Kantonsspital St.Gallen
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BI1199.214 Senscis

Silvia Forrer, Mira Bartz Batliner, Carina Hutz & Kathrin Schmidig

abstract

A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’(SSc-ILD).

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis.
   
type of project clinical studies
status completed
start of project 2016
end of project 2017
study design This is a multi-centre, multi-national, prospective, randomised, placebo-controlled, double blind clinical trial to investigate the efficacy and safety of nintedanib at a dose of 150 mg bid, in patients with SSc-ILD. The main efficacy analysis will be assessed at week 52. Patients will stay on treatment up to a maximum of 100 weeks in order to collect follow-up safety and efficacy Information. The trial will end for all ongoing patients at the timepoint when the last patient of the trial has completed his/her primary endpoint visit after 52 weeks and follow-up visit 28 days later (last patient out timepoint).
responsible person Rüdiger Müller