University of Nebraska Division of Rheumatology and Immunology Makes Education, Clinical Research Top Priorities

RAIN set the bar for community-based trial participation and low cost—Dr. O’Dell estimates the initial study cost $30,000–40,000—and the model has since been expanded to other clinical trial initiatives. Having established a trial infrastructure with the Veterans Administration, the division has grown its clinical trials. The recently published RACAT trial was a $20 million trial and was conducted in cooperation with 10 RAIN sites, 18 hospitals in the VA Cooperative Studies Program and eight Canadian centers.²

Dr. Mikuls, who is co-director of the Omaha VA RA/DMARD Clinic and principal investigator (PI) for the Nebraska Arthritis Outcomes Research Center (NAORC), has served as the PI for the multi-center Veterans Affairs Rheumatoid Arthritis (VARA) registry since its inception in 2003. The VARA includes more than 2,600 veteran patients from 13 VA centers.

Dr. Kaleb Michaud was the recipient of the 2016 AHRP Distinguished Scholar Award.

Serum, plasma and DNA samples are collected when patients meet ACR classification criteria for RA, give informed consent and are banked in a central biorepository housed at the Nebraska Western-Iowa VA Health Care System in Omaha. Studies (more than 60 publications since 2007) drawing upon this repository have produced a wealth of insights about the largely male older population of veterans, “a unique population which many think of as being atypical of people with rheumatoid arthritis,” Dr. Mikuls says.³

Dr. Mikuls is also working with the recently launched gout trial, also a VA Cooperative Study trial, which promises to be, says Dr. O’Dell, “the world’s largest gout trial ever done.”

Epidemiologist Kaleb Michaud, PhD, associate professor, Internal Medicine, Division of Rheumatology, is now PI of the RAIN database. He joined the division in 2007 after working with the renowned Fred Wolfe, founder of the National Data Bank for Rheumatic Diseases (NDB). Originally trained as a physicist, Dr. Michaud discovered his interest in rheumatology in 2001 when he took a break from grad school to work with Dr. Wolfe. Winner of an ARHP Distinguished Scholar Award in 2016, Dr. Michaud continues his work with the NDB as co-director, while also steering the Arthritis Internet Registry, which he founded in 2010.

He says he chose to join the division because the faculty “made it clear that they care about how patients do. Dr. O’Dell always emphasizes the whole patient picture and that patients are human and have other aspects of their lives that influence their health, including financial issues.”

Of the wealth of patient data now in biorepositories, Dr. Michaud says, “We have more data than we know what to do with. We are always looking for collaborations, and we are committed to sharing our data.”