Multiple Sclerosis, RelapsingPhase 4NCT04377555
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing, run by Genentech, Inc. at 28 sites in 3 countries.
Trial summary
Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 30 Jul 2020to 11 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
- Participants who self-identify as Black or African American or Hispanic/Latino American
- Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
- Neurologically stable for at least 30 days prior to randomization and baseline assessments
Who cannot join
- Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
- Primary Progressive Multiple Sclerosis (PPMS)
- Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
- Infection Related
- Cancer Related
- Pregnant or lactating, or intending to become pregnant during the study
Show all 10Show fewer
- Other Medical Conditions
- Known presence or history of other neurologic disorders
- Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab
- Laboratory: abnormalities or findings at screening
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States26 sites
Shepherd Center Inc.
Atlanta, Georgia, 30309
Atlanta Neuroscience Institute
Atlanta, Georgia, 30327
University of Maryland Medical Center
Baltimore, Maryland, 21201-1642
Johns Hopkins University Neurology Research Office
Baltimore, Maryland, 21287
Rush University Medical Center
Chicago, Illinois, 60612-3244
University of Chicago
Chicago, Illinois, 60637
Neurology Clinic - Cordova
Cordova, Tennessee, 38018
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Wayne State University
Detroit, Michigan, 48201
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
Frisco, Texas, 75034
Guilford Neurologic Research Partners, LLC
Greensboro, North Carolina, 27401
Baylor College of Medicine Medical Center
Houston, Texas, 77030
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, 46256
Baptist Neurology - Beaches
Jacksonville Beach, Florida, 32250
Keck School of Medicine of USC
Los Angeles, California, 90033-5315
University of Miami Miller School of Medicine
Miami, Florida, 33136
Wheaton Franciscan Healthcare - St. Francis Outpatient Center
Milwaukee, Wisconsin, 53215
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Multiple Sclerosis Center of Tidewater
Norfolk, Virginia, 23502
Hackensack University Medical Center
Paramus, New Jersey, 07652
Jefferson University Hospitals, Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Upstate Medical Center
Syracuse, New York, 13210
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab
Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.
- Conditions
- Multiple Sclerosis, Relapsing
- Being tested
- Ocrelizumab
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72. Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
Measured: 48 Weeks
Secondary outcomes (3)
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
Measured: Week 48
Time to protocol-defined event
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI
Measured: Week 48
Annualized relapse rate at week 48
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start30 Jul 2020
- Primary completion15 Dec 2022
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, RelapsingStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377555
- Sponsor's protocol ID
- ML42071
- Status last verified
- Feb 2026
- First submitted
- 1 May 2020
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Williams MJ, Okai AF, Cross AH, Monson NL, Vartanian T, Thrower BW, Reder AT, English JB, Wu GF, Bernitsas E, Yap S, Ndrio J, Pei J, Mowry EM, Magrini F, Acosta J, Amezcua L; CHIMES investigators. Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial. Mult Scler Relat Disord. 2023 Aug;76:104794. doi: 10.1016/j.msard.2023.104794. Epub 2023 Jun 9.
PubMed 37356256
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab
- ClinicalTrials.gov ID
- NCT04377555
- Acronym / sponsor ID
- ML42071
- Conditions
- Multiple Sclerosis, Relapsing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: OcrelizumabMain study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
- Participants who self-identify as Black or African American or Hispanic/Latino American
- Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
- Neurologically stable for at least 30 days prior to randomization and baseline assessments
Key exclusion criteria (10 listed)
- Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
- Primary Progressive Multiple Sclerosis (PPMS)
- Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
- Infection Related
- Cancer Related
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabOcrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks. | Drug | All Participants |
Primary outcome
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
Time frame: 48 Weeks
A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
3 secondary outcomes
Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
Time frame: Week 48
Time to protocol-defined event
Time frame: Week 48
Annualized relapse rate at week 48
Time frame: Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 37356256Williams MJ, Okai AF, Cross AH, Monson NL, Vartanian T, Thrower BW, Reder AT, English JB, Wu GF, Bernitsas E, Yap S, Ndrio J, Pei J, Mowry EM, Magrini F, Acosta J, Amezcua L; CHIMES investigators. Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial. Mult Scler Relat Disord. 2023 Aug;76:104794. doi: 10.1016/j.msard.2023.104794. Epub 2023 Jun 9.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing, run by Genentech, Inc. at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Kenya, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.