ReferenceCitation: Hervas A, Huss M, Johnson M, McNicholas F, van Stralen J, Sreckovic S, Lyne A, Bloomfield R, Sikirica V, Robertson B. Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol. 2014 Dec;24(12):1861-72. doi: 10.1016/j.euroneuro.2014.09.014. Epub 2014 Oct 23.

family: Hervas

full_name: Amaia Hervas

given: Amaia

family: Huss

full_name: Michael Huss

given: Michael

full_name: Mats Johnson

given: Mats

family: McNicholas

full_name: Fiona McNicholas

given: Fiona

family: van Stralen

full_name: Judy van Stralen

given: Judy

family: Sreckovic

full_name: Sasha Sreckovic

given: Sasha

family: Lyne

full_name: Andrew Lyne

given: Andrew

family: Bloomfield

full_name: Ralph Bloomfield

given: Ralph

family: Sikirica

full_name: Vanja Sikirica

given: Vanja

family: Robertson

full_name: Brigitte Robertson

given: Brigitte

journal_name: European Neuropsychopharmacology

title: Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: A randomized, controlled, Phase III trial

lead_sponsor: Shire

location_country:
Italy
Austria
Sweden
Germany
France
Poland
Romania
Ireland
Spain
United States
United Kingdom
Canada
Ukraine

location_facility: Praxisgemeinschaft Drs. Willem Geraets/Gabriele Lucassen

location_facility: James Paget University Hospital NHS Trust

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Borys Gniot

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"

location_facility: Somni Bene GmbH - Institut für Medizinische Forschung und Schlafmedizin

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept

location_facility: Rochester Center for Behavioral Medicine

location_facility: Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Miroslaw Dabkowski

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Zentralinstitut fur Seelische Geseundheit Mannheim Klinik for Psuchiatrie und Psychotherapie des Kindes

location_facility: Department of Child and Adolescent Psychiatry

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"

location_facility: Spitalul Clinic de Urgenta Pentru Copii Cluj

location_facility: Centre HospitalierUniversitaire d'Amiens, Hoptial Nord

location_facility: Praxis Dr. Friedrich Kaiser un Ingrid Marinesse

location_facility: JPM Van Stralen Medicine Professional Corp.

location_facility: Institut fur Ganzheitiche Medzin und Wissenschaft GmbH

location_facility: O.F. Maltsev Poltava Regional Psychiatric Hospital

location_facility: Klinikum der Johannes-Guttenberg-Universitat Mainz

location_facility: Centre Hospitalier Charles Perens - Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: University of Nebraska Medical Center, Dept. of Psychiatry

location_facility: IRCCS Stella Maris - U.O. Psichiatria e Psicofarmacologia Eta' Evolutiva

location_facility: Instituto Valenciano de Neurología Pediatrica

location_facility: Horsham Child and Adolescent Mental Health Services

location_facility: Municipal Institution "Institute of healthcare for children and adolescences NAMNU

location_facility: Psychiatric Centers at San Diego, Feighner Research

location_facility: Hospital de Dia Infantil y Juvenil Dr Diego Guigou y Costa

location_facility: Lviv Regional Clinical Psychiatric Hospital

location_facility: Vinnytsia National Medical University - Vinnytsia Regional Psycho-Neurological Hospital

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Ospedale Policlinico G.B.Rossi - Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Medizinische Universitat Graz-Universitaklinik fur Kinder-und Jugendheilkunde

title: A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

summary: For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).


title: A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

summary: The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.

family: Gonzales

full_name: D Gonzales

given: D

sequence: first

family: Hajek

full_name: P Hajek

given: P

sequence: additional

family: Pliamm

full_name: L Pliamm

given: L

family: Nackaerts

full_name: K Nackaerts

given: K

family: Tseng

full_name: L-J Tseng

given: L-J

family: McRae

full_name: T D McRae

given: T D

family: Treadow

full_name: J Treadow

given: J

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Pharmacology & Therapeutics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Retreatment With Varenicline for Smoking Cessation in Smokers Who Have Previously Taken Varenicline: A Randomized, Placebo-Controlled Trial

lead_sponsor: Pfizer

location_country:
United States
United Kingdom
Germany
France
Belgium
Australia
Canada
Czech Republic

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: CHU Côte de Nacre, Unité de Coordination de Tabacologie

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie

location_facility: Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie

location_facility: Mestska nemocnice Ostrava, Plicni oddeleni

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Krajska nemocnice Liberec a.s., Plicni oddeleni

location_facility: Synexus, Merseyside Clinical Research Centre

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: The Center for Pharmaceutical Research, PC

location_facility: Ronald Reagan University of California Los Angeles Medical Center

location_facility: University of California Los Angeles David Geffen School of Medicine

location_facility: Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire

location_facility: Synexus Scotland Clinical Research Centre

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

acronym: ESTEEM 2

summary: This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

study_start_date_type: Actual

lead_sponsor: Amgen

location_country:
Italy
Austria
Switzerland
Germany
France
Spain
Denmark
United States
Canada

location_facility: Centre d'lnvestigation Clinique, Hopital Jean Minjoz

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Northwestern University Northwestern Medical Faculty Foundation

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia

location_facility: Arizona Skin and Laser Therapy Inst., Ltd.

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

intervention_type: Other


title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies

summary: This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceCitation: Smyth LM, Reichel JB, Tang J, Patel JAA, Meng F, Selcuklu DS, Houck-Loomis B, You D, Samoila A, Schiavon G, Li BT, Razavi P, Piscuoglio S, Reis-Filho JS, Taylor BS, Baselga J, Solit DB, Hyman DM, Berger MF, Chandarlapaty S. Utility of Serial cfDNA NGS for Prospective Genomic Analysis of Patients on a Phase I Basket Study. JCO Precis Oncol. 2021 Jan 8;5. pii: PO.20.00184. doi: 10.1200/PO.20.00184. eCollection 2021.

name: Memorial Sloan Kettering Cancer Center, New York, NY

family: Smyth

full_name: Lillian M. Smyth

given: Lillian M.

family: Reichel

full_name: Jonathan B. Reichel

given: Jonathan B.

family: Tang

full_name: Jiabin Tang

given: Jiabin

family: Patel

full_name: Juber Ahamad A. Patel

given: Juber Ahamad A.

family: Meng

full_name: Fanli Meng

given: Fanli

family: Selcuklu

full_name: Duygu S. Selcuklu

given: Duygu S.

