Ocrevus for Multiple Sclerosis

(MOBILE-RMS Trial)

Not currently recruiting at 1 trial location

Overseen By Joash Lazarus, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Georgia State University

Must not be taking: B-cell therapies, Corticosteroids

Disqualifiers: Other MS types, Hepatitis, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if people with relapsing multiple sclerosis (RMS) can improve their walking abilities after one year of treatment with Ocrevus (ocrelizumab) compared to other approved medications. Participants will be divided into two groups: one receiving Ocrevus and the other receiving different FDA-approved treatments for multiple sclerosis. Researchers will assess walking abilities and brain scans several times throughout the year to compare the effects of the treatments. Suitable candidates for the trial include those with RMS who can walk at least 25 feet independently and stand unassisted for at least 30 seconds. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that certain treatments, like systemic corticosteroids and some other specific drugs, should not have been used recently. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

What is the safety track record for these treatments?

Previous studies have shown that Ocrevus (ocrelizumab) is safe for treating multiple sclerosis. Most patients tolerated it well, though some experienced side effects like injection site reactions. These reactions were usually mild to moderate, with symptoms such as redness or swelling at the injection site. One study found that about 70% of patients taking Ocrevus had infections, similar to the 68% in the group not receiving the treatment. This suggests that Ocrevus does not significantly increase the risk of infections.

The FDA has already approved Ocrevus for multiple sclerosis, indicating it has undergone thorough safety testing. While the treatment is generally well-tolerated, patients should be aware of possible injection reactions and discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ocrelizumab, marketed as Ocrevus, is unique because it targets a specific protein called CD20 on the surface of B cells, a type of immune cell involved in multiple sclerosis. This mechanism helps reduce inflammation and nerve damage more effectively than many traditional treatments, like interferons or glatiramer acetate, which generally aim to modulate the immune system more broadly. Researchers are excited about Ocrevus because it has shown promise in slowing disease progression and reducing relapse rates, offering hope for improved long-term outcomes for patients with multiple sclerosis. Additionally, Ocrevus is administered as an infusion every six months, potentially offering more convenience compared to some treatments that require more frequent dosing.

What is the effectiveness track record for Ocrevus in treating multiple sclerosis?

Research shows that Ocrevus, which participants in this trial may receive, effectively treats multiple sclerosis (MS). One study found that Ocrevus reduced the risk of worsening disability by 30% in patients with advanced MS. In trials, patients taking Ocrevus experienced fewer worsening symptoms compared to those on a placebo. It is also the only approved treatment specifically for primary progressive MS (PPMS) and has effectively delayed disability progression. These findings suggest that Ocrevus may improve movement in people with relapsing multiple sclerosis (RMS). ^{2 6 7 8 9}

Who Is on the Research Team?

Feng Yang, PhD

Principal Investigator

Georgia State University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with relapsing multiple sclerosis who can walk at least 25 feet and stand for 30 seconds. They must not be pregnant, have no other neurological or severe medical conditions, no recent surgeries or broken bones, and cannot be on certain medications like systemic corticosteroids.

Inclusion Criteria

Not pregnant at screening and throughout the study

I can walk at least 25 feet on my own, with or without help from a device.

Can read and understand English

Exclusion Criteria

I do not have neurological conditions like Lyme disease or vitamin B12 deficiency that could be confused with MS.

I have not received a live vaccine in the last 6 weeks.

I have had progressive multifocal leukoencephalopathy in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ocrevus or other Disease Modifying Treatments over a one-year course

12 months

5 visits (in-person) for ambulatory assessments, 3 visits (in-person) for MRI scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview The study tests if Ocrevus improves walking in people with RMS compared to other Disease Modifying Treatments over a year. Participants will receive either Ocrevus or another DMT and their walking ability and brain health (via MRI) will be monitored regularly.

How Is the Trial Designed?

Group I: Ocrevus Experimental Treatment 1 Intervention

Group II: Other Disease Modifying Treatments Active Control 1 Intervention

Other Disease Modifying Treatments will consist of FDA-approved injectable and oral medications for multiple sclerosis.

Ocrelizumab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ocrevus for:

• Primary progressive multiple sclerosis
• Relapsing forms of multiple sclerosis

Approved in European Union as Ocrevus for:

• Primary progressive multiple sclerosis
• Relapsing forms of multiple sclerosis

Approved in Canada as Ocrevus for:

• Primary progressive multiple sclerosis
• Relapsing forms of multiple sclerosis

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Multiple Sclerosis Center of Atlanta

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

Ocrelizumab significantly reduces annualized relapse rates in adults with relapsing multiple sclerosis (RMS) compared to interferon β-1a, based on results from two 96-week trials.

In patients with primary progressive multiple sclerosis (PPMS), ocrelizumab significantly lowers the risk of confirmed disability progression over 120 weeks compared to placebo, and it is generally well tolerated with mostly mild to moderate side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. Syed, YY.[2022]

In a review of 78 studies involving 4498 patients, 61.3% of those treated with ocrelizumab experienced adverse events, with the most common being infections (39.2%) and infusion-related reactions (26.2%).

