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RecruitingPhase 4

A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ocrelizumab mixed with rHuPH20, given as a shot under the skin, after people switch from another anti-CD20 treatment. It is for people with relapsing or primary progressive multiple sclerosis (MS). The study checks scan results, health outcomes, safety, side effects, and how satisfied people are with treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have relapsing MS or primary progressive MS diagnosed using the study’s required standards.
  • Have an EDSS score of 0–6.5 at screening or within the past 6 months. This score measures disability from MS.
  • Have used ofatumumab shots under the skin, or ublituximab-xiiy or ocrelizumab through a vein. These are anti-CD20 treatments.
  • May be stopping anti-CD20 treatment because of personal or doctor preference, insurance issues, moving, travel, or other practical reasons.

Who can't join

  • Your anti-CD20 treatment did not work well enough.
  • You are stopping anti-CD20 treatment because of a severe reaction to a shot or infusion, repeated severe infections, or at least 2 antibiotic courses in the past 12 months for infections the study doctor links to treatment.
  • You cannot safely receive gadolinium, a dye used for MRI scans, or cannot tolerate an MRI.
  • You have an active, repeated, or long-term infection; a positive hepatitis B or C antibody test; or past confirmed or suspected PML, a serious brain infection.
  • You have another brain or nerve disorder that could affect your MS diagnosis, or a disease that may need steroids or medicines that weaken the immune system during the study.
  • You are allergic to ocrelizumab, rHuPH20, or any other ingredient in the study shot.
  • You have had a bone marrow or blood-forming stem cell transplant, an experimental procedure for MS, or treatment with cladribine, atacicept, alemtuzumab, or mitoxantrone.
  • You received a live weakened vaccine within 6 weeks before the study’s baseline visit. Other study rules may also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (4)

AZ

FL

GA

TN