Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females between 18 and 60 years of age
Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study
Have Relapsing Remitting Multiple Sclerosis (RRMS) according to the revised McDonald criteria 2005
Have brain and/or spinal MRI with findings typical of Multiple Sclerosis (MS)
Have disease duration for more than 12 months
Have disease activity characterized by at least one clinical event and one or more Gadolinium-enhancing MRI lesions within the 6 months prior to randomization
Have score of \<=5.5 on the Expanded Disability Status Scale (EDSS)
Be willing and able to comply with the protocol for the duration of the study
Have given written informed consent prior to any study-related procedure not part of the normal medical practice
You may not be if
Have any disease other than MS that could better explain his/her signs and symptoms
Have complete transverse myelitis or bilateral optic neuritis
Have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone \[ACTH\]), or total lymphoid irradiation
Have received within 3 months prior to baseline any approved disease-modifying therapy for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure
Have received within 30 days prior to baseline oral or systemic corticosteroids or ACTH
