Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of South Florida |
---|---|
Information provided by: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00580229 |
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.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: prednisone |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. |
Estimated Enrollment: | 50 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Prednisone 40mg by mouth 30-60 minutes prior to rituximab.
|
Drug: prednisone
prednisone 40mg by mouth 30-60 minutes prior to rituximab
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John D Carter, M.D. | (813) 974-2681 | jocarter@health.usf.edu |
Contact: Nancy Albritton, LPN | (813) 974-8206 | nalbritt@health.usf.edu |
United States, Florida | |
University of South Florida | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Nancy Albritton, LPN 813-974-8206 nalbritt@health.usf.edu | |
Principal Investigator: John D. Carter, M.D. | |
Arthritis Research of Florida, Inc. | Recruiting |
Palm Harbor, Florida, United States, 34684 | |
Contact: Ginger Pfeiffer, R.N., C.C.R.C 727-210-2555 studies@tampabay.rr.com | |
Principal Investigator: Anthony I. Sebba, M.D. |
Principal Investigator: | John D. Carter, M.D. | University of South Florida |
Responsible Party: | University of South Florida ( John D. Carter, M.D. ) |
Study ID Numbers: | U4164s, 6173-A673CA |
Study First Received: | December 18, 2007 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00580229 History of Changes |
Health Authority: | United States: University of South Florida Institutional Review Board |
Rituxan Rituximab |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Immunologic Factors Antineoplastic Agents, Hormonal Rituximab Joint Diseases Hormone Antagonists Arthritis, Rheumatoid |
Hormones, Hormone Substitutes, and Hormone Antagonists Rheumatic Diseases Glucocorticoids Hormones Musculoskeletal Diseases Arthritis Connective Tissue Diseases Antirheumatic Agents |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Immunologic Factors Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Rituximab Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid |
Hormones, Hormone Substitutes, and Hormone Antagonists Rheumatic Diseases Glucocorticoids Hormones Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Antirheumatic Agents |