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

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Rebif (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Fernando Dangond, MD, Study Director, Affiliation: EMD Serono

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.

Clinical Details

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 Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif« 44 Mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control Group

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature 2. RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or Rebif®) 3. Have a disease duration of up to twenty years 4. Be willing and able to comply with the study procedures for the duration of the trial 5. Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out 6. 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: 1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature 2. Be willing and able to comply with the study procedures for the duration of the trial 3. Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out 4. Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: Exclusion Criteria: 1. Have received treatment within three months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis 2. 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) 3. Have had a relapse within thirty days prior to the Screening Visit 4. Have received steroid treatment within thirty days prior to the initial MRI scan date at Study Day 1 5. 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 6. Have inadequate bone marrow reserve, defined as a total white blood cell count < 3. 0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L 7. Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis 8. Have a history of alcohol or drug abuse 9. Have thyroid dysfunction 10. Have moderate to severe renal impairment 11. 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 12. Have a history of seizures not adequately controlled by treatment 13. Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure 14. Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from complying with the study protocol 15. Have a known hypersensitivity or allergy to interferon-beta or any of the excipients 16. Have received an investigational drug or experimental procedure within the past thirty days 17. Are pregnant or attempting to conceive The following exclusion criteria must be fulfilled by the Healthy Control subjects: 1. Have met any of the above noted criteria

Locations and Contacts

EMD Serono, Inc., Rockland, Massachusetts 02370, United States
Additional Information

Starting date: June 2010
Last updated: August 2, 2013

Page last updated: August 20, 2015

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