What side effects are associated with this type of intervention?

Ocrelizumab, a monoclonal antibody targeting CD20-positive B cells, is commonly associated with infusion-related reactions, infections, and a potential increased risk of malignancies. Fingolimod, another DMT, can cause headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased susceptibility to infections. Glatiramer acetate, an immunomodulator, may lead to injection site reactions, lipoatrophy, and transient systemic post-injection reactions. These treatments aim to reduce relapse rates and slow disease progression but come with varying side effect profiles that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS), including monoclonal antibodies similar to Ocrelizumab. Ocrelizumab itself is an FDA-approved monoclonal antibody that targets CD20-positive B cells, reducing disease activity in MS. Another similar treatment is Rituximab, which also targets CD20-positive B cells and has been studied for its efficacy in MS. These treatments work by depleting B cells, which are believed to play a role in the autoimmune process of MS. Other FDA-approved monoclonal antibodies for MS include Alemtuzumab, which targets CD52 on immune cells, and Natalizumab, which targets the alpha-4 integrin to prevent immune cells from crossing the blood-brain barrier.

What other types of research exist?

Promising alternatives to Ocrelizumab for Multiple Sclerosis patients include: 1) Ofatumumab, another anti-CD20 monoclonal antibody that has shown efficacy in reducing relapses and MRI lesions in MS. 2) Siponimod, a selective sphingosine-1-phosphate receptor modulator that has demonstrated benefits in secondary progressive MS. 3) Cladribine, an oral immunosuppressive drug that targets lymphocytes and has been effective in reducing relapse rates and disability progression. 4) Alemtuzumab, a monoclonal antibody targeting CD52, which depletes mature lymphocytes and has shown long-term efficacy in reducing MS activity.

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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis (AMS05 Trial)

Phase 4

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Immunization with an Food and Drug Administration (FDA) authorized or licensed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccines)

Be between 18 and 65 years old

Must not have

History of Primary Progressive Multiple Sclerosis (PPMS), Progressive Relapsing Multiple Sclerosis (PRMS), or Secondary Progressive Multiple Sclerosis (SPMS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 0, 6, 12, 18, 24, 30, 36, 42, 48

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if patients with early relapsing multiple sclerosis can stop taking Ocrelizumab after initial treatment without their disease getting worse. Ocrelizumab is a medication given through an IV that helps manage multiple sclerosis by reducing harmful immune cells. The study will monitor patients for new disease activity over several years.

Who is the study for?

This trial is for adults with early Relapsing Multiple Sclerosis (RMS) diagnosed within the last 2 years. Participants must be willing to use effective contraception and have received an FDA-authorized COVID-19 vaccine. Exclusions include pregnancy, certain heart conditions, substance abuse, recent steroid therapy or live vaccines, metal implants affecting MRI scans, other significant diseases or infections like HIV or hepatitis.

What is being tested?

The study tests if it's safe and effective to stop Ocrelizumab (OCR) after initial treatment in RMS patients. It starts with standard OCR doses for a year; then participants are randomly assigned to continue OCR, switch from OCR to placebo at different intervals, or receive placebos only for up to four years.

What are the potential side effects?

Ocrelizumab may cause infusion reactions like rash or fever, infections due to weakened immune response, potential liver issues indicated by blood tests changes. Side effects can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received an FDA-approved COVID-19 vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition is a form of progressive multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 0, 6, 12, 18, 24, 30, 36, 42, 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 0, 6, 12, 18, 24, 30, 36, 42, 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 0, 6, 12, 18, 24, 30, 36, 42, 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absence of clinical relapse

Secondary study objectives

Proportion of participants experiencing infusion related reactions

Proportion of participants who experience at least one Grade 3 or higher adverse event

The change in Expanded Disability Status Scale (EDSS) score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ocrelizumab ArmExperimental Treatment1 Intervention

All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6, 12, 18, and 24. In this arm participants will continue to receive OCR infusions every 6 months through Month 48.

Group II: Placebo ArmPlacebo Group1 Intervention

All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6, 12, 18, and 24. In this arm, starting at Month 30, participants will receive placebo infusions every 6 months through Month 48.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~8600

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ocrelizumab is a monoclonal antibody that targets CD20-positive B cells, which are implicated in the autoimmune response that damages myelin in Multiple Sclerosis (MS). By depleting these B cells, Ocrelizumab reduces inflammation and slows disease progression. Other common treatments include beta interferons and glatiramer acetate, which modulate the immune response to reduce the frequency of relapses and the formation of new lesions. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the central nervous system. These treatments are crucial for MS patients as they help manage symptoms, reduce relapses, and slow the progression of disability, thereby improving quality of life.

Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study.