A Study of Ocrelizumab in Participants With Relapsing Remitting Multip
An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
Results by group
Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period
Baseline up to Week 96
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ocrelizumab | 48.1 Percentage of Participants | 43.9–52.3 | 608 |
Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy
Week 96 to Week 100
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ocrelizumab (Substudy) | 0 Percentage of Participants | 0–2.8 | 129 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ocrelizumab | 608 | 47 (7.7%) | 0 |
| Ocrelizumab (Substudy) | 129 | 2 (1.6%) | 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 Without Any Protocol-Defined Events During 96-Week Period
Baseline up to Week 96
Disability progressionRelapsesMRI lesionsPercentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy
Week 96 to Week 100
Safety
Other measures (11)
Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period
Baseline up to Weeks 24 and 48
Disability progressionRelapsesMRI lesionsTime to Protocol-Defined Event
Baseline up to Week 96
Disability progressionRelapsesMRI lesionsTotal Number of Protocol-Defined Relapses Per Participant Year During 96-week Period
Baseline up to Week 96
Disability progressionRelapsesSafetyTime to Onset of First Protocol-Defined Relapse
Baseline up to Week 96
RelapsesSafetyTime to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI
Baseline up to Week 96
MRI lesionsTime to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI
Baseline up to Week 96
MRI lesionsTime to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score
Baseline up to Week 96
Disability progressionTotal Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
Weeks 24, 48, and 96
MRI lesionsChange From Baseline in Total T2 Lesion Volume as Detected by Brain MRI
Baseline, Weeks 24, 48, and 96
MRI lesionsTotal Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI
Weeks 24, 48, and 96
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
* Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria * Disease duration from first symptom of less than or equal to (\</=) 12 years * Treated with an adequate course of treatment with no more than three prior DMT regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the most recent adequately used DMT was due to suboptimal response * Suboptimal response while the participant was on his/her last adequately used DMT for >/=6 months (defined by having one of the following qualifying events despite being on a stable dose of the same DMT for at least 6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); these qualifying events must have occurred while on the last adequately used DMT. In participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT from the date of screening
Exclusion criteria
* History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS) * Contraindications for MRI * Known presence of other neurological disorders that may mimic multiple sclerosis * Pregnancy or lactation, or intention to become pregnant during the study * Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * History of or currently active primary or secondary immunodeficiency * Lack of peripheral venous access * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * Active infection, or history of or known presence of recurrent or chronic infection such as human immunodeficiency virus (HIV), syphilis, or tuberculosis * History of progressive multifocal leukoencephalopathy * Contraindications to or intolerance of oral or IV corticosteroids * Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in participants whose lymphocyte count is below the lower limit of normal (LLN) * Treatment with alemtuzumab (Lemtrada®) * Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate * Previous treatment with natalizumab within 12 months prior to screening unless failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was less than (\<) 1 year and natalizumab was not used in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive or negative) and titer (both assessed within the year of screening) must be documented prior to enrollment * Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to screening * Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) * Treatment with a drug that is experimental (Exception: treatment with an experimental drug that was subsequently approved in the participant's country is allowed)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.
Papers
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
ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial.J Neurol · 2024
Results
Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous disease-modifying therapy: A nonrandomized controlled trial.Mult Scler · 2022
Results
Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with suboptimal response to prior disease-modifying therapies: A primary analysis from the phase 3b CASTING single-arm, open-label trial.Eur J Neurol · 2022
Results
Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial.Ann Clin Transl Neurol · 2021
Results
Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis.Mult Scler Relat Disord · 2020
Results
Onset of clinical and MRI efficacy of ocrelizumab in relapsing multiple sclerosis.Neurology · 2019
Results
Vermersch P, Benedict RHB, Van Wijmeersch B, Cutter G, Kister L, Oreja-Guevara C, Siva A, Wiendl H, Wuerfel J, El Azzouzi B, Kuenzel T, Buffels R, Craveiro L, Dirks P, Comi G. Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial. Eur J Neurol. 2026 Jun;33(6):e70628. doi: 10.1111/
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History
Started
Feb 2016
Main results due
May 2019
Finished
May 2019
Results posted
May 2020