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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 €

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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.

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

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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