REFINE-MS
Research type
Research Study
Full title
REFINE-MS: A randomised, rater-blind, phase 3 trial to determine the optimal dose frequency of ocrelizumab for patients with relapsing remitting multiple sclerosis using a novel multi-arm multi-stage frequency-optimisation design
IRAS ID
1013232
Contact name
Olga Ciccarelli
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN17105865
Research summary
Multiple sclerosis (MS) can cause episodes of new or worsening symptoms called relapses, which occur when the immune system attacks the brain and spinal cord. This can lead to new areas of damage seen on MRI. Ocrelizumab is a treatment that reduces specific immune cells involved in this inflammation. It is highly effective at preventing new brain damage and relapses. However, ocrelizumab also lowers the body’s ability to fight infections and may reduce vaccine responses. There are also concerns about a possible increase in some cancers. It is costly (about £19,160 per person per year), and although most people receive it every six months, its benefits may last longer.
REFINE-MS will test whether people with relapsing–remitting MS (RRMS) who have been stable on ocrelizumab for at least two years can take it less often while keeping their MS under similar control compared with the standard six month schedule. The study will also examine whether reducing dosing frequency lowers side effects and NHS costs.
The trial will include 540 people with RRMS who have had no relapses and no new MRI lesions for at least 12 months. All participants will continue ocrelizumab but will be randomly assigned to receive it every 6, 9, 12, 15, or 18 months. The study will run in stages to safely identify the least frequent schedule that still works. It will start by comparing dosing every 6 months versus every 12 months, with an early safety and effectiveness review after the first 90 participants complete one year. If 12 month dosing appears as effective as standard treatment, the trial will continue with all five groups. If not, it will focus only on comparing 6 and 9 month schedules. REFINE-MS will follow participants for at least two years.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
26/EM/0057
Date of REC Opinion
7 Apr 2026
REC opinion
Further Information Favourable Opinion