family: Houck-Loomis

full_name: Brian Houck-Loomis

given: Brian

family: You

full_name: Daoqi You

given: Daoqi

family: Samoila

full_name: Aliaksandra Samoila

given: Aliaksandra

name: R&D Oncology, AstraZeneca, Cambridge, United Kingdom

family: Schiavon

full_name: Gaia Schiavon

given: Gaia

family: Li

full_name: Bob T. Li

given: Bob T.

family: Razavi

full_name: Pedram Razavi

given: Pedram

family: Piscuoglio

full_name: Salvatore Piscuoglio

given: Salvatore

family: Reis-Filho

full_name: Jorge S. Reis-Filho

given: Jorge S.

family: Taylor

full_name: Barry S. Taylor

given: Barry S.

family: Baselga

full_name: José Baselga

given: José

family: Solit

full_name: David B. Solit

given: David B.

family: Hyman

full_name: David M. Hyman

given: David M.

family: Berger

full_name: Michael F. Berger

given: Michael F.

family: Chandarlapaty

full_name: Sarat Chandarlapaty

given: Sarat

journal_name: JCO Precision Oncology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Smyth LM, Batist G, Meric-Bernstam F, Kabos P, Spanggaard I, Lluch A, Jhaveri K, Varga A, Wong A, Schram AM, Ambrose H, Carr TH, de Bruin EC, Salinas-Souza C, Foxley A, Hauser J, Lindemann JPO, Maudsley R, McEwen R, Moschetta M, Nikolaou M, Schiavon G, Razavi P, Banerji U, Baselga J, Hyman DM, Chandarlapaty S. Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer. NPJ Breast Cancer. 2021 Apr 16;7(1):44. doi: 10.1038/s41523-021-00251-7.

ReferenceCitation: Smyth LM, Tamura K, Oliveira M, Ciruelos EM, Mayer IA, Sablin MP, Biganzoli L, Ambrose HJ, Ashton J, Barnicle A, Cashell DD, Corcoran C, de Bruin EC, Foxley A, Hauser J, Lindemann JPO, Maudsley R, McEwen R, Moschetta M, Pass M, Rowlands V, Schiavon G, Banerji U, Scaltriti M, Taylor BS, Chandarlapaty S, Baselga J, Hyman DM. Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with AKT1 (E17K)-Mutant, ER-Positive Metastatic Breast Cancer. Clin Cancer Res. 2020 Aug 1;26(15):3947-3957. doi: 10.1158/1078-0432.CCR-19-3953. Epub 2020 Apr 20.

publisher: American Association for Cancer Research (AACR)

title: Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with AKT1E17K-Mutant, ER-Positive Metastatic Breast Cancer

ReferenceCitation: Banerji U, Dean EJ, Pérez-Fidalgo JA, Batist G, Bedard PL, You B, Westin SN, Kabos P, Garrett MD, Tall M, Ambrose H, Barrett JC, Carr TH, Cheung SYA, Corcoran C, Cullberg M, Davies BR, de Bruin EC, Elvin P, Foxley A, Lawrence P, Lindemann JPO, Maudsley R, Pass M, Rowlands V, Rugman P, Schiavon G, Yates J, Schellens JHM. A Phase I Open-Label Study to Identify a Dosing Regimen of the Pan-AKT Inhibitor AZD5363 for Evaluation in Solid Tumors and in PIK3CA-Mutated Breast and Gynecologic Cancers. Clin Cancer Res. 2018 May 1;24(9):2050-2059. doi: 10.1158/1078-0432.CCR-17-2260. Epub 2017 Oct 24.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Italy
Netherlands
France
Japan
Singapore
Spain
Denmark
United States
United Kingdom
Canada


type: Other Identifier

title: Two Approaches to Escalate Lispro Therapy in Patients With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone (AUTONOMY)

acronym: AUTONOMY

summary: Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.

lead_sponsor: Eli Lilly and Company

location_country:
Austria
United States
Brazil
South Africa
Mexico
Croatia
France
Lithuania
Poland
Romania
Argentina
Puerto Rico
Russian Federation
Denmark
Canada

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

summary: The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmelé T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.

family: Kashani

full_name: Kianoush Kashani

given: Kianoush

family: Al-Khafaji

full_name: Ali Al-Khafaji

given: Ali

family: Ardiles

full_name: Thomas Ardiles

given: Thomas

family: Artigas

full_name: Antonio Artigas

given: Antonio

family: Bagshaw

full_name: Sean M Bagshaw

given: Sean M

family: Bell

full_name: Max Bell

given: Max

family: Bihorac

full_name: Azra Bihorac

given: Azra

family: Birkhahn

full_name: Robert Birkhahn

given: Robert

family: Cely

full_name: Cynthia M Cely

given: Cynthia M

family: Chawla

full_name: Lakhmir S Chawla

given: Lakhmir S

family: Davison

full_name: Danielle L Davison

given: Danielle L

family: Feldkamp

full_name: Thorsten Feldkamp

given: Thorsten

family: Forni

full_name: Lui G Forni

given: Lui G

family: Gong

full_name: Michelle Gong

given: Michelle

family: Gunnerson

full_name: Kyle J Gunnerson

given: Kyle J

family: Haase

full_name: Michael Haase

given: Michael

family: Hackett

full_name: James Hackett

given: James

family: Honore

full_name: Patrick M Honore

given: Patrick M

family: Hoste

full_name: Eric AJ Hoste

given: Eric AJ

family: Joannes-Boyau

full_name: Olivier Joannes-Boyau

given: Olivier

family: Joannidis

full_name: Michael Joannidis

family: Kim

full_name: Patrick Kim

given: Patrick

family: Koyner

full_name: Jay L Koyner

given: Jay L

family: Laskowitz

full_name: Daniel T Laskowitz

repository_institution: Ghent University - Ghent University Academic Bibliography

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

repository_institution: University of California - eScholarship University of California

repository_institution: University of Pittsburgh - D-Scholarship@Pitt

ReferenceCitation: Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen HB, Rimmelé T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators. Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP, McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16.

ReferenceCitation: Kane-Gill SL, Ostermann M, Shi J, Joyce EL, Kellum JA. Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin-Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study. Drug Saf. 2019 Oct;42(10):1149-1155. doi: 10.1007/s40264-019-00846-x.

title: Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin–Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study

ReferenceCitation: Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.

location_country:
Austria
Sweden
Germany
France
Spain
United States
United Kingdom
Canada

location_facility: Hospital of the University of Pennsylvania

location_facility: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie

location_facility: Joseph M. Still Research Foundation, Inc.

location_facility: Bruce W. Carter Department of Veterans Affairs Medical Center

location_facility: University of Chicago Medical Center Section of Nephrology

location_facility: Beth Israel Deaconess Med. Center (BIDMC)


title: CHI SQUARE: Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A Phase II, Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome

acronym: CHI SQUARE

summary: Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

ReferenceType: background

ReferenceCitation: Nanjee MN, Doran JE, Lerch PG, Miller NE. Acute effects of intravenous infusion of ApoA1/phosphatidylcholine discs on plasma lipoproteins in humans. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):979-89.

