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Explore This IssueDecember 2012
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Dimitrios Pappas, MD, MPH, assistant professor of medicine at Columbia University, has been the scientific director for the CERTAIN substudy since July of 2009. He explains that patients in the study will be seen at three-month intervals for one year after initiation of a biologic agent. Biologic agents will be started at the discretion of the treating CORRONA investigator and there will not be any intervention by CORRONA regarding the treatment chosen. Information about disease activity, disease severity, functionality, concurrent medication, and comorbidities will be collected at every visit. Blood samples, to include complete blood count, comprehensive metabolic panel, serologies, immunoglobulin levels, high-sensitivity C-reactive protein, and a lipid panel with a direct low-density lipoprotein, will also be obtained and tested in a central laboratory. In addition DNA, RNA, serum, and plasma will be collected and stored for future research. After completion of their participation in CERTAIN, patients will be followed in the main CORRONA registry, allowing long-term follow-up on safety. “You know, most clinical trials last for a few months and enroll few hundreds of patients, thus possibly not allowing for rare safety signals to be detected,” says Dr. Pappas. “Participation in CERTAIN is followed by regular follow up in the main CORRONA registry and collection of information for adverse events—even the most rare ones. If the patients in our registry have any safety issues, we’ll be able to associate those with the biologic they began at the start of our study.”
Dr. Pappas began his association with CORRONA as an internal medicine resident at Albany Medical College, where Dr. Kremer was his mentor. He started working with the registry in earnest after completing his rheumatology fellowship at Johns Hopkins University in Baltimore in 2009. In addition to directing the CERTAIN substudy, he now heads the International Registry, which started enrolling patients in Asia, Eastern Europe, and Latin America just over a year ago.
The logic for starting the CORRONA International Registry was driven by trends in the pharmaceutical industry, says Dr. Kremer. Due to the dearth of U.S. participants, industry has now been conducting clinical trials in Asia, India, Mexico, and South America. “We have no societal context for these populations,” Dr. Kremer points out. CORRONA has stepped into the vacuum, to supply crucial “real-world data” information about those patients’ comorbidities, malignancies, and disease severity.
The time is now right for initiating another new arm to include the spondylarthritidies, says Dr. Mease, who will be the scientific director of that new nested study, set to roll out in the first quarter of 2013. The broadened criteria set developed by the Assessment of SpondyloArthritis International Society and a parallel interest from pharmaceutical companies to examine the effects of drugs such as adalimumab in the patients with axial and/or peripheral symptoms have set the stage for capturing a broader cohort of patients. “We think that some patients with spondylarthritidies may be ‘hidden’ in primary, orthopedic, or physiatry clinics because their symptoms are not recognized,” he says.