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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 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04510220
The ClinicalTrials.gov registry entry for NCT04510220 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which [F-18]PBR06 is the first listed.
NCT04510220 reports 0 study locations.
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.
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