Community Research and Development Information Service - CORDIS

H2020

GLORIA Report Summary

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

Periodic Reporting for period 1 - GLORIA (Comparing the effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis)

Reporting period: 2015-09-01 to 2016-08-31

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 first 12 months period have been used to start up the project: submission of the trial protocol to the competent authorities and ethical committees of each of the partner states; production and distribution of study drug; preparation of procedures, study database, personnel training, etc.
Development of the statistical analysis plan and a manuscript of trial protocol to be submitted to peer reviewed journal: ongoing.
First meeting of the general assembly was held; a very successful first networking meeting has been organised and in addition we managed the development and publication of the project website.
At the end of the reporting period Netherlands, Germany, Finland and Hungary had opened for inclusion of patients, and Netherlands included 4 patients. Portugal, Slovakia and Italy are imminent, and Rumania is delayed. Implementing this simple pragmatic trial is even more challenging than expected, with each country applying their own ethical interpretation, rules for reimbursement of standard health care, each hospital requesting amendments to the clinical trial contract, and issues related to Value-add Tax (VAT) associated with clinical research. In addition, some sites in the end declined to participate.
In view of the above, we have contracted several new centers in The Netherlands as contingency to achieve our inclusion targets.

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)

As described in WP7, we had a very successful networking meeting focused on improving the design and conduct of trials in the elderly. A report of this meeting was finalized and will be submitted for publication in the next period.
The review of guidelines in this WP is also complete and will be submitted for publication in the next period.

Related information

Record Number: 194858 / Last updated on: 2017-02-16
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