ReferenceCitation: Eriksson M, Carlson LA, Miettinen TA, Angelin B. Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I. Potential reverse cholesterol transport in humans. Circulation. 1999 Aug 10;100(6):594-8.

ReferenceCitation: Spieker LE, Sudano I, Hürlimann D, Lerch PG, Lang MG, Binggeli C, Corti R, Ruschitzka F, Lüscher TF, Noll G. High-density lipoprotein restores endothelial function in hypercholesterolemic men. Circulation. 2002 Mar 26;105(12):1399-402.

ReferenceCitation: Nieuwdorp M, Vergeer M, Bisoendial RJ, op 't Roodt J, Levels H, Birjmohun RS, Kuivenhoven JA, Basser R, Rabelink TJ, Kastelein JJ, Stroes ES. Reconstituted HDL infusion restores endothelial function in patients with type 2 diabetes mellitus. Diabetologia. 2008 Jun;51(6):1081-4. doi: 10.1007/s00125-008-0975-2. Epub 2008 Apr 4.

ReferenceCitation: Drew BG, Duffy SJ, Formosa MF, Natoli AK, Henstridge DC, Penfold SA, Thomas WG, Mukhamedova N, de Courten B, Forbes JM, Yap FY, Kaye DM, van Hall G, Febbraio MA, Kemp BE, Sviridov D, Steinberg GR, Kingwell BA. High-density lipoprotein modulates glucose metabolism in patients with type 2 diabetes mellitus. Circulation. 2009 Apr 21;119(15):2103-11. doi: 10.1161/CIRCULATIONAHA.108.843219. Epub 2009 Apr 6.

ReferenceCitation: Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM. Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque. Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063. Epub 2008 Oct 2.

ReferenceCitation: Waksman R, Torguson R, Kent KM, Pichard AD, Suddath WO, Satler LF, Martin BD, Perlman TJ, Maltais JA, Weissman NJ, Fitzgerald PJ, Brewer HB Jr. A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 15;55(24):2727-35. doi: 10.1016/j.jacc.2009.12.067.

ReferenceCitation: Tardif JC, Grégoire J, L'Allier PL, Ibrahim R, Lespérance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodés-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. Epub 2007 Mar 26.

ReferenceCitation: Nissen SE, Tsunoda T, Tuzcu EM, Schoenhagen P, Cooper CJ, Yasin M, Eaton GM, Lauer MA, Sheldon WS, Grines CL, Halpern S, Crowe T, Blankenship JC, Kerensky R. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2292-300.

ReferenceCitation: Tardif JC, Ballantyne CM, Barter P, Dasseux JL, Fayad ZA, Guertin MC, Kastelein JJ, Keyserling C, Klepp H, Koenig W, L'Allier PL, Lespérance J, Lüscher TF, Paolini JF, Tawakol A, Waters DD; Can HDL Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial. Eur Heart J. 2014 Dec 7;35(46):3277-86. doi: 10.1093/eurheartj/ehu171. Epub 2014 Apr 29.

family: Tardif

full_name: J.-C. Tardif

family: Ballantyne

full_name: C. M. Ballantyne

given: C. M.

family: Barter

full_name: P. Barter

given: P.

family: Dasseux

full_name: J.-L. Dasseux

family: Fayad

full_name: Z. A. Fayad

given: Z. A.

family: Guertin

full_name: M.-C. Guertin

family: Kastelein

full_name: J. J. P. Kastelein

given: J. J. P.

family: Keyserling

full_name: C. Keyserling

given: C.

family: Klepp

full_name: H. Klepp

given: H.

family: Koenig

full_name: W. Koenig

given: W.

family: L'Allier

full_name: P. L. L'Allier

given: P. L.

family: Lesperance

full_name: J. Lesperance

given: J.

family: Luscher

full_name: T. F. Luscher

given: T. F.

family: Paolini

full_name: J. F. Paolini

given: J. F.

family: Tawakol

full_name: A. Tawakol

given: A.

family: Waters

full_name: D. D. Waters

given: D. D.

family: Pfeffer

full_name: M. Pfeffer

given: M.

family: Brown

full_name: V. Brown

given: V.

family: Rouleau

full_name: J. Rouleau

family: Watkins

full_name: P. Watkins

family: Wei

full_name: L. J. Wei

given: L. J.

family: Gosselin

full_name: G. Gosselin

name: for the Can Hdl Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: California Digital Library - eScholarship

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_facility: Buffalo Cardiology & Pulmonary Associates

location_facility: Detroit Medical Center (DMC) Cardiovascular Institute

location_facility: Centre de Santé et de Services Sociaux de Laval

location_facility: University of North Carolina Medical Center

location_facility: Jacksonville Center for Clinical Research

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Centre Hospitalier Régional de Trois-Rivières

location_facility: Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ)

location_facility: Centre Hospitalier Universitaire de Toulouse Rangueil

location_facility: Montreal General Hospital Research Institute

location_facility: Palm Beach Heart Institute, LLC - Zasa Clinical Research

location_facility: MultiCare Health System Research Institute / Cardiac Study Center

location_facility: Cardiac and Vascular Research Center of Northern Michigan


status: No longer available

study_type: Expanded Access

lead_sponsor: Seagen Inc.

location_country:
Italy
Serbia
Switzerland
Germany
France
Bulgaria
Poland
Romania
Hungary
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom

location_facility: South Lyon Hospital Center, Department of Dermatology

location_facility: Johannes Wesling Hospital Minden, Department of Dermatology

location_facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

location_facility: University Hospital Zurich, Department of Dermatology

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: University Hospital 12 de Octubre, Department of Dermatology

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation

location_facility: Research Institute of Clinical Immunology

location_facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

location_facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii

location_facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

location_facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

location_facility: Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"

location_facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: MD Anderson Cancer Center / University of Texas

type: EudraCT Number

source: euctr

title: An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

summary: The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

status_simplified: Unknown


title: A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer

summary: This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

ReferenceCitation: Krop IE, Suter TM, Dang CT, Dirix L, Romieu G, Zamagni C, Citron ML, Campone M, Xu N, Smitt M, Gianni L. Feasibility and cardiac safety of trastuzumab emtansine after anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer. J Clin Oncol. 2015 Apr 1;33(10):1136-42. doi: 10.1200/JCO.2014.58.7782. Epub 2015 Feb 23.

