Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Alemtuzumab

• Registration Number: NCT01395316
• Lead Sponsor: University of Chicago

Brief Summary

The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

Detailed Description

To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple Sclerosis.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Primary Completion: 2015-10
• Study Completion: 2017-07
• Status Verified: 2018-11
• Results First Submitted: 2018-11-13
• Results First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Results First Posted: 2018-12-07
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alemtuzumab	Alemtuzumab	Single arm, single cohort study, all subjects will be dosed with alemtuzumab.

Primary Outcome Measures

Name	Time	Method
Diffusion and Myelin Fraction Water Changes on Magnetic Resonance Imaging (MRI)	Baseline to Month 24	Changes in normal appearing white matter from baseline through month 24.; The MRI is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.