A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab; methotrexate; methylprednisolone; acetaminophen; antihistamine
Intervention description: 1000 mg in 250 mL intravenous infusion; 10 to 25 mg/week (oral or parenteral); 100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion; 1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion; 50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion
Intervention MeSH terms: Acetaminophen; Methylprednisolone; Rituximab; Methotrexate; Histamine Antagonists; Histamine H1 Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was designed to evaluate the safety of administering rituximab at a more rapid
      infusion rate in patients with moderate to severe rheumatoid arthritis who have had an
      inadequate response to biopharmaceuticals that treat diseases by interfering with tumor
      necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than
      eight weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age

          -  Rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987
             American College of Rheumatology criteria

          -  Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept,
             infliximab, golimumab, or certolizumab)

          -  Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled,
             provided their most recent course of RTX occurred over 6 months but no more than 9
             months prior to baseline. The RTX dosage must have been two 1000 mg infusions per
             course administered at the standard approved rate

          -  Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8
             weeks immediately prior to baseline

        Key Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             surgery within 6 months following baseline

          -  Rheumatic autoimmune disease other than rheumatoid arthritis

          -  Functional class IV as defined by American College of Rheumatology (ACR) criteria

          -  Prior history of or current inflammatory joint disease other than rheumatoid arthritis

          -  History of severe allergic or anaphylactic reactions to human, humanized or murine
             monoclonal antibodies

          -  Previous serious infusion reaction to any prior biologic therapy

          -  Known active current or history of recurrent infection

          -  Evidence of chronic hepatitis B or C infection

          -  Pregnant or lactating women

          -  Body weight of > 150 kg