A study to find out the best length of time between ocrelizumab doses for patients with relapsing remitting multiple sclerosis using a trial design with multiple groups and multiple stages

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17105865

Enrollment

540

Registered

2026-03-26

Start date

2026-05-26

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical condition: Relapsing-remitting multiple sclerosis (RRMS) Medical condition in lay language: A long-term condition affecting the brain and spinal cord, where people experience episodes of new or worsening symptoms (relapses) followed by periods of recovery (remission). Therapeutic areas: Diseases [C] - Nervous System Diseases [C10] Nervous System Diseases

Interventions

Participants will be randomised in the REFINE-MS electronic data capture (eDC) system to receive ocrelizumab (ocrelizumab 600mg intravenous or 920mg subcutaneous). The dose frequency depends on the ar

if it is inferior, the trial will convert into a 2-arm non-inferiority trial of 9-monthly vs. 6-monthly frequencies. All participants will be followed up with for at least 2 years.

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Adult participants aged =18 yrs 2. Diagnosis of RRMS, according to the 2017 or 2024 revised McDonald criteria 3. Received 4 or more 6-monthly cycles of ocrelizumab (IV or SC) according to NICE TA533 guidelines and the ocrelizumab summary of product characteristics (SPC), prior to randomisation 4. Expanded Disability Status Scale (EDSS) score between 0 and =6.5 inclusive at baseline 5. Participants who wish to remain on ocrelizumab 6. Written informed consent provided 7. At randomisation, participants must have a QC-approved Baseline MRI scan (per the MRI Guide), performed up to 6 weeks after the Screening/Baseline/M0 visit

Exclusion criteria

Exclusion criteria: 1. Clinical relapse(s) within 12 months prior to randomisation 2. New MRI lesions prior to randomisation, assessed by the treating site through comparison of the trial baseline scan with the most recent preceding MRI performed at least 3 months earlier while the participant was receiving ocrelizumab 3. Co-treatment with other immunosuppressive medications 4. Any condition or circumstance that prevents the participant from undergoing regular MRI scanning 5. Pregnancy or intention to become pregnant during the study period

Countries

England, United Kingdom

Contacts

Public Contact- REFINE-MS Team

mrcctu.refinems@ucl.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026