To date, at least 11 CARRA studies and 16 abstracts have been published. Recently, findings of the Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) appeared in Arthritis & Rheumatism, and this study, sponsored by NIAMS and, although the study is closed to enrollment, tissue samples can be used for ongoing translational studies and novel ways of looking at the data are being pursued.2 Dr. Ilowite notes the seminal trials of early aggressive therapy in JIA, and a study of the safety and effectiveness of rilonacept in systemic JIA. See Table 1 for a complete listing of CARRA studies.
The CARRA Registry
Building on CARRA, the organization of pediatric rheumatologists, is CARRAnet, the network of sites where these investigators work. The first project for CARRAnet is the CARRA Registry, an observational retrospective and prospective cohort study enrolling pediatric patients with major rheumatic diseases who are being followed at participating study sites. But with human and financial resources strained at individual sites, CARRA has had to find outside means to support this endeavor.
“We would like to be able to add, as an organizational support, more infrastructure that is directly usable by sites and that will help them accomplish research. We have done that to some degree with the CARRAnet grant, which was awarded by the National Institutes of Health (NIH) with funds from the American Recovery and Reinvestment Act (ARRA) of 2009,” says Dr. Schanberg. The funds, totaling over $6 million, will enable CARRAnet to bolster its informatics capabilities at individual sites, allowing them to enter patients in the CARRAnet registry. The grant was awarded to Duke University, where Dr. Schanberg one of the lead investigators along with Dr. Sandborg, Dr. Ilowite, and Carol Wallace, MD, at Seattle Children’s Hospital. The grant is administered by the Duke Clinical Research Institute (DCRI).
The goal of CARRAnet is the creation of a unifying, scalable informatics infrastructure for CARRA sites. According to DCRI senior project leader Kathleen Fox, the infrastructure currently under development by CARRAnet will increase operational efficiencies at each CARRA site. “You systematically build on operational processes you agree to at the beginning, and these become less burdensome as you add more projects,” says Fox. “For example, we’ve developed master site agreements. The basic legalese is already agreed upon. When there is a new project, we just add an addendum, rather than renegotiating right from the beginning,” she says. Funding for the CARRAnet grant continues through August 2011 with the possibility of an extension through August 2012.
