title: Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study

acronym: APPROACH-IS

summary: The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

time_perspective: Cross-Sectional

ReferenceCitation: Fox KR, Hardy RY, Moons P, Kovacs AH, Luyckx K, Apers S, Cook SC, Veldtman G, Fernandes SM, White K, Kutty S, Jackson JL; APPROACH-IS Consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Smoking among adult congenital heart disease survivors in the United States: Prevalence and relationship with illness perceptions. J Behav Med. 2021 Dec;44(6):772-783. doi: 10.1007/s10865-021-00239-5. Epub 2021 Jun 29.

family: Fox

full_name: Kristen R. Fox

given: Kristen R.

family: Hardy

full_name: Rose Y. Hardy

given: Rose Y.

family: Moons

full_name: Philip Moons

given: Philip

family: Kovacs

full_name: Adrienne H. Kovacs

given: Adrienne H.

family: Luyckx

full_name: Koen Luyckx

given: Koen

family: Apers

full_name: Silke Apers

given: Silke

family: Cook

full_name: Stephen C. Cook

given: Stephen C.

family: Veldtman

full_name: Gruschen Veldtman

given: Gruschen

family: Fernandes

full_name: Susan M. Fernandes

given: Susan M.

family: White

full_name: Kamila White

given: Kamila

family: Kutty

full_name: Shelby Kutty

given: Shelby

family: Jackson

full_name: Jamie L. Jackson

given: Jamie L.

name: on behalf of the APPROACH-IS Consortium and the International Society for Adult Congenital Heart Disease (ISACHD)

journal_name: Journal of Behavioral Medicine

ReferenceCitation: Moons P, Luyckx K, Thomet C, Budts W, Enomoto J, Sluman MA, Lu CW, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Ombelet F, Apers S, Kovacs AH; APPROACH-IS Consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Physical Functioning, Mental Health, and Quality of Life in Different Congenital Heart Defects: Comparative Analysis in 3538 Patients From 15 Countries. Can J Cardiol. 2021 Feb;37(2):215-223. doi: 10.1016/j.cjca.2020.03.044. Epub 2020 Apr 6.

family: Thomet

full_name: Corina Thomet

given: Corina

family: Budts

full_name: Werner Budts

given: Werner

family: Enomoto

full_name: Junko Enomoto

given: Junko

family: Sluman

full_name: Maayke A. Sluman

given: Maayke A.

family: Lu

full_name: Chun-Wei Lu

given: Chun-Wei

family: Khairy

full_name: Paul Khairy

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Umeå University - DiVA at Umeå University

repositories_institution: Umeå University - DiVA at Umeå University

ReferenceCitation: Moons P, Apers S, Kovacs AH, Thomet C, Budts W, Enomoto J, Sluman MA, Wang JK, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Oechslin E, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Luyckx K; APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Sense of coherence in adults with congenital heart disease in 15 countries: Patient characteristics, cultural dimensions and quality of life. Eur J Cardiovasc Nurs. 2021 Feb 11;20(1):48-55. doi: 10.1177/1474515120930496.

name: KU Leuven Department of Public Health and Primary Care, KU Leuven, Belgium

name: Institute of Health and Care Sciences, University of Gothenburg, Sweden

name: Centre for Person-Centred Care (GPCC), University of Gothenburg, Sweden

name: Department of Paediatrics and Child Health, University of Cape Town, South Africa

name: Toronto Congenital Cardiac Center for Adults, University Health Network, University of Toronto, Canada

name: Knight Cardiovascular Institute, Oregon Health & Science University, USA

name: Center for Congenital Heart Disease, Department of Cardiology, Inselspital – Bern University Hospital, University of Bern, Switzerland

name: Division of Congenital and Structural Cardiology, University Hospitals Leuven, Belgium

name: KU Leuven Department of Cardiovascular Sciences, KU Leuven, Belgium

name: Department of Education, Toyo University, Japan

name: Coronel Institute of Occupational Health, Amsterdam UMC, University of Amsterdam, the Netherlands

name: Department of Cardiology, Jeroen Bosch Hospital, the Netherlands

name: Department of Pediatrics, National Taiwan University Hospital, Taiwan

name: Center for Biobehavioral Health, Nationwide Children’s Hospital, USA

name: Adult Congenital Heart Center, Montreal Heart Institute, Université de Montréal, Canada

name: Adult Congenital Heart Disease Center, Helen DeVos Children’s Hospital, USA

name: Pediatric Cardiology, Frontier Lifeline Hospital (Dr. K. M. Cherian Heart Foundation), India

name: Division of Cardiology, Hospital de Niños, Argentina

name: Adult Congenital Heart Disease Center, Oslo University Hospital - Rikshospitalet, Norway

name: Adult Congenital Heart Unit, Sahlgrenska University Hospital/Östra, Sweden

name: Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Sweden

name: Department of Health Sciences, University West, Sweden

name: Department of Paediatrics, Queen Silvia Children’s Hospital, Sahlgrenska University Hospital, Sweden

name: Department of Public Health and Clinical Medicine, Umeå University, Sweden

name: Division of Cardiology, Stollery Children’s Hospital, University of Alberta, Canada

name: Monash Heart, Monash Medical Centre, Monash University, Australia

name: Department of Cardiology, Mater Dei Hospital, Malta

name: Adult Congenital Heart Disease Center, Cincinnati Children’s Hospital Medical Center, USA

name: Department of Congenital Heart Disease, Louis Pradel Hospital, Hospices civils de Lyon, France

name: Adult Congenital Heart Program at Stanford, Lucile Packard Children’s Hospital and Stanford Health Care, USA

name: Adult Congenital Heart Disease Center, Washington University and Barnes Jewish Heart & Vascular Center, University of Missouri, USA

name: Clinical Psychology Service, IRCCS Policlinico San Donato, Italy

name: Department of Biomedical Sciences for Health, Università degli Studi di Milano, Italy

name: Adult Congenital Heart Disease Center University of Nebraska Medical Center/Children’s Hospital and Medical Center, USA

name: Taussig Heart Center, Johns Hopkins School of Medicine, USA

name: KU Leuven School Psychology and Development in Context, KU Leuven, Belgium

name: UNIBS, University of the Free State, South Africa

journal_name: European Journal of Cardiovascular Nursing

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Van Bulck L, Goossens E, Luyckx K, Apers S, Oechslin E, Thomet C, Budts W, Enomoto J, Sluman MA, Lu CW, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Eriksen K, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Fernandes SM, White K, Callus E, Kutty S, Moons P; APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Healthcare system inputs and patient-reported outcomes: a study in adults with congenital heart defect from 15 countries. BMC Health Serv Res. 2020 Jun 3;20(1):496. doi: 10.1186/s12913-020-05361-9.

name: on behalf of the APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD)

repository_institution: University of Cape Town - Open University of Cape Town

ReferenceCitation: Holbein CE, Veldtman GR, Moons P, Kovacs AH, Luyckx K, Apers S, Chidambarathanu S, Soufi A, Eriksen K, Jackson JL, Enomoto J, Fernandes SM, Johansson B, Alday L, Dellborg M, Berghammer M, Menahem S, Caruana M, Kutty S, Mackie AS, Thomet C, Budts W, White K, Sluman MA, Callus E, Cook SC, Khairy P, Cedars A; APPROACH-IS consortium and the International Society for Adult Congenital Heart Disease (ISACHD). Perceived Health Mediates Effects of Physical Activity on Quality of Life in Patients With a Fontan Circulation. Am J Cardiol. 2019 Jul 1;124(1):144-150. doi: 10.1016/j.amjcard.2019.03.039. Epub 2019 Apr 10.

ReferenceCitation: Apers S, Kovacs AH, Luyckx K, Alday L, Berghammer M, Budts W, Callus E, Caruana M, Chidambarathanu S, Cook SC, Dellborg M, Enomoto J, Eriksen K, Fernandes SM, Jackson JL, Johansson B, Khairy P, Kutty S, Menahem S, Rempel G, Sluman MA, Soufi A, Thomet C, Veldtman G, Wang JK, White K, Moons P; APPROACH-IS consortium; International Society for Adult Congenital Heart Disease (ISACHD). Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods. Int J Cardiol. 2015 Jan 20;179:334-42. doi: 10.1016/j.ijcard.2014.11.084. Epub 2014 Nov 8.

title: Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease — International Study (APPROACH-IS): Rationale, design, and methods

location_country:
Italy
United States
Sweden
India
Switzerland
Netherlands
France
Japan
Malta
Norway
Belgium
Argentina
Australia
Canada
Taiwan

location_facility: Northern Alberta Adult Congenital Heart Clinic

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital of Pittsburgh of UPMC


type: EudraCT Number

title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

summary:
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.

