Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
Stopped early · Phase 3
Conditions studied: Relapsing-Remitting Multiple Sclerosis (RRMS)
In brief
The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
Key facts
- Study ID
- NCT02881567
- Run by
- Biogen
- People needed
- 41
- Starts
- 2017-04-18
- Expected to finish
- 2018-09-12
- Last updated by the study team
- 2019-09-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Tampa, Florida, United States
- Research Site — Des Moines, Iowa, United States
- Research Site — Milwaukee, Wisconsin, United States
- Research Site — Edmonton, Alberta, Canada
- Research Site — Munich, Bavaria, Germany
- Research Site — Potsdam, Brandenburg, Germany
- Research Site — Dresden, Saxony, Germany
- Research Site — Hamburg, Germany
- Research Site — Pozzilli, Isernia, Italy
- Research Site — Naples, Italy
- Research Site — Guaynabo, Puerto Rico
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.