Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial (NCT01085318) | Clinical Trial Compass
CompletedPhase 4
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
United States38 participantsStarted 2010-06-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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:
✓. 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
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)
What they're measuring
1
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
✕. 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