Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Ofatumumab; Placebo
Intervention description: 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each treatment cycle consisting of two IV infusion taken 14 days apart. A total of 8 infusion cycles given over a 144 week period; 1000 mL sterile, pyrogen free 0.9% NaCl. A treatment cycle consisting of two IV infusion taken 14 days apart. Only one placebo treatment cycle provided over a 24 week period
Intervention MeSH terms: Ofatumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a
      duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the
      study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and
      symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years;

          -  Active disease at the time of screening as defined by:

             ≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints
             assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate
             (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR);

          -  Inadequate response to previous or current TNF-alpha antagonist treatment;

          -  Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a
             stable dose for at least 4 weeks.

        Exclusion Criteria:

          -  Patients with a history of a rheumatic autoimmune disease other than RA or with
             significant systemic involvement secondary to RA;

          -  Previous exposure to biologic anti-rheumatic therapies, including investigational
             compounds;

          -  Exposure to TNF-alpha antagonist treatment < 12 weeks prior to visit 2;

          -  Chronic or ongoing active infectious disease requiring systemic treatment;

          -  Clinically significant cardiac disease; History of significant cerebrovascular
             disease;

          -  Significant concurrent, uncontrolled medical condition including, but not limited to,
             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological,
             cerebral psychiatric disease, or evidence of demyelinating disease;

          -  Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for
             Hepatitis C; Positive plasma / white cell JC Virus PCR;

          -  Serum IgG < lower limit of normal;

          -  Breast feeding women or women with a positive pregnancy test at screening;

          -  Current participation in any other interventional clinical study;

          -  Patients known or suspected of not being able to comply with a study protocol.