CompletedPhase 3Relapsing MSNCT028610142015-005597-38

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

Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period

Week 96

GroupValueIntervalNumber analysed
Ocrelizumab74.8 Percentage of Participants71.3–78658

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Ocrelizumab68049 (7.2%)1
Ocrelizumab Safety Follow-up646 (9.4%)0

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

  • Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period

    Week 96

    Disability progressionRelapsesMRI lesions
  • 1. Proportion of patients who have no evidence of disease activity (NEDA), as per protocol defined events over 96-weeks (with MRI baseline at Week 8)

    MRI lesions

Other measures (27)

  • Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period

    Baseline up to 24 weeks

    Disability progressionRelapsesMRI lesions
  • Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period

    Baseline up to 48 weeks

    Disability progressionRelapsesMRI lesions
  • Time to First Protocol-Defined Event of Disease Activity

    Baseline up to 96 Weeks

    Disability progressionRelapsesMRI lesionsFatigue
  • Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)

    Baseline, Weeks: 24, 48, 72, 96

    Disability progression
  • Absolute Change From Baseline in EDSS Category at Week 96

    Up to Week 96

    Disability progression
  • Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96

    Week 96

    Disability progression
  • Annualized Protocol-defined Relapse Rate at Week 96

    Week 96

    Relapses
  • Time to Onset of 24-week Confirmed Disability Progression

    Baseline up to 96 Weeks

    Disability progression
  • Time to Onset of First Protocol-Defined Relapse

    Baseline up to 96 Weeks

    Disability progressionRelapsesFatigueSafety
  • Time to Onset of First New and/or Enlarging T2 Lesion

    Baseline up to 96 Weeks

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria * Have a length of disease duration, from first symptom, of less than (\<) 10 years * Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy * Suboptimal disease control while on a DMT * Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening * For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug Exclusion Criteria: * Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS) * Inability to complete an Magnetic Resonance Imaging (MRI) procedure * Known presence of other neurological disorders * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * History or currently active primary or secondary immunodeficiency * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * History of opportunistic infections * History or known presence of recurrent or chronic infection * History of malignancy * Congestive heart failure * Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds

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

About this trial

In the sponsor's words

The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Sept 2016

    2. Main results due

      Oct 2019

    3. Finished

      Dec 2020

    4. Results posted

      Feb 2021

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error