Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Autoimmune Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the impact of rapid infusion rituximab on the
      incidence of infusion-related reactions in patients with Autoimmune Diseases.
    

Detailed description: 
      Background Rituximab is a human/murine monoclonal antibody targeted at the CD20 antigen
      (cluster of differentiation antigen 20) on B-lymphocytes. The CD20 antigen is expressed in
      over 90% of B-cell non-Hodgkin's lymphomas. B cells are also believed to play a role in the
      pathogenesis of other oncologic and non-oncologic disorders. Targeting B cells appears to
      have a role in decreasing autoimmune and inflammatory processes, as well as antibody
      production in many autoimmune diseases. Rituximab is approved for the treatment of
      non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA)
      in combination with methotrexate, wegener's granulomatosis, and microscopic polyangiitis in
      combination with glucocorticoids. Although rituximab is not approved for multiple sclerosis,
      myasthenia gravis, or other autoimmune diseases, it is commonly used later in the treatment
      course for patients that are not responding to other treatment options. Rituximab's main
      limitation is the occurrence of infusion-related reactions (IRR). These reactions can include
      fever, chills, rash, respiratory compromise, and a variety of other symptoms, including
      death. The incidence of IRR is known to vary depending on the rituximab indication. The
      incidence of IRR with the first infusion of rituximab is approximately 77% with NHL, 27% with
      RA, and 12% with wegener's granulomatosis and microscopic polyangiitis. The incidence of IRR
      decreases with subsequent infusions of rituximab to approximately 5-10%. According to the
      National Cancer Institute, there are 5 grades of IRR. In general, grade 1 reactions are
      classified as asymptomatic or only mild symptoms that do not require intervention. Grade 2
      reactions are classified as moderate with minimal, local, or noninvasive interventions
      required. Grade 3 reactions are classified as severe and medically significant, but not
      immediately life-threatening. These reactions require hospitalization or prolongation of a
      current hospitalization. Grade 4 reactions are classified as life-threatening with urgent
      interventions required. Grade 5 reactions are classified as death related to an adverse drug
      event. The incidence of IRR is a chief concern for patients, nurses, and other healthcare
      providers.

      The package labeling recommends the administration of a standard infusion of rituximab for
      all patients initiating rituximab therapy to minimize IRR. If this infusion is tolerated then
      subsequent infusions may be titrated up to a faster rate to decrease infusion time. Based on
      the manufacturer's package insert, rituximab is infused at a rate of 50 mg/hr and can be
      increased every 30 minutes by 50 mg/hr (maximum rate of 400 mg/hr). If a grade 3 or 4 IRR
      does not occur, subsequent infusions are given at a rate of 100 mg/hr and can be increased
      every 30 minutes by 100 mg/hr (maximum rate of 400 mg/hr). The average infusion time is
      estimated to be 4-6 hours for the first infusion, and 3-4 hours for subsequent infusions.
      Rituximab is typically given in cycles and the timing will vary depending on the indication.
    

Intervention name(s): Rituximab Infusion
Intervention type(s): Drug
Intervention description(s): Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion.
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rapid Infusion Rituximab