MSFrontier

MN39158

A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials
CompletedPhase 3MS (type not specified)NCT035992452023-506543-41-002017-004886-29

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96

From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort222.1 weeks439

Time to Onset of CDP Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE CohortNot reached616

Time to Onset of CDP Sustained for at Least 48 Weeks From CASTING Baseline to LIBERTO Week 96

From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort222.1 weeks439

Time to Onset of CDP Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE CohortNot reached616

Percentage of Participants Who Had CDP Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96

From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort20.5 percentage of participants439

Percentage of Participants Who Had CDP Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort15.1 percentage of participants616

Percentage of Participants Who Had CDP Sustained for at Least 48 Weeks From CASTING Baseline to LIBERTO Week 96

From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort18.9 percentage of participants439

Percentage of Participants Who Had CDP Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort11.0 percentage of participants616

Percentage of Participants Who Had Confirmed Disability Improvement (CDI) Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96

From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort24.0 percentage of participants18.7–29.9242

Percentage of Participants Who Had CDI Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort40.3 percentage of participants320

Percentage of Participants Who Had CDI Sustained for at Least 48 Weeks From CASTING Baseline to LIBERTO Week 96

From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort20.7 percentage of participants15.7–26.3242

Percentage of Participants Who Had CDI Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort32.8 percentage of participants320

Percentage of Participants Who Had Improved, Stable or Worsened Disability Compared With CASTING Baseline in EDSS Category at LIBERTO Week 96

At LIBERTO Week 96

GroupValueIntervalNumber analysed
CASTING Cohort18.7 percentage of participants305
CASTING Cohort65.9 percentage of participants305
CASTING Cohort15.4 percentage of participants305

CASTING Cohort

18.7

CASTING Cohort

65.9

CASTING Cohort

15.4

Percentage of Participants Who Had Stable or Worsened Disability Compared With ENSEMBLE Baseline in EDSS Category at LIBERTO Week 96

At LIBERTO Week 96

GroupValueIntervalNumber analysed
ENSEMBLE Cohort11 percentage of participants616
ENSEMBLE Cohort89 percentage of participants616

ENSEMBLE Cohort

11

ENSEMBLE Cohort

89

Change From CASTING Baseline in EDSS Score to LIBERTO Week 96

CASTING Baseline to LIBERTO Week 96 (up to 4 years)

GroupValueIntervalNumber analysed
CASTING Cohort0.12 score on scale0.07 (Standard Error)305

Change From ENSEMBLE Baseline in EDSS Score to LIBERTO Week 96

ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort-0.119 score on scale0.059 (Standard Error)551

Time to ≥ 20% Increase in 25-foot Walk Test (T25FWT) Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE CohortNot reached616

Time to ≥ 20% Increase in 25FWT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE CohortNot reached616

Time to ≥ 20% Increase in 9 Hole Peg Test (9HPT) Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE CohortNot reached616

Time to ≥ 20% Increase in 9HPT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE CohortNot reached616

Percentage of Participants With ≥ 20% Increase in T25FWT Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort24.4 percentage of participants616

Percentage of Participants With ≥ 20% Increase in T25FWT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort17.7 percentage of participants616

Percentage of Participants With ≥ 20% Increase in 9HPT Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort9.4 percentage of participants616

Percentage of Participants With ≥ 20% Increase in 9HPT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

GroupValueIntervalNumber analysed
ENSEMBLE Cohort6.5 percentage of participants616

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
CASTING Cohort43941 (9.3%)0
ENSEMBLE Cohort616109 (17.7%)2

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigue

  • Time to Onset of CDP Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigue

  • Time to Onset of CDP Sustained for at Least 48 Weeks From CASTING Baseline to LIBERTO Week 96

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigue

  • Time to Onset of CDP Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDP Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDP Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDP Sustained for at Least 48 Weeks From CASTING Baseline to LIBERTO Week 96