name: Ian E. Krop, Dana-Farber Cancer Institute, Boston, MA; Thomas M. Suter, Bern University Hospital, Bern, Switzerland; Chau T. Dang, Memorial Sloan Kettering Cancer Center, New York; Marc L. Citron, Hofstra North Shore–Long Island Jewish School of Medicine, New Hyde Park, NY; Luc Dirix, Sint-Augustinus Hospital, Antwerp, Belgium; Gilles Romieu, Institut du Cancer de Montpellier Val d'Aurelle, Montpellier; Mario Campone, Institut de Cancérologie de l'Ouest/René Gauducheau, Nantes Saint-Herblain, France;...

family: Krop

full_name: Ian E. Krop

given: Ian E.

family: Suter

full_name: Thomas M. Suter

given: Thomas M.

family: Dang

full_name: Chau T. Dang

given: Chau T.

family: Dirix

full_name: Luc Dirix

given: Luc

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Zamagni

full_name: Claudio Zamagni

given: Claudio

family: Citron

full_name: Marc L. Citron

given: Marc L.

family: Campone

full_name: Mario Campone

given: Mario

family: Xu

full_name: Na Xu

family: Smitt

full_name: Melanie Smitt

given: Melanie

family: Gianni

full_name: Luca Gianni

given: Luca

journal_name: Journal of Clinical Oncology

oa_host_type: repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Feasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Belgium
Russian Federation
Spain
Germany
Korea, Republic of


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Germany
France
Australia
Canada

title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).


title: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin Versus the Chemotherapy Alone in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Progressed on or After Prior Platinum-Based Chemotherapy

summary: The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.

lead_sponsor: Oncolytics Biotech

location_country:
Italy
United States
United Kingdom
Germany
France
Poland
Greece
Hungary
Belgium
Russian Federation
Spain
Canada
Slovenia

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie

location_facility: Centre Antoine Lacassagne / Oncologie Médicale

location_facility: St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"

location_facility: Regional State Health Care Institution "Belgorod Oncology Dispensary"

location_facility: The Royal Marsden Cancer Center, Fulham Road branch

location_facility: State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"

location_facility: Mary Bird Perkinds Cancer Center - Baton Rouge

location_facility: Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals

location_facility: BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates

location_facility: State Health Care Institution "Tula Regional Oncology Dispensary"

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation

location_facility: State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department

location_facility: State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"

location_facility: Emory University - Winship Cancer Institute

location_facility: Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Institut Curie / Département d'Oncologie Médicale

location_facility: Wojewódzki Szpital Specjalistyczny im. M.Kopernika

location_facility: State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"

location_facility: Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol

location_facility: Fovarosi Onkormanyzat Uzsoki Utcai Kórház

location_facility: Federal State Budgetary Institution "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation

location_facility: Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk

location_facility: State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: Fondazione IRCCS Istituto Nazionale del Tumori

location_facility: Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region

location_facility: Case Comprehensive Cancer Center, University Hospitals Case Medical Center

location_facility: The Royal Marsden Cancer Center, Sutton Branch

location_facility: Hopital Saint-André / Service d'Oncologie-Radiothérapie


title: SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

acronym: MS

summary: The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

lead_sponsor: ResMed

location_country:
Switzerland
Netherlands
United Kingdom
Finland
France
Australia
Germany
Czech Republic

location_facility: Klinikum der Universität zu Köln-Schlaflabor

location_facility: Klinikum der Universität zu Köln- Herzzentrum

location_facility: Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

location_facility: Gemeinschaftspraxis Kardiologie Dr. Becker

location_facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

location_facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

location_facility: Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

intervention_type: Device


title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

acronym: PREPARE

summary: This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).

primary_purpose: Diagnostic

ReferenceCitation: Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaçi D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Nov;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023. Epub 2013 Aug 24.

family: Mease

full_name: Philip J. Mease

given: Philip J.

family: Gladman

full_name: Dafna D. Gladman

given: Dafna D.

family: Papp

full_name: Kim A. Papp

given: Kim A.

family: Khraishi

full_name: Majed M. Khraishi

given: Majed M.

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

family: Behrens

full_name: Frank Behrens

given: Frank

family: Northington

full_name: Robert Northington

given: Robert

family: Fuiman

full_name: Joanne Fuiman

given: Joanne

family: Bananis

full_name: Eustratios Bananis

given: Eustratios

family: Boggs

full_name: Robert Boggs

family: Alvarez

full_name: Daniel Alvarez

given: Daniel

journal_name: Journal of the American Academy of Dermatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
United States
Germany
France
Hungary
Belgium
Denmark
Canada

location_facility: Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat

location_facility: Rheumatology Practive of Scott Zashin, MD

location_facility: Centre de Recherche Dermatologique du Quebec metropolitain

location_facility: The Skin Care Centre-Clinical Trials Unit

location_facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

location_facility: Klinik und Poliklinik fuer Dermatologie und

location_facility: Praxis Dres. Bredlich, Rosenbach und Thiele

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: The Toronto Western Hospital-Division of Rheumatology

location_facility: Klinik fuer Dermatologie, Allergologie und Venerologie

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

intervention_type: Procedure


lead_sponsor: PTC Therapeutics

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Israel
Belgium
Spain
Canada
United Kingdom

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

ipd_sharing: No

type: Other Grant/Funding Number

title: A Phase 3 Extension Study of Ataluren (PTC124®) in Subjects With Nonsense-Mutation-Mediated Cystic Fibrosis

summary: Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.


ReferenceCitation: Felip E, Barlesi F, Besse B, Chu Q, Gandhi L, Kim SW, Carcereny E, Sequist LV, Brunsvig P, Chouaid C, Smit EF, Groen HJM, Kim DW, Park K, Avsar E, Szpakowski S, Akimov M, Garon EB. Phase 2 Study of the HSP-90 Inhibitor AUY922 in Previously Treated and Molecularly Defined Patients with Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Apr;13(4):576-584. doi: 10.1016/j.jtho.2017.11.131. Epub 2017 Dec 13.

