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H2020

GLORIA Report Summary

Project ID: 634886
Funded under: H2020-EU.3.1.

Periodic Reporting for period 2 - GLORIA (Comparing the effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis)

Reporting period: 2016-09-01 to 2017-08-31

Summary of the context and overall objectives of the project

GLORIA aims to prove that the addition of chronic low dose glucocorticoids (GC) to current antirheumatic therapy is highly cost-effective and safe in elderly patients with rheumatoid arthritis (RA). The main component of GLORIA is a large pragmatic trial: 800 elderly (>65y) 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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The second year of the project was mostly characterized by efforts aimed at boosting recruitment. We closed non-recruiting centres and opened new centres. We visited all foreign partners, and submitted a protocol amendment to the competent authorities and ethical committees to relax eligibility criteria. This amendment has now been approved in The Netherlands, Hungary and Germany, whilst approval procedures are ongoing in other partner countries. Together with our patient partner, we updated the patient information form and produced patient information material in written and video form. The above has resulted in a strongly increased uptake, and a steady recruitment rate of 20 patients per month. Because this is not enough to reach the target, we have extended the inclusion period until May 2018. Further we have consulted with the relevant officers at the European Committee, and are preparing an extension of the project with one year. In this period 164 patients were recruited, and the clinical sites have been monitored by the CRO. A new batch of study medication has been manufactured. 1800 adherence caps have been produced and the application for the adherence study finalysed. Two webbased surveys have been launched.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

"The ""official view"" on glucocorticoids in rheumatoid arthritis was published. A systematic review of international guidelines and consensus statements. Palmowski Y, Buttgereit T, Dejaco C, Bijlsma JW, Matteson EL, Voshaar M, Boers M, Buttgereit F. Arthritis Care Res (Hoboken). 2016 Dec 28. doi: 10.1002/acr.23185. [Epub ahead of print] PMID: 28029750
As was pre-planned, we also collected a convenience sample of national guidelines. These guidelines include those published by Czech, Finish, Slovakian, Portuguese, Spanish and Colombian authors. All respective publications are on file and will be used to inform participants of the 2nd Networking meeting.


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