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Monoclonal Antibodies

RR-MS for Multiple Sclerosis (OCREFINA Trial)

Phase 4
Waitlist Available
Led By Joseph Sabatino, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Ability to provide written informed consent and be compliant with the study protocol
* The treating neurologist's independent medical assessment and decision to initiate the patient on ocrelizumab treatment as most appropriate standard of care for the patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph nodes, which are important sites of B cell activation. This study is being conducted to determine to what extent B cells are targeted in lymph nodes following ocrelizumab treatment, which may have important consequences for long-term MS outcomes.

Who is the study for?
This trial is for individuals with Multiple Sclerosis (MS). Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of MS and meet certain health requirements.
What is being tested?
The study tests the effects of Ocrelizumab, a medication that targets B cells, on immune cells within lymph nodes in people with MS. It aims to understand how well B cells are eliminated from these areas after treatment.
What are the potential side effects?
While specific side effects for this trial aren't listed, Ocrelizumab can generally cause infusion reactions, infections due to weakened immune response, and potential risk of malignancies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lymphocyte analysis

Trial Design

1Treatment groups
Experimental Treatment
Group I: RR-MSExperimental Treatment1 Intervention
Two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 4
~7250

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,548 Previous Clinical Trials
15,264,446 Total Patients Enrolled
24 Trials studying Multiple Sclerosis
2,530 Patients Enrolled for Multiple Sclerosis
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,452 Total Patients Enrolled
27 Trials studying Multiple Sclerosis
4,747 Patients Enrolled for Multiple Sclerosis
Joseph Sabatino, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
~3 spots leftby Jun 2025
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