Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT01395316|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2011
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Alemtuzumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||July 2017|
Single arm, single cohort study, all subjects will be dosed with alemtuzumab.
10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
- Diffusion and myelin fraction water changes on MRI [ Time Frame: 24 months ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395316
|Principal Investigator:||Adil Javed, MD||University of Chicago|