A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
CompletedPhase 3Results postedLast updated 26 May 2020
What this trial tests
Phase 3 trial testing Ocrelizumab in Multiple Sclerosis, Relapsing-Remitting in 608 participants. Completed in 3 May 2019.
Adults 18 to 55, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Without Any Protocol-Defined Events During 96-Week PeriodPrimary· Baseline up to Week 96
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Group
Value
95% CI
Ocrelizumab
48.1
43.9 – 52.3
Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week PeriodSecondary· Baseline up to Weeks 24 and 48
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Week 24
Group
Value
95% CI
Ocrelizumab
59.0
54.9 – 63.1
Week 48
Group
Value
95% CI
Ocrelizumab
51.2
47.0 – 55.4
Time to Protocol-Defined EventSecondary· Baseline up to Week 96
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Group
Value
95% CI
Ocrelizumab
NA
53.86 – NA
Total Number of Protocol-Defined Relapses Per Participant Year During 96-week PeriodSecondary· Baseline up to Week 96
Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (\>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS \<2.5 vs. \>=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. \>1)
Group
Value
95% CI
Ocrelizumab
0.046
0.036 – 0.060
Time to Onset of First Protocol-Defined RelapseSecondary· Baseline up to Week 96
Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for \>24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.
Group
Value
95% CI
Ocrelizumab
NA
NA – NA
Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRISecondary· Baseline up to Week 96
Group
Value
95% CI
Ocrelizumab
NA
NA – NA
Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRISecondary· Baseline up to Week 96
Group
Value
95% CI
Ocrelizumab
NA
NA – NA
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) ScoreSecondary· Baseline up to Week 96
Group
Value
95% CI
Ocrelizumab
NA
NA – NA
Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRISecondary· Weeks 24, 48, and 96
The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.
Week 24
Group
Value
95% CI
Ocrelizumab
33
0.010 – 0.050
Week 48
Group
Value
95% CI
Ocrelizumab
16
0.002 – 0.031
Week 96
Group
Value
95% CI
Ocrelizumab
7
0.002 – 0.026
Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRISecondary· Baseline, Weeks 24, 48, and 96
Baseline data is represented as mean; post-Baseline date are represented as mean changes.
Baseline
Group
Value
95% CI
Ocrelizumab
11.551
± 0.590
Week 24
Group
Value
95% CI
Ocrelizumab
-0.484
± 0.118
Week 48
Group
Value
95% CI
Ocrelizumab
-0.549
± 0.123
Week 96
Group
Value
95% CI
Ocrelizumab
-0.560
± 0.129
Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRISecondary· Weeks 24, 48, and 96
Week 24
Group
Value
95% CI
Ocrelizumab
640
Week 48
Group
Value
95% CI
Ocrelizumab
39
Week 96
Group
Value
95% CI
Ocrelizumab
38
Percentage of Participants With Adverse EventsSecondary· Baseline up to 100 weeks
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Group
Value
95% CI
Ocrelizumab
86.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 100 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06677710 — IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis
· Phase 1
· suspended
NCT07282574 — A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrel
· Phase 2
· recruiting
NCT06846281 — Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Scle
· Phase 3
· recruiting
NCT07483450 — A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Rel
· Phase 4
· recruiting
NCT06495593 — Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
· Phase 4
· enrolling by invitation
Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting
Currently open trials in the same condition.
NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap
· Phase 3
· recruiting
NCT06569550 — Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis
· NA
· recruiting
NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
· NA
· recruiting
NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
· active not recruiting
NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy
· NA
· recruiting
Other Genentech, Inc. trials
Trials by the same sponsor.
NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P
· Phase 1
· recruiting
NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas
· Phase 2
· recruiting
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D
· Phase 1
· recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants
· Phase 1
· recruiting
NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 26 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02637856.