Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-15; most recent amendment 2025-12-05.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-07-23
Trial Details
NCT Number NCT07080125
Lead Sponsor Boehringer Ingelheim
Conditions Interstitial Lung Diseases, Systemic Sclerosis Associated Interstitial Lung Disease
Enrollment 2,000 participants
Start Date 2025-06-17
Primary Completion 2033-12-31 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-08