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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
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 belowSelect...
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:Select...
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
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
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
Find a Location
Who is running the clinical trial?
Valhalla FoundationUNKNOWN
1 Previous Clinical Trials
1,200 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,856 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,334 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been treated for latent or active tuberculosis.I had my first MS-like symptoms and an MRI showing inactive lesions within the last 90 days.You currently have a hepatitis C virus infection.I am HIV positive.I agree to use effective birth control or remain abstinent during and after the study.I have been diagnosed with high-risk clinically isolated syndrome or relapsing MS.You are very sensitive or allergic to the trial medications.I am between 18 and 50 years old.I have not taken any medication to modify my MS.I haven't taken corticosteroids in the last 7 days.You have had a serious allergic reaction to monoclonal antibodies in the past.I have an active hepatitis B infection.I am not pregnant or have been sterilized if I am of childbearing age.I can walk without aid or rest for at least 500 meters.My first demyelinating event is not due to MS but another condition.I cannot or should not have an MRI.My MS is getting worse over time.
Research Study Groups:
This trial has the following groups:- Group 1: Observational study cohort
- Group 2: Ocrelizumab treated
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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