Natalizumab and Chronic Inflammation
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Natalizumab 300 MG in 15 ML Injection
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, MRI, blood brain barrier, myelin
Eligibility Criteria
Inclusion Criteria:
- multiple sclerosis
- clinical eligibility to treatment with Natalizumab
- no previous exposure to Natalizumab treatment
Exclusion Criteria:
- inability to perform an MRI with contrast
- inability to undergo a paper-pencil questionnaires and blood work
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment Single Arm
Arm Description
SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05177718
First Posted
December 13, 2021
Last Updated
September 18, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
Biogen
1. Study Identification
Unique Protocol Identification Number
NCT05177718
Brief Title
Natalizumab and Chronic Inflammation
Official Title
Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Biogen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, MRI, blood brain barrier, myelin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open-label, prospective longitudinal study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Single Arm
Arm Type
Other
Arm Description
SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV
Intervention Type
Drug
Intervention Name(s)
Natalizumab 300 MG in 15 ML Injection
Intervention Description
Disease modifying agent
Primary Outcome Measure Information:
Title
Effect of Natalizumab on magnetic resonance imaging measures of blood brain barrier permeability: K-trans
Description
To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Effect of Natalizumab on magnetic resonance imaging measures of myelin integrity: pool saturation ratio (PSR)
Description
To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Effect of Natalizumab on questionnaire derived measures of Quality of Life
Description
To explore changes in QoL measurements and the relations between these changes and those seen in ktrans and natalizumab serum levels.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
multiple sclerosis
clinical eligibility to treatment with Natalizumab
no previous exposure to Natalizumab treatment
Exclusion Criteria:
inability to perform an MRI with contrast
inability to undergo a paper-pencil questionnaires and blood work
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Bagnato
Phone
615-875-9572
Email
francesca.r.bagnato@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Bagnato, MDPhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Bagnato
Phone
615-875-9572
Email
francesca.r.bagnato@vumc.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request from qualified investigators the PI will release all data listed below.
IPD Sharing Time Frame
[per PDBP policy]
IPD Sharing Access Criteria
[per PDBP policy]
IPD Sharing URL
https://pdbp.ninds.nih.gov/policy
Learn more about this trial
Natalizumab and Chronic Inflammation
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