Kusajili – Centralise les essais cliniques mondiaux

ZEUS - ZINBRYTA real world use study in Germany Background and study aims Multiple sclerosis (MS) is a chronic (long-term) inflammatory disease of the central nervous system (brain and/or spinal cord). More than 2 million people are affected worldwide. Most MS patients (90%) suffer from relapsing remitting MS, where they have episodes of new or worsening symptoms (e.g., vision problems, numbness, muscle weakness), known as relapses, which then slowly improve. Relapses are often reversible to begin with, but over time there is a slow deterioration of neurological functions. The aim of this study is to collect further data on the effectiveness and safety of the drug daclizumab, which is used to treat relapsing MS. Who can participate? Patients aged 18 and over with relapsing remitting MS who are starting treatment with daclizumab What does the study involve? Participants are followed for up to 60 months after starting treatment or until death, withdrawal, or the participants is considered lost to follow up, whichever occurs first. Follow up is planned regardless of whether treatment with daclizumab is stopped, unless informed consent is withdrawn or a participant joins another study. Assessments are completed and data is collected at the start of the study, 3 and 6 months after starting daclizumab treatment, and every 6 months thereafter for up to 60 months. The proportion of patients who still are on treatment with daclizumab, their reasons for stopping treatment, treatment adherence, relapses, progression of disability and side effects are all measured at each visit. What are the possible benefits and risks of participating? No benefits or risks are expected. Where is the study run from? 160 sites, led by Carl Gustav Carus Management GmbH, university hospital, clinic for neurosciences (Germany) When is the study starting and how long is it expected to run for? December 2016 to June 2023 Who is funding the study? Biogen GmbH (Germany) Who is the main contact? Dr Nadia Spitznagel [email protected]

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