title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

acronym: C-early

summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

ReferenceCitation: Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10.

family: Emery

full_name: P Emery

given: P

family: Bingham

full_name: C O Bingham

given: C O

suffix: III

family: Burmester

full_name: G R Burmester

given: G R

family: Bykerk

full_name: V P Bykerk

given: V P

family: Furst

full_name: D E Furst

given: D E

family: Mariette

full_name: X Mariette

given: X

family: van der Heijde

full_name: D van der Heijde

given: D

family: van Vollenhoven

full_name: R van Vollenhoven

given: R

family: Arendt

full_name: C Arendt

given: C

family: Mountian

full_name: I Mountian

given: I

family: Purcaru

full_name: O Purcaru

given: O

family: Tatla

full_name: D Tatla

family: VanLunen

full_name: B VanLunen

given: B

family: Weinblatt

full_name: M E Weinblatt

given: M E

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12.

name: Brigham and Women's Hospital; Boston Massachusetts

name: Johns Hopkins University; Baltimore Maryland

name: Charité University Medicine Berlin; Berlin Germany

name: Weill Cornell Medical College; New York New York

name: Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184; Le Kremlin Bicêtre France

name: Leiden University Medical Center; Leiden The Netherlands

name: Amsterdam Rheumatology and Immunology Center; Amsterdam The Netherlands

name: University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust; Leeds UK

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

location_country:
Romania
Australia
Belgium
France
Poland
Argentina
Canada
Monaco
Colombia
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Spain


type: EudraCT Number

title: A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma

acronym: CheckMate 143

summary: The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170.

name: Preston Robert Tisch Brain Tumor Center and Department of Pathology

family: Woroniecka

full_name: Karolina Woroniecka

given: Karolina

sequence: first

name: Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina

family: Fecci

full_name: Peter E Fecci

given: Peter E

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neuro-Oncology

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, Baehring J, Ahluwalia MS, Roth P, Bähr O, Phuphanich S, Sepulveda JM, De Souza P, Sahebjam S, Carleton M, Tatsuoka K, Taitt C, Zwirtes R, Sampson J, Weller M. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Jul 1;6(7):1003-1010. doi: 10.1001/jamaoncol.2020.1024.

name: Dana-Farber/Harvard Cancer Center, Boston, Massachusetts

family: Reardon

full_name: David A. Reardon

given: David A.

name: AUSL–IRCCS Institute of Neurological Sciences, Bologna, Italy

family: Brandes

full_name: Alba A. Brandes

given: Alba A.

name: Department of Neurology and Yale Cancer Center, Yale University, New Haven, Connecticut

family: Omuro

full_name: Antonio Omuro

given: Antonio

name: University College London Hospitals, London, United Kingdom

family: Mulholland

full_name: Paul Mulholland

given: Paul

name: The Johns Hopkins Hospital, Baltimore, Maryland

family: Lim

full_name: Michael Lim

given: Michael

name: Neurology Clinic, University of Heidelberg, National Center for Tumor Diseases, Heidelberg, Germany

family: Wick

full_name: Antje Wick

given: Antje

name: Yale School of Medicine, New Haven, Connecticut

family: Baehring

full_name: Joachim Baehring

given: Joachim

family: Ahluwalia

full_name: Manmeet S. Ahluwalia

given: Manmeet S.

name: Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland

family: Roth

full_name: Patrick Roth

given: Patrick

name: Dr Senckenberg Institute of Neurooncology, Goethe University Hospital, Frankfurt, Germany

family: Bähr

full_name: Oliver Bähr

given: Oliver

name: Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California

family: Phuphanich

full_name: Surasak Phuphanich

given: Surasak

name: Hospital Universitario 12 de Octubre, Madrid, Spain

family: Sepulveda

full_name: Juan Manuel Sepulveda

given: Juan Manuel

name: University of Wollongong School of Medicine, Wollongong, NSW, Australia

family: De Souza

full_name: Paul De Souza

name: Moffitt Cancer Center, University of South Florida, Tampa, Florida

family: Sahebjam

full_name: Solmaz Sahebjam

given: Solmaz

name: Bristol Myers Squibb, Princeton, New Jersey

family: Carleton

full_name: Michael Carleton

family: Tatsuoka

full_name: Kay Tatsuoka

given: Kay

family: Taitt

full_name: Corina Taitt

name: Duke University Hospital, Durham, North Carolina

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Stupp R. Drug development for glioma: are we repeating the same mistakes? Lancet Oncol. 2019 Jan;20(1):10-12. doi: 10.1016/S1470-2045(18)30827-1. Epub 2018 Dec 3.

location_country:
Italy
Switzerland
Netherlands
Germany
France
Poland
Belgium
Australia
Spain
Denmark
United States
United Kingdom

location_facility: Johns Hopkins University School Of Medicine

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

location_facility: The Regents of the University of California, San Francisco

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza


title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

summary:
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Müllhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18. Erratum in: Lancet Infect Dis. 2016 Jun;16(6):636.

family: Manns

full_name: Michael Manns

family: Samuel

full_name: Didier Samuel

given: Didier

family: Gane

full_name: Edward J Gane

given: Edward J

family: Mutimer

full_name: David Mutimer

given: David

family: McCaughan

full_name: Geoff McCaughan

given: Geoff

family: Buti

full_name: Maria Buti

given: Maria

family: Prieto

full_name: Martín Prieto

given: Martín

family: Calleja

full_name: José Luis Calleja

given: José Luis

family: Peck-Radosavljevic

full_name: Markus Peck-Radosavljevic

given: Markus

family: Müllhaupt

full_name: Beat Müllhaupt

given: Beat

family: Agarwal

full_name: Kosh Agarwal

given: Kosh

family: Angus

full_name: Peter Angus

given: Peter

family: Yoshida

full_name: Eric M Yoshida

given: Eric M

family: Colombo

full_name: Massimo Colombo

given: Massimo

family: Rizzetto

full_name: Mario Rizzetto

given: Mario

family: Dvory-Sobol

full_name: Hadas Dvory-Sobol

given: Hadas

family: Denning

full_name: Jill Denning

given: Jill

family: Arterburn

full_name: Sarah Arterburn

given: Sarah

family: Pang

full_name: Phillip S Pang

given: Phillip S

family: Brainard

full_name: Diana Brainard

given: Diana

family: McHutchison

full_name: John G McHutchison

given: John G

family: Dufour

full_name: Jean-François Dufour

given: Jean-François

family: Van Vlierberghe

full_name: Hans Van Vlierberghe

given: Hans

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Australia
Belgium
New Zealand
Spain
Canada
United Kingdom

location_facility: Royal Prince Alfred Hospital, University of Sydney

location_facility: Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Division of Gastroenterology, University of Alberta, Edmonton

location_facility: Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie

location_facility: Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre

location_facility: Kings College Hospital, Institute of Liver Studies

location_facility: University of British Columbia and Vancouver General Hospital

location_facility: McGill University Health Centre \\ Royal Victoria Hospital

location_facility: London Health Sciences Centre-University Hospital

location_facility: University Health Network // Toronto General Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: IRCCS Cà Grande Ospedale Maggiore Policlinico

location_facility: Hospital General Universitari Vall d' Hebron

location_facility: Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh

location_facility: University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I

location_facility: Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino


type: Other Identifier

title: A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma

summary:
Primary Objective:

- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)

Secondary Objectives:

To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409
To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL
To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

design_allocation: Non-Randomized

ReferenceCitation: Brown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14. Erratum in: Lancet Haematol. 2018 Jun;5(6):e240.

family: Brown

full_name: Jennifer R Brown

given: Jennifer R

family: Hamadani

full_name: Mehdi Hamadani

given: Mehdi

family: Hayslip

full_name: John Hayslip

given: John

family: Janssens

full_name: Ann Janssens

given: Ann

family: Wagner-Johnston

full_name: Nina Wagner-Johnston

given: Nina

family: Ottmann

full_name: Oliver Ottmann

given: Oliver

family: Arnason

full_name: Jon Arnason

given: Jon

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Millenson

full_name: Michael Millenson

given: Michael

family: Offner

full_name: Fritz Offner

given: Fritz

family: Gabrail

full_name: Nashat Y Gabrail

given: Nashat Y

family: Ganguly

full_name: Siddhartha Ganguly

given: Siddhartha

family: Ailawadhi

full_name: Sikander Ailawadhi

given: Sikander

family: Kasar

full_name: Siddha Kasar

given: Siddha

family: Kater

full_name: Arnon P Kater

given: Arnon P

family: Doorduijn

full_name: Jeanette K Doorduijn

given: Jeanette K

family: Gao

full_name: Lei Gao

given: Lei

family: Lager

full_name: Joanne J Lager

given: Joanne J

family: Wu

full_name: Bin Wu

given: Bin

family: Egile

full_name: Coumaran Egile

given: Coumaran

family: Kersten

full_name: Marie José Kersten

given: Marie José

journal_name: The Lancet Haematology

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

repository_institution: Cardiff University - ORCA Online Research @Cardiff

location_country:
Netherlands
Germany
France
Belgium
Australia
United States

location_facility:
Investigational Site Number 276001
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 250002
Investigational Site Number 840014
Investigational Site Number 250001
Investigational Site Number 840004
Investigational Site Number 840015
Investigational Site Number 036001
Investigational Site Number 036003
Investigational Site Number 840011
Investigational Site Number 250003
Investigational Site Number 840001
Investigational Site Number 840104
Investigational Site Number 528003
Investigational Site Number 840006
Investigational Site Number 056002
Investigational Site Number 528002
Investigational Site Number 840002
Investigational Site Number 840010
Investigational Site Number 036005
Investigational Site Number 036002
Investigational Site Number 840013
Investigational Site Number 056003
Investigational Site Number 056001
Investigational Site Number 840012
Investigational Site Number 840007
Investigational Site Number 276003
Investigational Site Number 276002
Investigational Site Number 528001


ReferenceCitation: O'Shaughnessy J, Campone M, Brain E, Neven P, Hayes D, Bondarenko I, Griffin TW, Martin J, De Porre P, Kheoh T, Yu MK, Peng W, Johnston S. Abiraterone acetate, exemestane or the combination in postmenopausal patients with estrogen receptor-positive metastatic breast cancer. Ann Oncol. 2016 Jan;27(1):106-13. doi: 10.1093/annonc/mdv487. Epub 2015 Oct 26.

family: O'Shaughnessy

full_name: J. O'Shaughnessy

given: J.

family: Campone

full_name: M. Campone

given: M.

family: Brain

full_name: E. Brain

given: E.

family: Neven

full_name: P. Neven

given: P.

family: Hayes

full_name: D. Hayes

given: D.

family: Bondarenko

full_name: I. Bondarenko

given: I.

family: Griffin

full_name: T.W. Griffin

family: Martin

full_name: J. Martin

family: De Porre

full_name: P. De Porre

family: Kheoh

full_name: T. Kheoh

given: T.

family: Yu

full_name: M.K. Yu

family: Peng

full_name: W. Peng

given: W.

family: Johnston

full_name: S. Johnston

given: S.

bso_classification: Chemistry

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

location_country:
Luxembourg
Netherlands
France
Poland
Ireland
Belgium
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of
Ukraine

source: euctr

title: Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

summary: The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study

summary:
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.

A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.

status: Terminated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
Sweden
Netherlands
Spain
Germany
France
Japan
Thailand
Hungary
Belgium
Argentina
Australia
New Zealand
Turkey
Denmark
United States
United Kingdom
Canada

location_facility: University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr

location_facility: Oregon Health & Science University Knight Cancer Institute

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
South Africa
India
France
Argentina
Australia
Puerto Rico
Spain
Canada
United Kingdom

location_facility: Neuropsychiatric Research Center Of Orange County

location_facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

location_facility: Dean Foundation For Health Research & Education

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial

acronym: Pyxis

summary: To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6). pii: 18m12680. doi: 10.4088/JCP.18m12680.

family: Newcomer

full_name: John W. Newcomer

given: John W.

family: Eriksson

full_name: Hans Eriksson

given: Hans

family: Zhang

full_name: Peter Zhang

given: Peter

family: Meehan

full_name: Stine R. Meehan

given: Stine R.

family: Weiss

full_name: Catherine Weiss

given: Catherine

journal_name: The Journal of Clinical Psychiatry

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ReferenceCitation: Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

name: Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson)

family: Hobart

full_name: Mary Hobart

given: Mary

full_name: Stine Rasmussen Meehan

given: Stine Rasmussen

currency_apc_doaj: GBP

journal_name: International Journal of Neuropsychopharmacology

oa_colors: green gold

evidence: oa journal (via doaj)

ReferenceCitation: McIntyre RS, Weiller E, Zhang P, Weiss C. Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials. J Affect Disord. 2016 Sep 1;201:116-23. doi: 10.1016/j.jad.2016.05.013. Epub 2016 May 12.

family: McIntyre

full_name: Roger S. McIntyre

given: Roger S.

