Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

Exclusion Criteria

• •Use of DMARDs other than methotrexate or exposure to other cell depleting therapy, including investigational compounds \< 6 months prior to Visit 2 A.
• •Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening).
• •Breast feeding women or women with a positive pregnancy test at Visit 1 (screening).
• •Received anti-cancer therapy, corticosteroids (intra-articular, i.m., or i.v.), or live/attenuated vaccinations, or exposure to cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents \< 5 years prior to screening.
• •Past or current malignancy, except for Cervical carcinoma Stage 1B or less, Non-invasive basal cell and squamous cell skin carcinoma, Malignant melanoma with a complete response of a duration of \> 10 years, or other cancer diagnoses with a complete response of a duration of \> 5 years.
• •Chronic or ongoing active infectious disease requiring systemic treatment.
• •Clinically significant cardiac disease, or history of significant cerebrovascular disease.
• •Significant concurrent, uncontrolled medical conditions, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease
• •Known or suspected HIV positive, positive serology for hepatitis B (HB), positive test for Hepatitis C, or positive plasma or white cell JC virus (JCV) PCR (either compartment).
• •A circulating IgG level \<lower limit of normal.
• •Known hypersensitivity to components of the investigational medicinal product.
• •Patients known or suspected of not being able to comply with a study protocol.
• •Women of child bearing potential not will to use adequate contraception during study