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Monoclonal Antibodies

Ocrelizumab for Relapsing Multiple Sclerosis

Q: What is the enrollment size for this research project?

Sadly, this trial is no longer welcoming applicants. Initially posted on April 1st 2019 and last amended on May 11th 2022, the research project has now ended recruitment. For those seeking other trials related to <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, 549 studies are actively enrolling patients while 29 clinical projects require volunteers for Ocrelizumab treatments.

Q: Are recruitment efforts being conducted for this trial currently?

Evidently, this medical study is not currently enrolling; its initial post date was April 1st 2019 and the most recent update happened on May 11th 2022. Fortunately, 578 other trials are actively recruiting participants.

Q: What threats should be considered when administering Ocrelizumab?

Our experts at Power have determined that ocrelizumab is safe, resulting in a score of 3 on the safety scale. This judgement was reached due to this drug being approved and entering Phase 4 trials.

Q: Does this research trial accommodate persons aged 45 or older?

This medical experiment requires that candidates between 18 and 99 years of age apply. There are 45 specialised trials available for people younger than 18, while 402 options exist to treat conditions affecting individuals over the age of 65.

Q: Might I gain admittance to this clinical experiment?

This medical trial is recruiting 10 individuals between 18 and 99 years old who are suffering from <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>. The inclusion criteria require that the participants be naive to disease modifying treatments, have an EDSS score of 3 or lower at screening, and if they have been exposed to natalizumab, fingolimod, dimethyl fumarate or teriflunomide in the past three months must not currently be taking it.

Q: Is this a groundbreaking research endeavor?

At this moment, Ocrelizumab is being tested in 29 trials held across 321 cities and 60 countries. The initial trial for this drug was funded by Genentech, Inc. back in 2008 with 220 participants; since then 10 more studies have been completed.

Phase 4

Waitlist Available

Led By Bardia Nourbakhsh, MD, MAS

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

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

Age 18 years and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months, up to 30 months

Awards & highlights

Study Summary

This trial is testing whether a short course of treatment with a B-cell depleting antibody can have long-term effects in people with relapsing multiple sclerosis, and whether this is associated with normalization of a B-cell tolerance defect.

Who is the study for?

This trial is for adults over 18 with relapsing-remitting multiple sclerosis (RRMS) who meet specific diagnostic criteria, have not used certain MS medications recently, and show at least two recent brain or spinal lesions. They must not have a history of B-cell depleting therapy or other excluded treatments, no serious medical conditions, and agree to contraception if applicable.Check my eligibility

What is being tested?

The study tests whether short-term treatment with the drug Ocrelizumab can provide long-lasting relief from MS without continuous medication. Participants will receive two courses of Ocrelizumab and be monitored clinically and through MRI scans for over two years to see if their disease activity returns.See study design

What are the potential side effects?

Ocrelizumab may cause side effects such as infusion reactions, infections due to weakened immune response (including respiratory tract infections), skin reactions, lower blood cell counts increasing bleeding/infection risk, and potential reactivation of hepatitis B in carriers.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am 18 years old or older.

Select...

I have been diagnosed with relapsing-remitting MS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months, up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months, up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months, up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to return of disease activity after the third month post-first-infusion

Secondary outcome measures

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

Quality of life measure as assessed by Neuro-QoL Computer Adaptive Test (CAT)

Trial Design

1Treatment groups

Experimental Treatment

Group I: OcrelizumabExperimental Treatment1 Intervention

All participants will receive Ocrelizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 3

~5730

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Multiple Sclerosis SocietyOTHER

95 Previous Clinical Trials

9,473 Total Patients Enrolled

93 Trials studying Multiple Sclerosis

9,119 Patients Enrolled for Multiple Sclerosis

Johns Hopkins UniversityLead Sponsor

2,259 Previous Clinical Trials

14,820,643 Total Patients Enrolled

30 Trials studying Multiple Sclerosis

2,627 Patients Enrolled for Multiple Sclerosis

Bardia Nourbakhsh, MD, MASPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

18 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

18 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03853746 — Phase 4

Multiple Sclerosis Research Study Groups: Ocrelizumab

Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT03853746 — Phase 4

Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03853746 — Phase 4

Frequently Asked Questions

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

What is the enrollment size for this research project?

"Sadly, this trial is no longer welcoming applicants. Initially posted on April 1st 2019 and last amended on May 11th 2022, the research project has now ended recruitment. For those seeking other trials related to multiple sclerosis, 549 studies are actively enrolling patients while 29 clinical projects require volunteers for Ocrelizumab treatments."

Answered by AI

Are recruitment efforts being conducted for this trial currently?

"Evidently, this medical study is not currently enrolling; its initial post date was April 1st 2019 and the most recent update happened on May 11th 2022. Fortunately, 578 other trials are actively recruiting participants."

Answered by AI

What threats should be considered when administering Ocrelizumab?

"Our experts at Power have determined that ocrelizumab is safe, resulting in a score of 3 on the safety scale. This judgement was reached due to this drug being approved and entering Phase 4 trials."

Answered by AI

Does this research trial accommodate persons aged 45 or older?

"This medical experiment requires that candidates between 18 and 99 years of age apply. There are 45 specialised trials available for people younger than 18, while 402 options exist to treat conditions affecting individuals over the age of 65."

Answered by AI

Might I gain admittance to this clinical experiment?

"This medical trial is recruiting 10 individuals between 18 and 99 years old who are suffering from multiple sclerosis. The inclusion criteria require that the participants be naive to disease modifying treatments, have an EDSS score of 3 or lower at screening, and if they have been exposed to natalizumab, fingolimod, dimethyl fumarate or teriflunomide in the past three months must not currently be taking it."

Answered by AI

Is this a groundbreaking research endeavor?

"At this moment, Ocrelizumab is being tested in 29 trials held across 321 cities and 60 countries. The initial trial for this drug was funded by Genentech, Inc. back in 2008 with 220 participants; since then 10 more studies have been completed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Short-term B-cell Depletion in Relapsing Multiple Sclerosis

2019. "Short-term B-cell Depletion in Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03853746.

All > Amyotrophic Lateral Sclerosis > Multiple Sclerosis