Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?

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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02588053

Enrollment

Registered

2015-10-27

Start date

2014-07-31

Completion date

2019-01-31

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in Brain Atrophy Rate	Baseline, Year 1, and Year 2

Secondary

Measure	Time frame
Change in Mean Cortical Thickness	Baseline, Year 1, and Year 2
Change in Neocortical Gray Matter Volume	Baseline, Year 1, and Year 2
Change in Subcortical Gray Matter Volume	Baseline, Year 1, and Year 2

Other

Measure	Time frame
Change in Patient-reported Quality of Life	Baseline, Year 1, and Year 2

Countries

United States

Outcome results