ReferenceCitation: Thase ME, Youakim JM, Skuban A, Hobart M, Augustine C, Zhang P, McQuade RD, Carson WH, Nyilas M, Sanchez R, Eriksson H. Efficacy and safety of adjunctive brexpiprazole 2 mg in major depressive disorder: a phase 3, randomized, placebo-controlled study in patients with inadequate response to antidepressants. J Clin Psychiatry. 2015 Sep;76(9):1224-31. doi: 10.4088/JCP.14m09688.

title: Efficacy and Safety of Adjunctive Brexpiprazole 2 mg in Major Depressive Disorder

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
France
Poland
Slovakia
United States
Canada


title: Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

acronym: ARCHER 1009

summary: This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

ReferenceCitation: Ramalingam SS, O'Byrne K, Boyer M, Mok T, Jänne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. Erratum in: Ann Oncol. 2016 Jul;27(7):1363.

family: Ramalingam

full_name: S.S. Ramalingam

family: O'Byrne

full_name: K. O'Byrne

given: K.

family: Boyer

full_name: M. Boyer

family: Mok

full_name: T. Mok

family: Jänne

full_name: P.A. Jänne

full_name: H. Zhang

given: H.

family: Liang

full_name: J. Liang

given: J.

family: Taylor

full_name: I. Taylor

family: Sbar

full_name: E.I. Sbar

family: Paz-Ares

full_name: L. Paz-Ares

given: L.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: Queensland University of Technology - QUT ePrints

ReferenceCitation: Ramalingam SS, Jänne PA, Mok T, O'Byrne K, Boyer MJ, Von Pawel J, Pluzanski A, Shtivelband M, Docampo LI, Bennouna J, Zhang H, Liang JQ, Doherty JP, Taylor I, Mather CB, Goldberg Z, O'Connell J, Paz-Ares L. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1369-78. doi: 10.1016/S1470-2045(14)70452-8. Epub 2014 Oct 15.

full_name: Suresh S Ramalingam

given: Suresh S

full_name: Pasi A Jänne

given: Pasi A

full_name: Tony Mok

given: Tony

full_name: Kenneth O'Byrne

given: Kenneth

full_name: Michael J Boyer

given: Michael J

family: Von Pawel

full_name: Joachim Von Pawel

given: Joachim

family: Pluzanski

full_name: Adam Pluzanski

given: Adam

family: Shtivelband

full_name: Mikhail Shtivelband

given: Mikhail

family: Docampo

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
India
France
Japan
Poland
Slovakia
Korea, Republic of
South Africa
Sweden
Switzerland
Hungary
Ireland
China
Germany
United States
United Kingdom
Austria
Mexico
Spain

location_facility: Good Samaritan Hospital Samaritan Ambulatory Infusion Services

location_facility: City of Hope South Pasadena Cancer Center

location_facility: Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)

location_facility: Hospital Universitario 12 de Octubre-Radiology

location_facility: Oncology and Hematology Specialists, P.A.

location_facility: Specializovana nemocnica sv. Svorada Zobor, n.o.

location_facility: Hospital General Universitario de Elche - Edificio UIAE

location_facility: Grand Hopital de Charleroi Oncologie-Hematologie

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: Investigational Drug Services, Florida Hospital

location_facility: Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat

location_facility: Ingalls Memorial Hospital - In-Patient Pharmacy

location_facility: Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: St.-Petersburg State Medical University I.P.Pavlov of Roszdrav

location_facility: National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology

location_facility: Hospital de la Santa Creu i Sant Pau - Hospital de Día

location_facility: Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear

location_facility: Asan Medical Center, Department of Oncology

location_facility: City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association

location_facility: Mercy Hospital Oklahoma City - Oncology Infusion

location_facility: Hematology and Oncology Consultants, P.A.

location_facility: Osaka City General Hospital Department of Clinical Oncology

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center

location_facility: Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Provincial de Castellon - Servicio de Oncologia

location_facility: UCLA Santa Monica Medical Center & Orthopedic Hospital

location_facility: Ironwood physicians P C dba Ironwood Cancer & Research Centers

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Winship Cancer Institute of Emory University

location_facility: Tumour Hospital of Guangxi Zhuang Autonomous Region

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Krankenhaus Bethanien, Medizinische Klinik III

location_facility: Samaritan Hematology & Oncology Consultants

location_facility: Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley

location_facility: Washington University School of Medicine-IDS Pharmacy

location_facility: Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum

location_facility: Hospital de la Santa Creu i Sant Pau - Anatomia Patológica

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet

location_facility: New Cross Hospital - Royal Wolverhampton Hospital NHS Trust

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Samsung Medical Center, Clinical Trial Center

location_facility: HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy

location_facility: Hospital Provincial de Castellon (Farmacia)

location_facility: Desert Oncology Associates dba Ironwood Cancer and Research Centers

location_facility: Hospital de la Santa Creu i Sant Pau - AGDAC

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: CHU Ambroise Parre- Service Biologie Clinique

location_facility: Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.

location_facility: Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka

location_facility: Suburban Hematology-Oncology Associates, P.C.

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: Kyushu University Hospital Respiratory Medicine

location_facility: Cancer Care Associates Medical Group Inc.

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital

location_facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center

location_facility: Oncology Specialists of North Georgia, LLC

location_facility: University of South Alabama Medical Center

location_facility: Institut de Cancerologie de lOuest - Rene Gauducheau

location_facility: North Mississippi Hematology and Oncology Associates, Ltd.,

location_facility: Zala Megyei Korhaz, Pulmonologiai Osztaly

location_facility: Karmanos Cancer Institute at Farmington Hills

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Central Coast Medical Oncology Corporation

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: Central Hematology Oncology Medical Group, Inc.

location_facility: West China Hospital of Sichuan University

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Aichi cancer center central hospital /Thoracic Oncology

location_facility: Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Semmelweis Egyetem Pulmonologiai Klinika


title: A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)

acronym: NURTURE 1

summary: The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.

