BAY16277 RISE

Project

BAY16277 RISE

Completed · 2016 until 2019

Forrer Silvia, Müller Rüdiger, Bartz-Batliner Mira, Hutz Carina Liane, Schmidig Kathrin

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Rheumatologie

Status

Completed

Start Date

2016

End Date

2019

Financing

Industry

Study Design

In this multinational, multicenter, randomized (1:1), double-blind, placebo-controlled, parallel-group study, a total of approximately 200 patients are planned for enrollment in order to randomize approximately 130 patients to study drug treatment (approximately 65 patients to the riociguat group and 65 to the placebo group). The study design consists of a main treatment phase followed by a long-term extension Phase.

Keywords

diffuse kutane Systemische Sklerose, Riociguat,

Brief description/objective

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Evaluierung der Wirksamkeit und Sicherheit einer 52-wöchigen Behandlung mit Riociguat im Vergleich zum Placebo bei Patienten mit diffuser kutaner systemischer Sklerose.