Multiple SclerosisNCT05131984
Ocrelizumab Access by Socio-Economic Status
An observational study of Multiple Sclerosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 1 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with relapsing remitting or primary progressive MS evaluated at Brigham and Women's Multiple Sclerosis Clinic or Boston Medical College Multiple Sclerosis Clinic between 03/2017 and 07/2021 who were started on ocrelizumab in that time period.
Who may be able to join
- All MS patients at the Brigham MS Center and Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.
Who cannot join
- Simultaneous use of high dose monthly IV steroids,
- Secondary progressive MS (SPMS) disease category,
- Additional serious medical or neurologic co-morbid diseases,
- Additional concomitant immunosuppressive therapy of any kind,
- Additional concomitant MS-specific therapy (DMT) of any kind,
- Change of infusion or care site and absence of neurologic or imaging follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Ocrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World Investigation
The primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. The study is a retrospective analysis of multiple sclerosis patients cared for at Brigham and Women's Hospital and Boston Medical Center who were treated with Ocrelizumab during the 4 year study period.
Read the detailed description
This study will be a two-center retrospective/observational analysis with data collected from the Research Patient Data Registry (RPDR), Brigham Multiple Sclerosis Center Patient Database (Oracle), and Boston Medical Center MS Clinic Database (BMC-MS).
Using the Oracle database, BMC-MS database and electronic medical records (EPIC), the investigators will capture all MS patients who satisfy inclusion criteria. This study will collect age, sex, race, socio-economic status by residence zip code, disease duration, previous treatment, current treatment status, the reason for discontinuing or switching to another treatment, expanded disability status scale (EDSS), and functional systems scores (FSS) where available.
Additionally, the investigators will collect the date, dose, and interval between each ocrelizumab infusion, as well as any pertinent laboratory values and MRI scan results.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab
- 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
At least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg over the course of 1 year
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis patients on Ocrelizumab at Brigham and Women's Hospital | All MS patients at the Brigham MS Center who have been diagnosed with relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS), ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period. Receives: Drug: Ocrelizumab | |
| Multiple Sclerosis patients on Ocrelizumab at Boston Medical Center | All MS patients at the Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period. Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment initiation
Time from diagnosis to Ocrelizumab treatment initiation in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS.
Measured: 03/2017 - 07/2021
Secondary outcomes (2)
Annualized relapse rate
Annualized relapse rate over 12 and 24 months in men and women of different racial and ethnic origins and socio-economic backgrounds in patients with RRMS.
Measured: 12-24 months from ocrelizumab initiation
MRI Changes
New T2 and new T1 gadolinium enhancing lesions over 12 and 24 months in men and women of different racial and ethnic origins and socio-economic backgrounds in patients with RRMS.
Measured: 12-24 months from ocrelizumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start18 Nov 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
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
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Boston Medical Center
- Responsible party
- Principal investigator, Maria Houtchens, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131984
- Sponsor's protocol ID
- 2021P002772
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2021
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World Investigation
- ClinicalTrials.gov ID
- NCT05131984
- Acronym / sponsor ID
- 2021P002772
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc., Boston Medical Center
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 Nov 2021 (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 primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. The study is a retrospective analysis of multiple sclerosis patients cared for at Brigham and Women's Hospital and Boston Medical Center who were treated with Ocrelizumab during the 4 year study period.
Detailed description
This study will be a two-center retrospective/observational analysis with data collected from the Research Patient Data Registry (RPDR), Brigham Multiple Sclerosis Center Patient Database (Oracle), and Boston Medical Center MS Clinic Database (BMC-MS).
Using the Oracle database, BMC-MS database and electronic medical records (EPIC), the investigators will capture all MS patients who satisfy inclusion criteria. This study will collect age, sex, race, socio-economic status by residence zip code, disease duration, previous treatment, current treatment status, the reason for discontinuing or switching to another treatment, expanded disability status scale (EDSS), and functional systems scores (FSS) where available.
Additionally, the investigators will collect the date, dose, and interval between each ocrelizumab infusion, as well as any pertinent laboratory values and MRI scan results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis patients on Ocrelizumab at Brigham and Women's Hospital | – | Drug: OcrelizumabAll MS patients at the Brigham MS Center who have been diagnosed with relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS), ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period. |
| Multiple Sclerosis patients on Ocrelizumab at Boston Medical Center | – | Drug: OcrelizumabAll MS patients at the Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with relapsing remitting or primary progressive MS evaluated at Brigham and Women's Multiple Sclerosis Clinic or Boston Medical College Multiple Sclerosis Clinic between 03/2017 and 07/2021 who were started on ocrelizumab in that time period.
Key inclusion criteria (1 listed)
- All MS patients at the Brigham MS Center and Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.
Key exclusion criteria (6 listed)
- Simultaneous use of high dose monthly IV steroids,
- Secondary progressive MS (SPMS) disease category,
- Additional serious medical or neurologic co-morbid diseases,
- Additional concomitant immunosuppressive therapy of any kind,
- Additional concomitant MS-specific therapy (DMT) of any kind,
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 |
|---|---|---|
| OcrelizumabAt least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg over the course of 1 year | Drug | Multiple Sclerosis patients on Ocrelizumab at Boston Medical Center, Multiple Sclerosis patients on Ocrelizumab at Brigham and Women's Hospital |
Primary outcome
Time to treatment initiation
Time frame: 03/2017 - 07/2021
Time from diagnosis to Ocrelizumab treatment initiation in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS.
2 secondary outcomes
Annualized relapse rate
Time frame: 12-24 months from ocrelizumab initiation
MRI Changes
Time frame: 12-24 months from ocrelizumab initiation
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 24 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 1 inclusion and 6 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 24 Nov 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?
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?
Time to treatment initiation (time frame: 03/2017 - 07/2021). 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 24 Nov 2025.