Ocrelizumab was associated with a higher risk of infections compared to beta-interferon, particularly herpes-related and respiratory infections, while the risk of serious adverse events was similar between ocrelizumab and comparator groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. Ng, HS., Rosenbult, CL., Tremlett, H.[2022]

Ocrelizumab is a humanized anti-CD20 monoclonal antibody specifically designed to deplete B cells, which are implicated in the development of multiple sclerosis (MS).

Approved in March 2017 in the USA for treating both relapsing and primary progressive forms of MS, ocrelizumab represents a significant advancement in MS therapy, with its approval in the EU currently pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval. Frampton, JE.[2022]

Ocrelizumab, a monoclonal antibody used for treating multiple sclerosis, can be associated with the development of alopecia areata, as observed in five patients (two females and three males).

All patients responded positively to conventional treatments for alopecia areata, such as corticosteroids and minoxidil, indicating that this side effect is potentially reversible with appropriate care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab-induced alopecia areata-A series of five patients from Ontario, Canada: A case report. Chin, LD., AbuHilal, M.[2022]

Ocrelizumab is an effective treatment for both relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), showing significant reductions in relapse rates and disease progression over at least 7.5 years of treatment.

The drug is generally well tolerated, with no new safety concerns identified during long-term use, and offers the convenience of infusions every six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. Lamb, YN.[2023]

In a study of 130 individuals with relapsing and progressive multiple sclerosis, treatment with ocrelizumab led to significant improvements in health-related quality of life (HRQOL) after 12 months, particularly in mental health domains.

The improvements were measured using patient-reported outcome tools, showing enhanced scores in areas like vitality, emotional health, and reduced anxiety, indicating that ocrelizumab not only affects physical symptoms but also positively impacts mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis. Glanz, BI., Zurawski, J., Casady, EC., et al.[2022]

In a study of 1104 multiple sclerosis patients treated with ocrelizumab over a median follow-up of 1.3 years, 94.5% were free of MRI activity, indicating strong effectiveness in stabilizing the disease.

Ocrelizumab was generally well tolerated, with only 10% of patients reporting side effects, primarily infusion-related reactions and infections, aligning with safety profiles observed in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab treatment in multiple sclerosis: A Danish population-based cohort study. Pontieri, L., Blinkenberg, M., Bramow, S., et al.[2022]

In a post hoc analysis of pivotal trials, ocrelizumab significantly reduced the risk of confirmed disability progression in multiple sclerosis patients with higher baseline disability (Expanded Disability Status Scale scores ≥4.0).

The analysis included patients from the OPERA trials (relapsing MS) and ORATORIO trial (primary progressive MS), showing that ocrelizumab was more effective than interferon β-1a and placebo in slowing disability progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability. Wolinsky, JS., Engmann, NJ., Pei, J., et al.[2022]

Ocrelizumab is the first drug approved by the European Medicines Agency for treating both early primary progressive multiple sclerosis and relapsing forms of multiple sclerosis, highlighting its significance in MS treatment.

The review discusses the safety and effectiveness of ocrelizumab, indicating it has undergone rigorous evaluation to support its use in adults with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis. [2018]

Ocrelizumab is the first approved treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS), demonstrating significant efficacy in slowing disability progression in PPMS patients at 12 and 24 weeks.

The safety profile of ocrelizumab aligns with findings from clinical trials, showing no unexpected safety concerns, which supports its use in managing multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: its efficacy and safety in multiple sclerosis. Juanatey, A., Blanco-Garcia, L., Tellez, N.[2019]

Citations

1. ocrevus-hcp.com ocrevus-hcp.com/ocrevus/efficacy.html

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- ...

2. gene.com gene.com/media/press-releases/15078/2025-09-23/genentech-presents-new-data-for-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 ...

3. ocrevus.com ocrevus.com/patient/ocrevus-101/primary-progressive-multiple-sclerosis.html

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.

4. roche.com roche.com/media/releases/med-cor-2025-09-24

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 ...

5. rarediseaseadvisor.com rarediseaseadvisor.com/therapies/ocrevus-ocrelizumab/

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/ocrevus-zunovo/safety.html

Safety | OCREVUS ZUNOVO® (ocrelizumab & hyaluronidase ... In the PPMS trial, 70% of OCREVUS-treated patients experienced one or more infections compared to 68% of patients on placebo. OCREVUS was not associated with an ...

7. roche.com roche.com/media/releases/med-cor-2024-09-16

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 ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761371s000lbl.pdf

Ocrevus Zunovo - accessdata.fda.gov OCREVUS ZUNOVO can cause injection reactions, which can be local or systemic. Common symptoms of local injection reactions reported by patients treated with ...

9. ocrevus-hcp.com ocrevus-hcp.com/content/dam/gene/ocrevus-hcp/pdfs/ocrevus-zunovo-core-data-brochure.pdf

OCREVUS ZUNOVO Core Data Brochure Select Important Safety Information. The warnings and precautions for ocrelizumab are infusion reactions (OCREVUS) or injection reactions (OCREVUS ZUNOVO).