Clinical Trial: Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune St

Brief Summary: The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central nervous system (CNS) iron deposition, and d) immune status in subjects with relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.

Detailed Summary:
Sponsor: EMD Serono

Current Primary Outcome: Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months [ Time Frame: Baseline to Month 6 ]

To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).


Original Primary Outcome: The effect of Rebif® 44 mcg sc tiw on remyelination/ demyelination using a voxel-wise magnetization transfer ratio (VW-MTR) dynamic mapping of normal appearing brain tissue (NABT) in subjects with RRMS with reference to healthy controls (HC) [ Time Frame: 6 months ]

Current Secondary Outcome: Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months [ Time Frame: Baseline to Month 6 ]

To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).


Original Secondary Outcome:

Information By: EMD Serono

Dates:
Date Received: March 10, 2010
Date Started: June 2010
Date Completion:
Last Updated: August 2, 2013
Last Verified: August 2013