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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