1199.225 open label extension study of nintedanib in SSc-ILD
Research type
Research Study
Full title
An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD)
IRAS ID
235678
Contact name
Christopher Denton
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2016-003403-66
Duration of Study in the UK
3 years, 3 months, 29 days
Research summary
This is an open-label extension study to investigate the long term safety of nintedanib in patients with ’Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD). Patients who have completed the parent trial 1199.214 (SENSCIS) as planned will be eligible for enrolment in this extension study. The trial will last approximately 3 years and will end either when nintedanib is available on the market or will be made otherwise available to the patient. The study will be performed by investigators specialized in the treatment of SSc-ILD.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0001
Date of REC Opinion
18 Jan 2018
REC opinion
Favourable Opinion