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Chu

full_name: Quincy Chu

given: Quincy

family: Gandhi

full_name: Leena Gandhi

given: Leena

family: Kim

full_name: Sang-We Kim

given: Sang-We

family: Carcereny

full_name: Enric Carcereny

given: Enric

family: Sequist

full_name: Lecia V. Sequist

given: Lecia V.

family: Brunsvig

full_name: Paal Brunsvig

given: Paal

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Smit

full_name: Egbert F. Smit

given: Egbert F.

family: Groen

full_name: Harry J.M. Groen

given: Harry J.M.

full_name: Dong-Wan Kim

given: Dong-Wan

family: Park

full_name: Keunchil Park

given: Keunchil

family: Avsar

full_name: Emin Avsar

given: Emin

family: Szpakowski

full_name: Sebastian Szpakowski

given: Sebastian

family: Akimov

full_name: Mikhail Akimov

given: Mikhail

family: Garon

full_name: Edward B. Garon

given: Edward B.

journal_name: Journal of Thoracic Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Phase 2 Study of the HSP-90 Inhibitor AUY922 in Previously Treated and Molecularly Defined Patients with Advanced Non–Small Cell Lung Cancer

location_country:
United States
Netherlands
France
Korea, Republic of
Norway
Singapore
Spain
Turkey
Germany
Canada

location_facility: St. Luke's Hospital and Health Network St Luke's

location_facility: University of California at Los Angeles UCLA - Santa Monica

location_facility: Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem

title: A Phase II, Multi-center, Open-label Study of AUY922 Administered IV on a Once-weekly Schedule in Patients With Advanced Non-small-cell Lung Cancer Who Have Received at Least Two Lines of Prior Chemotherapy

summary: This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata was assigned: Patients with Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma kinase) translocations and patients that were both EGFR and Kras wild type.


ReferenceCitation: Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.

family: Stevens

full_name: Toer W. Stevens

given: Toer W.

family: Gecse

full_name: Krisztina Gecse

given: Krisztina

family: Turner

full_name: Jerrold R. Turner

given: Jerrold R.

family: de Hertogh

full_name: Gert de Hertogh

given: Gert

family: Rubin

full_name: David T. Rubin

given: David T.

family: D’Haens

full_name: Geert R. D’Haens

given: Geert R.

journal_name: Clinical Gastroenterology and Hepatology

license: cc-by

license_normalized: cc-by

ReferenceCitation: Willian MK, D'Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.

family: Willian

full_name: Mary Kaye Willian

given: Mary Kaye

full_name: Geert D’Haens

given: Geert

family: Yarlas

full_name: Aaron Yarlas

given: Aaron

family: Joshi

full_name: Ashish V. Joshi

given: Ashish V.

currency_apc_doaj: GBP

journal_name: Journal of Patient-Reported Outcomes

oa_colors: green gold

evidence: oa journal (via doaj)

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Yarlas A, D'Haens G, Willian MK, Teynor M. Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study. Inflamm Bowel Dis. 2018 Jan 18;24(2):450-463. doi: 10.1093/ibd/izx041.

name: Inflammatory Bowel Disease Centre, Academic Medical Centre, University of Amsterdam, The Netherlands

family: Teynor

full_name: Megan Teynor

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
United States
South Africa
India
Germany
France
Czechia
Poland
Romania
Hungary
Belgium
Ireland
Spain
Canada
United Kingdom
Colombia

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Stawdtisches Klinikum Lueneburg Gastroenterologie

location_facility: Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie

location_facility: IKEM (Institute klinicke a experimentalni mediciny)

location_facility: Orlickoustecka nemocnice a.s. (Hospital)

location_facility: Birmingham Gastroenterology Associates, PC

location_facility: Gastroenterology Clinic of San Antonio, PA

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Manikya Institute of Gastroenterology & Hepatology

location_facility: Center for Digestive & Liver Disease, Inc.

location_facility: Javorszky Odon Varosi Korhaz, Gasztroenterologia

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: Karolina Korhaz, Belgyogyaszat es Gasztroenterologia

location_facility: Emergency University Clinical Hospital Bucuresti

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat

location_facility: Chhatrapati Shahuji Maharaj Medical University

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium

location_facility: Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii

location_facility: Heilig Hart ziekenhuis vzw Roeselare-Menen

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Ohio Gastroenterolgy and Liver Intstitute

location_facility: S R Kalla Memorial Gastro & General Hospital

title: A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

summary: This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.


title: Advisa MRI™ System Clinical Investigation

summary: The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

ReferenceCitation: Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.

family: Rod Gimbel

full_name: J. Rod Gimbel

given: J.

family: Bello

full_name: David Bello

given: David

family: Schmitt

full_name: Matthias Schmitt

given: Matthias

family: Merkely

full_name: Béla Merkely

given: Béla

family: Schwitter

full_name: Juerg Schwitter

given: Juerg

family: Hayes

full_name: David L. Hayes

given: David L.

family: Sommer

full_name: Torsten Sommer

given: Torsten

family: Schloss

full_name: Edward J. Schloss

given: Edward J.

family: Chang

full_name: Yanping Chang

given: Yanping

family: Willey

full_name: Sarah Willey

given: Sarah

family: Kanal

full_name: Emanuel Kanal

given: Emanuel

journal_name: Heart Rhythm

repository_institution: Semmelweis University - Semmelweis University Repository

ReferenceCitation: Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Tóth A, Chang Y, van Osch D, Sommer T; Advisa MRI System Study Investigators. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. 2013 Jun;10(6):864-72. doi: 10.1016/j.hrthm.2013.02.019. Epub 2013 Feb 19.

family: Anselme

full_name: Frederic Anselme

given: Frederic

family: Albert

full_name: Timothy Albert

given: Timothy

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Israel
Hungary
Australia
Belgium
Canada
United Kingdom

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Centre Hospitalier Universitaire Saint Étienne

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität

location_facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

family: Davies

full_name: Michael J. Davies

given: Michael J.

family: Merton

full_name: Katherine Merton

given: Katherine

family: Vijapurkar

full_name: Ujjwala Vijapurkar

given: Ujjwala

family: Yee

full_name: Jacqueline Yee

given: Jacqueline

family: Qiu

full_name: Rong Qiu

given: Rong

journal_name: Cardiovascular Diabetology

ReferenceCitation: Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

family: Pfeifer

full_name: Michael Pfeifer

given: Michael

family: Townsend

full_name: Raymond R. Townsend

given: Raymond R.

