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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 from baseline to 9 years

Awards & highlights

Study Summary

This trial will study whether ocrelizumab is effective and safe in people with primary progressive multiple sclerosis. People will be randomly assigned to receive either ocrelizumab or a placebo, and the treatment period will last at least 120 weeks.

Eligible Conditions

Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 9 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 Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period

Secondary outcome measures

Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120

Number of Participants With at Least One Adverse Event (AE)

Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PlaceboExperimental Treatment2 Interventions

Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.

Group II: Ocrelizumab 600 mgPlacebo Group1 Intervention

Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 3

~5730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,319 Total Patients Enrolled

34 Trials studying Multiple Sclerosis

24,294 Patients Enrolled for Multiple Sclerosis

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,767 Total Patients Enrolled

35 Trials studying Multiple Sclerosis

17,621 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.

Are people who are older than 25 years of age being recruited for this particular clinical trial?

"Eligibility for this particular clinical trial is restricted to adults aged 18 to 55. There are 44 other trials that welcome participants under 18 and 414 that allow patients that are 65 or older."

Answered by AI

How many people are you looking for in this clinical trial?

"This study is no longer recruiting patients. However, at the time of this writing, 558 trials for patients with multiple sclerosis, primary progressive are actively recruiting, 29 of which specifically for Ocrelizumab."

Answered by AI

Does this research stand alone or has similar work been conducted in the past?

"Since 2008, when the first 220-person trial was sponsored by Roche Pharma AG, ocrelizumab has been the subject of 29 ongoing clinical trials in 321 cities and 60 countries."

Answered by AI

What other studies has Ocrelizumab been involved in?

"Ocrelizumab was first studied in 2008 by researchers at John Hopkins University. In the years since, there have been 18,250 completed clinical trials. As of now, there are 29 clinical trials recruiting patients with many of these trials based in Sacramento, California."

Answered by AI

What is the margin of error for Ocrelizumab?

"Ocrelizumab has been studied in prior clinical trials, so it received a score of 3."

Answered by AI

What are the screening requirements for this experiment?

"The ideal participant for this study on multiple sclerosis is aged 18 to 55, has had primary progressive MS for less than 15 years (10 years if their EDSS is greater than 5.0), and is sexually active. If you fit these criteria and are interested in the study, please note that you must be willing to use two forms of contraception throughout the entirety of the trial and for 48 weeks after the study ends."

Answered by AI

Recent research and studies

Multiple Sclerosis JournalJournal

Ocrelizumab Reduces Progression of Upper Extremity Impairment in Patients with Primary Progressive Multiple Sclerosis: Findings from the Phase III Randomized ORATORIO Trial

Fox, Edward J, Clyde Markowitz, Angela Applebee, Xavier Montalban, Jerry S Wolinsky, Shibeshih Belachew, Damian Fiore, Jinglan Pei, Bruno Musch, and Gavin Giovannoni. 2018. “Ocrelizumab Reduces Progression of Upper Extremity Impairment in Patients with Primary Progressive Multiple Sclerosis: Findings from the Phase III Randomized ORATORIO Trial”. Multiple Sclerosis Journal. SAGE Publications. doi:10.1177/1352458518808189.

New England Journal of MedicineJournal

Ocrelizumab Versus Placebo in Primary Progressive Multiple Sclerosis

Montalban, Xavier, Stephen L. Hauser, Ludwig Kappos, Douglas L. Arnold, Amit Bar-Or, Giancarlo Comi, Jérôme de Seze, et al.. 2017. “Ocrelizumab Versus Placebo in Primary Progressive Multiple Sclerosis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1606468.

The Lancet NeurologyJournal

Long-term Follow-up from the ORATORIO Trial of Ocrelizumab for Primary Progressive Multiple Sclerosis: A Post-hoc Analysis from the Ongoing Open-label Extension of the Randomised, Placebo-controlled, Phase 3 Trial

Wolinsky, Jerry S, Douglas L Arnold, Bruno Brochet, Hans-Peter Hartung, Xavier Montalban, Robert T Naismith, Marianna Manfrini, et al.. 2020. “Long-term Follow-up from the ORATORIO Trial of Ocrelizumab for Primary Progressive Multiple Sclerosis: A Post-hoc Analysis from the Ongoing Open-label Extension of the Randomised, Placebo-controlled, Phase 3 Trial”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(20)30342-2.

Annals of NeurologyJournal