← Back to Search

Monoclonal Antibodies

Ocrelizumab for Relapsing-Remitting Multiple Sclerosis

Phase 2

Waitlist Available

Research Sponsored by Genentech, Inc.

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 week 12 to week 24

Awards & highlights

Study Summary

This trial is testing two doses of a new drug, ocrelizumab, to see if it can help people with RRMS by reducing the number of brain lesions.

Who is the study for?

This trial is for adults aged 18-55 with Relapsing-Remitting Multiple Sclerosis (RRMS). Participants must be able to consent, follow the study schedule, and use reliable contraception if of reproductive potential. Excluded are those with progressive MS, MRI incompatibility, severe diseases, recent serious infections or hospitalizations, cancer history (with some exceptions), drug abuse history, immunodeficiency disorders, coagulation disorders or previous treatments that could interfere.Check my eligibility

What is being tested?

The study tests two doses of Ocrelizumab against a placebo and Avonex to see which is better at reducing brain MRI lesions in RRMS patients. It's a phase II trial where participants are randomly assigned to one of these treatments in different groups while researchers partially know who gets what.See study design

What are the potential side effects?

Ocrelizumab may cause infusion reactions like rash or fever; infections due to immune system effects; and possibly other side effects similar to Avonex such as flu-like symptoms. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain

Secondary outcome measures

Annualized Protocol Defined Relapse Rate at Week 24

Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24

Percentage of Participants Who Remained Relapse Free at Week 24

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Ocrelizumab 600 mgExperimental Treatment1 Intervention

Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

Group II: Ocrelizumab 1000 mgExperimental Treatment1 Intervention

Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.

Group III: AvonexActive Control1 Intervention

Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

Group IV: PlaceboPlacebo Group1 Intervention

Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.

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?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

567,469 Total Patients Enrolled

26 Trials studying Multiple Sclerosis

4,528 Patients Enrolled for Multiple Sclerosis

Roche Pharma AGIndustry Sponsor

408 Previous Clinical Trials

395,576 Total Patients Enrolled

9 Trials studying Multiple Sclerosis

750 Patients Enrolled for Multiple Sclerosis

Clinical TrialsStudy DirectorGenentech, Inc.

2,199 Previous Clinical Trials

888,282 Total Patients Enrolled

35 Trials studying Multiple Sclerosis

18,136 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00676715 — Phase 2

Multiple Sclerosis Research Study Groups: Placebo, Ocrelizumab 600 mg, Ocrelizumab 1000 mg, Avonex

Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT00676715 — Phase 2

Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00676715 — Phase 2

Frequently Asked Questions

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

Has Ocrelizumab been sanctioned by the U.S. Food and Drug Administration?

"There is evidence of safety for Ocrelizumab, so it was assigned a score 2. Despite data being available on the drug's security profile, no studies have been conducted to verify its efficacy."

Answered by AI

Is there an age restriction to partake in this experiment?

"This trial requires that participants be of legal age (18 or older) and no more than 55 years old."

Answered by AI

What precedent has been established with Ocrelizumab research?

"Ocrelizumab was introduced to the scientific community in 2007 by Children's Hospital of Geneva (HUG). Since then, 18520 studies have been completed. At present, 42 active clinical trials are underway; notably a considerable number of these experiments take place out of San Francisco, California."

Answered by AI

What is the current scope of this clinical trial in terms of participating medical facilities?

"A variety of 29 medical sites are participating in this trial, including the University of California San Francisco in San Francisco, Columbia University Medical Center; The Neurological Institute of New york in New York and Legacy Health System; Clinical Research & Tech Ctr. Additionally, many other locations across America are also recruiting patients for this research study."

Answered by AI

How many individuals have participated in this research project thus far?

"Regrettably, this research project is currently not accepting applicants. The trial was first published on July 17th 2008 and last updated October 17th 2022. Alternatively, there are presently 549 clinical trials for patients with multiple sclerosis actively seeking participants as well as 42 studies utilising the drug Ocrelizumab that are open to new enrolment."

Answered by AI

What medical conditions is Ocrelizumab most commonly utilized to address?

"Ocrelizumab is regularly employed to treat a range of conditions including parenteral drug administration therapy, multiple sclerosis, and primary progressive multiple sclerosis through intravenous delivery."

Answered by AI

Who would be an eligible participant in this clinical trial?

"This research effort is seeking 220 individuals experiencing multiple sclerosis and acute relapsing between 18 to 55 years of age. Crucially, the applicant must fall within that specified range in order to be considered for participation."

Answered by AI

Is this experiment presently seeking participants?

"This clinical trial is not currently open for enrollment. It was initially posted in July 2008 and the last update to its information occurred on October 17th 2022. If you are still seeking opportunities, there are 549 trials registered with ClinicalTrials.gov that involve multiple sclerosis and 42 involving ocrelizumab that have openings available."

Answered by AI