Ocrevus for Multiple Sclerosis

(MOBILE-RMS Trial)

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test if people with relapsing multiple sclerosis (RMS) can improve ambulatory functions after one-year treatment with Ocrevus in comparison with other Disease Modifying Treatments (DMT). Sixty qualified individuals with RMS will be evenly assigned into two groups: Ocrevus and other DMT. Each group will receive the respective treatment following the FDA regulations over the one-year course. Their ambulatory functions will be assessed five times three months apart. In addition, they will receive brain MRI scans three times six months apart. Their ambulatory functions and MRI measurements will be compared between groups over time to fulfill the purposes of this study.

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 data supports the effectiveness of the drug Ocrevus for treating multiple sclerosis?

Ocrevus (ocrelizumab) has been shown to reduce disease progression in multiple sclerosis, particularly in patients with increased disability. In clinical trials, it significantly reduced relapse rates and slowed disability progression compared to other treatments, making it an effective option for both relapsing and primary progressive forms of the disease. ^{1 2 3 4 5}

Is Ocrevus (Ocrelizumab) safe for humans?

Ocrevus (Ocrelizumab) has been studied for safety in treating multiple sclerosis, with systematic reviews and real-world studies evaluating its adverse events. It is approved by health agencies in the US and Europe, indicating a recognized safety profile for its intended use. ^{1 4 6 7 8}

What makes the drug Ocrevus unique for treating multiple sclerosis?

Ocrevus is unique because it is the first drug approved for both relapsing and primary progressive forms of multiple sclerosis, offering a high-efficacy treatment option with convenient twice-yearly infusions. It works by targeting and depleting B cells, which are involved in the disease process of multiple sclerosis. ^{1 3 7 9 10}

Research Team

Feng Yang, PhD

Principal Investigator

Georgia State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Ocrelizumab: its efficacy and safety in multiple sclerosis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Ocrelizumab treatment in multiple sclerosis: A Danish population-based cohort study. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

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