NCT05335278

Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is likely a role for using anti-fibrotic medications in patients with myositis-associated interstitial lung disease (MA-ILD) to slow down disease progression, especially in patients who have fibrotic and progressive disease. These patients however are currently being excluded from clinical trials of anti-fibrotic agents in progressive ILD because of the concomitant use of immunosuppression. The benefit of anti-fibrotic agents is being assessed in other rheumatic diseases and should be assessed in MA-ILD as well. They are a unique group of patients with a heterogeneous disease, and are much more frequently on concomitant immune-modulating therapy. As such, they should be studied on their own in separate clinical trials, and the use of nintedanib should be studied as an addition to standard of care immunosuppression. The objective of this study is to assess safety and tolerability of nintedanib in patients with MA-ILD.

Conditions

• Interstitial Lung Disease
• Myopathy, Inflammatory

Interventions

Type	Name	Description
DRUG	Nintedanib 150 milligrams [Ofev]	All patients will be given nintedanib 150 milligrams orally twice daily

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-31
• Completion: 2025-04-30
• First posted: 2022-04-19
• Last updated: 2025-09-02

Locations

1 site across 1 country: Canada