Gastro immunology - 21 Oct 2019
Responder Definitions for the Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS) Tool Using Patients with Crohn’s Disease Teated with Etrolizumab
The Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS) diary is the first PRO tool to undergo a rigorous development process outlined by health authorities, with input from patients and clinical experts. This study provides preliminary responder definitions for the CD-PRO/SS using patients treated with etrolizumab from the Phase 3 BERGAMOT trial.
Neuroscience - 17 Oct 2019
Continued large amyloid PET reductions at 36 months in the gantenerumab open label extension studies
Gantenerumab is a fully human monoclonal antibody currently under evaluation at titrated doses up to 1200 mg sc monthly in the Scarlet RoAD (SR, NCT01224106) and Marguerite RoAD (MR, NCT02051608) open label extension (OLE) studies. Here we report change from baseline in amyloid burden, using SUVR and centiloid scales, in patients treated with gantenerumab for up to 36 months in the OLE studies.
Neuroscience - 11 Oct 2019
GRADUATE I & II better by design or how to optimize study designs by integrating learnings from previous studies
Gantenerumab is a human monoclonal antibody targeting aggregated beta-amyloid currently being investigated as disease-modifying treatment for early Alzheimer’s disease. This presentation describes the detailed methodologies of GRADUATE I & II (NCT03444870; NCT03443973), two Phase III, multicentre, randomized, double-blind, placebo-controlled, parallel-group studies, and explains how these studies were designed using the key learnings from previous Phase III studies (SCarlet RoAD and Marguerite RoAD).