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NCT04510220 · ClinicalTrials.gov registry record · Phase 3
9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
NCT04510220: Completed Phase 3 study, sponsored by Brigham and Women's Hospital.
NCT04510220 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 10 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04510220, a Phase 3 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
Study Summary
We aim to assess the effect of Ofatumumab on microglial activation using \[F-18\]PBR06 PET in MS patients in relation to changes in serum markers, MRI abnormalities and clinical impairment longitudinally over 9 months. Specific Aims: Specific Aim 1: To determine the effect of Ofatumumab on microglial activation in MS over 9 months. Specific Aim 2: To determine the time course of effect of Ofatumumab on microglial activation and its relationship with peripheral B-cell depletion, serum neurofilament light (sNfL) chain and glial-fibrillary acid protein (GFAP) levels and other serum biomarkers Specific Aim 3: To determine the relationship of PET changes following Ofatumumab initiation with 3T MRI changes and clinical parameters.
Primary Outcome
The primary endpoint of the study will be the regional glial activity on PET (GALP) measurements at 3 months and 9 months compared to baseline. Individualized z-score maps of brain parenchymal microglial activation were generated using a voxel-by-voxel comparison between each subject's 60-90 minute PET standardized uptake value ratio (SUVR) images (globally normalized) and a control dataset of 9 healthy individuals. GALP scores were calculated as the sum of voxel-by-voxel z-scores \>4 in a give
Interventions
- DRUG [F-18]PBR06
- DRUG Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 3 |
What the finished NCT04510220 record still lists
NCT04510220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which [F-18]PBR06 is the first listed.
NCT04510220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04510220 about?
NCT04510220 is a clinical study titled "9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis". We aim to assess the effect of Ofatumumab on microglial activation using \[F-18\]PBR06 PET in MS patients in relation to changes in serum markers, MRI abnormalities and clinical impairment longitudinally over 9 months. Specific Aims: Specific Aim 1: To determine the effect of Ofatumumab on microgl...
What is the current status of trial NCT04510220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2020-09-21. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT04510220?
The interventions under investigation include: [F-18]PBR06 (DRUG), Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT04510220?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04510220's enrollment target sits among peer trials
10 1989th of 2000 higher than 9 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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