Multicentric system for the assessment of the progress and results of biological therapy of ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and systemic lupus erythematosus.
start of the project: January 2002
The ATTRA project involves several clinical registries which have been maintained since 2002 under the surveillance of the Czech Rheumatological Society - the expert guarantor for this project. The ATTRA project is a multicentre system which has been designed to monitor the progress and results of biological therapy applied to inflammatory rheumatic diseases. A number of Czech rheumatology centres already participate in the project, and the system is open for additional participants who might be interested in it.
The project was initiated at the Institute of Biostatistics and Analyses of the Masaryk University (IBA MU) and has continued at the Institute of Biostatistics and Analyses Ltd (IBA Ltd), a university company.
The following diagnoses have been monitored:
In 2012, the entire project was revised in order to be adjusted to the current needs. Demands on the quality of collected data have steadily raised, and more emphasis is put on the long-term follow-up of patients (even after the termination of biological therapy) as well as on the possibility to compare the results of biological therapy with a control group. These requirements have recently been formulated by the EULAR expert group, for example (Dixon et al., Ann Rheum Dis 2010; 69: 1596-1602) and are a natural consequence of the basic purpose of the registry, which is the follow-up and a comprehensive analysis of safety and real effectiveness of biological therapy.
Registration of clinical data is centrally managed and its objectives are not only aimed at scientific research. An agreement on parametric assessment of the treatment process made it possible to develop treatment guidelines, to define entry criteria for treatment start, and to assess the treatment response correctly.
Continuous data assessment and feedback are provided to physicians and health care management, meeting the requirements of evidence-based medicine. Patient rights are fully respected and data collection is anonymous (de-identified), i.e. it does not involve any personal data. An extensive programme of Quality of Life (QoL) monitoring is involved in the ATTRA project.
Adverse effects are classified using the MedDRA (Medical Dictionary for Regulatory Activities) terminology, which, besides other things, makes it possible to use data from the ATTRA registry in common analyses of European registries.