A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab

A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab

Publication date: Aug 07, 2019

This is an open-label study of patients with relapsing forms of MS is designed to assess the biochemical, immunological, and kinetic profiles of natalizumab being used with specific brief dosing interruption. The study will be conducted at one site in the US. Ten subjects currently treated with natalizumab will be enrolled and will be evaluated for both PK/PD and cell trafficking in blood and/or CSF during standard dosing of natalizumab and at the end of a planned 12-week dosing interruption. MS disease activity will be carefully monitored clinically and by MRI and NfL.

Concepts Keywords
Alcohol Medicine
Antigen Medical specialties
Biochemical Form Multiple Sclerosis
Blood Forms Multiple Sclerosis
Blood Brain Barrier MRI
California Dosing
Central Nervous System Progressive multifocal leukoencephalopathy
Immune Surveillance Dose
Informed Consent Multiple sclerosis
Infusion Natalizumab
Leukocyte Drugs
Leukocytes Monoclonal antibodies
MRI Immunosuppressants
Multiple Sclerosis
Natalizumab
Neurofilament
NfL
PhD
PML
Privacy
Progressive Multifocal Leukoencephalopathy
Questionnaire
Randomization
Receptor
Regina
Serum
Standard Operating Procedure
Tysabri
West Hollywood

Semantics

Type Source Name
drug DRUGBANK Ethanol
gene UNIPROT PML
disease DOID PML
disease DOID Multiple Sclerosis
disease MESH Multiple Sclerosis
disease MESH privacy
gene UNIPROT GPI
gene UNIPROT NEFL
gene UNIPROT CYREN
gene UNIPROT CSF2
drug DRUGBANK Pentaerythritol tetranitrate
drug DRUGBANK Natalizumab
gene UNIPROT EGR3
gene UNIPROT PDC
disease MESH Sclerosis
gene UNIPROT ALG3
gene UNIPROT NR4A2

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