John D. Carter, MD, an assistant professor of medicine in the Division of Rheumatology, was recently awarded two investigator-initiated grants totaling nearly $735,000.

Dr. Carter received a 2-year, $501,125 award from Genentech for a pilot clinical study titled “A Safety Analysis of Oral Prednisone as a Pre- Treatment for Rituximab in Rheumatoid Arthritis.” He will evaluate whether a one-time dose of oral prednisone, a corticosteroid, is as effective as standard pre-treatment with the intravenous methylprednisolone, also a corticosteroid, at reducing acute infusion reactions in patients subsequently treated with Rituxan, a new FDA-approved IV therapy for rheumatoid arthritis.

Pre-medication with IV methylprednisolone has been shown to decrease the frequency and severity of hypersensitivity reactions to Rituxan, including hives, low blood pressure, and respiratory distress. However this IV pre-medication adds significant time and cost to the infusion process. If the study demonstrates pre-treatment with oral steroids works as well IV steroids, patients would spend less time at the infusion center or hospital because they could self-adminster the oral steroids at home, Dr. Carter said. The study will enroll 50 patients.

A second pilot study titled “MRI and Ultrasound Findings in Patients with Gout and Normal Plain Radiographs” was funded by TAP Pharmaceuticals for $233,650. Physicians typically use standard X-rays to help manage gout, a disease characterized by severe pain, redness and tenderness in the joints. Dr. Carter will evaluate whether magnetic resonance imaging and ultrasound detect joint damage in patients with gout before any skeletal abnormalities appear on standard X-rays.

“We expect the MR imaging and ultrasound to show that patients who are left untreated based on normal X-rays are likely to already have skeletal damage,” Dr. Carter said. “If that proves true, it could change the treatment paradigm for gout.” The study will enroll 35 patients.

Most clinical studies conducted by physicians are industry initiated and sponsored drug trials with multiple sites. Pharmaceutical companies negotiate with the MD to serve as principal investigator of a particular local study. Instead, Dr. Carter proposed these “investigator-initiated” studies and the companies indicated that his research questions had merit by awarding him two large grants through a competitive peer-review process. Once the grants were awarded, USF became the sponsor.