Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01395316|
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
|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|
|Actual 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 Magnetic Resonance Imaging (MRI) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395316
|Principal Investigator:||Adil Javed, MD||University of Chicago|