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|
|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|