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Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Single, first clinical event suggestive of MS within 60 days prior to study Day 1, which is the day of randomization (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic, other than a paresthesia, vegetative or cerebral dysfunction
At least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 millimeter (mm), at least one of which is ovoid or periventricular or infratentorial
EDSS 0 - 5.0 at least one time point during the screening period before start of treatment
18 and 50 years old, inclusive
Willing to follow study procedures
Written informed consent
If female, subject must:
* be neither pregnant nor breast-feeding nor attempting to conceive
* use a highly effective method of contraception. A highly effective method of contraception is defined as those which result in a low failure rate (that is \[i.e.\] less than 1 percent \[%\] per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner
You may not be if
Diagnosis of MS (per McDonald criteria 2005)
Any other disease that could better explain the subject's signs and symptoms
Complete transverse myelitis or bilateral optic neuritis
Subject uses or has used any other approved MS disease-modifying drug (DMD)
Any investigational drug or undergone an experimental procedure within 12 weeks prior to study Day 1
Oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to study Day 1
Total bilirubin greater than 2.5 times upper limit of normal (ULN)
Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (ALP) greater than 2.5 times the ULN
Inadequate bone marrow reserve, defined as a total white blood cell count less than 3.0 x 109 per liter (/L), platelet count less than 75 x 109/L, hemoglobin less than 100 gram per liter (g/L)
Current autoimmune disease
Major medical or psychiatric illness (including history of or current severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
History of seizures not adequately controlled by treatment
Cardiac disease, such as angina, congestive heart failure or arrhythmia
Known allergy to IFN-beta or the excipient(s) of the study medication
Any condition that could interfere with the MRI evaluation;
Known allergy to gadolinium-diethylene triamine pentaacetic acid (DTPA)
Previously participated in this study
Participated in any clinical trial within the past 6 months
Any immunomodulatory or immunosuppressive therapy at any time prior to enrollment, including, but not limited to, the following products: any IFN, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4 \[CD4\]), intravenous, immunoglobulins (Igs), cytokines or anti-cytokine therapy
Any experimental MS treatment prior to trial entry, including, but not limited to, any statins (if given to prevent MS) and pentoxyfylline
History of alcohol or drug abuse
Intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen
Inability to administer subcutaneous injections either by self or by caregiver
Moderate to severe renal impairment
Clareo Health | REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
