Natalizumab and Chronic Inflammation

Phase 4TerminatedNCT05177718

Vanderbilt University Medical Center1 enrolled

Overview

In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).

The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity. As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Natalizumab 300 MG in 15 ML InjectionDRUG

Disease modifying agent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. multiple sclerosis 2. clinical eligibility to treatment with Natalizumab 3. no previous exposure to Natalizumab treatment Exclusion Criteria: 1. inability to perform an MRI with contrast 2. inability to undergo a paper-pencil questionnaires and blood work

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans

To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Time frame: 12 months

Secondary Outcomes

Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)

To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

Time frame: 12 months

Data from ClinicalTrials.gov

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