•During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Tarrant JM, Galien R, Li W, Goyal L, Pan Y, Hawtin R, Zhang W, Van der Aa A, Taylor PC. Filgotinib, a JAK1 Inhibitor, Modulates Disease-Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials. Rheumatol Ther. 2020 Mar;7(1):173-190. doi: 10.1007/s40744-019-00192-5. Epub 2020 Jan 7.

family: Tarrant

full_name: Jacqueline M. Tarrant

given: Jacqueline M.

sequence: first

family: Galien

full_name: René Galien

given: René

sequence: additional

family: Li

full_name: Wanying Li

given: Wanying

family: Goyal

full_name: Lovely Goyal

given: Lovely

family: Pan

full_name: Yang Pan

given: Yang

family: Hawtin

full_name: Rachael Hawtin

given: Rachael

family: Zhang

full_name: Wangshu Zhang

given: Wangshu

family: Van der Aa

full_name: Annegret Van der Aa

given: Annegret

family: Taylor

full_name: Peter C. Taylor

given: Peter C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Rheumatology and Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Westhovens R, Taylor PC, Alten R, Pavlova D, Enríquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017 Jun;76(6):998-1008. doi: 10.1136/annrheumdis-2016-210104. Epub 2016 Dec 19.

family: Westhovens

full_name: R Westhovens

given: R

full_name: P C Taylor

given: P C

family: Alten

full_name: R Alten

family: Pavlova

full_name: D Pavlova

given: D

family: Enríquez-Sosa

full_name: F Enríquez-Sosa

given: F

family: Mazur

full_name: M Mazur

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Guatemala
Australia
Belgium
Russian Federation
Ukraine
France
Poland
Argentina
Moldova, Republic of
Colombia
Chile
Bulgaria
Hungary
Germany
United States
Austria
Mexico
Czechia
Israel
New Zealand
Spain
Latvia

location_facility: Diagnostic Consultative Center "Sveta Anna" LTD

location_facility: Charite Mitte, Rheumatologie Neue Therapien

location_facility: Hospital Regional "Guillermo Grant Benavente"

location_facility: Centro Integral de Reumatologia e Inmunologia SAS

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: Municipal Institution Lutsk City Clinical Hospital

location_facility: Centro de Investigacion Clínica del Sur Freire

location_facility: Instituto Terapias Oncologicas Providencia

location_facility: Instituto de Asistencia Reumatologia Integral

location_facility: Clinica Medica Especializada en Reumatologia

location_facility: Center for Innovative TherapyDivision of Rheumatology, UCSD

location_facility: "Multiprofile Hospital for Active Treatment - Kaspela" LTD

location_facility: Artho Care, Arthritis Care & Research P.C.

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Schlossparkklinik - Akad. Lehrkrankenhaus Charite

location_facility: State University of Medicine and Dentistry

location_facility: National Transport Hospital "Tsar Boris" III

location_facility: Centro Integral de Reumatologia de Caribe

location_facility: Ambulance Revmatologie a Interniho Lekarstvi

location_facility: Central Outpatient Hospital of Deanyanskyy Distric

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

location_facility: V. Gusak Institute of Urgent and Recovery Surgery

location_facility: Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Centro de Estudios de Investigacion Basica y Clinica, SC

location_facility: Fundación del caribe para la investigación medica Fundación BIOS

location_facility: Central regional polyclinic of Pechersk District

location_facility: Medical University/ AKH Vienna/ Dep.of Rheumatology 6J

location_facility: Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly

location_facility: Rheumatology Associates of North Alabama, PC


title: Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

acronym: REASSURE

summary: Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bayer

location_country:
Italy
Austria
United States
Luxembourg
Sweden
Mexico
Netherlands
Germany
Spain
France
Czechia
Greece
Israel
Argentina
Belgium
Portugal
Denmark
Canada
United Kingdom
Colombia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShuntTM Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

acronym: IMS

summary: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

ReferenceCitation: Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 May 27. pii: S0161-6420(21)00384-5. doi: 10.1016/j.ophtha.2021.05.023. [Epub ahead of print]

family: Baker

full_name: N. Douglas Baker

given: N. Douglas

family: Barnebey

full_name: Howard S. Barnebey

given: Howard S.

family: Moster

full_name: Marlene R. Moster

given: Marlene R.

family: Stiles

full_name: Michael C. Stiles

given: Michael C.

family: Vold

full_name: Steven D. Vold

given: Steven D.

family: Khatana

full_name: Anup K. Khatana

given: Anup K.

family: Flowers

full_name: Brian E. Flowers

given: Brian E.

family: Grover

full_name: Davinder S. Grover

given: Davinder S.

family: Strouthidis

full_name: Nicholas G. Strouthidis

given: Nicholas G.

family: Panarelli

full_name: Joseph F. Panarelli

given: Joseph F.

journal_name: Ophthalmology

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: InnFocus Inc.

location_country:
Italy
Netherlands
France
Spain
United States
United Kingdom

location_facility: Rashid, Rice, Flynn and Reilley Eye Associates

location_facility: Pole Ophtalmologique de la Clinique Mutualiste

location_facility: Chicago Glaucoma Consultants and CGC Eye Center

location_facility: Ophthalmic Surgeons and Consultants of Ohio

location_facility: New York Eye and Ear Infirmary of Mt. Sinai

location_facility: University of California at Davis Eye Center

location_facility: Glaucoma Consultants of the Capital Region

intervention_type: Device

status_simplified: Completed


ReferenceType: background

ReferenceCitation: Yardley DA, Brufsky A, Coleman RE, Conte PF, Cortes J, Glück S, Nabholtz JM, O'Shaughnessy J, Beck RM, Ko A, Renschler MF, Barton D, Harbeck N. Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial. Trials. 2015 Dec 16;16:575. doi: 10.1186/s13063-015-1101-7. Erratum in: Trials. 2016;17:63.

ReferenceCitation: Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, Beck R. First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial. Cancer Manag Res. 2019 Dec 12;11:10427-10433. doi: 10.2147/CMAR.S208712. eCollection 2019.

family: Liu

full_name: Minetta C Liu

given: Minetta C

family: Janni

full_name: Wolfgang Janni

given: Wolfgang

family: Georgoulias

full_name: Vassilis Georgoulias

given: Vassilis

family: Yardley

full_name: Denise A Yardley

given: Denise A

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

family: Wei

full_name: Xin Wei

given: Xin

family: McGovern

full_name: Desmond McGovern

given: Desmond

family: Beck

full_name: Robert Beck

given: Robert

bso_classification: Chemistry

currency_apc_doaj: USD

journal_name: Cancer Management and Research

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Celgene

location_country:
Italy
Austria
United States
Brazil
Spain
Germany
France
Greece
Australia
Portugal
Canada
United Kingdom

acronym: tnAcity

location_facility: University of California San Diego Moores Cancer Center

location_facility: Facharztpraxis fur Gynakologie und Geburtshilfe

location_facility: Praxis fur interdisziplinare Onkologie & Hamatologie

location_facility: Cancer Care Centers of South Texas - Loop

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

location_facility: Instituto Ribeiraopretano de Combate Ao Cancer

location_facility: Northwest Cancer Specialists, P.C. - Hoyt

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: Joliet Oncology-Hematology Associates, Ltd

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

location_facility: Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna

location_facility: Hospital du Saint Scarement Sacrement Laboratory

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Onkologikoa - Kutxaren Institutu Onkologikoa

location_facility: The East and North Hertfordshire NHS Trust

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Schwerpunktpraxis fur Gynakologische Onkologie

location_facility: Instituto Brasileiro de Controle Do Cancer IBCC

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: University of Athens Medical school - Regional General Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Henry Ford Medical Center - New Center One

location_facility: The Center for Cancer and Blood Disorders

location_facility: Alan Blair Cancer Centre at Pasqua Hosptial

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Central Coast Medical Oncology Corporation

location_facility: University General Hospital of Heraklion

location_facility: Hospital de Base Da Faculdade de Medicina de

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Chattanooga Oncology Hematology Associates

source: euctr

title: A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

summary: The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.


title: Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Trial A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

acronym: FAME 3

summary: The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).

enrollment_type: Anticipated

ReferenceCitation: Zimmermann FM, De Bruyne B, Pijls NH, Desai M, Oldroyd KG, Park SJ, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2015 Oct;170(4):619-626.e2. doi: 10.1016/j.ahj.2015.06.024. Epub 2015 Jul 9.

