Ocrelizumab for Multiple Sclerosis Patients Switching Therapy
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Recruiting
Phase 4Interventional Study
Multiple Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Genentech, Inc. · Industry
Who this trial is looking for
This trial is looking for people with relapsing or primary progressive multiple sclerosis who are changing from another anti-CD20 treatment. Participants will receive ocrelizumab combined with an additional medication through injections and will be monitored for their health outcomes and side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with relapsing or primary progressive multiple sclerosis.
I have an EDSS score between 0 and 6.5.
I am switching from another approved anti-CD20 therapy.
I have received treatment with ofatumumab, ublituximab, or ocrelizumab before.
You may not be able to join if
I did not respond well to anti-CD20 therapy.
I had serious reactions or infections from my previous therapy.
I have an active or chronic infection.
I have experienced progressive multifocal leukoencephalopathy.
I have any neurological disorders affecting my diagnosis.
I have allergies to ocrelizumab or the related medications.
I have received live vaccines in the past 6 weeks.
I have been treated with specific other medications like cladribine or alemtuzumab.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differenti…
The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
* Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
* Participants discontinuing aCD20 therapy for reasons including, but not lim…
Inclusion Criteria:
* Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
* Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
* Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study
* Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy
Exclusion Criteria:
* Participants who have demonstrated suboptimal response to aCD20 therapy
* Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy
* Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
* Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, human papillomavirus \[HPV\], tuberculosis \[TB\])
* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
* Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
* Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
* Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
* Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
* Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
* Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
* Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening
Other protocol defined inclusion and exclusion criteria may apply.
Contacts
Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
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