family: Ren

full_name: Jimmy Ren

given: Jimmy

ReferenceCitation: Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

name: Janssen Research & Development, LLC, Raritan, NJ, USA;

name: Janssen Scientific Affairs, LLC, Raritan, NJ, USA

ReferenceCitation: John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

name: Providence Endocrine & Diabetes Specialty Centre  Trivandrum Kerala India

name: Hospital Cima Centro de Investigacíon Clínica San Agustín  San José Costa Rica

name: Centro de Estudios de Investigacíon Metabólicos y Cardiovasculares S.C.  Tampico Mexico

name: Rajavithi Hospital Rangsit Medical School  Bangkok Thailand

name: Dubai Hospital Dubai Health Authority  Dubai United Arab Emirates

name: Janssen Global Services, LLC  Raritan NJ USA

journal_name: International Journal of Clinical Practice

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

name: aOchsner Diabetes Clinical Research Unit, Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, LA, USA

name: bEndocrinology Section, Department of Internal Medicine, University of Manitoba, Winnipeg, Canada

name: cClinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium

name: dJanssen Research & Development LLC, Raritan, NJ, USA

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

name: aEmory University School of Medicine, Atlanta, GA, USA

name: bDiabetes Research Centre, University of Leicester, Leicester, UK

name: cJanssen Scientific Affairs LLC, Raritan, NJ, USA

ReferenceCitation: Cefalu WT, Stenlöf K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

ReferenceCitation: Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

name: Division of Nephrology; Department of Medicine; University of Maryland School of Medicine; Baltimore MD

name: Department of Hypertension; Institute of Cardiology; Warsaw Poland

name: University of Toronto; St. Michael's Hospital; Toronto ON Canada

name: Janssen Research & Development; LLC; Raritan NJ

title: Effect of Canagliflozin on Blood Pressure and Adverse Events Related to Osmotic Diuresis and Reduced Intravascular Volume in Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

title: Safety and Tolerability of Canagliflozin in Patients With Type 2 Diabetes Mellitus: Pooled Analysis of Phase 3 Study Results

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

name:
Division of Nephrology, University of Maryland School of Medicine
Baltimore, MDUSA

name: Janssen Research & Development, LLC Raritan, NJUSA

ReferenceCitation: Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

name:
Drexel University College of Medicine
Philadelphia, PAUSA

name:
Wayne State University School of Medicine
Detroit, MIUSA

name: Janssen Research & Development LLC Raritan, NJUSA

name: Janssen Research & Development LLC Titusville, NJUSA

location_country:
United States
India
Mexico
Finland
France
Thailand
Greece
Spain
Germany
United Kingdom
Canada


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

ReferenceCitation: Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.

family: Januzzi

full_name: James L. Januzzi

given: James L.

suffix: Jr.

family: Butler

full_name: Javed Butler

given: Javed

family: Jarolim

full_name: Petr Jarolim

given: Petr

family: Sattar

full_name: Naveed Sattar

given: Naveed

family: Desai

full_name: Mehul Desai

given: Mehul

journal_name: Journal of the American College of Cardiology

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

name: Janssen Research & Development, LLC, Raritan, NJ, USA;

family: Balis

full_name: Dainius Balis

given: Dainius

family: Xie

full_name: John Xie

given: John

name: Janssen Scientific Affairs, LLC, Raritan, NJ, USA

family: Meininger

full_name: Gary Meininger

given: Gary

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis

ReferenceCitation: Blonde L, Stenlöf K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.

family: Blonde

full_name: Lawrence Blonde

given: Lawrence

family: Stenlöf

full_name: Kaj Stenlöf

given: Kaj

title: Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.

title: Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR)

title: Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies

ReferenceCitation: Bode B, Stenlöf K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.

title: Efficacy and Safety of Canagliflozin Treatment in Older Subjects With Type 2 Diabetes Mellitus: A Randomized Trial

location_country:
United States
South Africa
Sweden
India
Hong Kong
Switzerland
France
Poland
Greece
Romania
Australia
New Zealand
Spain
Canada
United Kingdom
Colombia
Ukraine


title: A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis

summary: This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

status: Terminated

ReferenceCitation: Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11.

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

family: Gottlieb

full_name: Alice Gottlieb

given: Alice

family: Lebwohl

full_name: Mark Lebwohl

given: Mark

family: Liu

full_name: Clive Liu

given: Clive

family: Israel

full_name: Robert J. Israel

given: Robert J.

family: Jacobson

full_name: Abby Jacobson

given: Abby

journal_name: American Journal of Clinical Dermatology

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Lebwohl MG, Blauvelt A, Menter A, Papp KA, Guenthner S, Pillai R, Israel RJ, Jacobson A. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2.

full_name: Mark G. Lebwohl

given: Mark G.

family: Blauvelt

full_name: Andrew Blauvelt

given: Andrew

family: Menter

full_name: Alan Menter

given: Alan

family: Papp

full_name: Kim A. Papp

given: Kim A.

family: Guenthner

full_name: Scott Guenthner

given: Scott

family: Pillai

full_name: Radhakrishnan Pillai

given: Radhakrishnan

location_country:
United States
France
Australia
Denmark
Canada


ReferenceCitation: Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, van der Heijde D. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014 Jan;73(1):48-55. doi: 10.1136/annrheumdis-2013-203696. Epub 2013 Aug 13.

family: Mease

full_name: P J Mease

given: P J

family: Fleischmann

full_name: R Fleischmann

given: R

family: Deodhar

full_name: A A Deodhar

given: A A

family: Wollenhaupt

full_name: J Wollenhaupt

given: J

family: Khraishi

full_name: M Khraishi

given: M

family: Kielar

full_name: D Kielar

given: D

family: Woltering

full_name: F Woltering

given: F

family: Stach

full_name: C Stach

given: C

family: Hoepken

full_name: B Hoepken

given: B

family: Arledge

full_name: T Arledge

given: T

family: van der Heijde

full_name: D van der Heijde

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, Mease PJ. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis. 2014 Jan;73(1):233-7. doi: 10.1136/annrheumdis-2013-203697. Epub 2013 Aug 13.

full_name: A Deodhar

given: A

ReferenceCitation: van der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb AB, Hoepken B, Bauer L, Irvin-Sellers O, Khraishi M, Peterson L, Turkiewicz A, Wollenhaupt J, Mease PJ. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018 Mar 14;4(1):e000582. doi: 10.1136/rmdopen-2017-000582. eCollection 2018. Erratum in: RMD Open. 2018 Mar 26;4(1):.

ReferenceCitation: Walsh JA, Gottlieb AB, Hoepken B, Nurminen T, Mease PJ. Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial. Clin Rheumatol. 2018 Dec;37(12):3285-3296. doi: 10.1007/s10067-018-4227-7. Epub 2018 Sep 6. Erratum in: Clin Rheumatol. 2018 Oct 11;:.

