CORRONA is a virtual enterprise, and its key board members and investigators also run their own full-time academic or private practices, as well as independent research studies. Dr. Kremer notes that the penchant for dedicating time to the venture has been linked to what members have dubbed the “CORRONA virus.” “It’s bizarre and it’s frightening,” Dr. Kremer laughs. “You catch this uncontrollable desire to do good things working with your other collaborators in this company. And as a consequence, nobody works a 40-hour week.”
A Good Fit
Dr. Greenberg first became involved with CORRONA as a rheumatology fellow in 2003, when he was searching for interesting data sets for his own rheumatology research. He has since become the chief scientific officer for the organization, juggling his own research, busy academic practice, and CORRONA participation. “Observational registries, both in the U.S. and Europe, have made substantial contributions to our understanding of long-term biologic drug safety, and they’ll continue to do so,” he says. “CORRONA is a unique resource in the U.S. for rheumatology research.”
Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center and clinical professor at the University of Washington in Seattle, is a member of CORRONA’s board of directors and scientific advisory committee. He joined the venture because he was impressed with the uniqueness of the registry: “It has the computer and biostatistics infrastructure and a broad array of clinics across the country—both private and academic—that is representative of rheumatology in general,” he says. At the Swedish Medical Center, he and his department have been “early adopters” of quantitative measurement, employing the Disease Activity Score-28 and other patient assessments. “It’s been pretty easy for us to slip into efforts like the Treat-to-Target paradigm,” Dr. Mease notes, “because of the fact that we’ve been collecting that quantitative information.” Joining the CORRONA registry was a good fit for his practice and for his patients. “Oftentimes, our patients will track their own quantitative information, and it helps them think through decision making with us. So, [participation in CORRONA] has been a win–win in our setting.”
Nested Trials and Studies
Jeffrey Curtis, MD, MPH, associate professor of medicine, clinical immunology, and rheumatology at the University of Alabama at Birmingham, has been involved with CORRONA for the past five years and was the initial designer of the CERTAIN substudy, a comparative effectiveness study which has now enrolled 2,733 patients with inflammatory arthritis treated with biologics. The study will follow patients for one year after the initiation of a biologic agent for moderate or high disease activity and is designed to supply “real-world data,” mainly on biologic treatment comparative effectiveness and safety, but also on treatment patterns and preferences of U.S. patients with inflammatory arthritis. This is especially needed, says Dr. Curtis, because data on biologic treatments have mostly originated from clinical trials where biologic agents are compared against placebo and not compared head to head. In addition, most other large available observational registries are European; and in those countries, biologic therapies are not allowed in patients with moderate disease activity, as is the case in the U.S. “In terms of maximizing the generalizability of what we learn from registries, it’s important to make sure the registry provides results relevant for the kinds of people, practice settings, and geography of the patients doctors see on a day-to-day basis,” says Dr. Curtis. “In the U.S., I think CORRONA is quite unique in that regard.”