TALOS
Research type
Research Study
Full title
Retrospective, non-interventional study of Multiple Sclerosis routine clinical practice: Impact on adherence and clinical outcomes of Ofatumumab treated patients
IRAS ID
322574
Contact name
David Paling
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Multiple sclerosis (MS) is a lifelong condition that affects the brain and spinal. It can cause a wide variety of symptoms, including extreme tiredness, difficulty walking, problems with balance and coordination as well as muscle stiffness or spasms.
There are different types of MS, but the most common is relapsing-MS. People with this kind of MS will have episodes of worsening symptoms (‘relapses’) which can last for a few days, weeks or months. People can then go into remission, either with or without treatment, and remission can last for several years before a person relapses again.
Kesimpta (ofatumumab) is a disease modifying therapy (DMT) developed by Novartis, a pharmaceutical company, to help people manage their relapsing-MS. It is injected under the skin once every four weeks and people taking Ofatumumab can be trained to inject themselves in the home setting so they don’t need to go to the hospital.
This study aims to describe the patients prescribed ofatumumab as part of routine clinical practice. Specifically, the study will describe the demographic and clinical characteristics, clinical outcomes as well as patient adherence to ofatumumab treatment.
Around 120 patients with relapsing-MS over 18 years of age who were prescribed ofatumumab will be enrolled in the study. Patients must have received their first dose between 26 March 2021 and 31 December 2022 to be included.
The study will only involve the collection of data from medical records and patients will not be required to attend additional clinical visits or provide additional clinical data. All data collected will be part of standard routine medical care.
This is a retrospective observational study and will not influence how doctors care for patients or introduce new treatments. Rather, it will give us information on how current treatments for relapsing-MS are helping patients to manage their MS.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
23/NE/0127
Date of REC Opinion
19 Jun 2023
REC opinion
Favourable Opinion