Ocrelizumab for Multiple Sclerosis

(ML45855 Trial)

Overseen By Anza Memon, M.D, FAAN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anza Memon

Must be taking: Ocrelizumab

Must not be taking: Other MS therapies, Corticosteroids

Disqualifiers: Psychiatric conditions, Cognitive impairment, Neurological disorders, Substance abuse, others

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

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of ocrelizumab on fatigue and cognitive skills, such as memory and attention, in veterans with multiple sclerosis (MS). The researchers aim to determine how long-term use of this treatment influences daily life and thinking abilities. Participants will undergo various assessments over a year to track changes in these areas. Individuals may qualify if they have been diagnosed with MS, have used ocrelizumab for at least a year, and experience issues with fatigue or cognition. As an unphased trial, this study offers a unique opportunity to contribute to understanding how ocrelizumab affects daily life and cognition in veterans with MS.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on ocrelizumab therapy for at least 1 year and not be on any other disease-modifying therapies for MS. If you are taking other medications for MS, you would need to stop those before joining the trial.

Is there any evidence suggesting that ocrelizumab is likely to be safe for humans?

Research shows that ocrelizumab, the treatment under study, has been safely used for people with multiple sclerosis. In earlier studies, the most common side effect was reactions at the injection site, occurring in about 49% of patients. These reactions can include itching, rash, or swelling at the injection site. Other studies found unwanted effects at a rate of about 230 events per 100 person-years. More serious unwanted effects were less common, occurring at about 8 per 100 person-years.

Ocrelizumab has been used for up to 7 years in some patients, and the safety information has remained consistent. While side effects can occur, the treatment is generally considered well-tolerated. It's important to remember that everyone's experience can differ, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ocrelizumab is unique because it specifically targets CD20-positive B cells, a type of immune cell involved in the abnormal immune response seen in multiple sclerosis (MS). Most treatments for MS, like interferons and glatiramer acetate, aim to modulate the immune system more broadly, whereas ocrelizumab offers a targeted approach. Researchers are excited about this treatment because it has shown potential in reducing the frequency of MS flare-ups and slowing disease progression, potentially offering a more effective and focused option for patients with MS.

What evidence suggests that ocrelizumab might be an effective treatment for multiple sclerosis?

Research has shown that ocrelizumab can effectively reduce symptoms and improve nerve function in people with multiple sclerosis, particularly those with relapsing forms. Studies have found that ocrelizumab helps control flare-ups and slow the progression of symptoms over several years. For example, after five years of treatment, patients with relapsing MS experienced fewer instances of worsening symptoms. Additionally, after ten years, most patients did not face severe disability or need a walking aid. This evidence suggests that ocrelizumab has strong potential to help manage multiple sclerosis symptoms over the long term. Participants in this trial will receive ocrelizumab to further evaluate its effectiveness in managing multiple sclerosis. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for veterans with multiple sclerosis who have been receiving Ocrelizumab therapy. Participants will be assessed for changes in fatigue and cognition over time.

Inclusion Criteria

I am between 18 and 75 years old.

I have been diagnosed with Multiple Sclerosis.

My disability score is between 0 and 7.5.

Exclusion Criteria

Uncorrected vision or hearing impairments interfering with cognitive testing

Currently enrolled in other interventional clinical trials affecting cognitive or fatigue outcomes

Patients without a confirmed diagnosis of MS based on McDonald 2017 Criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial cognitive and fatigue assessments using BICAMS and MFIS

1 day

1 visit (in-person)

Ongoing Treatment

Participants continue their ongoing Ocrelizumab therapy

12 months

3 visits (in-person) at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for changes in fatigue and cognition over 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview The study measures the long-term effects of Ocrelizumab on fatigue and cognitive functions in MS patients, using cognitive scales, clinical evaluations, and patient-reported outcomes at baseline, 6 months, and 12 months.

How Is the Trial Designed?

Group I: Ocrelizumab Arm Experimental Treatment 1 Intervention

This is a prospective, interventional study involving 30 subjects who have been diagnosed with multiple sclerosis and being treated with Ocrelizumab for at least one year.

Who Is Running the Clinical Trial?

Anza Memon

Lead Sponsor

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39860559/

Effectiveness of Ocrelizumab on Disease Progression and ... Conclusions: Ocrelizumab effectively reduced disease activity and improved neurological disability over two years in both RRMS and SPMS patients ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X25001947

Ocrelizumab as first-line therapy in highly active relapsing ... As a first-line treatment of highly active RRMS, ocrelizumab demonstrated significant efficacy and very good tolerability.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11406495/

Five-year efficacy outcomes of ocrelizumab in relapsing ... OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period.

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

Efficacy | OCREVUS® (ocrelizumab) Long-term reduction in 48-week confirmed disability progression after 5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis. Presented ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000205584

10 Years of Ocrelizumab Treatment in Multiple Sclerosis After 10 years, over three-quarters (76.6%) of pwRMS on OCR-OCR were free from 48W-CDP-EDSS events and 91.9% did not need a walking aid.

6. ocrevus-hcp.com ocrevus-hcp.com/ocrevus/safety.html

Safety | OCREVUS® (ocrelizumab) The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8548959/

Safety of Ocrelizumab in Patients With Relapsing and ... To report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221103482300809X

Safety of Ocrelizumab in Multiple Sclerosis: Updated ... Reported rates per 100 PY (95% CI) were: Adverse events (AEs), 230.32 (228.55–232.09); infections, 71.24 (70.26–72.23); serious AEs, 7.97 (7.64–8.30); serious ...

9. genentech-medinfo.com genentech-medinfo.com/our-products/neuroscience/ocrevus.html

Ocrelizumab | Genentech Prescribing & Product Information The Prescribing Information is the primary source of information on the known and potential risks of ocrelizumab for relapsing forms of multiple sclerosis (RMS)

10. mscare.org mscare.org/new-ocrevus-ocrelizumab-data-demonstrate-reductions-in-activity-progression-in-rms/

New Ocrevus (Ocrelizumab) data demonstrate reductions ... New safety data remain consistent with OCREVUS' favorable benefit-risk profile in both relapsing and primary progressive multiple sclerosis (PPMS). “The OCREVUS ...