ReferenceCitation: van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.

name: Leiden University Medical Center; Leiden The Netherlands

name: Oregon Health and Science University; Portland

name: University of Texas SW Medical Center; Dallas

name: Swedish Medical Center and University of Washington; Seattle

name: Klinikum Bielefeld and Charité Berlin, Berlin, Germany, and Ghent University; Ghent Belgium

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

ReferenceCitation: Osterhaus JT, Purcaru O. Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis. Arthritis Res Ther. 2014 Jul 4;16(4):R140. doi: 10.1186/ar4602.

ReferenceCitation: Kavanaugh A, Gladman D, van der Heijde D, Purcaru O, Mease P. Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study. Ann Rheum Dis. 2015 Jan;74(1):44-51. doi: 10.1136/annrheumdis-2014-205198. Epub 2014 Jun 18.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1085-92. doi: 10.1002/acr.22256.

name: Toronto Western Research Institute and Toronto Western HospitalToronto, OntarioCanada

name: Metroplex Clinical Research CenterDallasTexas

name: Swedish Medical Center and University of WashingtonSeattle

title: Effect of Certolizumab Pegol on Multiple Facets of Psoriatic Arthritis as Reported by Patients: 24‐Week Patient‐Reported Outcome Results of a Phase III, Multicenter Study

location_country:
Italy
United States
Brazil
Mexico
Germany
France
Czechia
Poland
Hungary
Belgium
Argentina
Ireland
Spain
Canada
United Kingdom

title: Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)

summary: Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).


title: A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy

summary: A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Singapore
Australia
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: USC/Kenneth Norris Comprehensive Cancer Center USC/Norris

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: University of California at Los Angeles Dept. of UCLA (4)

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU


title: A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies

summary:
Primary Objective:

Phase 1:

To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).

Phase 2 (stage 1):

To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone.

Phase 2 (stage 2):

To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm).

Secondary Objectives:

Phase 1:

To characterize the global safety profile including cumulative toxicities.
To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s).
To assess the pharmacodynamics (PD), immune response, and preliminary disease response.

Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:

Safety
Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.

Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):

Safety
Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.
Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status.
Pharmacokinetic profile of Isatuximab.
Immunogenicity of Isatuximab.
Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.

ReferenceCitation: Dimopoulos M, Bringhen S, Anttila P, Capra M, Cavo M, Cole C, Gasparetto C, Hungria V, Jenner M, Vorobyev V, Ruiz EY, Yin JY, Saleem R, Hellet M, Macé S, Paiva B, Vij R. Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma. Blood. 2021 Mar 4;137(9):1154-1165. doi: 10.1182/blood.2020008209.

name: Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece;

family: Dimopoulos

full_name: Meletios Dimopoulos

given: Meletios

name: Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy;

family: Bringhen

full_name: Sara Bringhen

given: Sara

name: Division of Hematology, Comprehensive Cancer Center, Helsinki University and Helsinki University Hospital, Helsinki, Finland;

family: Anttila

full_name: Pekka Anttila

given: Pekka

name: Hospital Mãe de Deus, Porto Alegre, Brazil;

family: Capra

full_name: Marcelo Capra

given: Marcelo

name: “Seràgnoli” Institute of Hematology, Sant’Orsola-Malpighi University Hospital, Bologna, Italy;

family: Cavo

full_name: Michele Cavo

given: Michele

name: Division of Hematology and Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;

family: Cole

full_name: Craig Cole

given: Craig

name: Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC;

family: Gasparetto

full_name: Cristina Gasparetto

given: Cristina

name: Department of Hematology, Clínica São Germano, São Paulo, Brazil;

family: Hungria

full_name: Vania Hungria

given: Vania

name: Department of Haematology, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom;

family: Jenner

full_name: Matthew Jenner

given: Matthew

family: Vorobyev

full_name: Vladimir Vorobyev

given: Vladimir

name: Clinical Oncology, Universidad de la Frontera, Temuco, Chile;

family: Ruiz

full_name: Eduardo Yanez Ruiz

given: Eduardo Yanez

family: Yin

full_name: Jian Y. Yin

given: Jian Y.

family: Saleem

full_name: Rao Saleem

given: Rao

family: Hellet

full_name: Maeva Hellet

given: Maeva

family: Macé

full_name: Sandrine Macé

given: Sandrine

name: Clinica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra (IdiSNA), CIBER-ONC number CB16/12/00369, Pamplona, Spain; and

family: Paiva

full_name: Bruno Paiva

given: Bruno

name: Division of Medical Oncology, Washington University, St. Louis, MO

family: Vij

full_name: Ravi Vij

given: Ravi

journal_name: Blood

evidence: open (via free article)

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

ReferenceCitation: Mikhael J, Richter J, Vij R, Cole C, Zonder J, Kaufman JL, Bensinger W, Dimopoulos M, Lendvai N, Hari P, Ocio EM, Gasparetto C, Kumar S, Oprea C, Chiron M, Brillac C, Charpentier E, San-Miguel J, Martin T. A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma. Leukemia. 2020 Dec;34(12):3298-3309. doi: 10.1038/s41375-020-0857-2. Epub 2020 May 14.

ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

location_country:
Italy
Brazil
Chile
Peru
Mexico
Finland
France
Greece
Israel
Belgium
Argentina
Russian Federation
Spain
Turkey
United States
United Kingdom
Ukraine

location_facility:
Investigational Site Number 724008
Investigational Site Number 792001
Investigational Site Number 840027
Investigational Site Number 250004
Investigational Site Number 840016
Investigational Site Number 380001
Investigational Site Number 792005
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 826001
Investigational Site Number 840009
Investigational Site Number 032001
Investigational Site Number 250001
Investigational Site Number 484003
Investigational Site Number 376004
Investigational Site Number 643001
Investigational Site Number 840004
Investigational Site Number 840003
Investigational Site Number 246001
Investigational Site Number 724001
Investigational Site Number 300001
Investigational Site Number 604002
Investigational Site Number 804001
Investigational Site Number 804002
Investigational Site Number 643002
Investigational Site Number 840011
Investigational Site Number 604001
Investigational Site Number 376002
Investigational Site Number 152001
Investigational Site Number 250003
Investigational Site Number 724006
Investigational Site Number 840017
Investigational Site Number 076003
Investigational Site Number 840001
Investigational Site Number 792002
Investigational Site Number 792004
Investigational Site Number 076001
Investigational Site Number 724004
Investigational Site Number 840018
Investigational Site Number 840002
Investigational Site Number 076004
Investigational Site Number 804004
Investigational Site Number 840010
Investigational Site Number 076002
Investigational Site Number 643004
Investigational Site Number 032002
Investigational Site Number 643003
Investigational Site Number 724005
Investigational Site Number 826002
Investigational Site Number 032003
Investigational Site Number 380002
Investigational Site Number 840013
Investigational Site Number 246002
Investigational Site Number 056001
Investigational Site Number 840022
Investigational Site Number 840012
Investigational Site Number 724007
Investigational Site Number 724002
Investigational Site Number 484001


title: A Randomized, Placebo-Controlled, Phase 1/2 Study Of ARQ 197 in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Who Have Received Front-Line Systemic Therapy

summary:
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2.