ReferenceCitation: Zimmermann FM, De Bruyne B, Pijls NHJ, Desai M, Oldroyd KG, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. A protocol update of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial: A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2019 Aug;214:156-157. doi: 10.1016/j.ahj.2019.04.012. Epub 2019 Apr 29.

ReferenceCitation: Fearon WF, Zimmermann FM, De Bruyne B, Piroth Z, van Straten AHM, Szekely L, Davidavičius G, Kalinauskas G, Mansour S, Kharbanda R, Östlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angerås O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrøm T, Christiansen EH, Tonino PAL, Reardon MJ, Lu D, Ding VY, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, Pijls NHJ; FAME 3 Investigators. Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery. N Engl J Med. 2021 Nov 4. doi: 10.1056/NEJMoa2112299. [Epub ahead of print]

name: From the Division of Cardiovascular Medicine and Stanford Cardiovascular Institute (W.F.F., M.A.H., A.C.Y.), the Quantitative Sciences Unit (D.L., V.Y.D., M.D.), and the Departments of Health Policy (M.A.H.) and Cardiothoracic Surgery (Y.J.W.), Stanford University, and the Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine (K.W.M.), Stanford, and the VA Palo Alto Health Care System, Palo Alto (W.F.F.) — all in California; Catharina Hospital, Eindhoven (F...

family: Fearon

full_name: William F. Fearon

given: William F.

family: Zimmermann

full_name: Frederik M. Zimmermann

given: Frederik M.

family: De Bruyne

full_name: Bernard De Bruyne

given: Bernard

family: Piroth

full_name: Zsolt Piroth

given: Zsolt

family: van Straten

full_name: Albert H.M. van Straten

given: Albert H.M.

family: Szekely

full_name: Laszlo Szekely

given: Laszlo

family: Davidavičius

full_name: Giedrius Davidavičius

given: Giedrius

family: Kalinauskas

full_name: Gintaras Kalinauskas

given: Gintaras

family: Mansour

full_name: Samer Mansour

given: Samer

family: Kharbanda

full_name: Rajesh Kharbanda

given: Rajesh

family: Östlund-Papadogeorgos

full_name: Nikolaos Östlund-Papadogeorgos

given: Nikolaos

family: Aminian

full_name: Adel Aminian

given: Adel

family: Oldroyd

full_name: Keith G. Oldroyd

given: Keith G.

family: Al-Attar

full_name: Nawwar Al-Attar

given: Nawwar

family: Jagic

full_name: Nikola Jagic

given: Nikola

family: Dambrink

full_name: Jan-Henk E. Dambrink

given: Jan-Henk E.

family: Kala

full_name: Petr Kala

given: Petr

family: Angerås

full_name: Oskar Angerås

given: Oskar

family: MacCarthy

full_name: Philip MacCarthy

given: Philip

family: Wendler

full_name: Olaf Wendler

given: Olaf

family: Casselman

full_name: Filip Casselman

given: Filip

family: Witt

full_name: Nils Witt

given: Nils

family: Mavromatis

full_name: Kreton Mavromatis

title: Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery

location_country:
United States
Sweden
Serbia
Netherlands
France
Czechia
Lithuania
Norway
Hungary
Belgium
Australia
New Zealand
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Karolinska Institutet, Dep of clinical science and education, Södersjukhuset

location_facility: University Hospitals Coventry and Warwickshire

location_facility: Masaryk University and University Hospital Brno

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Le'Centre Hospitalier de l'Universite de Montreal

location_facility: Southampton University Hospitals NHS Trust


type: Other Identifier

title: A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

acronym: SIRROUND-LTE

summary: The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

ReferenceCitation: Aletaha D, Bingham CO, Karpouzas GA, Takeuchi T, Thorne C, Bili A, Agarwal P, Hsu B, Rao R, Brown K, Tanaka Y. Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE). RMD Open. 2021 Jan;7(1). pii: e001465. doi: 10.1136/rmdopen-2020-001465.

family: Aletaha

full_name: Daniel Aletaha

given: Daniel

family: Bingham

full_name: Clifton O Bingham

given: Clifton O

family: Karpouzas

full_name: George Athanasios Karpouzas

given: George Athanasios

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

family: Thorne

full_name: Carter Thorne

given: Carter

family: Bili

full_name: Androniki Bili

given: Androniki

family: Agarwal

full_name: Prasheen Agarwal

given: Prasheen

family: Hsu

full_name: Benjamin Hsu

given: Benjamin

family: Rao

full_name: Ravi Rao

given: Ravi

family: Brown

full_name: Kurt Brown

given: Kurt

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

currency_apc_doaj: GBP

journal_name: RMD Open

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Janssen Research & Development, LLC

location_country:
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Lithuania
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Netherlands
Bulgaria
Puerto Rico
Portugal
Germany
United States
United Kingdom
Austria
Serbia
Mexico
Spain


title: A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation

summary: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four arms of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or at Investigator discretion.

ReferenceCitation: Aguado-Fraile E, Tassinari A, Ishii Y, Sigel C, Lowery MA, Goyal L, Gliser C, Jiang L, Pandya SS, Wu B, Bardeesy N, Choe S, Deshpande V. Molecular and morphological changes induced by ivosidenib correlate with efficacy in mutant-IDH1 cholangiocarcinoma. Future Oncol. 2021 Jun;17(16):2057-2074. doi: 10.2217/fon-2020-1274. Epub 2021 Mar 12.

name: Agios Pharmaceuticals, Inc., Cambridge, MA 02139, USA

family: Aguado-Fraile

full_name: Elia Aguado-Fraile

given: Elia

family: Tassinari

full_name: Ania Tassinari

given: Ania

family: Ishii

full_name: Yuko Ishii

given: Yuko

name: Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

family: Sigel

full_name: Carlie Sigel

given: Carlie

name: Trinity St James Cancer Institute, Trinity College Dublin, Dublin D02, Ireland

family: Lowery

full_name: Maeve A Lowery

given: Maeve A

name: Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA 02114, USA

family: Goyal

full_name: Lipika Goyal

given: Lipika

family: Gliser

full_name: Camelia Gliser

given: Camelia

family: Jiang

full_name: Liewen Jiang

given: Liewen

family: Pandya

full_name: Shuchi S Pandya

given: Shuchi S

family: Wu

full_name: Bin Wu

given: Bin

family: Bardeesy

full_name: Nabeel Bardeesy

given: Nabeel

family: Choe

full_name: Sung Choe

given: Sung

name: Department of Pathology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA 02114, USA

family: Deshpande

full_name: Vikram Deshpande

given: Vikram

journal_name: Future Oncology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Mellinghoff IK, Ellingson BM, Touat M, Maher E, De La Fuente MI, Holdhoff M, Cote GM, Burris H, Janku F, Young RJ, Huang R, Jiang L, Choe S, Fan B, Yen K, Lu M, Bowden C, Steelman L, Pandya SS, Cloughesy TF, Wen PY. Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Advanced Glioma. J Clin Oncol. 2020 Oct 10;38(29):3398-3406. doi: 10.1200/JCO.19.03327. Epub 2020 Jun 12.

name: Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY

family: Mellinghoff

full_name: Ingo K. Mellinghoff

given: Ingo K.

name: UCLA Brain Tumor Imaging Laboratory, Department of Radiological Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA

family: Ellingson

full_name: Benjamin M. Ellingson

given: Benjamin M.

name: Drug Development Department, Gustave Roussy Cancer Center, Villejuif, France

family: Touat

full_name: Mehdi Touat

given: Mehdi

name: Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX

family: Maher

full_name: Elizabeth Maher

given: Elizabeth

name: Department of Neurology and Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL

family: De La Fuente

full_name: Macarena I. De La Fuente

given: Macarena I.

