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

Multiple Sclerosis Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588053
• Other study ID #: 13-2927
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: July 2014
• Est. completion date: January 2019

Study information

• Verified date: April 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient-reported Quality of Life		Baseline, Year 1, and Year 2
Primary	Change in Brain Atrophy Rate		Baseline, Year 1, and Year 2
Secondary	Change in Mean Cortical Thickness		Baseline, Year 1, and Year 2
Secondary	Change in Neocortical Gray Matter Volume		Baseline, Year 1, and Year 2
Secondary	Change in Subcortical Gray Matter Volume		Baseline, Year 1, and Year 2