A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.