Trial · NCT04230174
Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia Activation
NCT04230174, Phase 4, Completed, Massachusetts General Hospital; results first posted 2025-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia Activation. Trials, record NCT04230174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04230174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia Activation
- NCT number
- NCT04230174
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 22 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Multiple Sclerosis
- Interventions
- 11C-PBR28
- First posted
- 2020-01-18
- Last updated
- 2025-12-30
- Results first posted
- 2025-12-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Baseline to 12 month | The primary endpoint is change in mean 11C-PBR28 SUVR in multiple sclerosis patients after 1-year of ocrelizumab therapy in different brain regions. |
| Secondary | Magnetization Transfer Ratio (MTR) | Baseline to 12-month | Secondary endpoint is changes in mean magnetization transfer ratio (MTR) in cortex and normal appearing white matter (NAWM) of multiple sclerosis patients after 1-year of ocrelizumab therapy. MTR is defined as: S0 - S\_MT/S0; where S0 is the signal intensity without the magnetization transfer (MT) pulse and S\_MT is the signal intensity with the MT pulse. It is dimensionless because it is defined as a ratio of two signals with the same physical units, so the units cancel out. Larger MTR indicate stronger interaction between free water protons and macromolecular-bound protons. |
| Secondary | Cortical Thickness | Baseline to 12-month | Secondary endpoint is changes in cortical thickness after 1-year ocrelizumab treatment in patients with multiple sclerosis. |
| Secondary | White Matter (WM) Lesion Volume | Baseline to 12 months | Secondary endpoint is changes in WM lesion load after 1-year of ocrelizumab therapy in patients with MS. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Baseline to 12 month | Fifteen MS patients completed the follow-up MR-PET study, which was performed at an average interval of 19.8 days (SD=22.6) after receiving the 1-year ocrelizumab dose. A patient was excluded from the PET analysis after it was discovered that they were using a medication not allowed by the study protocol. | SUVR | MEAN |
| SECONDARY | Magnetization Transfer Ratio (MTR) | Baseline to 12-month | Longitudinal MTR scans were acquired in 15 patients; in one subject, however, the MT\_off acquisition was not completed due to early scan termination as the subject was unable to tolerate the scan duration. MTR maps from another subject were excluded from the group analysis due to severe motion artifacts. | % of MTR | MEAN |
| SECONDARY | Cortical Thickness | Baseline to 12-month | A patient was excluded from the study analysis after it was discovered that they were using a medication not allowed by the study protocol. | mm2 | MEAN |
| SECONDARY | White Matter (WM) Lesion Volume | Baseline to 12 months | A patient was excluded from the study analysis after it was discovered that they were using a medication not allowed by the study protocol. | mm cubic | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Multiple sclerosis patients | Baseline SUVR in perilesional white matter | 0.9 | Standard Deviation 0.19 | SUVR |
| 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Multiple sclerosis patients | Baseline SUVR in white matter lesions | 0.9 | Standard Deviation 0.21 | SUVR |
| 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Multiple sclerosis patients | Baseline SUVR in thalamus | 1.31 | Standard Deviation 0.26 | SUVR |
| 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Multiple sclerosis patients | 12-month SUVR in perilesional white matter | 0.84 | Standard Deviation 0.19 | SUVR |
| 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Multiple sclerosis patients | 12-month SUVR in white matter lesions | 0.83 | Standard Deviation 0.2 | SUVR |
| 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) | Multiple sclerosis patients | 12-month SUVR in thalamus | 1.23 | Standard Deviation 0.25 | SUVR |
| Magnetization Transfer Ratio (MTR) | Multiple sclerosis patients | Baseline NAWM MTR | 27.9 | Standard Deviation 1.4 | % of MTR |
| Magnetization Transfer Ratio (MTR) | Multiple sclerosis patients | Baseline cortical MTR | 17.3 | Standard Deviation 0.9 | % of MTR |
| Magnetization Transfer Ratio (MTR) | Multiple sclerosis patients | 12-month NAWM MTR | 27.0 | Standard Deviation 1.9 | % of MTR |
| Magnetization Transfer Ratio (MTR) | Multiple sclerosis patients | 12-month cortical MTR | 16.8 | Standard Deviation 1.1 | % of MTR |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Multiple Sclerosis Patients | 20 | |
| Overall Study | COMPLETED | Multiple Sclerosis Patients | 15 | |
| Overall Study | NOT COMPLETED | Multiple Sclerosis Patients | 5 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | Multiple Sclerosis Patients | 4 | 20 | 4 |
| other | Typical multiple sclerosis relapse | Nervous system disorders | Multiple Sclerosis Patients | 2 | 20 | 2 |
| other | Urinary infection | Infections and infestations | Multiple Sclerosis Patients | 1 | 20 | 1 |
| other | Hiatal hernia | Gastrointestinal disorders | Multiple Sclerosis Patients | 1 | 20 | 1 |
| other | Pregnancy | Pregnancy, puerperium and perinatal conditions | Multiple Sclerosis Patients | 1 | 20 | 1 |
| other | Ocrevus infusion reaction | Skin and subcutaneous tissue disorders | Multiple Sclerosis Patients | 2 | 20 | 2 |
| other | Urinary incontinence | Renal and urinary disorders | Multiple Sclerosis Patients | 1 | 20 | 1 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Multiple Sclerosis Patients | 1 | 20 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Multiple Sclerosis Patients | 0 | 20 |
| Total, other adverse events | Multiple Sclerosis Patients | 12 | 20 |
| Total, serious adverse events | Multiple Sclerosis Patients | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04230174
GET https://conductscience.org/api/trials/v1/NCT04230174/registered