← Back to Search

Monoclonal Antibodies

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 4
Awards & highlights

Study Summary

This trial is studying ocrelizumab to see if it is effective and safe in treating patients with early stage RRMS. The study will last for 192 weeks and have a follow-up period of at least 48 weeks. There is also an optional shorter infusion substudy which will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants.

Eligible Conditions
  • Multiple Sclerosis, Relapsing-Remitting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized Relapse Rate
Mean Change From Baseline in EDSS Score at Week 120
Mean Change From Baseline in EDSS Score at Week 144
+20 more
Secondary outcome measures
Change From Baseline in Brain Volume as Detected by Brain MRI
Change from Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score
Change from Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score
+19 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Substudy Group 2Experimental Treatment1 Intervention
At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration
Group II: OcrelizumabExperimental Treatment1 Intervention
Ocrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period.
Group III: Substudy Group 1Active Control1 Intervention
At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration
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?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,087,829 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
23,790 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
887,209 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
17,117 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

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

Who would this clinical trial be most appropriate for?

"This study is looking for 1225 people with multiple sclerosis who meet the following criteria: - between 18 and 55 years old- have had at least one relapse or one sign of MRI activity in the past 12 months- have a definite diagnosis of RRMS according to the revised McDonald 2010 criteria- disease duration of less than or equal to 3 years- EDSS score of 0.0 to 3.5 inclusive at screening- willing to use an acceptable birth control method during treatment and for at least 6 months after the last dose of study drug"

Answered by AI

To your knowledge, has a study like this been conducted before?

"As of now, there are 29 ongoing clinical trials for Ocrelizumab in 60 different countries. The first trial was held back in 2008 and sponsored by Genentech, Inc. A total of 220 patients participated in the Phase 2 drug approval stage of the trial. In the years since 2008, 10 more trials have been completed."

Answered by AI

Are people currently signing up for this experiment?

"Yes, this information is available on clinicaltrials.gov. According to the website, the trial was posted on March 24th, 2017 and was last edited on November 14th, 2022."

Answered by AI

Does this trial cater to minors, or is the age limit for participants 18 and up?

"The age bracket for recruitment in this trial are patients that are aged 18 or older, but younger than 55."

Answered by AI

Are there any Ocrelizumab-related dangers that patients should be aware of?

"Ocrelizumab has undergone multiple rounds of clinical trials, with some data supporting efficacy. Therefore, it received a safety score of 3."

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?
Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Neurology - Neuroimmunology NeuroinflammationJournal
Ocrelizumab Shorter Infusion
Hartung, Hans-Peter. 2020. “Ocrelizumab Shorter Infusion”. Neurology - Neuroimmunology Neuroinflammation. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/nxi.0000000000000807.
clinicaltrials.govStudy
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
2017. "Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03085810.
~155 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top