← Back to Search

Monoclonal Antibodies

Ocrelizumab for Relapsing Multiple Sclerosis

Phase 4
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Study Summary

This trial is testing a new MS drug in black and Latino patients to see if it's effective and safe. Around 150 people will be enrolled, and half of them will also have their spinal fluid tested.

Who is the study for?
This study is for Black or African American and Hispanic/Latino individuals with relapsing multiple sclerosis (RMS). They should have an EDSS score of 0-5.5, be stable neurologically for at least 30 days, and women must use contraception or abstain from sex. It's not for those with progressive MS without recent relapses, pregnant women, or those with other neurological disorders.Check my eligibility
What is being tested?
The trial is testing Ocrelizumab in minority patients to see how it affects disease activity and biomarkers related to nerve damage. This single-arm study will enroll about 150 participants who are either new to treatment or switching from certain therapies.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions, infections due to a weakened immune system, potential risk of cancers like breast cancer, skin reactions at the injection site, and possibly increased risk of heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have RMS and can still walk without aid or rest for 200 meters.
Select...
I am starting or have switched once or twice from specific MS treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
Secondary outcome measures
Annualized relapse rate at week 48
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
Time to protocol-defined event

Trial Design

1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment1 Intervention
Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 3
~5730

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,510 Total Patients Enrolled
26 Trials studying Multiple Sclerosis
4,569 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,323 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,177 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04377555 — Phase 4
Multiple Sclerosis Research Study Groups: All Participants
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04377555 — Phase 4
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04377555 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Ocrelizumab deemed a secure treatment for patients?

"Due to its approval status, Ocrelizumab's safety is rated a 3 on our evaluation scale. This rating indicates that the drug has completed Phase 4 of clinical trials."

Answered by AI

Does this experiment currently accept enrollment of participants?

"Clinicaltrials.gov states that this research trial is currently not enrolling any new participants; it was uploaded on July 30th 2020 and edited september 12th 2022, but there are 578 other trials in progress at the moment."

Answered by AI

Who has the opportunity to participate in this research endeavor?

"This clinical trial is looking to enrol 150 individuals suffering from multiple sclerosis, between the ages of 18 and 65. Additionally, eligible candidates must self-identify as Black or African American or Hispanic/Latino American; have a diagnosis of RMS with an EDSS score no higher than 5.5 at enrollment; be new to treatment (or switching away from certain disease modifying therapies); and remain neurologically stable for 30 days before randomization and baseline assessments. Moreover, female participants must agree to avoid sexual intercourse or utilize accepted contraceptive methods during the study period plus 6 months following their final dose of ocrelizumab if they"

Answered by AI

Does this medical research include participants aged eighty or above?

"As indicated by the requirements for inclusion, study participants must fall within an age range of 18 to 65 years. Alternatively, there are 45 studies that target minors and a further 402 trials designed specifically for people over the age of 65."

Answered by AI

Is this experimental procedure a pioneering venture?

"Ocrelizumab was first tested in 2008 under the sponsorship of Genentech, Inc. which included 220 participants. This initial trial resulted in Phase 2 approval for Ocrelizumab and today there are 29 live studies taking place over 321 cities and 60 countries worldwide."

Answered by AI

What additional investigations have been conducted involving Ocrelizumab?

"Ocrelizumab was first studied in 2008 at CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge and has since been a subject of 10 completed clinical trials. Presently, 29 distinct studies are actively enrolment patients with numerous locations situated within the Dallas area of Texas."

Answered by AI

How many healthcare facilities have been enlisted for this trial's implementation?

"This clinical trial has 34 recruitment sites, such as the MS Treatment Center of Dallas in Dallas, Guilford Neurologic Associates in Greensboro, and Center for Neurology and Spine - Phoenix - Hunt - PPDS in Phoenix."

Answered by AI

How extensive is the enrollment for this research project?

"Regrettably, this particular study is not actively seeking participants at the moment. It was initially registered on July 30th 2020 and further modified as recently as September 12th 2022. If you are interested in engaging with other clinical trials, there are 549 medical studies for multiple sclerosis and 29 investigations utilising Ocrelizumab that currently require patient recruitment."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medical College
SUNY Upstate Medical University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

~56 spots leftby Dec 2025