MSFrontier

REFINE-MS

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
Ongoing (inferred)Phase 3Relapsing MSISRCTN17105865

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ocrevus 300 mg concentrate for solution for infusion [Ocrelizumab]
  • Ocrevus 920 mg solution for injection [Ocrelizumab]

What it measured

Main measures

  • The proportion of participants without new T2 lesions brain MRI scans

    baseline, 1 year for the Stage 1 (interim) analysis and at 2 years for the Stage 2 (final) analysis

    MRI lesions

Other measures (10)

  • Number of new T2 lesions brain MRI

    2 years

    MRI lesions

  • Time-to-relapse the MS relapse notable events reported by site clinician

    2 years

    Relapses

  • Annualised relapse rate the MS relapse notable events reported by site clinician

    2 years

    Relapses

  • Proportion of participants without disability progression (defined by Expanded Disability Status Scale (EDSS) score increase of ≥1 point or ≥0.5 point if baseline EDSS >5.5) data collected by a blinded rater at site

    2 years

    Disability progression

  • Rate of adverse events (graded by severity) and infections data reported by site clinician

    2 years

    Safety

  • Rate of whole brain atrophy brain MRI

    2 years

    MRI lesionsBrain volume loss

  • Proportion of participants with hypogammaglobulinaemia immunoglobulin laboratory test results

    2 years

  • Changes in serum neurofilament light concentration laboratory tests results

    2 years

    Blood or spinal fluid markers

  • Changes in cognitive functions assessed by Symbol Digit Modalities Test (SDMT)) data collected by a blinded rater at site

    2 years

    Thinking and memory

  • Changes in quality-of-life, patient-reported outcomes, and therapy administration satisfaction EuroQol EQ5D-5L, Multiple Sclerosis Impact Scale (MSIS-29) and the Client Services Receipt Inventory and Work Productivity and Activity Impairment participant-reported outcome measures (PROMs) questionnaires

    2 years

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 110

Inclusion: 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: 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Not provided at time of registration.

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History

    1. Started

      May 2026

    2. Finished

      Sept 2030

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