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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.

Call for proposal

H2020-PHC-2014-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

STICHTING VUMC
Address
De Boelelaan 1117
1081 HV Amsterdam
Netherlands
Activity type
Research Organisations
EU contribution
€ 1 993 816,89

Participants (12)

CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA EPE
Portugal
EU contribution
€ 198 836,71
Address
Av De Bissaya, Praceta De Mota Pinto
3000-075 Coimbra
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 188 180,44
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI GENOVA
Italy
EU contribution
€ 156 875,25
Address
Via Balbi 5
16126 Genova
Activity type
Higher or Secondary Education Establishments
NARODNY USTAV REUMATICKYCH CHOROB-NURCH NIRD NATIONAL INSTITUTE OF RHEUMATIC DISEASES
Slovakia
EU contribution
€ 22 015
Address
Nabrezie Ivana Krasku 4
92112 Piestany
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
DEBRECENI EGYETEM
Hungary
EU contribution
€ 20 486
Address
Egyetem Ter 1
4032 Debrecen
Activity type
Higher or Secondary Education Establishments
UNIVERSITATEA DE MEDICINA SI FARMACIE CAROL DAVILA DIN BUCURESTI
Romania
EU contribution
€ 86 760
Address
Dionisie Lupu 37
020021 Bucuresti
Activity type
Higher or Secondary Education Establishments
LINICAL NETHERLANDS B.V.
Netherlands
EU contribution
€ 317 373,99
Address
Victorialaan 15
5213 JG 'S-hertogenbosch
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CR2O BV
Netherlands
EU contribution
€ 1 909 020
Address
Bisonspoor 3002, C701
3605 LT Maarssen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
STICHTING TOOLS
Netherlands
EU contribution
€ 96 125
Address
Majellapark 36
1406 TP Bussum
Activity type
Other
BLUEPHARMA - INDUSTRIA FARMACEUTICASA
Portugal
EU contribution
€ 479 923,75
Address
Sao Martinho Do Bispo
3045 016 Coimbra
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BEYONDEVICES LDA
Portugal
EU contribution
€ 385 806
Address
Zona Industrial Casal Espinheira Lote 10
2590 057 Sobral Monte Agraço
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
STICHTING VU

Participation ended

Netherlands
EU contribution
€ 0
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments