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).

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Relapsing Multiple Sclerosis and Healthy Controls

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Augusto Miravalle, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pathological Conditions, Anatomical; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Atrophy
• Other Study ID Numbers: 13-2927; UL1TR001082 (U.S. NIH Grant/Contract)