CompletedPhase 3Progressive MSNCT011945702010-020338-25

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“The percentage of patients with 12-week confirmed disability progression was 32.9% with ocrelizumab versus 39.3% with placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.59 to 0.98; P=0.03).”
Read by software from the paper's abstract

percentage of patients with disability progression confirmed at 12 weeks in a time-to-event analysis · at least 120 weeks

GroupnValue
ocrelizumab32.9%
placebo39.3%

hazard ratio 0.76 (95% CI 0.59–0.98)

p = 0.03

Total participants: 732

Read by software from the paper's abstract

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period

Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

GroupValueIntervalNumber analysed
PlaceboNot reached244
Ocrelizumab 600 mgNot reached487

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
DB PLACEBO23958 (24.3%)3
DB OCRELIZUMAB486104 (21.4%)3
OLE PLACEBO15859 (37.3%)4
OLE OCRELIZUMAB369167 (45.3%)19

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 Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period

    Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

    Disability progression
  • 1. Efficacy: Time to onset of confirmed disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks

    Disability progression

Other measures (7)

  • Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period

    Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

    Disability progression
  • Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120

    Baseline, Week 120

    Disability progressionWalking and mobility
  • Percent Change From Baseline in Total Volume of T2 Lesions at Week 120

    From Baseline to Week 120

    MRI lesions
  • Percent Change in Total Brain Volume From Week 24 to Week 120

    From Week 24 to Week 120

    Brain volume loss
  • Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120

    From Baseline to Week 120

    PainQuality of life (reported by participants)
  • Number of Participants With at Least One Adverse Event (AE)

    From baseline to 9 years

    RelapsesSafety
  • 1. Time to confirmed disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks

    Disability progression

Who could take part

Progressive MS · 18 to 55

Inclusion Criteria: * Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria) * EDSS at screening from 3 to 6.5 points * Disease duration from onset of MS symptoms less than (\<) 15 years if EDSS greater than (>) 5.0; \<10 years if EDSS greater than or equal to (>/=) 5.0 * Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose Exclusion Criteria: * History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening * Inability to complete an MRI (contraindications for MRI) * Known presence of other neurologic disorders * Known active infection or history of or presence of recurrent or chronic infection * History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved) * Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) * Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study

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

About this trial

In the sponsor's words

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.

Papers

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Related trials

History

    1. Started

      Mar 2011

    2. Main results due

      Jul 2015

    3. Finished

      Dec 2022

    4. Results posted

      Dec 2017

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