CompletedPhase 3

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

United States10 participantsStarted 2020-09-21

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Exclusion criteria

✕. History of any malignancy
✕. History of alcohol or drug abuse
✕. Primary or secondary immunodeficiency
✕. Prior hematopoietic stem cell transplantation
✕. History of transplantation or anti-rejection therapy
✕. Abnormal CD19+ B-cell levels at screening (defined as CD19 count \<110 cells per microliter)
✕. Leukopenia (defined as white blood cell (WBC) count \<4000 WBCs per microliter)
✕. Lymphopenia (defined as lymphocyte count \<1000 lymphocytes per microliter)

What they're measuring

Glial Activity Load on PET

Timeframe: Baseline, 3 Months, and 9 Months

Trial details

NCT IDNCT04510220

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-28

Results submitted2024-07-29

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