Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX 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 700mg IV infusions taken 14 days apart. A total of 8 infusions cycles given over a 144 week period; 1000 mL dilution of 35ml of ofatumumab in sterile, pyrogen free 0.9% NaCl. Each Treatment Cycle consisting of two IV infusions 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: 265.0
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 of ofatumumab in reducing clinical signs and symptoms in
      adult RA patients after a single course of ofatumumab.
    

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 methotrexate 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;

          -  Previous exposure to biologic DMARDs; 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.