TIMIOS
Research type
Research Study
Full title
Time and motion study for Ocrelizumab and Ofatumumab administration in relapsing multiple sclerosis. The TIMIOS study.
IRAS ID
280356
Contact name
Richard Nicholas
Contact email
Sponsor organisation
Novartis Pharma AG
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Multiple Sclerosis (MS) is an auto-immune disease that affects the central nervous system. The type of MS that will be observed is Relapsing Multiple Sclerosis (RMS). This form includes patients suffering with Clinically Isolated Syndrome (CIS), Relapsing-Remitting MS (RRMS) or active Secondary Progressive MS (aSPMS).
This is an observational study that is being carried out to determine and compare the time spent by healthcare workers to prepare and administer Ocrelizumab and Ofatumumab, the latter can potentially be administered at the patient’s home. This study will help healthcare workers save a lot of time and resources and reduce the need for patients to visit the hospital.
Ocrelizumab is an antibody therapy which is administered intravenously and is followed by a one-hour observation. It also requires a corticosteroid (drug to lower inflammation and immune system response) pre-medication and some antipyretics (drug to prevent or reduce fever).
Ofatumumab is also an antibody therapy which is yet to be commercially available. It will be administered through an injection under the skin and will allow self-administration after training.
Any adult patient aged 18 and over will be eligible for the study provided that they have confirmed diagnosis of RMS. The patient must also be prescribed with Ocrelizumab and Ofatumumab prior to their enrolment on the study. They must be literate in English and agree to participate by signing the informed consent form.
This is a multi-country study that will be simultaneously carried out in America, UK and Australia. A total of 8 sites will be recruited in the UK. Sites with an infusion chair and treating RMS patients will be recruited.
The study will be carried out in two arms and is expected to last until December 2021.
There will be no change to the way patients receive their medical care on this study.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/LO/1119
Date of REC Opinion
15 Feb 2021
REC opinion
Further Information Favourable Opinion