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Monoclonal Antibodies

High-Dose Ocrelizumab for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expanded disability status scale (EDSS) score from 0 to 5.5 inclusive at screening and baseline
Diagnosis of relapsing multiple sclerosis (RMS) in accordance with the revised McDonald Criteria 2017
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 4.3 years
Awards & highlights

Study Summary

This trial is testing a higher dose of ocrelizumab, given every 24 weeks, to see if it is more effective than the current 600 mg dose, in people with RMS. The trial will also look at safety and how the body processes the drug.

Who is the study for?
Adults with Relapsing Multiple Sclerosis (RMS) who've had at least one or two relapses in the past year or two, have an EDSS score of 0-5.5, and stable neurological condition for 30 days before the trial. Women must use contraception if of childbearing potential. Exclusions include those with certain immunodeficiencies, recent drug abuse, cancer history within 10 years, or previous treatments that could interfere with results.Check my eligibility
What is being tested?
The study is testing a higher dose of Ocrelizumab given every 24 weeks to see if it's more effective than the approved lower dose for RMS treatment. It's randomized and double-blind, meaning neither participants nor researchers know who gets which dose until after the trial ends.See study design
What are the potential side effects?
Ocrelizumab may cause infusion reactions like rash or fever; infections due to weakened immune response; and potentially serious brain infection called PML. Methylprednisolone can increase blood sugar levels and cause mood swings while antihistamines might lead to drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability level is moderate or less.
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I have been diagnosed with relapsing multiple sclerosis.
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I've had at least 2 relapses in the last 2 years or 1 in the last year with none in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 4.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 4.3 years 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 Onset of 12-week cCDP (cCDP12)
Secondary outcome measures
Brain
B-cell levels in blood
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ocrelizumab Higher DoseExperimental Treatment3 Interventions
Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Group II: Ocrelizumab Approved DoseActive Control3 Interventions
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 3
~5730
Methylprednisolone
2015
Completed Phase 4
~2280
Antihistamine
2016
Completed Phase 3
~220

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,268 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,165 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
887,696 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,492 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04544436 — Phase 3
Multiple Sclerosis Research Study Groups: Ocrelizumab Approved Dose, Ocrelizumab Higher Dose
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04544436 — Phase 3
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544436 — Phase 3

Frequently Asked Questions

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

Is this clinical trial open to people who are less than 25 years old?

"In order to take part in this study, potential trial participants must fall within the age bracket of 18 to 55 years old. There are 78 other trials for those under 18 and 540 for seniors above 65."

Answered by AI

Could you please tell me if Ocrelizumab has been used in other research studies?

"The first clinical trial for ocrelizumab was completed in 2003 at Penn State Hershey Cancer Institute. As of now, a total of 313 have been completed with 180 more ongoing. There is a high concentration of these active trials taking place in Alexandria, Louisiana."

Answered by AI

Are there still patients being accepted for this research project?

"Yes, this is an active recruitment clinical trial that was first posted on 11/26/2020. The most recent update was on 11/8/2022 and the study is looking for 786 participants total from 11 different locations."

Answered by AI

Who does this trial require as participants?

"This study is recruiting 786 patients with multiple sclerosis who are between the ages of 18 and 55. Patients must also meet the following criteria: they must be neurologically stable for at least 30 days prior to being randomized into the study, they must have had at least two documented clinical relapses in the last 2 years or one relapse in the year prior to screening, they cannot have had a relapse in the 30 days prior to screening or at baseline, they cannot have started any new symptomatic treatment for MS or physiotherapy within 4 weeks of being randomized, their average T25FWT score over two trials at screening and over two"

Answered by AI

How many sites are running this clinical trial?

"Currently, 11 clinical trial sites are running this study. Some notable locations include The NeuroMedical Clinic of Central Louisiana in Alexandria, Stanford University Medical Center and Stanford Neuroscience Health Center in Cullman, and North Central Neurology Associates in Cullman."

Answered by AI

How many subjects are enrolling in this experiment?

"That is correct. The clinicaltrials.gov website has the most recent information on this study, which was posted on November 26th, 2020 and updated on November 8th, 2020. This study is looking to recruit 786 patients from 11 different locations."

Answered by AI

What is the official government stance on Ocrelizumab?

"There is both efficacy and safety data available for Ocrelizumab from Phase 3 clinical trials, thus it receives a score of 3."

Answered by AI

For what medical purpose is Ocrelizumab most often given to patients?

"Ocrelizumab is the standard care medication for treating ophthalmia, sympathetic. Additionally, it can also help manage scalp structure, temporal arteritis, and lupus erythematosus."

Answered by AI
~144 spots leftby Dec 2024