A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020338-25-BE

Enrollment

630

Registered

2010-09-22

Start date

2011-05-26

Completion date

Unknown

Last updated

2020-03-11

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

Conditions

Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab CAS Number: 637334-45-3 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult patients, 18-55 years of age • Primary Progressive Multiple Sclerosis (according to revised McDonald criteria) • Expanded Disability Status Scale (EDSS) 3.0 to 6.5 points • Disease duration from onset of MS symptoms 5.0, =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening • Contraindications for Magnetic Resonance Imaging (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-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;

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks, based on regularly scheduled visits.;Secondary Objective: To evaluate the efficacy of ocrelizumab compared with placebo, as reflected by the following: • The time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 24 weeks • The change in 25-foot timed walk from baseline to Week 120 • The change in total volume of T2 lesions on MRI scans of the brain from baseline to week 120 • The percentage change in total brain volume as detected by brain MRI from Week 24 to Week 120 • The change in SF-36 Health Survey version 2 (SF-36v2) Physical Component Summary (PCS) score from baseline to Week 120 • To evaluate the safety and tolerability of ocrelizumab 300 mg × 2 (over 24-week treatment cycles) compared with placebo in patients with PPMS;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 1. Up to 11 years	—

Measure

Time frame

Main Objective: To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks, based on regularly scheduled visits.;Secondary Objective: To evaluate the efficacy of ocrelizumab compared with placebo, as reflected by the following: • The time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 24 weeks • The change in 25-foot timed walk from baseline to Week 120 • The change in total volume of T2 lesions on MRI scans of the brain from baseline to week 120 • The percentage change in total brain volume as detected by brain MRI from Week 24 to Week 120 • The change in SF-36 Health Survey version 2 (SF-36v2) Physical Component Summary (PCS) score from baseline to Week 120 • To evaluate the safety and tolerability of ocrelizumab 300 mg × 2 (over 24-week treatment cycles) compared with placebo in patients with PPMS;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: 1. Up to 11 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time to confirmed disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks 2. Change in timed 25-foot walk 3. Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain 4. Safety and tolerability: Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1. Up to 11 years 2. From baseline to Week 120 3. From baseline to Week 180 4. Up to 11 years	—

Measure

Time frame

Secondary end point(s): 1. Time to confirmed disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks 2. Change in timed 25-foot walk 3. Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain 4. Safety and tolerability: Incidence of adverse events;Timepoint(s) of evaluation of this end point: 1. Up to 11 years 2. From baseline to Week 120 3. From baseline to Week 180 4. Up to 11 years

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Countries

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russian Federation, Slovakia, Spain, Switzerland, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026