ALITHIOS- Open-label extension study of ofatumumab in relapsing MS
Research type
Research Study
Full title
An open-label, single arm, multicenter extension study evaluating the long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis
IRAS ID
254032
Contact name
Katharina Boehm Boehm
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2017-004703-51
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Multiple Sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system, where the body’s immune system attacks and damages the protective myelin cover around the nerves of the central nervous sytem. MS affects approximately 2.5 million individuals worldwide. People with relapsing MS will have repeated attacks or relapses, which can result in symptoms including difficulty walking, balance and vision problems and more. Some symptoms may not completely recover after the relapse leading to accumulation of disability over time.
The study drug ofatumumab targets cells in the immune system by temporarily removing the number B cells, which are a type of white blood cells that are responsible for some of the damage done to the nerve cells in MS.
ALITHIOS is a long-term extension study which aims to evaluate how safe and well-tolerated ofatumumab is over the long-term in patients with relapsing MS who previously participated in clinical trials with ofatumumab. In the UK, only patients who have previously taken part in the two ASCLEPIOS trials will be invited to participate in ALITHIOS.
ALITHIOS is open-label, and all patients will receive ofatumumab as an injection under the skin. There are currently 35 UK patients in the ASCLEPIOS trials. The patients will be in ALITHIOS for a minimum of 2 years and the treatment duration will not exceed a maximum of 5 years.REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0149
Date of REC Opinion
18 Jun 2019
REC opinion
Further Information Favourable Opinion