Ocrelizumab for Multiple Sclerosis
(OCREFINA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well the medication ocrelizumab (also known as Ocrevus or Ocrevus Zunovo) targets B cells in the lymph nodes of people with relapsing-remitting multiple sclerosis (RR-MS). B cells, a type of white blood cell, may play a significant role in MS, and understanding their behavior could improve long-term outcomes. Participants will receive ocrelizumab infusions, which serve as a standard treatment for MS. The trial seeks individuals diagnosed with RR-MS who have not yet started treatment and whose symptoms began less than 15 years ago. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be treatment-naïve, meaning they should not have taken any disease-modifying therapy for multiple sclerosis before. If you are currently on such medications, you would need to stop them to participate.
What is the safety track record for ocrelizumab?
Research has shown that ocrelizumab is generally well-tolerated by patients. In studies for relapsing multiple sclerosis (RMS), 58% of patients taking ocrelizumab reported infections, compared to 52% of those taking another drug, Rebif. This indicates that slightly more than half of the patients experienced infections, a common occurrence with both treatments.
Ocrelizumab has been used to treat multiple sclerosis for some time, supporting its safety profile. Some patients have experienced reactions during IV administration, which is important to note. Overall, evidence suggests that ocrelizumab is relatively safe for use.12345Why are researchers enthusiastic about this study treatment?
Ocrelizumab is unique because it targets CD20-positive B cells, which play a crucial role in the progression of multiple sclerosis (MS). Unlike standard treatments like interferons or glatiramer acetate that modulate the immune system more generally, ocrelizumab directly depletes these specific B cells, potentially reducing the frequency and severity of relapses in RR-MS. Researchers are excited about this treatment because its targeted approach may offer improved outcomes and a more favorable safety profile compared to broader immune-modulating therapies.
What is the effectiveness track record for ocrelizumab in treating multiple sclerosis?
Research has shown that ocrelizumab, which participants in this trial will receive, effectively treats multiple sclerosis (MS). Studies have found that it can reduce the risk of worsening disability by 30% in people with advanced MS. It remains the only approved treatment for primary progressive multiple sclerosis (PPMS) and can help delay symptom progression. Fewer patients experience symptom worsening with ocrelizumab compared to those receiving a placebo. Overall, ocrelizumab ranks among the most effective medications for MS because it targets B cells, which play a crucial role in the disease.46789
Who Is on the Research Team?
Joseph Sabatino, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for individuals with Multiple Sclerosis (MS). Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of MS and meet certain health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ocrelizumab
Trial Overview
The study tests the effects of Ocrelizumab, a medication that targets B cells, on immune cells within lymph nodes in people with MS. It aims to understand how well B cells are eliminated from these areas after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later.
Ocrelizumab is already approved in United States, European Union, Canada for the following indications:
- Primary progressive multiple sclerosis
- Relapsing forms of multiple sclerosis
- Primary progressive multiple sclerosis
- Relapsing forms of multiple sclerosis
- Primary progressive multiple sclerosis
- Relapsing forms of multiple sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Citations
Efficacy | OCREVUS® (ocrelizumab)
In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS- ...
Genentech: Press Releases | Tuesday, Sep 23, 2025
Ocrevus shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression (cCDP) in adults with advanced ...
results in primary progressive ms (ppms)
Proven effective · OCREVUS is the only approved treatment for PPMS · Clinical study by the numbers · OCREVUS was proven to delay disability progression of PPMS.
Roche presents new data for OCREVUS and fenebrutinib ...
OCREVUS shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression (cCDP) in adults with advanced ...
Ocrevus and Ocrevus Zunovo
Results have shown that fewer patients treated with Ocrevus had worsening symptoms compared to those treated with placebo.4 Data also showed ...
6.
ocrevus-hcp.com
ocrevus-hcp.com/content/dam/gene/ocrevus-hcp/pdfs/ocrevus-zunovo-core-data-brochure.pdfOCREVUS ZUNOVO Core Data Brochure
Select Important Safety Information. The warnings and precautions for ocrelizumab are infusion reactions (OCREVUS) or injection reactions (OCREVUS ZUNOVO).
OCREVUS® (ocrelizumab) Results for RMS (Relapsing MS)
In 2 large, identical clinical studies over 2 years, OCREVUS was proven effective against Rebif, a currently approved treatment for relapsing MS, not a placebo.
Safety | OCREVUS® (ocrelizumab)
In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS- ...
FDA approves OCREVUS ZUNOVO™ as the first and only ...
Additionally, one of several patient-reported outcomes measured during the study showed more than 92% of trial participants reported being ...
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