Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ofatumumab
Intervention description: 1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl
Intervention MeSH terms: Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and
      who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the
      trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9
      treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo
      in Trial Hx-CD20-403.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously received ofatumumab or placebo in Trial Hx-CD20-403.

          -  Patients on methotrexate therapy (7.5 - 25 mg/week, p.o., i.m., and/or s.c.).

          -  Oral corticosteroids therapy (≤ 10 mg/day prednisolone or equivalent).

          -  Active disease at the time of screening as defined by:

               -  3 swollen joints (of 28 joints assessed) and ≥ 3 tender joints (of 28 joints
                  assessed), DAS28≥3.2 (based on ESR)

        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