In about a year, researchers anticipate integrating a third cohort into the study, this one from the United Kingdom, which also has a national, socialized healthcare system.
Tease out Disease Predictors
Sharing cohorts comes in handy for AutoCure’s second goal: that of developing better prognostic markers for disease. “You need large cohorts that you can follow over many years where you can take samples and test new assays,” says Dr. Klareskog.
Another project lead by Dr. Huizinga and colleagues at the University of Leiden, entails 11 research groups working together to find predictors of response to new therapies. This will be done through a series of clinical trials, including newly launched trials and expansion of previously existing trials.
“Many projects in AutoCure have been going on for years, but now can be brought together,” says Dr. Klareskog.
Clinical trial formats within AutoCure will be standardized, and researchers will investigate new targeted therapies in patients with recent onset disease. Standardization between different international centers will ensure patient selection and evaluation is performed using the same protocols, and that data collection and analyses are done in the same rigorous manner.
In fact, a multi-center clinical trial that was already being conducted by three of the network members, Stop Arthritis Very Early (SAVE), is now part of AutoCure and will be expanded. The trial investigates whether an additional pulse of prednisone added to standard medication is beneficial for treating RA. Plus, several targeted therapies that were already under development by some of the partners will be available to AutoCure trials for further study.
Another key advantage to the conduct of clinical trials under the auspices of AutoCure, is that promising biomarkers and assays being developed by other arms within the network can be used. Information such as genetic and environmental data pertaining to patient populations can also be incorporated into findings from the trials.
“The network allows for easier crossover between studies and sharing of materials—such as the biomarkers, and new therapies being integrated into the clinical trials,” says Dr. Klareskog.
One project relating to prognostic factors is being lead by Scandinavian researchers Tore Saxne, MD, PhD, and Dick Heinegard, MD, PhD, from Lund University in Sweden. They are working with five other AutoCure partners to investigate cartilage and bone markers to predict outcome and response to therapy. The research, which is just starting, will aim to develop and evaluate markers that can be used to monitor tissue processes in both in vitro and in vivo systems.