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Comparing the effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis

Comparing the effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis

Objective

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). 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 antirheumatic drugs, but without good evidence on the balance of benefit and harm. Thus, existing guidelines and information on safety and efficacy of GC are inadequate.
GLORIA will address these problems by conducting 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. Very liberal eligibility criteria will ensure representativeness to the target population, and most data will be collected from routine clinical practice, minimizing patient and physician load, and operating costs. 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.

Coordinator

STICHTING VUMC

Address

De Boelelaan 1117
1081 Hv Amsterdam

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 860 831,79

Participants (12)

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CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA E.P.E.

Portugal

EU Contribution

€ 198 836,71

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 188 180,43

UNIVERSITA DEGLI STUDI DI GENOVA

Italy

EU Contribution

€ 184 558,96

NARODNY USTAV REUMATICKYCH CHOROB-NURCH NIRD NATIONAL INSTITUTE OF RHEUMATIC DISEASES

Slovakia

EU Contribution

€ 23 991,65

DEBRECENI EGYETEM

Hungary

EU Contribution

€ 23 036,66

UNIVERSITATEA DE MEDICINA SI FARMACIE'CAROL DAVILA' DIN BUCURESTI

Romania

EU Contribution

€ 88 317,43

ACCELOVANCE EUROPE BV

Netherlands

EU Contribution

€ 406 677

CURVE CLINICAL BV

Netherlands

EU Contribution

€ 1 909 020

STICHTING TOOLS

Netherlands

EU Contribution

€ 96 125

BLUEPHARMA - INDUSTRIA FARMACEUTICASA

Portugal

EU Contribution

€ 479 923,75

BEYONDEVICES LDA

Portugal

EU Contribution

€ 395 719,65

STICHTING VU

Netherlands

Project information

Grant agreement ID: 634886

Status

Ongoing project

  • Start date

    1 September 2015

  • End date

    31 August 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 855 219,03

  • EU contribution

    € 5 855 219,03

Coordinated by:

STICHTING VUMC

Netherlands