name: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD

family: Holdhoff

full_name: Matthias Holdhoff

given: Matthias

name: Henri and Belinda Termeer Center for Targeted Therapies, Massachusetts General Hospital Cancer Center, Boston, MA

family: Cote

full_name: Gregory M. Cote

name: Sarah Cannon Research Institute, Nashville, TN

name: Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX

name: Radiology, Neuroradiology Service, Memorial Sloan Kettering Cancer Center, New York, NY

name: Department of Radiology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Boston, MA

name: Biostatistics, Agios Pharmaceuticals, Cambridge, MA

name: Bioinformatics, Agios Pharmaceuticals, Cambridge, MA

name: Pharmacology, Agios Pharmaceuticals, Cambridge, MA

name: Clinical Sciences, Agios Pharmaceuticals, Cambridge, MA

name: Medical, Agios Pharmaceuticals, Cambridge, MA

name: Department of Neurology, Ronald Reagan UCLA Medical Center, University of California, Los Angeles, Los Angeles, CA

name: Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

publisher: American Society of Clinical Oncology (ASCO)

title: Ivosidenib in Isocitrate Dehydrogenase 1–Mutated Advanced Glioma

ReferenceCitation: Tap WD, Villalobos VM, Cote GM, Burris H, Janku F, Mir O, Beeram M, Wagner AJ, Jiang L, Wu B, Choe S, Yen K, Gliser C, Fan B, Agresta S, Pandya SS, Trent JC. Phase I Study of the Mutant IDH1 Inhibitor Ivosidenib: Safety and Clinical Activity in Patients With Advanced Chondrosarcoma. J Clin Oncol. 2020 May 20;38(15):1693-1701. doi: 10.1200/JCO.19.02492. Epub 2020 Mar 24.

name: Weill Cornell Medical College, New York, NY

name: University of Colorado Anschutz Medical Campus, Aurora, CO

name: Center for Sarcoma and Connective Tissue Oncology, Massachusetts General Hospital Cancer Center, Boston, MA

name: Phase I Clinical Trials Program, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX

name: Department of Ambulatory Care, Gustave Roussy Cancer Campus, Villejuif, France

name: START Center for Cancer Care, San Antonio, TX

name: Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, MA

ReferenceCitation: Lowery MA, Burris HA 3rd, Janku F, Shroff RT, Cleary JM, Azad NS, Goyal L, Maher EA, Gore L, Hollebecque A, Beeram M, Trent JC, Jiang L, Fan B, Aguado-Fraile E, Choe S, Wu B, Gliser C, Agresta SV, Pandya SS, Zhu AX, Abou-Alfa GK. Safety and activity of ivosidenib in patients with IDH1-mutant advanced cholangiocarcinoma: a phase 1 study. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):711-720. doi: 10.1016/S2468-1253(19)30189-X. Epub 2019 Jul 9.

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Fan B, Mellinghoff IK, Wen PY, Lowery MA, Goyal L, Tap WD, Pandya SS, Manyak E, Jiang L, Liu G, Nimkar T, Gliser C, Prahl Judge M, Agresta S, Yang H, Dai D. Clinical pharmacokinetics and pharmacodynamics of ivosidenib, an oral, targeted inhibitor of mutant IDH1, in patients with advanced solid tumors. Invest New Drugs. 2020 Apr;38(2):433-444. doi: 10.1007/s10637-019-00771-x. Epub 2019 Apr 26.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

summary: This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

ReferenceCitation: Solomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.

name: Department of Surgery, University of Cincinnati College of Medicine, 6005 Given Road Cincinnati, OH 45243, USA

family: Solomkin

full_name: Joseph S Solomkin

given: Joseph S

name: Medical Writing, World Surgical Infection Society, Cincinnati, OH 45243, USA

family: Sway

full_name: Angie Sway

given: Angie

name: Medical Affairs, Tetraphase Pharmaceuticals, Watertown, MA 02472, USA

family: Lawrence

full_name: Kenneth Lawrence

given: Kenneth

family: Olesky

full_name: Melanie Olesky

given: Melanie

family: Izmailyan

full_name: Sergey Izmailyan

given: Sergey

family: Tsai

full_name: Larry Tsai

given: Larry

journal_name: Future Microbiology

ReferenceCitation: Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.

name: Department of Surgery, University of Cincinnati College of Medicine, Ohio

name: Department of Surgery, Riga Stradins University, Latvia

family: Gardovskis

full_name: Janis Gardovskis

given: Janis

name: Tetraphase Pharmaceuticals, Watertown, Massachusetts

name: Département d’Anesthésie-Réanimation, CHU Bichat Claude Bernard

name: Université Paris Diderot, PRESS Sorbonne Cité, Paris, France

name: Institut National de la Santé et de la Recherche Médicale (INSERM) UMR, Paris, France

family: Montravers

full_name: Philippe Montravers

given: Philippe

name: World Surgical Infection Society, Cincinnati, Ohio

name: Department of Surgery, Ohio State University School of Medicine, Columbus

family: Evans

full_name: David Evans

given: David

journal_name: Clinical Infectious Diseases

oa_colors: green hybrid

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

ReferenceCitation: Solomkin J, Evans D, Slepavicius A, Lee P, Marsh A, Tsai L, Sutcliffe JA, Horn P. Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial: A Randomized Clinical Trial. JAMA Surg. 2017 Mar 1;152(3):224-232. doi: 10.1001/jamasurg.2016.4237.

name: University of Cincinnati College of Medicine, Cincinnati, Ohio

name: Klaipeda University Hospital, Klaipeda, Lithuania

name: Baystate Medical Center, Springfield, Massachusetts

name: Tetraphase Pharmaceuticals Inc, Watertown, Massachusetts

location_country:
South Africa
Germany
France
Bulgaria
Lithuania
Romania
Latvia
Argentina
Russian Federation
Estonia
United States
Czech Republic
Ukraine


ReferenceCitation: Kavanaugh A, Westhovens RR, Winthrop KL, Lee SJ, Tan Y, An D, Ye L, Sundy JS, Besuyen R, Meuleners L, Stanislavchuk M, Spindler AJ, Greenwald M, Alten R, Genovese MC. Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs. J Rheumatol. 2021 Aug;48(8):1230-1238. doi: 10.3899/jrheum.201183. Epub 2021 Feb 1.

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

family: Westhovens

full_name: Rene R. Westhovens

given: Rene R.

family: Winthrop

full_name: Kevin L. Winthrop

given: Kevin L.

family: Lee

full_name: Susan J. Lee

given: Susan J.

family: Tan

full_name: YingMeei Tan

given: YingMeei

family: An

full_name: Di An

given: Di

family: Ye

full_name: Lei Ye

given: Lei

family: Sundy

full_name: John S. Sundy

given: John S.

family: Besuyen

full_name: Robin Besuyen

given: Robin

family: Meuleners

full_name: Luc Meuleners

given: Luc

family: Stanislavchuk

full_name: Mykola Stanislavchuk

given: Mykola

family: Spindler

full_name: Alberto J. Spindler

given: Alberto J.

family: Greenwald

full_name: Maria Greenwald

given: Maria

family: Alten

full_name: Rieke Alten

given: Rieke

family: Genovese

full_name: Mark C. Genovese

given: Mark C.

journal_name: The Journal of Rheumatology

evidence: open (via free pdf)

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

lead_sponsor: Galapagos NV

location_country:
Guatemala
Romania
Belgium
Australia
Russian Federation
Ukraine
France
Poland
Argentina
Moldova, Republic of
Colombia
Chile
Bulgaria
Hungary
Germany
United States
Mexico
Czechia
Israel
New Zealand
Spain
Latvia

location_facility: Diagnostic Consultative Center "Sveta Anna" LTD

location_facility: Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city

location_facility: Hospital Regional "Guillermo Grant Benavente"

location_facility: Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin

location_facility: Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13

location_facility: Vladimir Regional State Instituion of Healthcare

location_facility: MVZ Rheumatologie and Autoimmun Medizin HH GmbH

location_facility: CIMeL Centro dee Investigacion Medico Lanus

location_facility: Specjalisty Czne Centrum Medyczne Nowomed

location_facility: Instituto de Asistencia Reumatologia Integral - IARI

location_facility: Organizacion Medica de Investigaciones (OMI)

location_facility: Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department

location_facility: Clinica Medica Especializada en Reumatologia

location_facility: NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Multiprofile Hospital for Active Treatment - Ruse

location_facility: Schlossparkklinik - Akad. Lehrkrankenhaus Charite

location_facility: L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine

location_facility: GBOU VPO Orenburg State Medical University

location_facility: Scientific Research Institute of Rheumatology

location_facility: First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health

location_facility: National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases

location_facility: Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv

location_facility: University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic

location_facility: University "Multiprofile Hospital for Active Treatment - Kaspela" LTD

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)

location_facility: Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach

location_facility: NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie

location_facility: Centro de Estudios de Investigacion Basica y Clinica, SC

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Sanatorio Nuestra Señora de la Esperanza

location_facility: Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology

ipd_sharing: No

title: A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis

summary:
The primary objective of the study is to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.

Participants will be enrolled in this open-label long-term follow-up study after they have completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204 (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants will also be examined for long-term effects of filgotinib administration on disease activity (efficacy), subjects' disability, fatigue, and quality of life.


title: A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer

summary: The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

design_allocation: Non-Randomized

ReferenceCitation: Overman MJ, Lonardi S, Wong KYM, Lenz HJ, Gelsomino F, Aglietta M, Morse MA, Van Cutsem E, McDermott R, Hill A, Sawyer MB, Hendlisz A, Neyns B, Svrcek M, Moss RA, Ledeine JM, Cao ZA, Kamble S, Kopetz S, André T. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.

name: Michael J. Overman and Scott Kopetz, University of Texas MD Anderson Cancer Center, Houston, TX; Sara Lonardi, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padova; Fabio Gelsomino, University Hospital of Modena, Modena; Massimo Aglietta, Institute for Cancer Research and Treatment of Candiolo, University of Torino Medical School, Turin, Italy; Ka Yeung Mark Wong, Sydney Medical School, University of Sydney, Sydney, New South Wales; Andrew Hill, Tasman Oncology Research...

family: Overman

full_name: Michael J. Overman

given: Michael J.

family: Lonardi

full_name: Sara Lonardi

given: Sara

family: Wong

full_name: Ka Yeung Mark Wong

given: Ka Yeung Mark

family: Lenz

full_name: Heinz-Josef Lenz

given: Heinz-Josef

family: Gelsomino

full_name: Fabio Gelsomino

given: Fabio

family: Aglietta

full_name: Massimo Aglietta

given: Massimo

family: Morse

full_name: Michael A. Morse

given: Michael A.

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: McDermott

full_name: Ray McDermott

given: Ray

family: Hill

full_name: Andrew Hill

given: Andrew

family: Sawyer

full_name: Michael B. Sawyer

given: Michael B.

family: Hendlisz

full_name: Alain Hendlisz

given: Alain

family: Neyns

full_name: Bart Neyns

given: Bart

family: Svrcek

full_name: Magali Svrcek

given: Magali

family: Moss

full_name: Rebecca A. Moss

given: Rebecca A.

family: Ledeine

full_name: Jean-Marie Ledeine

given: Jean-Marie

family: Cao

full_name: Z. Alexander Cao

given: Z. Alexander

family: Kamble

full_name: Shital Kamble

given: Shital

family: Kopetz

full_name: Scott Kopetz

given: Scott

family: André

full_name: Thierry André

given: Thierry

journal_name: Journal of Clinical Oncology

oa_host_type: repository

repository_institution: University of Turin - Institutional Research Information System University of Turin

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair–Deficient/Microsatellite Instability–High Metastatic Colorectal Cancer

ReferenceCitation: Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, Goldberg MV, Cao ZA, Ledeine JM, Maglinte GA, Kopetz S, André T. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017 Sep;18(9):1182-1191. doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19. Erratum in: Lancet Oncol. 2017 Sep;18(9):e510.

location_country:
Italy
United States
France
Ireland
Belgium
Australia
Spain
Canada

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Duke University Office of Research Administration

location_facility: Providence Cancer Center Oncology and Hematology Care- Eastside

location_facility: University Of Pittsburgh Cancer Institute


ReferenceCitation: Chan ML, Qi Y, Larimore K, Cherukuri A, Seid L, Jayaram K, Jeha G, Fisheleva E, Day J, Huntsman-Labed A, Savarirayan R, Irving M, Bacino CA, Hoover-Fong J, Ozono K, Mohnike K, Wilcox WR, Horton WA, Henshaw J. Pharmacokinetics and Exposure-Response of Vosoritide in Children with Achondroplasia. Clin Pharmacokinet. 2021 Aug 25. doi: 10.1007/s40262-021-01059-1. [Epub ahead of print]

family: Chan

full_name: Ming Liang Chan

given: Ming Liang

family: Qi

full_name: Yulan Qi

given: Yulan

family: Larimore

full_name: Kevin Larimore

given: Kevin

family: Cherukuri

full_name: Anu Cherukuri

given: Anu

family: Seid

full_name: Lori Seid

given: Lori

family: Jayaram

full_name: Kala Jayaram

given: Kala

family: Jeha

full_name: George Jeha

given: George

family: Fisheleva

full_name: Elena Fisheleva

given: Elena

family: Day

full_name: Jonathan Day

given: Jonathan

family: Huntsman-Labed

full_name: Alice Huntsman-Labed

given: Alice

family: Savarirayan

full_name: Ravi Savarirayan

given: Ravi

family: Irving

full_name: Melita Irving

given: Melita

family: Bacino

full_name: Carlos A. Bacino

given: Carlos A.

family: Hoover-Fong

full_name: Julie Hoover-Fong

given: Julie

family: Ozono

full_name: Keiichi Ozono

given: Keiichi

family: Mohnike

full_name: Klaus Mohnike

given: Klaus

family: Wilcox

full_name: William R. Wilcox

given: William R.

family: Horton

full_name: William A. Horton

given: William A.

family: Henshaw

full_name: Joshua Henshaw

given: Joshua

journal_name: Clinical Pharmacokinetics

title: Pharmacokinetics and Exposure–Response of Vosoritide in Children with Achondroplasia

ReferenceCitation: Savarirayan R, Irving M, Bacino CA, Bostwick B, Charrow J, Cormier-Daire V, Le Quan Sang KH, Dickson P, Harmatz P, Phillips J, Owen N, Cherukuri A, Jayaram K, Jeha GS, Larimore K, Chan ML, Huntsman Labed A, Day J, Hoover-Fong J. C-Type Natriuretic Peptide Analogue Therapy in Children with Achondroplasia. N Engl J Med. 2019 Jul 4;381(1):25-35. doi: 10.1056/NEJMoa1813446. Epub 2019 Jun 18.

name: From Murdoch Children’s Research Institute, Royal Children’s Hospital, University of Melbourne, Parkville, VIC, Australia (R.S.); Guy’s and St. Thomas’ NHS Foundation Trust, Evelina Children’s Hospital, London (M.I.); Baylor College of Medicine, Houston (C.A.B., B.B.); Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago (J.C.); the Medical Genetics Department, Université Paris Descartes–Sorbonne Paris Cité, INSERM Unité Mixte de Recherche 1163, Institute Imagine, Assistance Publique–Hôpitaux...

location_country:
United States
United Kingdom
Australia
France

location_facility: Ann and Robert H. Lurie Childrens Hospital of Chicago

location_facility: Guys & St. Thomas NHS Foundation Trust Evelina Hospital

location_facility: Children's Hospital & Research Center Oakland

location_facility: Johns Hopkins McKusick - Institute of Genetic Medicine

title: A Phase 2, Open-label, Sequential Cohort Dose-escalation Study of BMN 111 in Children With Achondroplasia

summary: This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children with achondroplasia. The primary objective is to assess the safety and tolerability of daily BMN 111 administered to children with achondroplasia.


title: The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial

acronym: PRESOX

summary: The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

status: Terminated

lead_sponsor: Sharp HealthCare

location_country:
Italy
Austria
Sweden
United Kingdom
Germany
France
Poland
Ireland
Russian Federation
Spain
United States
Slovenia

location_facility: Oklahoma University Health Sciences Center

location_facility: University of Miami Miller School of Medicine

location_facility: St. Petersberg State Pediatric Medical University

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Sharp Mary Birch Hospital for Women and Newborns

intervention_type: Other

status_simplified: Unknown


title: A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation of RO5503781 With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)

summary: This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.

