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Interferon

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 pre-infusion at weeks 1, 24, 48, 72; and 30 minutes post-infusion at week 72; at any time during weeks 84 and 96

Awards & highlights

Study Summary

This trial will compare the effects of ocrelizumab to interferon beta-1a in people with relapsing multiple sclerosis. 600 mg of ocrelizumab or matching placebo will be given intravenously on days 1 and 15, then every 24 weeks. Participants will also receive interferon beta-1a injections 3 times per week or matching placebo.

Eligible Conditions

Multiple Sclerosis (MS)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-infusion at weeks 1, 24, 48, 72; and 30 minutes post-infusion at week 72; at any time during weeks 84 and 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-infusion at weeks 1, 24, 48, 72; and 30 minutes post-infusion at week 72; at any time during weeks 84 and 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-infusion at weeks 1, 24, 48, 72; and 30 minutes post-infusion at week 72; at any time during weeks 84 and 96 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 (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period

Secondary outcome measures

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96 In Double Blind Period

Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96 In Double Blind Period

Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC) In Double Blind Period

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OcrelizumabExperimental Treatment2 Interventions

Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.

Group II: Interferon beta-1a 44 mcg SCActive Control2 Interventions

Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 3

~5730

Interferon beta-1a-matching placebo

2011

Completed Phase 3

~1660

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

1,088,219 Total Patients Enrolled

34 Trials studying Multiple Sclerosis

24,194 Patients Enrolled for Multiple Sclerosis

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,667 Total Patients Enrolled

35 Trials studying Multiple Sclerosis

17,521 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 there any other precedent studies that have included Ocrelizumab?

"Ocrelizumab is being trialled in 37 studies, 22 of which are in Phase 3. The global distribution for these studies is 3386 locations, with the majority being in Bordeaux, RS."

Answered by AI

How many test subjects are there in this clinical trial?

"This study is no longer recruiting patients for participation. The original posting date for this trial was September 20th, 2011 and the last edit was made on October 4th, 2022. However, there are 558 other active clinical trials for sclerosis and 37 trials for Ocrelizumab that are currently looking for patients."

Answered by AI

Are researchers still recruiting for this clinical trial?

"This study is not recruiting patients at the moment, according to the information available on clinicaltrials.gov. The trial was first posted on September 20th, 2011 and was last updated on October 4th, 2022. However, if you are looking for other active trials, 558 studies are currently recruiting patients with sclerosis and 37 studies are recruiting patients for Ocrelizumab."

Answered by AI

Does this research involve testing on patients that are over 45 years old?

"This trial includes a criteria that potential participants must be between 18 and 55 years old."

Answered by AI

Are there many different locations conducting this research in the city?

"Patients are currently being enrolled at Raleigh Neurology Associates, Multiple sclerosis Clinic, SUNY at Stony Brook, and an additional 57 clinical sites."

Answered by AI

Is this a brand new clinical trial?

"As of now, 37 clinical trials involving Ocrelizumab are underway in 645 cities and 66 countries. The first study was executed in 2008 by Roche Pharma AG. 220 people were initially enrolled and it completed Phase 2 drug approval. In the 12 years since, 126 trials have finished."

Answered by AI

Am I eligible to be a subject in this research?

"Eligible patients for this sclerosis study must be between 18-55 years old, have had 2 clinical attacks in the last 2 years or 1 attack more than 30 days before screening, demonstrate neurological stability, and have an EDSS score of 0-5.5."

Answered by AI