Phase 3
N=680
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)
Multiple Sclerosis, Relapsing-Remitting
Bottom Line
View on ClinicalTrials.gov: NCT02861014 ↗Enrolled (actual)
680
Serious AEs
7.4%
Results posted
Feb 2021
Primary outcome: Primary: Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period — 74.8 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ocrelizumab (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period |
74.8 | — |
| SECONDARY Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period |
87.1 | — |
| SECONDARY Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period |
82.6 | — |
| SECONDARY Time to First Protocol-Defined Event of Disease Activity |
NA | — |
| SECONDARY Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS) |
2.09; -0.02; 0.01; -0.03; -0.01 | — |
| SECONDARY Absolute Change From Baseline in EDSS Category at Week 96 |
13.4; 72.2; 14.4 | — |
| SECONDARY Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96 |
17.3 | — |
| SECONDARY Annualized Protocol-defined Relapse Rate at Week 96 |
0.030 | — |
| SECONDARY Time to Onset of 24-week Confirmed Disability Progression |
NA | — |
| SECONDARY Time to Onset of First Protocol-Defined Relapse |
NA | — |
| SECONDARY Time to Onset of First New and/or Enlarging T2 Lesion |
NA | — |
| SECONDARY Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96 |
0.004; 0.004; NA | — |
| SECONDARY Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From |
-558.6 | — |
| SECONDARY Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI |
-8.5 | — |
| SECONDARY Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96 |
21.4; 23.1; 3.7 | — |
| SECONDARY Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan |
0.053; 0.009; 0.011 | — |
| SECONDARY Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume |
-416.5; -528.5 | — |
| SECONDARY Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume |
-4.0; -12.5 | — |
| SECONDARY Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume |
-461.8; -576.5 | — |
| SECONDARY Adjusted Mean Percentage Change From Baseline in Brain Volume |
-0.153; -0.445; -0.805 | — |
| SECONDARY Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume |
-0.312; -0.618 | — |
| SECONDARY Adjusted Mean Percentage Change From Baseline in White Matter Volume |
-0.382; -0.745 | — |
| SECONDARY Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score |
53.8; 2.5; 1.3 | — |
| SECONDARY Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score |
25.0; -1.9; -1.5 | — |
| SECONDARY Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score |
7.2; 4.8 | — |
| SECONDARY Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score |
-4.4; -2.0 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
89.1; 57.8; 7.2; 9.4; 0.1; 0 | — |
Summary
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
Eligibility Criteria
Inclusion Criteria
- Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- Have a length of disease duration, from first symptom, of less than (<) 10 years
- Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
- Suboptimal disease control while on a DMT
- Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
- For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
Exclusion Criteria
- Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
- Inability to complete an Magnetic Resonance Imaging (MRI) procedure
- Known presence of other neurological disorders
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- History or currently active primary or secondary immunodeficiency
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of opportunistic infections
- History or known presence of recurrent or chronic infection
- History of malignancy
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
Data sourced from ClinicalTrials.gov (NCT02861014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.