After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
United States
France
Russian Federation
Germany


ReferenceCitation: Ketter TA, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder. J Affect Disord. 2015 Aug 1;181:87-91. doi: 10.1016/j.jad.2015.04.012. Epub 2015 Apr 15.

family: Ketter

full_name: Terence A. Ketter

given: Terence A.

family: Yang

full_name: Ronghua Yang

given: Ronghua

family: Frye

full_name: Mark A. Frye

given: Mark A.

journal_name: Journal of Affective Disorders

lead_sponsor: Cephalon

location_country:
United States
South Africa
France
Bulgaria
Poland
Argentina
Australia
Spain
Canada
Ukraine

location_facility: Centro de Investigación y asistencia en Psiquiatria (CIAP)

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc

location_facility: Northern Area Mental Health Services Northern Psychiatric R

location_facility: Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie

location_facility: Odessa Regional Psychoneurology Dispensary

location_facility: Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.)

location_facility: Diagnostic Consultative Center "Tchaika"

location_facility: Hopital Universitaire Caremeau-Batiment Polyvalent, Service

location_facility: Donetsk National Medical University n.a. M. Horkyy

location_facility: Behavioral Medical Research of Staten Island

location_facility: Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy

location_facility: Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"

location_facility: Danylo Galitsky Lviv State Medical University

location_facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM

location_facility: District Department of Psychiatric Disorders With Stationary

location_facility: Vinnytsa National Medical University named by M.I. Pirogov

location_facility: Psychiatric clinic, University Hospital "Alexandrovska"

location_facility: Kiev City Psychoneurological Hospital N 1, CNTRP

location_facility: South Coast Medical Associates/SC Clinical Trials, Inc.

location_facility: Belmont Center for Comprehensive Treatment

location_facility: Public Institution "Institute of Neurology, Psychiatry and N

location_facility: Midwest Center for Neurobehavioral Medicine

title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

summary: The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.


lead_sponsor: Bayer

location_country:
Austria
Mexico
Philippines
Germany
France
Ireland
Argentina
Belgium
United States

acronym: COMPOSE 2

title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

summary: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


title: Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks

acronym: CONFIDENT-PD

summary: A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

lead_sponsor: Phytopharm

location_country:
United States
Serbia
United Kingdom
France
Poland
Romania
Hungary
Germany
Czech Republic
Canada

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika

location_facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

location_facility: Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Fakultni nemocnice Olomouc Neurologicka klinika

location_facility: Rush University Medical Center Neuroscience Inst.

location_facility: prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski

location_facility: Neurological Institute, Cleveland Clinic

location_facility: Luton and Dunstable Hospital Foundation Trust

location_facility: Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik

location_facility: University of Tennessee Health Science Center

location_facility: Semmelweis Egyetem AOK Neurologiai Klinika

location_facility: Institute for Neurodegenerative Disorders

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly

location_facility: Weil Medical College of Cornell University

location_facility: Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya

location_facility: Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly

location_facility: Washington University School of Medicine

location_facility: The Royal Devon and Exeter NHS Foundation Trust

location_facility: Wisconsin Institute for Neurologic and Sleep Disorders

location_facility: Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju

location_facility: Parkinsons Neurodegenerative Disorder Clinic

location_facility: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus

location_facility: Southern Illinois University School of Medicine

location_facility: Fakultni nemocnice Hradec Kralove Neurologicka klinika

location_facility: Vseobecna fakultni nemocnice v Praze Neurologicka klinika

location_facility: Klinik für Neurologie Charité, Universitaetsmedizin Berlin

location_facility: Colorado Neurological Institute, Rocky Mountain Movement Disorders Center

location_facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril

location_facility: Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly

location_facility: Spitalul Clinic de Recuperare Cluj-Napoca

location_facility: Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Clinique Sainte-Anne "Memoire et mouvement"


title: AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA

summary: This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

ReferenceCitation: Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017.

name: Cross Cancer Institute, Edmonton, Canada;

family: Sangha

full_name: Randeep Sangha

given: Randeep

name: Cancer Research UK Centre, Somers Cancer Research Building, University of Southampton, Southampton, UK;

family: Davies

full_name: Andrew Davies

given: Andrew

name: University of Florida, Gainesville, FL, USA;

family: Dang

full_name: Nam H. Dang

given: Nam H.

name: Nagoya Daini Red Cross Hospital, Nagoya, Japan;

name: Tokai Central Hospital, Kakamigahara, Gifu, Japan;

family: Ogura

full_name: Michinori Ogura

given: Michinori

name: Queen Elizabeth II Health Sciences Center, Halifax, Canada;

family: MacDonald

full_name: David A. MacDonald

given: David A.

family: Ananthakrishnan

full_name: Revathi Ananthakrishnan

given: Revathi

family: Paccagnella

full_name: M. Luisa Paccagnella

given: M. Luisa

family: Vandendries

full_name: Erik Vandendries

given: Erik

family: Boni

full_name: Joseph Boni

given: Joseph

family: Goh

full_name: Yeow Tee Goh

given: Yeow Tee

journal_name: Journal of Drug Assessment

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. Epub 2016 May 6.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
United States
Hong Kong
France
Japan
Singapore
Belgium
Canada
United Kingdom
Korea, Republic of

location_facility: Hopital Saint-Louis -Universite Paris VII

location_facility: Cancer Sciences Division, Somers Cancer Research Building

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie

location_facility: Shands Cancer Hospital At The University Of Florida

location_facility: Hospital Saint-Louis - Service d'Hemato-Oncologie

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Shands Hospital at the University of Florida

location_facility: Davis Cancer Pavillion and Shands Medical Plaza

location_facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research

location_facility: Guy's and St Thomas' NHS Foundation Trust