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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis

Phase 4

Waitlist Available

Led By Bardia Nourbakhsh

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Diagnosis of relapsing remitting multiple sclerosis (RRMS) based on revised McDonald criteria

Expanded Disability Status Scale (EDSS) score at the time of screening =<3

Must not have

Ever received B-cell depleting antibodies (rituximab, ocrelizumab, ofatumumab), alemtuzumab, daclizumab, mitoxantrone or hematopoietic stem-cell transplant

Contraindication to treatment with an anti- cluster of differentiation antigen 20 (CD20) antibodies, including being seropositive for HBsAg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 18-24 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will help to understand if the efficacy of ocrelizumab in MS is linked to the normalization of central B-cell tolerance. If so, this would have important implications for the development of new therapies for MS.

Who is the study for?

This trial is for people with relapsing-remitting multiple sclerosis (RRMS) who have an EDSS score of 3 or less, are not pregnant, and agree to use effective contraception. They must have recent MRI changes indicative of MS activity but can't join if they're allergic to ocrelizumab, previously used certain MS drugs or treatments, are pregnant/lactating, or have active hepatitis B.

What is being tested?

The study tests Ocrelizumab's effect on B-cell tolerance defects in RRMS patients. It involves treating participants with two courses of the drug and monitoring them clinically and through MRIs for over two years to see how their immune cells behave post-treatment.

What are the potential side effects?

Ocrelizumab may cause infusion reactions like rash or fever, infections due to weakened immunity, potential reactivation of hepatitis B in those previously infected, and possibly other side effects related to its action on B-cells.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with relapsing-remitting MS.

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My disability level is low, with a score of 3 or less.

Exclusion Criteria

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

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I have received treatments that target B-cells or had a stem-cell transplant.

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I cannot receive CD20 antibody treatment due to health reasons.

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I have not taken steroids in the last 30 days.

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I have an active hepatitis B infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 18-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 18-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 18-24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in B-cell subpopulations

Change in frequency of T-cell phenotypes

Change in peripheral B-cell tolerance checkpoints in people with MS before and after ocrelizumab therapy.

+2 more

Secondary study objectives

Change in disability as assessed by Expanded Disability Status Scale (EDSS)

Change in quality of life as assessed by Neuro-QoL

Time to return of disease activity

Awards & Highlights

Drug Has Already Been Approved

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: OcrelizumabExperimental Treatment1 Intervention

Patients will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience the return of the disease activity can go back on the medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~8600

0 / 6Eligibility criteria met