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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 €

0

EC-Contrib. €

0

Partnership

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 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.

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

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 NL (AMSTERDAM) coordinator 1˙953˙483.00
2    CURVE CLINICAL BV NL (AMSTERDAM DUIVENDRECHT) participant 1˙909˙020.00
3    BLUEPHARMA - INDUSTRIA FARMACEUTICASA PT (COIMBRA) participant 479˙923.00
4    BEYONDEVICES LDA PT (SOBRAL MONTE AGRAÇO) participant 395˙719.00
5    LINICAL ACCELOVANCE EUROPE BV NL ('S-HERTOGENBOSCH) participant 314˙025.00
6    CENTRO HOSPITALAR E UNIVERSITARIO DE COIMBRA E.P.E. PT (COIMBRA) participant 198˙836.00
7    CHARITE - UNIVERSITAETSMEDIZIN BERLIN DE (BERLIN) participant 188˙180.00
8    UNIVERSITA DEGLI STUDI DI GENOVA IT (GENOVA) participant 184˙558.00
9    STICHTING TOOLS NL (BUSSUM) participant 96˙125.00
10    UNIVERSITATEA DE MEDICINA SI FARMACIE CAROL DAVILA DIN BUCURESTI RO (BUCURESTI) participant 88˙317.00
11    NARODNY USTAV REUMATICKYCH CHOROB-NURCH NIRD NATIONAL INSTITUTE OF RHEUMATIC DISEASES SK (PIESTANY) participant 23˙991.00
12    DEBRECENI EGYETEM HU (DEBRECEN) participant 23˙036.00
13    STICHTING VU 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 patient’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

year authors and title journal last update
List of publications.
2017 Yannick Palmowski, Thomas Buttgereit, Christian Dejaco, Johannes W. Bijlsma, Eric L. Matteson, Marieke Voshaar, Maarten Boers, Frank Buttgereit
“Official View” 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; Rovenský, 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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