Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

Inclusion Criteria

• Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria
• Patients with:
• At least two confirmed relapses within the last 24 months or
• At least one confirmed relapse within the last 12 months or
• One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening.
• Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening
• Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase
• Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period
• Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.

Exclusion Criteria

• Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS), Primary Progressive Multiple Sclerosis (PPMS) or Progressive Relapsing Multiple Sclerosis (PRMS) or Neuromyelitis optica
• Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML
• Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS
• Patients unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media) or who lack adequate peripheral venous access
• Patients who have had the following treatments:
• Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-Cluster of Differentiation (CD4), cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide at any time
• Anti-CD20 treatments or any monoclonal antibodies at any time
• Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and Interferon Beta (IFN-b).
• Glatiramer Acetate or IFN-b within three months prior to the randomization in the trial.
• Glucocorticoids or Adrenocorticotropic Hormone (ACTH) within one month prior to the screening in the trial.
• Receipt of a live vaccine within one month prior to screening in the trial.
• Plasmapheresis for treatment of relapses within 2 months prior to randomization in the trial.
• Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening in the trial.
• Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis after discussion with the sponsors medical monitor
• Past or current history of medically significant adverse effects (including allergic reactions) from:
• Cetirizine
• Prednisolone
• Paracetamol/acetaminophen
• Plasma proteins or a known hypersensitivity to components of the investigational product.
• Past or current malignancy, except for
• Cervical carcinoma Stage 1B or less
• Non-invasive basal cell and squamous cell skin carcinoma
• Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response
• Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy.
• Electrocardiogram (ECG) showing significant abnormality that t