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Monoclonal Antibodies

Ocrelizumab for Multiple Sclerosis

Q: Does my profile meet the criteria for participating in this research?

To be considered for admission to this medical trial, participants must have been diagnosed with <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> (MS) and present in an acute relapse. The age limit is between 18 and 99 years old, and the team behind the study hopes to recruit up 10 patients.

Q: Is the age range for this trial inclusive of those above sixty?

This trial is open to <a href="https://www.withpower.com/clinical-trials/all">all</a> adults aged 18 and under 99.

Q: Does this endeavor set a precedent for future trials?

Exploration of this therapeutic intervention has been ongoing for over a decade. Genentech, Inc sponsored the initial clinical trial in 2008 with 220 participants and, following successful results, it was granted Phase 2 drug approval. Currently, 29 studies are being conducted across 321 cities and 60 nations.

Q: Has this therapy been granted regulatory clearance by the FDA?

This treatment has been approved, so it was given a safety score of 3 on the Power team's rating system.

Q: Does this research require any additional participants at the moment?

At this time, recruitment is not open for the trial initially posted on August 1st 2020 and last updated on May 11th 2022. However, if you are looking for further studies related to <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> or acute relapsing treatments, 549 clinical trials presently seek patients. 29 of these trials require immediate enrollment.

Q: What is the enrollment size of this research endeavor?

This study has completed patient recruitment and is no longer seeking participants. The trial was initiated on the 8th of August 2020 before being concluded, with its last iteration posted on May 11th 2022. For those still looking for other clinical studies, 549 trials related to <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> acute relapsing are actively recruiting patients; additionally there are 29 more specifically related to this treatment also enrolling volunteers.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 18-24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with relapsing-remitting MS.

Select...

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

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

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

Primary outcome measures

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 outcome measures

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

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 3

~5730

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,770 Total Patients Enrolled

30 Trials studying Multiple Sclerosis

2,627 Patients Enrolled for Multiple Sclerosis

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,679 Total Patients Enrolled

26 Trials studying Multiple Sclerosis

4,738 Patients Enrolled for Multiple Sclerosis

Bardia NourbakhshPrincipal InvestigatorJohns Hopkins University

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04261790 — Phase 4

Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04261790 — Phase 4

Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04261790 — Phase 4

Multiple Sclerosis Research Study Groups: Ocrelizumab

Frequently Asked Questions

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

Does my profile meet the criteria for participating in this research?

"To be considered for admission to this medical trial, participants must have been diagnosed with multiple sclerosis (MS) and present in an acute relapse. The age limit is between 18 and 99 years old, and the team behind the study hopes to recruit up 10 patients."

Answered by AI

Is the age range for this trial inclusive of those above sixty?

"This trial is open to all adults aged 18 and under 99."

Answered by AI

Does this endeavor set a precedent for future trials?

"Exploration of this therapeutic intervention has been ongoing for over a decade. Genentech, Inc sponsored the initial clinical trial in 2008 with 220 participants and, following successful results, it was granted Phase 2 drug approval. Currently, 29 studies are being conducted across 321 cities and 60 nations."

Answered by AI

Has this therapy been granted regulatory clearance by the FDA?

"This treatment has been approved, so it was given a safety score of 3 on the Power team's rating system."

Answered by AI

Does this research require any additional participants at the moment?

"At this time, recruitment is not open for the trial initially posted on August 1st 2020 and last updated on May 11th 2022. However, if you are looking for further studies related to multiple sclerosis or acute relapsing treatments, 549 clinical trials presently seek patients. 29 of these trials require immediate enrollment."

Answered by AI

What is the enrollment size of this research endeavor?

"This study has completed patient recruitment and is no longer seeking participants. The trial was initiated on the 8th of August 2020 before being concluded, with its last iteration posted on May 11th 2022. For those still looking for other clinical studies, 549 trials related to multiple sclerosis acute relapsing are actively recruiting patients; additionally there are 29 more specifically related to this treatment also enrolling volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis

2020. "Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04261790.

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