Phase 3
Completed N=608
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
Source: ClinicalTrials.gov NCT02637856 ↗
Enrolled (actual)
608
Serious AEs
6.7%
Results posted
May 2020
Primary outcomePrimary: Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period — 48.1 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period |
48.1 | — |
| PRIMARY Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy |
— | — |
| SECONDARY Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period |
59.0; 51.2 | — |
| SECONDARY Time to Protocol-Defined Event |
NA | — |
| SECONDARY Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period |
0.046 | — |
| SECONDARY Time to Onset of First Protocol-Defined Relapse |
NA | — |
| SECONDARY Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI |
NA | — |
| SECONDARY Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI |
NA | — |
| SECONDARY Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score |
NA | — |
| SECONDARY Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI |
33; 16; 7 | — |
| SECONDARY Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI |
11.551; -0.484; -0.549; -0.560 | — |
| SECONDARY Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI |
640; 39; 38 | — |
| SECONDARY Percentage of Participants With Adverse Events |
86.3 | — |
Eligibility 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 ( /=) 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 ( /=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)
Data sourced from ClinicalTrials.gov (NCT02637856). 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. Informational only — not medical advice.