Multiple SclerosisNCT03138525
Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
An observational study of Multiple Sclerosis and Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy
- What is being tested?
- Blood sampling (MS)
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2017to 20 Dec 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
Who may be able to join
- Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
- Healthy controls
- Ability to understand and sign informed consent
Who cannot join
- Other concomitant autoimmune or inflammatory diseases
- Ongoing treatment with other immunomodulatory medications
- Previous treatment with rituximab, methotrexate, cyclophosphamide, mitoxantrone, mycophenolate mofetil, or alemtuzumab
- Pregnancy or lactation
- Hypersensitivity to ocrelizumab
- MS
- First-degree relatives with MS
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.
- Conditions
- Multiple Sclerosis, Healthy
- Being tested
- Blood sampling (MS), Blood sampling (controls)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling (MS)Other
Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.
Blood sampling (controls)Other
Blood samples will be collected once at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab Receives: Other: Blood sampling (MS) | |
| Healthy | Healthy individuals serving as controls to the subjects with MS Receives: Other: Blood sampling (controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte Transcriptome Profiling
Changes in messenger ribonucleic acid (mRNA) expression
Measured: 12 months
Antigen microarrays
Changes in serum autoantibody immune signatures
Measured: 12 months
Serum microRNA profiles
Changes in serum microRNA expression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start20 Jun 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 Brigham and Women's HospitalThe 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Howard L Weiner, Brigham and Women's Hospital
- Investigators
- Howard L Weiner, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138525
- Sponsor's protocol ID
- ML39789
- Status last verified
- Jan 2021
- First submitted
- 1 May 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03138525
- Acronym / sponsor ID
- ML39789
- Conditions
- Multiple Sclerosis, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 May 2017 (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 assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | Other: Blood sampling (MS)Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab |
| Healthy | – | Other: Blood sampling (controls)Healthy individuals serving as controls to the subjects with MS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
Key inclusion criteria (3 listed)
- Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
- Healthy controls
- Ability to understand and sign informed consent
Key exclusion criteria (7 listed)
- Other concomitant autoimmune or inflammatory diseases
- Ongoing treatment with other immunomodulatory medications
- Previous treatment with rituximab, methotrexate, cyclophosphamide, mitoxantrone, mycophenolate mofetil, or alemtuzumab
- Pregnancy or lactation
- Hypersensitivity to ocrelizumab
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 |
|---|---|---|
| Blood sampling (MS)Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment. | Other | Multiple Sclerosis |
| Blood sampling (controls)Blood samples will be collected once at enrollment. | Other | Healthy |
Primary outcome
Monocyte Transcriptome Profiling
Time frame: 12 months
Changes in messenger ribonucleic acid (mRNA) expression
Antigen microarrays
Time frame: 12 months
Changes in serum autoantibody immune signatures
Serum microRNA profiles
Time frame: 12 months
Changes in serum microRNA expression
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 27 Jan 2021.
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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.
Howard L Weiner, MD principal investigator
Brigham and Women's Hospital
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 Healthy, run by Brigham and Women's Hospital 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 3 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 27 Jan 2021. 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?
Monocyte Transcriptome Profiling (time frame: 12 months). The study lists 3 primary outcomes in all. 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 27 Jan 2021.