The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis (GLORIA) studyA aims to prove that the addition of chronic low dose glucocorticoids (GC) to current anti-rheumatic therapy is highly cost-effective and safe in elderly patients with rheumatoid arthritis (RA).
RA is a frequent (affecting > 2% of the elderly population), painful and disabling chronic disease with high societal costs. RA is associated with multiple comorbidities, polypharmacy and adverse events; these problems, together with challenges in compliance (adherence) are dramatically increased in the elderly population.
About 50% of patients are chronically treated with low-dose glucocorticoids (GC) in combination with other anti-rheumatic drugs, but without good evidence on the balance of benefit and harm.
GLORIA will address these problems by conducting a large pragmatic trial: 800 elderly (>65 years) RA patients receiving standard of care will be randomized to additionally receive 5 mg prednisolone daily or placebo for 2 years. A novel tool will monitor compliance; it can send personalized reminders to a patient’s smart device. The efficacy of this technology will be tested in a nested trial. Compliance and other characteristics will be entered into a model that will allow personalized risk and benefit assessment in the future. Qualitative research in patients and physicians of member states will explore expectations and challenges in guideline implementation. This information and the study results will enable an update to existing guidelines and patient information, in collaboration with guideline committees and regulatory agencies. Networking conferences will improve health technology assessment in the elderly in general.