ReferenceCitation: Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

family: Huang

full_name: Yanrong Huang

given: Yanrong

family: Fan

full_name: Yong Fan

given: Yong

family: Liu

full_name: Yang Liu

given: Yang

family: Xie

full_name: Wenhui Xie

given: Wenhui

family: Zhang

full_name: Zhuoli Zhang

given: Zhuoli

journal_name: Clinical Rheumatology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Blanco FJ, Möricke R, Dokoupilova E, Codding C, Neal J, Andersson M, Rohrer S, Richards H. Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study. Arthritis Rheumatol. 2017 Jun;69(6):1144-1153. doi: 10.1002/art.40070. Epub 2017 May 3.

name: Hospital Universitario A CoruñaA Coruña Spain

family: Blanco

full_name: Francisco J. Blanco

given: Francisco J.

name: Institut für Präventive Medizin & Klinische ForschungMagdeburg Germany

family: Möricke

full_name: Rüdiger Möricke

given: Rüdiger

name: Medical PlusUherske Hradiste Czech Republic

family: Dokoupilova

full_name: Eva Dokoupilova

given: Eva

name: Health Research of OklahomaOklahoma City

family: Codding

full_name: Christine Codding

given: Christine

name: Bluegrass Community ResearchLexington Kentucky

family: Neal

full_name: Jeffrey Neal

given: Jeffrey

family: Andersson

full_name: Mats Andersson

given: Mats

family: Rohrer

full_name: Susanne Rohrer

given: Susanne

family: Richards

full_name: Hanno Richards

given: Hanno

journal_name: Arthritis & Rheumatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double‐Blind, Active Comparator– and Placebo‐Controlled Study

location_country:
Italy
Brazil
Mexico
Germany
France
Bulgaria
Slovakia
Romania
Hungary
Russian Federation
Spain
United States
Czech Republic
Canada
Colombia

intervention_type: Biological


lead_sponsor: Bayer

primary_purpose: Diagnostic

location_country:
Italy
Austria
Sweden
Switzerland
Germany
France
Czechia
Poland
Argentina
Australia
China
Turkey
United States
Korea, Republic of

acronym: GEMSAV

title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).


title: Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

summary:
The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing.

The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. Review.

name: Parkinson’s advocate, Innovation Fixer Ltd, Oxford, UK

family: McFarthing

full_name: Kevin McFarthing

given: Kevin

name: Parkinson’s Disease and Movement Disorders Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

family: Prakash

full_name: Neha Prakash

given: Neha

family: Simuni

full_name: Tanya Simuni

given: Tanya

journal_name: Journal of Parkinson's Disease

oa_colors: green other

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: CLINICAL TRIAL HIGHLIGHTS – DYSKINESIA

lead_sponsor: Addex Pharma S.A.

location_country:
Austria
United States
Germany
France


title: A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

acronym: OPSALIN

summary:
Primary Objective:

- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.

Secondary Objectives:

To compare the overall survival (OS) between the 2 treatment arms
To compare the objective response rate (RR) between the 2 treatment arms

lead_sponsor: Sanofi

location_country:
Italy
United States
France
Poland
Belgium
Russian Federation
Spain
Germany
Czech Republic
Ukraine

location_facility:
Investigational Site Number 276001
Investigational Site Number 250004
Investigational Site Number 056005
Investigational Site Number 380001
Investigational Site Number 250002
Investigational Site Number 840009
Investigational Site Number 250001
Investigational Site Number 380004
Investigational Site Number 616002
Investigational Site Number 643001
Investigational Site Number 804003
Investigational Site Number 616005
Investigational Site Number 616003
Investigational Site Number 724001
Investigational Site Number 250006
Investigational Site Number 804002
Investigational Site Number 804005
Investigational Site Number 643002
Investigational Site Number 250003
Investigational Site Number 840001
Investigational Site Number 616001
Investigational Site Number 056002
Investigational Site Number 203001
Investigational Site Number 840002
Investigational Site Number 380003
Investigational Site Number 804004
Investigational Site Number 724003
Investigational Site Number 643004
Investigational Site Number 643003
Investigational Site Number 203004
Investigational Site Number 203003
Investigational Site Number 056003
Investigational Site Number 056001
Investigational Site Number 840202
Investigational Site Number 840007
Investigational Site Number 203002
Investigational Site Number 724002
Investigational Site Number 616004


title: A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

summary: This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
United States
Brazil
Mexico
Germany
France
Poland
Australia
Puerto Rico
Spain
Canada
United Kingdom


type: Registry Identifier

title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial

acronym: REACT

summary:
The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.

ReferenceCitation: Facius A, Marostica E, Gardiner P, Watz H, Lahu G. Pharmacokinetic and Pharmacodynamic Modelling to Characterize the Tolerability of Alternative Up-Titration Regimens of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2018 Aug;57(8):1029-1038. doi: 10.1007/s40262-018-0671-4.

family: Facius

full_name: Axel Facius

given: Axel

family: Marostica

full_name: Eleonora Marostica

given: Eleonora

family: Gardiner

full_name: Philip Gardiner

given: Philip

family: Watz

full_name: Henrik Watz

given: Henrik

family: Lahu

full_name: Gezim Lahu

given: Gezim

journal_name: Clinical Pharmacokinetics

ReferenceCitation: Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Román J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.

name: Weill Cornell Medicine, New York, New York

family: Martinez

full_name: Fernando J. Martinez

given: Fernando J.

name: LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany

family: Rabe

full_name: Klaus F. Rabe

given: Klaus F.

name: Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

name: Department of Clinical Medicine, University of Ferrara, Ferrara, Italy

name: COPD Center, Sahlgrenska University Hospital, Gothenburg, Sweden

family: Fabbri

full_name: Leonardo M. Fabbri

given: Leonardo M.

name: University at Buffalo, State University of New York, Buffalo, New York

family: Sethi

full_name: Sanjay Sethi

given: Sanjay

name: Universidade Federal de Santa Catarina, Santa Catarina, Brazil

family: Pizzichini

full_name: Emilio Pizzichini

given: Emilio

name: McMaster University, Firestone Institute for Respiratory Health, St. Joseph’s Healthcare, Hamilton, Ontario, Canada

family: McIvor

full_name: Andrew McIvor

given: Andrew

name: University of Texas Health Science Center and South Texas Veterans Health Care System, San Antonio, Texas

family: Anzueto

full_name: Antonio Anzueto

given: Antonio

family: Alagappan

full_name: Vijay K. T. Alagappan

given: Vijay K. T.

family: Siddiqui

full_name: Shahid Siddiqui

given: Shahid

family: Reisner

name: PHASTAR Corporation, Manchester, United Kingdom

name: Takeda Development Centre Europe Ltd., London, United Kingdom

name: University of Nebraska Medical Center, Omaha, Nebraska; and

name: Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, United Kingdom

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Rabe KF, Calverley PMA, Martinez FJ, Fabbri LM. Effect of roflumilast in patients with severe COPD and a history of hospitalisation. Eur Respir J. 2017 Jul 5;50(1). pii: 1700158. doi: 10.1183/13993003.00158-2017. Print 2017 Jul.