ReferenceCitation: Yee K, Papayannidis C, Vey N, Dickinson MJ, Kelly KR, Assouline S, Kasner M, Seiter K, Drummond MW, Yoon SS, Lee JH, Blotner S, Jukofsky L, Pierceall WE, Zhi J, Simon S, Higgins B, Nichols G, Monnet A, Muehlbauer S, Ott M, Chen LC, Martinelli G. Murine double minute 2 inhibition alone or with cytarabine in acute myeloid leukemia: Results from an idasanutlin phase 1/1b study⋆. Leuk Res. 2021 Jan;100:106489. doi: 10.1016/j.leukres.2020.106489. Epub 2020 Dec 1.

family: Yee

full_name: Karen Yee

given: Karen

family: Papayannidis

full_name: Cristina Papayannidis

given: Cristina

family: Vey

full_name: Norbert Vey

given: Norbert

family: Dickinson

full_name: Michael J. Dickinson

given: Michael J.

family: Kelly

full_name: Kevin R. Kelly

given: Kevin R.

family: Assouline

full_name: Sarit Assouline

given: Sarit

family: Kasner

full_name: Margaret Kasner

given: Margaret

family: Seiter

full_name: Karen Seiter

family: Drummond

full_name: Mark W. Drummond

given: Mark W.

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

family: Lee

full_name: Je-Hwan Lee

given: Je-Hwan

family: Blotner

full_name: Steven Blotner

given: Steven

family: Jukofsky

full_name: Lori Jukofsky

family: Pierceall

full_name: William E. Pierceall

given: William E.

family: Zhi

full_name: Jianguo Zhi

given: Jianguo

family: Simon

full_name: Silke Simon

given: Silke

family: Higgins

full_name: Brian Higgins

given: Brian

family: Nichols

full_name: Gwen Nichols

given: Gwen

family: Monnet

full_name: Annabelle Monnet

given: Annabelle

family: Muehlbauer

full_name: Susanne Muehlbauer

given: Susanne

family: Ott

full_name: Marion Ott

given: Marion

family: Chen

full_name: Lin-Chi Chen

given: Lin-Chi

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

location_country:
Italy
United States
France
Australia
Canada
United Kingdom
Korea, Republic of

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Institut J Paoli I Calmettes; Onco Hematologie 2

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Cancer Therapy & Research Ctr; Dept Institute for Drug Development

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept


title: A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific

acronym: DIALOGUE 1

summary:
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.

location_country:
Italy
France
Bulgaria
Japan
Israel
Poland
Romania
Hungary
Australia
Spain
Turkey
Germany
United Kingdom
Korea, Republic of

location_facility:
Baskent University Medical Faculty
Ankara Univ. Medical Faculty
Sifa University Medical Faculty


title: A Phase 1b Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Erlotinib or Alectinib in Patients With Advanced Non-Small Cell Lung Cancer

summary:
This open-label, multicenter study will assess the safety, tolerability, and pharmacokinetics of intravenous (IV) dosing of atezolizumab in combination with oral erlotinib or alectinib in participants with NSCLC.

This study has two stages. In the erlotinib group, the combination treatment will be given to participants with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-treatment-naive, advanced (nonresectable) NSCLC in a safety-evaluation stage and to participants with previously untreated EGFR mutation-positive, advanced NSCLC in an expansion stage (Stage 2). In the alectinib group, for both the safety-evaluation and expansion stages (Stages 1 and 2), the combination will be given to participants who are treatment-naive with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.

In Stage 1, erlotinib will be given at a starting dose of 150 milligrams (mg) by mouth (PO) once daily (QD) and the starting dose of alectinib will be 600 mg twice daily (BID), for 28 consecutive days during Cycle 1 and on Days 1 through 21 of each cycle thereafter. The starting dose of atezolizumab will be 1200 mg, administered every 3 weeks (q3W) starting on Day 8 of Cycle 1. If the starting regimen for a combination treatment is not tolerated, alternative doses and/or schedules of erlotinib and atezolizumab or alectinib and atezolizumab may be tested to determine potential recommended Phase 2 dose (RP2D) for that combination treatment. In Stage 2, a potential RP2D and schedule for each combination treatment will be investigated in an expansion cohort.

For both stages, continuation of treatment beyond Cycle 1 will be at the discretion of the treating investigator. Study treatment will be discontinued in participants who experience disease progression or unacceptable toxicity, are not compliant with the study protocol, or, in their opinion or in the opinion of the investigator, are not benefiting from study treatment. However, in the absence of unacceptable toxicity, participants with second-line or greater NSCLC who are still receiving atezolizumab at the time of radiographic disease progression may be permitted to continue study treatment.

lead_sponsor: Hoffmann-La Roche

location_country:
Hong Kong
France
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Karmanos Cancer Center; Department of Oncology

location_facility: Case Western Reserve University; Medicine-Hematology and Oncology

location_facility: Beth Israel Deaconess Med Ctr; Neurology/MS Center

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Memorial Sloan Kettering - Basking Ridge

location_facility: Massachusetts General Hospital;Hematology/ Oncology

location_facility: Hospital Clinico Universitario de Valencia


title: A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination Dasatinib (BMS-354825) Plus Nivolumab (BMS-936558) in Patients Chronic Myeloid Leukemia (CML)

summary: The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Germany
France
Australia
Spain
Canada

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Froedtert Hospital & Medical College of Wisconsin

location_facility: Ut Southwestern Medical Center At Dallas


title: Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"

acronym: SPECTAcolor

summary:
The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.

Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.

A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.

The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.

status: Unknown status

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Italy Sweden Switzerland Spain Cyprus France Poland Greece Belgium Portugal Germany

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: I.P.O. Francisco Gentil - Centro De Lisboa

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro

intervention_type: Genetic


title: A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

summary: The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.

lead_sponsor: MedImmune LLC

location_country:
Serbia
United Kingdom
Mexico
Spain
France
Greece
Israel
Slovakia
Hungary
Argentina
Russian Federation
Portugal
Czech Republic
Colombia

intervention_type: Biological


title: A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil

summary: This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.

ReferenceCitation: Fullerton T, Binneman B, David W, Delnomdedieu M, Kupiec J, Lockwood P, Mancuso J, Miceli J, Bell J. A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil. Alzheimers Res Ther. 2018 Apr 5;10(1):38. doi: 10.1186/s13195-018-0368-9.

family: Fullerton

full_name: Terence Fullerton

given: Terence

family: Binneman

full_name: Brendon Binneman

given: Brendon

family: David

full_name: William David

given: William

family: Delnomdedieu

full_name: Marielle Delnomdedieu

given: Marielle

family: Kupiec

full_name: James Kupiec

given: James

family: Lockwood

full_name: Peter Lockwood

given: Peter

family: Mancuso

full_name: Jessica Mancuso

given: Jessica

family: Miceli

full_name: Jeffrey Miceli

given: Jeffrey

family: Bell

full_name: Joanne Bell

given: Joanne

journal_name: Alzheimer's Research & Therapy

title: A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer’s disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil

lead_sponsor: Pfizer

location_country:
United States
Chile
France
Spain
Germany
United Kingdom
Canada

location_facility: Chatham-kent Clinical Trials Research Centre

location_facility: Yale-New Haven Hospital, Temple Radiology

location_facility: Medical Research Group of Central Florida

location_facility: University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center

location_facility: Surrey and Borders Partnership NHS Foundation Trust

location_facility: Chatham-Kent Clinical Trials Research Centre

location_facility: Behavioral Medical Research of Staten Island

location_facility: Cary J. Kohlenberg, MD, dba, IPC Research

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum

location_facility: Yale University School of Medicine, MRI Research Center (MRI)

location_facility: Columbus Research & Wellness Institute, Inc.

location_facility: Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde

location_facility: University of Rochester Medical Center (MRI Imaging Only)

location_facility: The Ohio State University (administrative offices only)

location_facility: Roper St. Francis Pharmacy (IP Shipment/Storage)

location_facility: Eastside Comprehensive Medical Center, LLC

location_facility: Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic

location_facility: Dean Foundation for Health, Research and Education

location_facility: The Research Institute for the Care of Older People Centre

location_facility: Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs


title: Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

acronym: PROMISE

summary: The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

ReferenceCitation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12:CD013756. doi: 10.1002/14651858.CD013756.pub2. Review.

