A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will be an open-label prospective analysis of oral prednisone (compared to IV
      methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis.
      The study will be useful as pilot data to establish that there are no different trends
      between the two treatment strategies at decreasing the frequency and severity of acute
      infusion reactions. It would also establish proof of principle that pre-treatment with oral
      prednisone is equally as efficacious as IV methylprednisolone.

      The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in
      RA.

      By showing that there are no differences in the frequency or severity of acute infusion
      reactions after rituximab when using pre-treatment with oral prednisone compared to I.V.
      methylprednisolone, we will establish proof of principle that oral prednisone is a viable
      alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a
      practical advantage for both the patient and the treating physician. The patient could
      self-administer this treatment at home thereby decreasing the time they would need to spend
      at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of
      methylprednisolone.
    

Detailed description: 
      This study will be an open-label prospective analysis of oral prednisone (compared to IV
      methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis.
      The study will be useful as pilot data to establish that there are no different trends
      between the two treatment strategies at decreasing the frequency and severity of acute
      infusion reactions. It would also establish proof of principle that pre-treatment with oral
      prednisone is equally as efficacious as IV methylprednisolone.

      The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in
      RA.

      By showing that there are no differences in the frequency or severity of acute infusion
      reactions after rituximab when using pre-treatment with oral prednisone compared to I.V.
      methylprednisolone, we will establish proof of principle that oral prednisone is a viable
      alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a
      practical advantage for both the patient and the treating physician. The patient could
      self-administer this treatment at home thereby decreasing the time they would need to spend
      at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of
      methylprednisolone..
    

Intervention name(s): prednisone
Intervention type(s): Drug
Intervention description(s): prednisone 40mg by mouth 30-60 minutes prior to rituximab
Other intervention name(s): Rayos
Intervention MeSH terms: Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituxan; Rituximab