Multiple SclerosisNCT04459988
Mechanistic Study of Ocrevus
An observational study of Multiple Sclerosis, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. 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
- What is being tested?
- Ocrelizumab
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 25 Oct 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS). Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline immune cell profiles. The patients and healthy controls will be recruited at the University of Michigan Neurology Clinic.
Who may be able to join
- Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment
- OR
- Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.
- Ability to give informed consent
- Willing to have blood drawn as scheduled in the protocol
- Willing and able to complete all procedures and evaluations related to the study
Who cannot join
- Medical or psychiatric conditions that may affect the patient's ability to give informed consent
- Has received an experimental drug within 30 days of enrollment
- Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
- Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
- Active hepatitis B virus infection
- History of life-threatening infusion reaction to Rituxan or Ocrevus
- Chronic infection or any severe acute infection within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis
The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab
- Keywords
- Ocrevus, B cell, T cell, cytokines
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Also called Ocrevus
Description Needed
| Study group | Role | What they receive |
|---|---|---|
| Patients with MS | Patients with MS who have been newly prescribed Ocrevus Receives: Drug: Ocrelizumab | |
| Healthy Controls | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of regulatory B cells
Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls
Measured: From baseline to 24 months
Secondary outcomes (1)
Change in frequency of T cell subtypes
Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls
Measured: From baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2020
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Fox, MD, University of Michigan
- Investigators
- Yang Mao-Draayer, MD/PHD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459988
- Sponsor's protocol ID
- HUM00066792
- Status last verified
- May 2024
- First submitted
- 30 Jun 2020
- Last updated
- 31 May 2024
- Results posted
- No
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04459988
- Acronym / sponsor ID
- HUM00066792
- Conditions
- Multiple Sclerosis
- Keywords
- Ocrevus, B cell, T cell, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 7 Jul 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.
The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MS | – | Drug: OcrelizumabPatients with MS who have been newly prescribed Ocrevus |
| Healthy Controls | – | –Healthy Controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS). Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline immune cell profiles. The patients and healthy controls will be recruited at the University of Michigan Neurology Clinic.
Key inclusion criteria (6 listed)
- Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment
- OR
- Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.
- Ability to give informed consent
- Willing to have blood drawn as scheduled in the protocol
Key exclusion criteria (7 listed)
- Medical or psychiatric conditions that may affect the patient's ability to give informed consent
- Has received an experimental drug within 30 days of enrollment
- Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
- Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
- Active hepatitis B virus infection
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: OcrevusDescription Needed | Drug | Patients with MS |
Primary outcome
Change in frequency of regulatory B cells
Time frame: From baseline to 24 months
Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls
1 secondary outcome
Change in frequency of T cell subtypes
Time frame: From baseline to 24 months
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 31 May 2024.
- 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.
Yang Mao-Draayer, MD/PHD principal investigator
University of Michigan
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, run by University of Michigan 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 6 inclusion and 7 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 31 May 2024. 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?
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?
Change in frequency of regulatory B cells (time frame: From baseline to 24 months). 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 31 May 2024.