Trials / Active Not Recruiting
Active Not RecruitingNCT07080125
A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis
Non-interventional Post-authorization Effectiveness Study to Assess Long-term Outcomes of Nintedanib Treatment in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ofev® | Ofev® |
Timeline
- Start date
- 2025-06-17
- Primary completion
- 2033-12-31
- Completion
- 2033-12-31
- First posted
- 2025-07-23
- Last updated
- 2025-12-08
Locations
1 site across 1 country: Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07080125. Inclusion in this directory is not an endorsement.