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

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Rebif

Registration Number: NCT01085318

Lead Sponsor: EMD Serono

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or Rebif®)
Have a disease duration of up to twenty years
Be willing and able to comply with the study procedures for the duration of the trial
Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:

The following inclusion criteria must be fulfilled by the Healthy Control subjects:

Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
Be willing and able to comply with the study procedures for the duration of the trial
Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:

Exclusion Criteria

Have received treatment within three months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
Have received treatment within thirty days prior to screening with immunosuppressant agents (e.g. including but not limited to mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation) or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate, CellCept®, natalizumab, alemtuzumab/Campath and other immunomodulators/monoclonal agents)
Have had a relapse within thirty days prior to the Screening Visit
Have received steroid treatment within thirty days prior to the initial MRI scan date at Study Day 1
Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 1.5x ULN
Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
Have a history of alcohol or drug abuse
Have thyroid dysfunction
Have moderate to severe renal impairment
Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
Have a history of seizures not adequately controlled by treatment
Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from complying with the study protocol
Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
Have received an investigational drug or experimental procedure within the past thirty days
Are pregnant or attempting to conceive

The following exclusion criteria must be fulfilled by the Healthy Control subjects:

Have met any of the above noted criteria

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 MS Patients	Rebif	Rebif 44 tiw

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
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	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).