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Monoclonal Antibodies

Ocrelizumab for Early Multiple Sclerosis (IMPACT MS Trial)

Phase 4

Waitlist Available

Led By Bruce Cree, MD, PhD, MAS

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

High-risk clinically isolated syndrome or relapsing MS Diagnosis (based on 2017 International Panel Criteria)

Age 18-50 inclusive

Must not have

Untreated latent or active tuberculosis

HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will test if ocrelizumab can prevent or delay MS in people who have just been diagnosed.

Who is the study for?

This trial is for adults aged 18-50 newly diagnosed with relapsing MS or high-risk CIS, who haven't received any MS treatments and can start treatment within 90 days of their first symptoms. Participants must not be pregnant, planning pregnancy, or breastfeeding and agree to effective contraception.

What is being tested?

The study tests whether Ocrelizumab given at the onset of MS alters markers in cerebrospinal fluid that indicate chronic inflammation. It's aimed at understanding early intervention impacts on disease progression.

What are the potential side effects?

Ocrelizumab may cause infusion reactions, increase risk of infections including hepatitis B reactivation, possibly lead to a higher risk of cancer, and can cause immune-related side effects such as low immunoglobulin levels.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with high-risk clinically isolated syndrome or relapsing MS.

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I am between 18 and 50 years old.

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I have not taken any medication to modify my MS.

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I can walk without aid or rest for at least 500 meters.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been treated for latent or active tuberculosis.

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I am HIV positive.

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I have an active hepatitis B infection.

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My first demyelinating event is not due to MS but another condition.

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I cannot or should not have an MRI.

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My MS is getting worse over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Observational study cohortActive Control1 Intervention

Subjects enrolled into an observational study matched for the same disease duration and who are either untreated or treated with alternate MS disease modifying therapies will serve as a parallel reference group

Group II: Ocrelizumab treatedActive Control1 Intervention

Participants age 18-50 with a first clinical presentation of MS or high-risk CIS diagnosed within 90 days of screening will be treated with ocrelizumab (300 mg IV x 2 doses given 2 weeks apart) at disease origin and with maintenance ocrelizumab 600 mg every 6 months through 30 months with a final study visit at 3 years

0 / 10Eligibility criteria met