ReferenceCitation: Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial. Lancet. 2015 Mar 7;385(9971):857-66. doi: 10.1016/S0140-6736(14)62410-7. Epub 2015 Feb 13.

ReferenceCitation: Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, Rabe KF. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis. 2012;7:375-82. doi: 10.2147/COPD.S31100. Epub 2012 Jun 20.

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

title: Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? the REACT study protocol

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Canada
Korea, Republic of
South Africa
Netherlands
Hungary
Germany
United Kingdom
Italy
Austria
Brazil
Israel
Spain
Turkey

location_facility:
Nycomed Investigational Site
Nycomed Investigational site


title: Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

acronym: BOLT

summary: This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

ReferenceCitation: Gutzmer R, Robert C, Loquai C, Schadendorf D, Squittieri N, Arntz R, Martelli S, Dummer R. Assessment of various efficacy outcomes using ERIVANCE-like criteria in patients with locally advanced basal cell carcinoma receiving sonidegib: results from a preplanned sensitivity analysis. BMC Cancer. 2021 Nov 19;21(1):1244. doi: 10.1186/s12885-021-08968-1.

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Robert

full_name: Caroline Robert

given: Caroline

family: Loquai

full_name: Carmen Loquai

given: Carmen

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Squittieri

full_name: Nicholas Squittieri

given: Nicholas

family: Arntz

full_name: Ramon Arntz

given: Ramon

family: Martelli

full_name: Serena Martelli

given: Serena

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

journal_name: BMC Cancer

license: cc-by

license_normalized: cc-by

ReferenceCitation: Lewis K, Dummer R, Farberg AS, Guminski A, Squittieri N, Migden M. Effects of Sonidegib Following Dose Reduction and Treatment Interruption in Patients with Advanced Basal Cell Carcinoma During 42-Month BOLT Trial. Dermatol Ther (Heidelb). 2021 Oct 20. doi: 10.1007/s13555-021-00619-4. [Epub ahead of print]

family: Lewis

full_name: Karl Lewis

given: Karl

family: Farberg

full_name: Aaron S. Farberg

given: Aaron S.

family: Guminski

full_name: Alexander Guminski

given: Alexander

family: Migden

full_name: Michael Migden

given: Michael

journal_name: Dermatology and Therapy

ReferenceCitation: Lear JT, Migden MR, Lewis KD, Chang ALS, Guminski A, Gutzmer R, Dirix L, Combemale P, Stratigos A, Plummer R, Castro H, Yi T, Mone M, Zhou J, Trefzer U, Kaatz M, Loquai C, Kudchadkar R, Sellami D, Dummer R. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018 Mar;32(3):372-381. doi: 10.1111/jdv.14542. Epub 2017 Nov 6.

name: Manchester Academic Health Science Centre; University of Manchester; Manchester UK

family: Lear

name: Departments of Dermatology and Head and Neck Surgery; The University of Texas MD Anderson Cancer Center; Houston TX USA

name: Division of Medical Oncology; University of Colorado School of Medicine; Aurora CO USA

name: Stanford University School of Medicine; Redwood City CA USA

name: Royal North Shore Hospital; St Leonards NSW Australia

name: Medizinische Hochschule Hannover; Hannover Germany

name: Sint-Augustinus Ziekenhuis; Antwerp Belgium

name: Anti Cancer Institute, Léon Bérard; Lyon France

name: Andreas Syggros Hospital; University of Athens; Athens Greece

name: Northern Centre for Cancer Care; Freeman Hospital; Newcastle upon Tyne UK

name: Novartis Pharmaceuticals Corporation; East Hanover NJ USA

name: University Medical Center Mainz; Mainz Germany

name: Winship Cancer Institute of Emory University; Atlanta GA USA

name: UniversitätsSpital Zürich-Skin Cancer Center; University Hospital; Zürich Switzerland

journal_name: Journal of the European Academy of Dermatology and Venereology

ReferenceCitation: Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, Herd RM, Kudchadkar R, Trefzer U, Gogov S, Pallaud C, Yi T, Mone M, Kaatz M, Loquai C, Stratigos AJ, Schulze HJ, Plummer R, Chang AL, Cornélis F, Lear JT, Sellami D, Dummer R. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015 Jun;16(6):716-28. doi: 10.1016/S1470-2045(15)70100-2. Epub 2015 May 14.

location_country:
Italy
United States
Switzerland
Germany
France
Greece
Hungary
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Texas Oncology Cancer Care & Research Center

location_facility: H Lee Moffitt Cancer Center and Research Institute Cutaneous Onc Dept

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

location_facility: Washington Hospital Center Wash Hospital

location_facility: University of California at Los Angeles UCLA 3

location_facility: University of Texas MD Anderson Cancer Center MD Anderson

location_facility: Texoma Cancer Center Texoma Cancer Center

location_facility: Stanford University Medical Center Stanford Univ 2

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinator

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr Siteman

location_facility: University of Pittsburgh Medical Center UPMC

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2)

location_facility: University of Utah / Huntsman Cancer Institute Huntsman/Univ UT

location_facility: Hackensack University Medical Center Hackensack (SC)

location_facility: University of Colorado School of Medicine UC

location_facility: Penn State University / Milton S. Hershey Medical Center Hershey Medical


title: A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

summary: The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

lead_sponsor: Fovea Pharmaceuticals SA

location_country:
Italy
Germany
France
Poland
Israel
Belgium
Australia
Spain
United States
Czech Republic

location_facility:
Center 2003
Center 1115
Center 1505
Center 1205
Center 1502
Center 1107
Center 1604
Center 1404
Center 1702
Center 1905
Center 1901
Center 1601
Center 1101
Center 1607
Center 1116
Center 1908
Center 1201
Center 1609
Center 1301
Center 1701
Center 1110
Center 1902
Center 1402
Center 1703
Center 1302
Center 1401
Center 1103
Center 1112
Center 1501
Center 1909
Center 1202
Center 1907
Center 1209
Center 1303
Center 1109
Center 1507
Center 1610
Center 1903
Center 1106
Center 1204
Center 1206
Center 1203
Center 1706
Center 1503
Center 1114
Center 1403
Center 1506
Center 1208
Center 1108
Center 1105
Center 1405
Center 1606
Center 1608
Center 2001
Center 1904
Center 2002
Center 1906
Center 1504
Center1801
Center 1705
Center 1111
Center 1704
Center 1802
Center 1104
Center 2004


title: A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

summary: This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

lead_sponsor: Debiopharm International SA

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Vietnam
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Mexico
Spain


title: A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease

summary: The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

ReferenceCitation: Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.

