The Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) was founded in 2000 by leading rheumatologists dedicated to advancing and improving the care of patients with rheumatic diseases.
CORRONA's mission is to advance rheumatology research and improve the quality of rheumatology patient care. CORRONA is an independent registry without any ownership links to the pharmaceutical industry.
Comparative effectiveness research is becoming a major focus in the drive to improve US health care, and the CORRONA database provides a unique resource for this effort. This research will help guide physicians and patients to the most effective treatments, and reassure all parties, from the patient to the payers, that the drugs prescribed are indeed safe and effective in a ‘real world’ setting. Society needs hard data to prove that expensive new treatments control disease with an acceptable safety margin. CORRONA’s practice sites can generate the data needed to address these very important issues.
The goal of CORRONA-CERTAIN is to measure in a more controlled robust manner the clinical effectiveness of biologic therapies in Rheumatoid Arthritis (RA) patients at specific time intervals after they are started, and to compare the effectiveness across alternative treatments. Patients with RA and with at least moderate disease activity started on biologics (naïve or switchers) will be enrolled into this comparative effectiveness study, and followed over time as with regular CORRONA enrollees. In order to rigorously relate treatment to disease activity, adverse effects, and laboratory measures, CORRONA-CERTAIN will begin to collect data at the encounter at which the decision is made to start or change biologic treatment, along with regular mandated visits at three month intervals.
The study will use the existing but updated CORRONA data collection questionnaires to collect information in a variety of outcomes including but not limited to full ACR core dataset, HAQ, as well as EQ5D and fatigue.
The protocol will also investigate the important effects of biologic agents on lipids, liver enzymes and high sensitivity C-reactive protein on blood samples collected during each of the CORRONA-CERTAIN visits and sent to a collaborating central laboratory. Blood tests include complete blood count, a comprehensive metabolic profile, high sensitivity CRP, immunoglobulin levels, Rheumatoid Factor, and anti CCP antibodies. We will also be storing serum, plasma and DNA samples, as well as RNA for gene expression profiling, to determine whether genetic variants (single nucleotide polymorphisms or SNPs), molecular signatures (expression profiles) or specific proteomic biomarkers can be used to predict response to different therapies – creating truly personalized medicine.
Safety data will be generated using the established CORRONA mechanism for reporting Targeted Adverse Events including serious infections, malignancies, cardiovascular outcomes, neurologic, anaphylactic events and others. Through collaboration with an independent party we will be able to track participants in case of loss of follow up and also collect medical records pertinent to adverse events and hospitalizations. Linkage to the administrative databases is also planned.
The study will be launched in the early fall 2010.