Oratorio
What it found
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
| Group | n | Value |
|---|---|---|
| ocrelizumab | 32.9% | |
| placebo | 39.3% |
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
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | Not reached | 244 | |
| Ocrelizumab 600 mg | Not reached | 487 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| DB PLACEBO | 239 | 58 (24.3%) | 3 |
| DB OCRELIZUMAB | 486 | 104 (21.4%) | 3 |
| OLE PLACEBO | 158 | 59 (37.3%) | 4 |
| OLE OCRELIZUMAB | 369 | 167 (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 progression1. 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 progressionPercent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120
Baseline, Week 120
Disability progressionWalking and mobilityPercent Change From Baseline in Total Volume of T2 Lesions at Week 120
From Baseline to Week 120
MRI lesionsPercent Change in Total Brain Volume From Week 24 to Week 120
From Week 24 to Week 120
Brain volume lossChange 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
RelapsesSafety1. 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
Results
Two Years of Ocrelizumab Treatment in Black and Hispanic People with Multiple Sclerosis in CHIMES: A Single-Arm Clinical Trial.Ann Neurol · 2026
Results
Short- and long-term effects of early versus delayed treatment with ocrelizumab on cerebellar volume loss in patients with RMS and PPMS.Mult Scler · 2025
Results
Long-Term Treatment With Ocrelizumab in Patients With Early-Stage Relapsing MS: Nine-Year Data From the OPERA Studies Open-Label Extension.Neurology · 2025
Results
Evolution of atrophied T2 lesion volume in primary-progressive multiple sclerosis: results from the phase 3 ORATORIO study.J Neurol Neurosurg Psychiatry · 2024
Results
ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial.J Neurol · 2024
Results
Association of Higher Ocrelizumab Exposure With Reduced Disability Progression in Multiple Sclerosis.Neurol Neuroimmunol Neuroinflamm · 2023
Results
Safety and patient experience with at-home infusion of ocrelizumab for multiple sclerosis.Ann Clin Transl Neurol · 2023
Results
Blood neurofilament light levels predict non-relapsing progression following anti-CD20 therapy in relapsing and primary progressive multiple sclerosis: findings from the ocrelizumab randomised, double-blind phase 3 clinical trials.EBioMedicine · 2023
Results
Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning.Nat Commun · 2022
Results
Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry.Eur J Neurol · 2022
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History
Started
Mar 2011
Main results due
Jul 2015
Finished
Dec 2022
Results posted
Dec 2017
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