Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, MRI, blood brain barrier, myelin
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.
Interventions
DRUGNatalizumab 300 MG in 15 ML Injection
Disease modifying agent
Sponsors
Biogen
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, prospective longitudinal study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans | 12 months | To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR) | 12 months | To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life | 12 months | To explore changes in QoL measurements and the relations between these changes and those seen in ktrans and natalizumab serum levels. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Single Arm SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV
Natalizumab 300 MG in 15 ML Injection: Disease modifying agent | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Treatment Single Arm |
|---|---|
| Age, Customized 46 | 1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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
Population: Data analysis was not completed because only one participant completed (each arm) and disclosing data could violate privacy interests.
Secondary
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
Population: Data analysis is not reported because only one participant completed (each arm) and disclosing data could violate privacy interests.
Other Pre-specified
Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life
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