Project ENSEMBLE – AN OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATETHE EFFECTIVENESS AND SAFETY OFOCRELIZUMAB IN PATIENTS WITH…

Basic data

Acronym:
ENSEMBLE
Title:
AN OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATETHE EFFECTIVENESS AND SAFETY OFOCRELIZUMAB IN PATIENTS WITH EARLY STAGERELAPSING REMITTING MULTIPLE SCLEROSIS
Duration:
14/10/2017 to 14/10/2023
Abstract / short description:
This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in patients with early stage RRMS. The first dose of ocrelizumab will be administered as an initial dose of two 300-mg infusions (600 mg total) in 250 mL 0.9% sodium chloride each separated by 14 days (i.e., Days 1 and 15) followed by one 600-mg infusion in 500 mL 0.9% sodium chloride every 24 weeks for the remainder of the study duration.
The study will consist of the following periods:
· Screening period: Up to 4 weeks
· Treatment period: Open-label treatment period of 192 weeks (i.e. 24 weeks after the last dose of ocrelizumab, which will be administered at Week 168)
· A follow-up period of at least 48 weeks, which is independent of the disease modifying treatment (DMT) administered as explained below
Keywords:
multiple sclerosis
Multiple Sklerose
autoimmune diseases
Autoimmunerkrankungen
clinical trial
klinische Studie
safety
Sicherheit
Ocrelizumab
Immunmodulation

Involved staff

Managers

University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine
University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine
University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine

Local organizational units

Department of Neurology with Focus on Neurovascular Diseases
University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine

Funders

Grenzach-Wyhlen, Baden-Württemberg, Germany
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