family: Horne

full_name: Benjamin D Horne

given: Benjamin D

family: Hegewald

full_name: Matthew J Hegewald

given: Matthew J

family: Crim

full_name: Courtney Crim

given: Courtney

family: Rea

full_name: Susan Rea

given: Susan

family: Bair

full_name: Tami L Bair

given: Tami L

family: Blagev

full_name: Denitza P Blagev

given: Denitza P

currency_apc_doaj: USD

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22.

name: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA

family: Wise

full_name: Robert A Wise

given: Robert A

name: Research & Development, GSK, Stockley Park, Middlesex, UK

family: Anderson

full_name: Julie A Anderson

given: Julie A

name: Department of Neurology and Stroke Centre, Paris-Diderot-Sorbonne University, Paris, France

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

name: Statistics and Programming, Veramed Ltd., Twickenham, UK

family: Cowans

full_name: Nicholas J Cowans

given: Nicholas J

name: Research & Development, GSK, Research Triangle Park, Durham, NC, USA

name: Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK

family: Denvir

full_name: Martin A Denvir

given: Martin A

name: Department of Neurology, University of Missouri Columbia School of Medicine, Columbia, MO, USA

family: Gomez

full_name: Camilo R Gomez

given: Camilo R

family: Jones

full_name: Matthew PA Jones

given: Matthew PA

family: Morris

full_name: Andrea Morris

given: Andrea

name: Pulmonary, Critical Care and Sleep Apnea, Minneapolis Veterans Affairs Health Care System, and University of Minnesota, Minneapolis, MN, USA

family: Niewoehner

full_name: Dennis Niewoehner

given: Dennis

family: Yates

full_name: Julie C Yates

given: Julie C

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019.

ReferenceCitation: Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1.

ReferenceCitation: Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1). pii: 00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb.

ReferenceCitation: Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051. Erratum in: J Am Coll Cardiol. 2018 Oct 30;72(18):2282.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC.

name: Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota

name: University of Minnesota, Minneapolis, Minnesota

name: Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama

name: Birmingham Veterans Affairs Medical Center, Birmingham, Alabama

name: GlaxoSmithKline, Stockley Park, United Kingdom

name: University of Michigan, Ann Arbor, Michigan

name: University of Liverpool, Liverpool, United Kingdom

name: Brigham and Women’s Hospital, Boston, Massachusetts

name: GlaxoSmithKline, Research Triangle Park, North Carolina

name: Veramed Ltd., Twickenham, United Kingdom

name: Weill Cornell Medical College of Cornell University, New York, New York

name: University of Edinburgh, Edinburgh, United Kingdom; and

name: University of Manchester, Manchester, United Kingdom

repository_institution: The University of Manchester - Research Explorer

repositories:
PubMed Central
Pure (Denmark)
pure.ed.ac.uk

repositories_institution: The University of Manchester - Research Explorer

ReferenceCitation: Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting β-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE.

name: Brigham and Women's HospitalBoston, Massachusetts

name: GlaxoSmithKlineStockley Park, United Kingdom

name: University of MichiganAnn Arbor, Michigan

name: University of LiverpoolLiverpool, United Kingdom

name: GlaxoSmithKlineResearch Triangle Park, North Carolina

name: Veramed LimitedTwickenham, United Kingdom

name: Weill Cornell Medical College of Cornell UniversityNew York, New York

name: University of EdinburghEdinburgh, United Kingdom

name: University of ManchesterManchester, United Kingdom

ReferenceCitation: Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. β-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC.

name: Lung Health Center, University of Alabama at Birmingham and Birmingham VA Medical Center, Birmingham, Alabama

name: Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom

name: GlaxoSmithKline Research and Development, Stevenage, United Kingdom

name: Cornell Medical College, New York, New York

name: Manchester Academic Health Science Centre, Manchester, United Kingdom; and

name: Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1). pii: 1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan.

ReferenceCitation: Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1.

ReferenceCitation: Calverley PMA, Anderson JA, Brook RD, Crim C, Gallot N, Kilbride S, Martinez FJ, Yates J, Newby DE, Vestbo J, Wise R, Celli BR; SUMMIT (Study to Understand Mortality and Morbidity) Investigators. Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. Am J Respir Crit Care Med. 2018 Jan 1;197(1):47-55. doi: 10.1164/rccm.201610-2086OC.

name: Department of Medicine, University of Liverpool, Liverpool, United Kingdom

name: Research & Development, GlaxoSmithKline, Stockley Park, United Kingdom

name: University of Michigan Health System, Ann Arbor, Michigan

name: Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina

name: Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New York, New York

name: Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and University Hospital South Manchester NHS Foundation Trust, Manchester, United Kingdom

name: Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, Maryland; and

name: Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

ReferenceCitation: Brook RD, Anderson JA, Calverley PM, Celli BR, Crim C, Denvir MA, Magder S, Martinez FJ, Rajagopalan S, Vestbo J, Yates J, Newby DE; SUMMIT Investigators. Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk. Heart. 2017 Oct;103(19):1536-1542. doi: 10.1136/heartjnl-2016-310897. Epub 2017 Apr 17.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, Crim C, Dransfield M, Kilbride S, Yates J, Newby DE, Niewoehner D, Calverley PM; SUMMIT Investigators. Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC.

name: Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and South Manchester, Manchester, United Kingdom

name: Research & Development, GlaxoSmithKline, Stockley Park, Middlesex, United Kingdom

name: Pulmonary and Critical Care Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

name: University of Alabama Birmingham, Birmingham, Alabama

name: University of Minnesota, Minneapolis, Minnesota; and

name: University of Liverpool, Department of Medicine, Clinical Sciences Centre, University Hospital Aintree, Liverpool, United Kingdom

ReferenceCitation: Vestbo J, Anderson JA, Brook RD, Calverley PM, Celli BR, Crim C, Martinez F, Yates J, Newby DE; SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1817-26. doi: 10.1016/S0140-6736(16)30069-1. Epub 2016 Apr 28.