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDP Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had Confirmed Disability Improvement (CDI) Sustained for at Least 24 Weeks From CASTING Baseline to LIBERTO Week 96

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDI Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDI Sustained for at Least 48 Weeks From CASTING Baseline to LIBERTO Week 96

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had CDI Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigue

  • Percentage of Participants Who Had Improved, Stable or Worsened Disability Compared With CASTING Baseline in EDSS Category at LIBERTO Week 96

    At LIBERTO Week 96

    Disability progressionFatigueBladder, bowel and sexual function

  • Percentage of Participants Who Had Stable or Worsened Disability Compared With ENSEMBLE Baseline in EDSS Category at LIBERTO Week 96

    At LIBERTO Week 96

    Disability progressionFatigueBladder, bowel and sexual function

  • Change From CASTING Baseline in EDSS Score to LIBERTO Week 96

    CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionFatigueBladder, bowel and sexual function

  • Change From ENSEMBLE Baseline in EDSS Score to LIBERTO Week 96

    ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionFatigueBladder, bowel and sexual function

  • Time to ≥ 20% Increase in 25-foot Walk Test (T25FWT) Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionWalking and mobility

  • Time to ≥ 20% Increase in 25FWT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionWalking and mobility

  • Time to ≥ 20% Increase in 9 Hole Peg Test (9HPT) Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progression

  • Time to ≥ 20% Increase in 9HPT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progression

  • Percentage of Participants With ≥ 20% Increase in T25FWT Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionWalking and mobility

  • Percentage of Participants With ≥ 20% Increase in T25FWT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionWalking and mobility

  • Percentage of Participants With ≥ 20% Increase in 9HPT Sustained for at Least 24 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progression

  • Percentage of Participants With ≥ 20% Increase in 9HPT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progression

  • 1. Evaluate clinical measures related to disease progression over two years in MS patients

Other measures (53)

  • Time to First Protocol-Defined Event of Disease Activity

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years); From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionRelapsesMRI lesionsFatigueSafety

  • Time to First Relapse

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years); From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionRelapsesFatigueSafety

  • Annualized Protocol-Defined Relapse Rate

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years); From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionRelapsesFatigueSafety

  • Percentage of Relapse Free Participants

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years); From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionRelapsesFatigueSafety

  • Percentage of Participants With No Protocol-Defined Event of Disease Activity (NEDA) for CASTING Rollover Cohort

    From CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Disability progressionRelapsesMRI lesions

  • Percentage of Participants With NEDA for ENSEMBLE Cohort

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionRelapsesMRI lesions

  • Percentage of Participants With No Evidence of Progression (NEP) From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionWalking and mobility

  • Percentage of Participants With No Evidence of Progression Sustained for at Least 24 Weeks and Disease Activity (NEPAD) From ENSEMBLE Baseline ENSEMBLE to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Disability progressionRelapsesMRI lesionsWalking and mobility

  • Change From Baseline in Symbol Digit Modalities Test (SDMT) Score for CASTING Rollover Cohort

    CASTING Baseline to LIBERTO Week 96 (up to 4 years)

    Thinking and memory

  • Time to 8-point Improvement Change in the SDMT Sustained for at Least 48 Weeks From ENSEMBLE Baseline to LIBERTO Week 96

    From ENSEMBLE Baseline to LIBERTO Week 96 (up to 6 years)

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 65

Inclusion Criteria: * Signed Informed Consent Form * Able to comply with the study protocol, in the investigator's judgment * Completed the treatment period of Roche sponsored ocrelizumab P-trials Exclusion Criteria: * Hypersensitivity to ocrelizumab or to any of its excipients. * Participantss in a severely immunocompromised state until the condition resolves. * Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation. * Existence of a contra-indication as per SmPC * Prohibited concomitant medication as specified in protocol * Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study

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

About this trial

In the sponsor's words

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Jul 2018

    2. Main results due

      Jul 2025

    3. Finished

      Jul 2025

    4. Results posted

      Sept 2026

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