drugset / Trial / NCT04510220

9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

NCT04510220

Phase 3 Completed 10 enrolled Brigham and Women's Hospital Novartis · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-21
Primary completion
2022-12-28
Completion
2022-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 20 mg Subcutaneous

Indications