ReferenceCitation: Vestbo J, Anderson J, Brook RD, Calverley PM, Celli BR, Crim C, Haumann B, Martinez FJ, Yates J, Newby DE. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Respir J. 2013 May;41(5):1017-22. doi: 10.1183/09031936.00087312. Epub 2012 Sep 27.

location_country: Macedonia, The Former Yugoslav Republic of


ReferenceCitation: Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, Moore KN, Mackowiak-Matejczyk B, Pikiel J, Ray-Coquard I, Trask P, Lin K, Schuth E, Vaze A, Choi Y, Marsters JC, Maslyar DJ, Lemahieu V, Wang Y, Humke EW, Liu JF. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023.

family: Banerjee

full_name: S. Banerjee

given: S.

family: Oza

full_name: A.M. Oza

family: Birrer

full_name: M.J. Birrer

family: Hamilton

full_name: E.P. Hamilton

family: Hasan

full_name: J. Hasan

given: J.

family: Leary

full_name: A. Leary

given: A.

family: Moore

full_name: K.N. Moore

family: Mackowiak-Matejczyk

full_name: B. Mackowiak-Matejczyk

given: B.

family: Pikiel

full_name: J. Pikiel

family: Ray-Coquard

full_name: I. Ray-Coquard

given: I.

family: Trask

full_name: P. Trask

given: P.

family: Lin

full_name: K. Lin

given: K.

family: Schuth

full_name: E. Schuth

given: E.

family: Vaze

full_name: A. Vaze

family: Choi

full_name: Y. Choi

given: Y.

family: Marsters

full_name: J.C. Marsters

family: Maslyar

full_name: D.J. Maslyar

family: Lemahieu

full_name: V. Lemahieu

given: V.

family: Wang

full_name: Y. Wang

family: Humke

full_name: E.W. Humke

family: Liu

full_name: J.F. Liu

title: Anti-NaPi2b antibody–drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study

lead_sponsor: Genentech, Inc.

location_country:
United States
France
Poland
Belgium
Spain
Canada
United Kingdom

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Oklahoma University Health Sciences Center

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: University of California Irvine Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Neumologia

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer

summary: This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks.


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

summary: The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.

primary_purpose: Prevention

ReferenceCitation: Vincenti F, Budde K, Merville P, Shihab F, Ram Peddi V, Shah M, Wyburn K, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Am J Transplant. 2018 Dec;18(12):2945-2954. doi: 10.1111/ajt.14925. Epub 2018 Jun 20.

name: Department of Medicine and Surgery; University of California San Francisco; San Francisco CA USA

family: Vincenti

full_name: Flavio Vincenti

given: Flavio

name: Department of Nephrology; Charité Universitätsmedizin; Berlin Germany

family: Budde

full_name: Klemens Budde

given: Klemens

name: Department of Nephrology - Transplantation - Dialysis - Apheresis; Université de Bordeaux; Bordeaux France

family: Merville

full_name: Pierre Merville

given: Pierre

name: Department of Internal Medicine; University of Utah; Salt Lake City UT USA

family: Shihab

full_name: Fuad Shihab

given: Fuad

name: Department of Transplantation; California Pacific Medical Center; San Francisco CA USA

family: Ram Peddi

full_name: V. Ram Peddi

name: Department of Surgery; University of Kentucky; Lexington KT USA

family: Shah

full_name: Malay Shah

given: Malay

name: Department of Renal Medicine; Royal Prince Alfred Hospital; Camperdown Australia

family: Wyburn

full_name: Kate Wyburn

given: Kate

name: Département de Néphrologie et de transplantation; Centre Hospitalier Universitaire de Nice; Nice France

family: Cassuto-Viguier

full_name: Elisabeth Cassuto-Viguier

given: Elisabeth

name: Department of Nephrology and Hypertension; Universitätsklinikum Erlangen; Erlangen Germany

name: Department of Nephrology, Transplantation and Medical Intensive Care; Universität Witten/Herdecke; Medical Centre Cologne-Merheim; Cologne Germany

family: Weidemann

full_name: Alexander Weidemann

given: Alexander

name: Biostatistics; Astellas Pharma Global Development, Inc.; Northbrook IL USA

family: Lee

full_name: Misun Lee

given: Misun

name: Immunology, Transplant, Inflammation & CNS/Pain; Astellas Pharma Global Development, Inc.; Northbrook IL USA

family: Flegel

full_name: Teresa Flegel

given: Teresa

family: Erdman

full_name: Jay Erdman

given: Jay

full_name: Xuegong Wang

given: Xuegong

family: Lademacher

full_name: Christopher Lademacher

given: Christopher

journal_name: American Journal of Transplantation

evidence: open (via free article)

ipd_sharing: Yes

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
United States
Germany
France
Australia
Spain
Canada

location_facility:
Site FR33001
Site US10011
Site US10028
Site CA15004
Site AU61001
Site CA15003
Site US10037
Site US10029
Site DE49005
Site ES34002
Site ES34001
Site US10031
Site US10003
Site US10036
Site US10026
Site US10023
Site US10014
Site US10030
Site US10046
Site ES34003
Site US10012
Site DE49002
Site US10027
Site US10049
Site US10044
Site FR33005
Site US10016
Site US10013
Site US10047
Site US10050
Site CA15005
Site US10015
Site DE49003
Site AU61004
Site US10041
Site US10038
Site US10018
Site DE49001
Site FR33004
Site US10045
Site US10009
Site US10042
Site US10058
Site FR33003
Site CA15006
Site ES34004
Site AU61002
Site US10048
Site US10057
Site US10004
Site DE49008
Site US10001
Site US10020


title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

summary: The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

lead_sponsor: FORUM Pharmaceuticals Inc

location_country:
Italy
United States
South Africa
Mexico
Germany
France
Poland
Belgium
Australia
Spain
Canada
Korea, Republic of


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia

summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Spain
United States
France
Netherlands


title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)

summary: Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

ReferenceType: background

ReferenceCitation: Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Müller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

name: Department of Cardiology; Medical University Graz; Graz Austria

family: Pieske

full_name: Burkert Pieske

given: Burkert

name: Division of Cardiology; Emory University School of Medicine; Atlanta GA USA

family: Butler

full_name: Javed Butler

given: Javed

name: Department of Cardiology; University Hospital Attikon; Athens Greece

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

name: Cardiovascular Research Institute; Singapore

family: Lam

full_name: Carolyn Lam

given: Carolyn

name: Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Florence Italy

family: Maggioni

full_name: Aldo Pietro Maggioni

given: Aldo Pietro

name: Department of Heart Diseases; Medical University; Military Hospital Wroclaw Poland

