A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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.