STHENOS
Research type
Research Study
Full title
An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS
IRAS ID
1003539
Contact name
Irina Simion
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-004505-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to provide clinical, MRI and patient reported outcome (PRO) data demonstrating a better efficacy, patient quality of life and patient compliance to ofatumumab in this treatment-naïve population compared to the current standard of care (SoC) first line disease modifying treatments (DMT). This data will provide additional evidence to support local patients access processes and establish ofatumumab as an early interventional treatment in Europe, The study will be run at 10 centres in the UK,
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0503
Date of REC Opinion
20 Sep 2021
REC opinion
Further Information Favourable Opinion