Clinical trial NCT00404352 (phase 3, status: completed)
Conditions: multiple sclerosis
ICD codes: G35, C81.18
Drugs: rnf, rnf, placebo
SMILES: [Na+].[Cl-], [Na+].[Cl-], CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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