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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 3 - GLORIA (Comparing the effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis)

Teaser

Summary

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: 450 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 patientâ€™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

The third period of the project was mostly characterized by efforts aimed at boosting trial recruitment and requesting the 12-month extension. We closed non-recruiting clinical centres and opened new centres. We regularly contacted all recruitment partners and visited all Dutch centres. The amendment loosening selection criteria was approved in all countries. Together with our patient partner, we drafted a patient newsletter which was sent to the patients in countries where this was allowed. All recruitment efforts resulted in a strongly increased uptake, and a steady recruitment rate of 15-20 patients per month. Based on observations in the blinded dataset a new sample size calculation was performed. This calculation yielded a sample size of 450 patients to achieve the objectives of this study. The project and the recruitment period were extended with one year. On Dec 31 2018, 452 patients had been recruited, and recruitment stopped.

In addition to successfully ending recruitment, the adherence sub-study commenced during this third period several posters were presented at scientific meetings, and manuscripts were published (open access) in peer review journals.

Final results

\"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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