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

NCT02588053 | Completed

• 2 other identifiers: 13-2927UL1TR001082
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in Brain Atrophy Rate

  Baseline, Year 1, and Year 2

Secondary Outcomes (3)

• 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 Outcomes (1)

• Change in Patient-reported Quality of Life

  Baseline, Year 1, and Year 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Relapsing Multiple Sclerosis and Healthy Controls

You may qualify if:

• 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

You may not qualify if:

• Systemic steroid users
• comorbidities that could confound MRI outcomes

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Augusto Miravalle, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: October 27, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)