ReferenceCitation: Rigoard P, Basu S, Desai M, Taylor R, Annemans L, Tan Y, Johnson MJ, Van den Abeele C, North R; PROMISE Study Group. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. 2019 Jun;160(6):1410-1420. doi: 10.1097/j.pain.0000000000001510.

family: Rigoard

full_name: Philippe Rigoard

given: Philippe

family: Basu

full_name: Surajit Basu

given: Surajit

family: Desai

full_name: Mehul Desai

given: Mehul

family: Taylor

full_name: Rod Taylor

given: Rod

family: Annemans

full_name: Lieven Annemans

given: Lieven

family: Tan

full_name: Ye Tan

given: Ye

family: Johnson

full_name: Mary Jo Johnson

given: Mary Jo

family: Van den Abeele

full_name: Carine Van den Abeele

given: Carine

family: North

full_name: Richard North

given: Richard

journal_name: Pain

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Rigoard P, Desai MJ, North RB, Taylor RS, Annemans L, Greening C, Tan Y, Van den Abeele C, Shipley J, Kumar K. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). Trials. 2013 Nov 7;14:376. doi: 10.1186/1745-6215-14-376.

full_name: Mehul J Desai

given: Mehul J

full_name: Richard B North

given: Richard B

full_name: Rod S Taylor

given: Rod S

repository_institution: Ghent University - Ghent University Academic Bibliography

ipd_sharing_description: Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.

location_country:
United States
Netherlands
Germany
France
Belgium
Spain
Canada
United Kingdom
Colombia

location_facility: University of Rochester Neurosurgery Partners in Pain Management

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Weill Medical College of Cornell University

location_facility: Nottingham University Hospital NHS Trust

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Department of Neurosurgery: St. Augustinus Ziekenhuizen

location_facility: Hospital Clinico Universitario de Valencia


title: A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension

summary: The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

ReferenceCitation: Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254.

family: Williams

full_name: Bryan Williams

given: Bryan

family: Cockcroft

full_name: John R Cockcroft

given: John R

family: Kario

full_name: Kazuomi Kario

given: Kazuomi

family: Zappe

full_name: Dion H Zappe

given: Dion H

family: Cardenas

full_name: Pamela Cardenas

given: Pamela

family: Hester

full_name: Allen Hester

given: Allen

family: Brunel

full_name: Patrick Brunel

given: Patrick

family: Zhang

full_name: Jack Zhang

given: Jack

journal_name: BMJ Open

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Japan
Greece
Argentina
Russian Federation
Spain
Germany
Korea, Republic of
Taiwan
Colombia


title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant

summary: This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

ReferenceType: result

ReferenceCitation: Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7.

family: Charlton

full_name: Michael Charlton

given: Michael

family: Gane

full_name: Edward Gane

given: Edward

family: Manns

full_name: Michael P. Manns

given: Michael P.

family: Brown

full_name: Robert S. Brown

given: Robert S.

suffix: Jr.

family: Curry

full_name: Michael P. Curry

family: Kwo

full_name: Paul Y. Kwo

given: Paul Y.

family: Fontana

full_name: Robert J. Fontana

given: Robert J.

family: Gilroy

full_name: Richard Gilroy

family: Teperman

full_name: Lewis Teperman

given: Lewis

family: Muir

full_name: Andrew J. Muir

given: Andrew J.

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Symonds

full_name: William T. Symonds

given: William T.

family: Brainard

full_name: Diana Brainard

given: Diana

family: Kirby

full_name: Brian Kirby

given: Brian

family: Dvory-Sobol

full_name: Hadas Dvory-Sobol

given: Hadas

family: Denning

full_name: Jill Denning

given: Jill

family: Arterburn

full_name: Sarah Arterburn

given: Sarah

family: Samuel

full_name: Didier Samuel

given: Didier

family: Forns

full_name: Xavier Forns

given: Xavier

family: Terrault

full_name: Norah A. Terrault

given: Norah A.

journal_name: Gastroenterology

title: Sofosbuvir and Ribavirin for Treatment of Compensated Recurrent Hepatitis C Virus Infection After Liver Transplantation

lead_sponsor: Gilead Sciences

location_country:
United States
France
New Zealand
Spain
Germany


title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

summary: A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).

ReferenceCitation: Nishio M, Felip E, Orlov S, Park K, Yu CJ, Tsai CM, Cobo M, McKeage M, Su WC, Mok T, Scagliotti GV, Spigel DR, Viraswami-Appanna K, Chen Z, Passos VQ, Shaw AT. Final Overall Survival and Other Efficacy and Safety Results From ASCEND-3: Phase II Study of Ceritinib in ALKi-Naive Patients With ALK-Rearranged NSCLC. J Thorac Oncol. 2020 Apr;15(4):609-617. doi: 10.1016/j.jtho.2019.11.006. Epub 2019 Nov 25.

family: Nishio

full_name: Makoto Nishio

given: Makoto

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Orlov

full_name: Sergey Orlov

given: Sergey

family: Park

full_name: Keunchil Park

given: Keunchil

family: Yu

full_name: Chong-Jen Yu

given: Chong-Jen

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Cobo

full_name: Manuel Cobo

given: Manuel

family: McKeage

full_name: Mark McKeage

given: Mark

family: Su

full_name: Wu-Chou Su

given: Wu-Chou

family: Mok

full_name: Tony Mok

given: Tony

family: Scagliotti

full_name: Giorgio V. Scagliotti

given: Giorgio V.

family: Spigel

full_name: David R. Spigel

given: David R.

family: Viraswami-Appanna

full_name: Kalyanee Viraswami-Appanna

given: Kalyanee

family: Chen

full_name: Zhe Chen

given: Zhe

family: Passos

full_name: Vanessa Q. Passos

given: Vanessa Q.

family: Shaw

full_name: Alice T. Shaw

given: Alice T.

journal_name: Journal of Thoracic Oncology

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. Review.

family: Lin

full_name: Yen-Ting Lin

given: Yen-Ting

title: Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non–Small-Cell Lung Cancer: Analysis and Literature Review

location_country:
Italy
United States
Sweden
Hong Kong
Spain
France
Japan
Thailand
Norway
Singapore
Belgium
Australia
New Zealand
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: Washington University School of Medicine Washington University (16)

location_facility: Massachusetts General Hospital Mass Gen 5


title: A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

acronym: ASCEND

summary:
Primary Objective:

The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult patients with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States [US] only, in association with patient perception related to spleen volume as measured by splenomegaly related score [SRS]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO).

Secondary Objectives:

To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks.
To characterize the effect of olipudase alfa on the patient perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the splenomegaly related score is part of the primary objective).
To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following endpoints assessed sequentially:
The effect of olipudase alfa on liver volume;
The effect of olipudase alfa on platelet count;
The effect of olipudase alfa on fatigue;
The effect of olipudase alfa on pain;
The effect of olipudase alfa on dyspnea.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Brazil
Chile
Netherlands
Spain
Germany
France
Bulgaria
Japan
Tunisia
Belgium
Argentina
Australia
Portugal
Turkey
United States
United Kingdom

location_facility:
Investigational Site Number :826002
Investigational Site Number :100001
Investigational Site Number :380002
Investigational Site Number :056001
Investigational Site Number :152001
Investigational Site Number :792001
Investigational Site Number :392001
Investigational Site Number :528001
Investigational Site Number :380001
Investigational Site Number :840003
Investigational Site Number :788001
Investigational Site Number :840006
Investigational Site Number :792002
Investigational Site Number :250001
Investigational Site Number :792003
Investigational Site Number :840005
Investigational Site Number :036001
Investigational Site Number :076001
Investigational Site Number :724001
Investigational Site Number :276001
Investigational Site Number :620002
Investigational Site Number :826001
Investigational Site Number :032001


title: A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA The "RELEVANCE" Trial (Rituximab Lenalidomide Versus ANy ChEmotherapy)is Being Conducted as Two Companion Studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the Combined Total of 1000 Patients Enrolled in Both Studies Will be Analyzed.

acronym: RELEVANCE

summary: The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.

