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GLORIA SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

GLORIA project word cloud

Explore the words cloud of the GLORIA project. It provides you a very rough idea of what is the project "GLORIA" about.

expectations painful ra gt risk chronically nested patients adherence explore 50 rheumatoid randomized societal 2 collected harm balance regulatory safety model 800 safe prove physician prednisolone combination compliance 65y pragmatic care arthritis monitor trial dose disabling chronic events dramatically receive mg reminders guideline multiple frequent criteria liberal patient good minimizing entered data qualitative routine health inadequate smart population load clinical comorbidities efficacy gloria benefit personalized conducting conferences tool physicians glucocorticoids tested adverse therapy committees networking receiving disease agencies device guidelines eligibility drugs additionally elderly gc antirheumatic send placebo representativeness standard update daily polypharmacy

Project "GLORIA" data sheet

The following table provides information about the project.

Coordinator	STICHTING VUMC Organization address address: DE BOELELAAN 1117 city: AMSTERDAM postcode: 1081 HV website: www.vumc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Netherlands [NL]
Project website	http://www.gloriatrial.org
Total cost	5˙855˙219 €
EC max contribution	5˙855˙219 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-PHC-2014-two-stage
Funding Scheme	RIA
Starting year	2015
Duration (year-month-day)	from 2015-09-01 to 2021-08-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	STICHTING VUMC STICHTING VUMC Organization address address: DE BOELELAAN 1117 city: AMSTERDAM postcode: 1081 HV website: www.vumc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (AMSTERDAM)	coordinator	1˙953˙483.00
2	CURVE CLINICAL BV CURVE CLINICAL BV Organization address address: JOOP GEESINKWEG 701 2E ETAGE city: AMSTERDAM DUIVENDRECHT postcode: 1114 AB website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (AMSTERDAM DUIVENDRECHT)	participant	1˙909˙020.00
3	BLUEPHARMA - INDUSTRIA FARMACEUTICASA BLUEPHARMA - INDUSTRIA FARMACEUTICASA Organization address address: SAO MARTINHO DO BISPO city: COIMBRA postcode: 3045 016 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PT (COIMBRA)	participant	479˙923.00
4	BEYONDEVICES LDA BEYONDEVICES LDA Organization address address: ZONA INDUSTRIAL CASAL ESPINHEIRA LOTE 10 city: SOBRAL MONTE AGRAÇO postcode: 2590 057 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PT (SOBRAL MONTE AGRAÇO)	participant	395˙719.00
5	LINICAL ACCELOVANCE EUROPE BV LINICAL ACCELOVANCE EUROPE BV Organization address address: VICTORIALAAN 15 city: 'S-HERTOGENBOSCH postcode: 5213 JG website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL ('S-HERTOGENBOSCH)	participant	314˙025.00
6	CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA E.P.E. CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA E.P.E. Organization address address: AV DE BISSAYA, PRACETA DE MOTA PINTO city: COIMBRA postcode: 3000-075 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PT (COIMBRA)	participant	198˙836.00
7	CHARITE - UNIVERSITAETSMEDIZIN BERLIN CHARITE - UNIVERSITAETSMEDIZIN BERLIN Organization address address: Chariteplatz 1 city: BERLIN postcode: 10117 website: www.charite.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BERLIN)	participant	188˙180.00
8	UNIVERSITA DEGLI STUDI DI GENOVA UNIVERSITA DEGLI STUDI DI GENOVA Organization address address: VIA BALBI 5 city: GENOVA postcode: 16126 website: www.unige.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (GENOVA)	participant	184˙558.00
9	STICHTING TOOLS STICHTING TOOLS Organization address address: MAJELLAPARK 36 city: BUSSUM postcode: 1406 TP website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (BUSSUM)	participant	96˙125.00
10	UNIVERSITATEA DE MEDICINA SI FARMACIE CAROL DAVILA DIN BUCURESTI UNIVERSITATEA DE MEDICINA SI FARMACIE CAROL DAVILA DIN BUCURESTI Organization address address: DIONISIE LUPU 37 city: BUCURESTI postcode: 20021 website: http://www.univermed-cdgm.ro/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	RO (BUCURESTI)	participant	88˙317.00
11	NARODNY USTAV REUMATICKYCH CHOROB-NURCH NIRD NATIONAL INSTITUTE OF RHEUMATIC DISEASES NARODNY USTAV REUMATICKYCH CHOROB-NURCH NIRD NATIONAL INSTITUTE OF RHEUMATIC DISEASES Organization address address: NABREZIE IVANA KRASKU 4 city: PIESTANY postcode: 92112 website: www.nurch.sk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SK (PIESTANY)	participant	23˙991.00
12	DEBRECENI EGYETEM DEBRECENI EGYETEM Organization address address: EGYETEM TER 1 city: DEBRECEN postcode: 4032 website: http://www.unideb.hu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	HU (DEBRECEN)	participant	23˙036.00
13	STICHTING VU STICHTING VU Organization address address: DE BOELELAAN 1105 city: AMSTERDAM postcode: 1081 HV website: www.vu.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (AMSTERDAM)	participant	0.00

Map

Project 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.

Deliverables

List of deliverables.
Reports on the progress of GLORIA project at European and American Rheumatology Annual Congresses (1)	Documents, reports	2020-04-22 09:57:24
Report on the educational activities and surveys conducted under GLORIA (1)	Documents, reports	2020-04-22 09:57:24
Report on analysis of existing guidelines and recommendations	Documents, reports	2020-04-22 09:57:24
Report on current status of the involvement of the elderly in clinical trials	Documents, reports	2020-04-22 09:57:24
Launch of a web-based survey of patientâ€™s opinions	Websites, patent fillings, videos etc.	2020-04-22 09:57:24
Written scientific documents addressing the limitations of current knowledge	Documents, reports	2020-04-22 09:57:24
Launch of web-based survey	Websites, patent fillings, videos etc.	2020-04-22 09:57:24
Scientific content with applicable lay versions made available at website.	Websites, patent fillings, videos etc.	2020-04-22 09:57:24

Take a look to the deliverables list in detail: detailed list of GLORIA deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2017	Yannick Palmowski, Thomas Buttgereit, Christian Dejaco, Johannes W. Bijlsma, Eric L. Matteson, Marieke Voshaar, Maarten Boers, Frank Buttgereit â€œOfficial Viewâ€ on Glucocorticoids in Rheumatoid Arthritis: A Systematic Review of International Guidelines and Consensus Statements published pages: 1134-1141, ISSN: 2151-464X, DOI: 10.1002/acr.23185	Arthritis Care & Research 69/8	2020-04-22
2018	Hartman, L; Rasch, La; Klausch, T; Bijlsma, Hwj; Christensen, R; Smulders, Ym; Ralston, Sh; Buttgereit, F; Cutolo, M; Da Silva JAP,; Opris, D; RovenskÃ½, J; Szamosi, S; Middelink, Lm; Lems, Wf; Boers, M. Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial. published pages: , ISSN: 1745-6215, DOI: 10.1186/s13063-017-2396-3	Trials 2018;19:67.	2020-04-22

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