Multiple SclerosisNCT03344094
Mechanism of Action of Ocrelizumab in Multiple Sclerosis
An observational study of Multiple Sclerosis and Immune System Diseases, run by University of Chicago at 1 site in United States.
Trial summary
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Immune System Diseases
- What is being tested?
- ocrelizumab
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 10 Apr 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: MS and healthy controls from the U of Chicago Neurology Clinic population
Who may be able to join
- All patients who are eligible for Ocrelizumab therapy based on FDA criteria
Who cannot join
- All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
- Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests.
- Hepatitis B and HIV infections.
- Pregnant or lactating women.
- Hypersensitivity to trial medications.
Trial locations and contacts
1 site in 1 country.
About this study
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.
Read the detailed description
The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.
Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.
- Conditions
- Multiple Sclerosis, Immune System Diseases
- Being tested
- ocrelizumab
- Medical subject headings
- Multiple Sclerosis, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocrelizumabDrug
Also called interferon-beta
FDA-approved MS drugs
| Study group | Role | What they receive |
|---|---|---|
| MS-ocrelizumab treated | ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start Receives: Drug: ocrelizumab | |
| MS untreated | age- and sex-matched untreated MS controls | |
| Healthy control | age- and sex-matched untreated healthy controls | |
| MS interferon-treated | MS with ongoing interferon-beta therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Depletion of B Cells
measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy Mononuclear cells (MNC) will be stained, for flow cytometry, with marker antibodies to B cells.
The change in the percentage of each subset will be compared before and after treatment with paired t tests and ANOVA.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start23 Feb 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- anthony t reder, md, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344094
- Sponsor's protocol ID
- IRB10681A
- Status last verified
- May 2024
- First submitted
- 13 Oct 2017
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action of Ocrelizumab in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03344094
- Acronym / sponsor ID
- IRB10681A
- Conditions
- Multiple Sclerosis, Immune System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.
Detailed description
The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.
Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MS-ocrelizumab treated | – | Drug: ocrelizumabocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start |
| MS untreated | – | –age- and sex-matched untreated MS controls |
| Healthy control | – | –age- and sex-matched untreated healthy controls |
| MS interferon-treated | – | –MS with ongoing interferon-beta therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MS and healthy controls from the U of Chicago Neurology Clinic population
Key inclusion criteria (1 listed)
- All patients who are eligible for Ocrelizumab therapy based on FDA criteria
Key exclusion criteria (5 listed)
- All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
- Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests.
- Hepatitis B and HIV infections.
- Pregnant or lactating women.
- Hypersensitivity to trial medications.
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 |
|---|---|---|
| ocrelizumabAlso: interferon-betaFDA-approved MS drugs | Drug | MS-ocrelizumab treated |
Primary outcome
Number of Participants With Complete Depletion of B Cells
Time frame: 1 year
measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy Mononuclear cells (MNC) will be stained, for flow cytometry, with marker antibodies to B cells. The change in the percentage of each subset will be compared before and after treatment with paired t tests and ANOVA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
anthony t reder, md principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Immune System Diseases, run by University of Chicago at 1 site in United States.
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 1 inclusion and 5 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Depletion of B Cells (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2025.