their data included in the EUSTAR registry for a broad range of research studies, and agree to visit the site every 12 months * Have a diagnosis of ILD defined by radiological findings on High Resolution Computed Tomography (HRCT) and/or X-ray that is documented in the electronic Case Report Form (eCRF) by the treating physician Exclusion Criteria: * Women with Systemic Sclerosis Interstitial Lung Disease (SSc-ILD) who are pregnant, or breastfeeding will be excluded since Ofev® is contraindicated for women who are pregnant due to safety concerns * SSc-ILD patients aged \<18 years: only adults will be included in the study since Ofev® is approved for treatment of SSc-ILD in adults * Patients with a previous Hematopoietic Stem Cell Transplantation (HSCT)

What they're measuring

Time to absolute Forced Vital Capacity (FVC) decline (% predicted) ≥5%, lung transplantation (indicating end stage ILD), or death

Timeframe: up to 10 years

Time to absolute FVC decline (% predicted) ≥10%, lung transplantation (indicating end-stage ILD), or deat

Timeframe: up to 10 years

Trial details

NCT IDNCT07080125

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-12-31

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