ReferenceCitation: Delfau-Larue MH, Boulland ML, Beldi-Ferchiou A, Feugier P, Maisonneuve H, Casasnovas RO, Lemonnier F, Pica GM, Houot R, Ysebaert L, Tilly H, Eisenmann JC, Le Gouill S, Ribrag V, Godmer P, Glaisner S, Cartron G, Xerri L, Salles GA, Fest T, Morschhauser F. Lenalidomide/rituximab induces high molecular response in untreated follicular lymphoma: LYSA ancillary RELEVANCE study. Blood Adv. 2020 Aug 11;4(14):3217-3223. doi: 10.1182/bloodadvances.2020001955.

name: Biological Hematology and Immunology Department, Groupe Hospitalier Mondor, INSERM U955, Creteil, France;

family: Delfau-Larue

full_name: Marie-Helene Delfau-Larue

given: Marie-Helene

name: Hematobiology Department, Centre Hospitalo-Universitaire (CHU) Pontchaillou, Rennes, France;

family: Boulland

full_name: Marie-Laure Boulland

given: Marie-Laure

family: Beldi-Ferchiou

full_name: Asma Beldi-Ferchiou

given: Asma

name: Service d'Hématologie, Centre Hospitalier Regional Universitaire de Nancy, Vandoeuvre les Nancy, France;

family: Feugier

full_name: Pierre Feugier

given: Pierre

name: Service d'Onco-Hématologie, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France;

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

name: Service d'Hématologie Clinique, CHU Le Bocage, Dijon, France;

family: Casasnovas

full_name: Rene-Olivier Casasnovas

given: Rene-Olivier

name: Unité Hémopathies Lymphoïdes, University Hospital Mondor, Creteil, France;

family: Lemonnier

full_name: François Lemonnier

given: François

name: Service Hématologie, Centre Hospitalier (CH) Métropole Savoie, Chambéry, France;

family: Pica

full_name: Gian Matteo Pica

given: Gian Matteo

name: Service d'Hématologie Clinique, CHU Pontchaillou, Rennes, France;

family: Houot

full_name: Roch Houot

given: Roch

name: Service d'Hématologie, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France;

family: Ysebaert

full_name: Loic Ysebaert

given: Loic

name: U1245 and Département d’Hématologie, Centre Henri Becquerel, Rouen, France;

family: Tilly

full_name: Hervé Tilly

name: Département d'Hématologie, CH de Mulhouse, Hôpital Emile Muller, Mulhouse, France;

family: Eisenmann

full_name: Jean-Claude Eisenmann

given: Jean-Claude

name: Service d’hématologie clinique du CHU de Nantes, INSERM CRCINA Nantes-Angers, Nantes Excellence Trajectory Université de Nantes, Nantes, France;

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

name: Hematology Department, Gustave Roussy Cancer Campus Grand Paris, Villejuif, France;

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

name: Service Hématologie, Centre Hospitalier Bretagne-Atlantique, Vannes, France;

family: Godmer

full_name: Pascal Godmer

given: Pascal

name: Service d'Hématologie, Centre René Huguenin, Saint-Cloud, France;

family: Glaisner

full_name: Sylvie Glaisner

given: Sylvie

name: Department of Hematology, CHU Montpellier, Montpellier, France;

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

name: Departement de Bio-pathologie, Institut Paoli-Calmettes, Marseille, France;

family: Xerri

full_name: Luc Xerri

given: Luc

name: Département d’Hématologie, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France; and

family: Salles

full_name: Gilles André Salles

given: Gilles André

family: Fest

full_name: Thierry Fest

given: Thierry

name: Département d'Hématologie, Equipe d'Accueil 7365, CHU Lille, Lille, France

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

journal_name: Blood Advances

ReferenceCitation: Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, López-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, André M, Zachée P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

name: From Université Lille, Centre Hospitalier Universitaire (CHU), Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille (F.M.), CHU Régional de Nancy, Service d’Hématologie, Vandoeuvre lès Nancy (P.F.), Institut Paoli-Calmettes (R.B.) and Department of Pathology, Institut Paoli-Calmettes, Centre de Recherche en Cancerologie de Marseille, INSERM, Centre National de la Recherche Scientifique, Aix-Marseille Université (L.X.), Marseille, Centre Henri Becquerel, Unité 1245 and...

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Italy Spain Germany France Belgium Australia Portugal Canada

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Atlantic Health Sciences Corp - Saint John Regional Hospital

location_facility: Hôpital de l'Enfant-Jesus, CHU de Quebec

location_facility: Institut Català d'Oncologia de Girona (ICO Girona)

location_facility: Medizinische Klinik der Universität Tübingen

location_facility: McGill University Department of Oncology


title: An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

summary: To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

ReferenceCitation: Carmeli Y, Armstrong J, Laud PJ, Newell P, Stone G, Wardman A, Gasink LB. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016 Jun;16(6):661-673. doi: 10.1016/S1473-3099(16)30004-4. Epub 2016 Apr 20.

ReferenceCitation: Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.

family: Cheng

full_name: Karen Cheng

given: Karen

family: Newell

full_name: Paul Newell

given: Paul

family: Chow

full_name: Joseph W. Chow

given: Joseph W.

family: Broadhurst

full_name: Helen Broadhurst

given: Helen

family: Wilson

full_name: David Wilson

given: David

family: Yates

full_name: Katrina Yates

given: Katrina

family: Wardman

full_name: Angela Wardman

given: Angela

journal_name: Drug Safety

title: Safety Profile of Ceftazidime–Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme

ReferenceCitation: Mendes RE, Castanheira M, Woosley LN, Stone GG, Bradford PA, Flamm RK. Characterization of β-Lactamase Content of Ceftazidime-Resistant Pathogens Recovered during the Pathogen-Directed Phase 3 REPRISE Trial for Ceftazidime-Avibactam: Correlation of Efficacy against β-Lactamase Producers. Antimicrob Agents Chemother. 2019 May 24;63(6). pii: e02655-18. doi: 10.1128/AAC.02655-18. Print 2019 Jun.

name: JMI Laboratories, North Liberty, Iowa, USA

family: Mendes

full_name: Rodrigo E. Mendes

given: Rodrigo E.

family: Castanheira

full_name: Mariana Castanheira

given: Mariana

family: Woosley

full_name: Leah N. Woosley

given: Leah N.

name: AstraZeneca Pharmaceuticals, Waltham, Massachusetts, USA

family: Stone

full_name: Gregory G. Stone

given: Gregory G.

family: Bradford

full_name: Patricia A. Bradford

given: Patricia A.

family: Flamm

full_name: Robert K. Flamm

given: Robert K.

journal_name: Antimicrobial Agents and Chemotherapy

ReferenceCitation: Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

name: Quantitative Solutions Raleigh North Carolina USA

name: AstraZeneca Alderley Park Macclesfield UK

title: Ceftazidime‐Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

name: AstraZeneca, Waltham, Massachusetts, USA

name: AstraZeneca, Macclesfield, United Kingdom

name: Wright Dose Ltd., Altrincham, United Kingdom

ReferenceCitation: Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.

name: AstraZeneca Pharmaceuticals, 35 Gatehouse Drive, Waltham, MA 02451, USA

name: AstraZeneca Global Medicines Development, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK

name: AstraZeneca, 1800 Concord Pike, Wilmington, DE 19803, USA

name: AstraZeneca, 199 Liangjing Road, Shanghai 201203, China

ReferenceCitation: Stone GG, Bradford PA, Newell P, Wardman A. In Vitro Activity of Ceftazidime-Avibactam against Isolates in a Phase 3 Open-Label Clinical Trial for Complicated Intra-Abdominal and Urinary Tract Infections Caused by Ceftazidime-Nonsusceptible Gram-Negative Pathogens. Antimicrob Agents Chemother. 2017 Jan 24;61(2). pii: e01820-16. doi: 10.1128/AAC.01820-16. Print 2017 Feb.

name: AstraZeneca Pharmaceuticals, Alderley Park, United Kingdom

location_country:
South Africa
Peru
Mexico
Philippines
Croatia
Czechia
Bulgaria
France
Israel
Poland
Romania
Argentina
Russian Federation
Spain
Turkey
United States
Korea, Republic of
Ukraine