Natalizumab and Chronic Inflammation

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Natalizumab 300 MG in 15 ML Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05177718

201600

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Treatment Single Arm

Other group

Description:

SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV

Treatment:

Drug: Natalizumab 300 MG in 15 ML Injection