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Completed

NCT Number: NCT02588053

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Brain Atrophy Rate

    Time frame: Baseline, Year 1, and Year 2

Secondary outcomes

  1. Change in Mean Cortical Thickness

    Time frame: Baseline, Year 1, and Year 2

  2. Change in Neocortical Gray Matter Volume

    Time frame: Baseline, Year 1, and Year 2

  3. Change in Subcortical Gray Matter Volume

    Time frame: Baseline, Year 1, and Year 2

Other outcomes

  1. Change in Patient-reported Quality of Life

    Time frame: Baseline, Year 1, and Year 2

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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).

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Oct 27, 2015
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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