Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 12/29/2018 |
| Start Date: | July 2014 |
| End Date: | November 2019 |
Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)? A Longitudinal Study Using Whole Brain, Neocortical and Subcortical Atrophy Rates and Patient Reported Outcomes (PROs).
Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing
the progression of whole brain atrophy. Whole brain atrophy rates will be measured through
magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis
(MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy
controls. The primary outcome will be whole brain atrophy rate measured as the percent change
in brain volume (PBVC) over a two-year period.
Primary hypothesis:
The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of
whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change
in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a
true "disease activity free" state).
the progression of whole brain atrophy. Whole brain atrophy rates will be measured through
magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis
(MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy
controls. The primary outcome will be whole brain atrophy rate measured as the percent change
in brain volume (PBVC) over a two-year period.
Primary hypothesis:
The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of
whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change
in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a
true "disease activity free" state).
Inclusion Criteria:
- 18-55 inclusive years of age at the time of informed consent
- Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald
criteria
- Currently taking Tysabri
Exclusion Criteria:
- Systemic steroid users
- comorbidities that could confound MRI outcomes
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