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

  c.denton@ucl.ac.uk

• 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