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

name: Division of Cardiology, Department of Medicine; Northwestern University Feinberg School of Medicine; Chicago IL USA

full_name: Sanjiv Shah

given: Sanjiv

name: Cardiovascular Division; Brigham and Women's Hospital; Boston MA USA

family: Solomon

full_name: Scott Solomon

given: Scott

family: Kraigher-Krainer

full_name: Elisabeth Kraigher-Krainer

family: Samano

full_name: Eliana Tibana Samano

given: Eliana Tibana

family: Scalise

full_name: Andrea Viviana Scalise

given: Andrea Viviana

family: Müller

full_name: Katharina Müller

given: Katharina

family: Roessig

full_name: Lothar Roessig

given: Lothar

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

name: on behalf of the SOCRATES Investigators and Coordinators

journal_name: European Journal of Heart Failure

location_country:
Greece
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Fevery

full_name: Bart Fevery

given: Bart

family: Tambuyzer

full_name: Lotke Tambuyzer

given: Lotke

family: Vijgen

full_name: Leen Vijgen

given: Leen

family: Peeters

full_name: Monika Peeters

given: Monika

family: Buelens

full_name: Annemie Buelens

given: Annemie

family: Ceulemans

full_name: Hugo Ceulemans

given: Hugo

family: Beumont

full_name: Maria Beumont

given: Maria

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

journal_name: Journal of Hepatology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4. Erratum in: Lancet. 2016 Apr 30;387(10030):1816.

family: Manns

full_name: Michael Manns

given: Michael

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Poordad

full_name: Fred Poordad

given: Fred

family: de Araujo

full_name: Evaldo Stanislau Affonso de Araujo

given: Evaldo Stanislau Affonso

family: Buti

full_name: Maria Buti

family: Horsmans

full_name: Yves Horsmans

given: Yves

family: Janczewska

full_name: Ewa Janczewska

given: Ewa

family: Villamil

full_name: Federico Villamil

given: Federico

location_country:
Austria
Brazil
Netherlands
Spain
Germany
France
Bulgaria
Poland
Slovakia
Argentina
Belgium
Puerto Rico
Portugal
Turkey
United States


title: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

summary: This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab vedotin in combination with rituximab.

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

family: Shi

full_name: Rong Shi

given: Rong

family: Lu

full_name: Tong Lu

given: Tong

family: Ku

full_name: Grace Ku

given: Grace

family: Ding

full_name: Hao Ding

given: Hao

family: Saito

full_name: Tomohisa Saito

given: Tomohisa

family: Gibiansky

full_name: Leonid Gibiansky

given: Leonid

family: Agarwal

full_name: Priya Agarwal

given: Priya

family: Li

full_name: Xiaobin Li

given: Xiaobin

family: Jin

full_name: Jin Yan Jin

given: Jin Yan

family: Girish

full_name: Sandhya Girish

given: Sandhya

family: Miles

full_name: Dale Miles

given: Dale

full_name: Chunze Li

given: Chunze

full_name: Dan Lu

given: Dan

journal_name: Cancer Chemotherapy and Pharmacology

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

name: Genentech, Inc, South San Francisco, CA, USA

name: Genentech, Inc./F. Hoffmann-La Roche Ltd, Lyon, France

ReferenceCitation: Palanca-Wessels MC, Czuczman M, Salles G, Assouline S, Sehn LH, Flinn I, Patel MR, Sangha R, Hagenbeek A, Advani R, Tilly H, Casasnovas O, Press OW, Yalamanchili S, Kahn R, Dere RC, Lu D, Jones S, Jones C, Chu YW, Morschhauser F. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015 Jun;16(6):704-15. doi: 10.1016/S1470-2045(15)70128-2. Epub 2015 Apr 27.

title: Safety and activity of the anti-CD79B antibody–drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

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

location_facility: Centre Hospitalier Regional Universitaire de Lille


ReferenceCitation: Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, Kurzeder C, Colombo N, Vuylsteke P, Lorusso D, Hall M, Renard V, Pignata S, Kristeleit R, Altintas S, Rustin G, Wenham RM, Mirza MR, Fong PC, Oza A, Monk BJ, Ma H, Vogl FD, Bach BA. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017 Jan;70:111-121. doi: 10.1016/j.ejca.2016.09.004. Epub 2016 Dec 1.

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Hong Kong
Switzerland
Germany
France
Poland
Slovakia
Singapore
Hungary
Australia
Belgium
New Zealand
Denmark
Canada
United Kingdom
Taiwan

title: A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

summary:
To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

acronym: HELIOS

summary: The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

ReferenceCitation: Ljungman P, Bermudez A, Logan AC, Kharfan-Dabaja MA, Chevallier P, Martino R, Wulf G, Selleslag D, Kakihana K, Langston A, Lee DG, Solano C, Okamoto S, Smith LR, Boeckh M, Wingard JR, Cywin B, Fredericks C, Lademacher C, Wang X, Young J, Maertens J. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients. EClinicalMedicine. 2021 Mar 19;33:100787. doi: 10.1016/j.eclinm.2021.100787. eCollection 2021 Mar.

family: Ljungman

full_name: Per Ljungman

given: Per

family: Bermudez

full_name: Arancha Bermudez

given: Arancha

family: Logan

full_name: Aaron C. Logan

given: Aaron C.

family: Kharfan-Dabaja

full_name: Mohamed A. Kharfan-Dabaja

given: Mohamed A.

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

family: Martino

full_name: Rodrigo Martino

given: Rodrigo

family: Wulf

full_name: Gerald Wulf

given: Gerald

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Kakihana

full_name: Kazuhiko Kakihana

given: Kazuhiko

family: Langston

full_name: Amelia Langston

given: Amelia

family: Lee

full_name: Dong-Gun Lee

given: Dong-Gun

family: Solano

full_name: Carlos Solano

given: Carlos

family: Okamoto

full_name: Shinichiro Okamoto

given: Shinichiro

family: Smith

full_name: Larry R. Smith

given: Larry R.

family: Boeckh

full_name: Michael Boeckh

given: Michael

family: Wingard

full_name: John R. Wingard

given: John R.

family: Cywin

full_name: Beth Cywin

given: Beth

family: Fredericks

full_name: Christine Fredericks

given: Christine

family: Lademacher

full_name: Christopher Lademacher

given: Christopher

family: Wang

full_name: Xuegong Wang

given: Xuegong

family: Young

full_name: James Young

given: James

family: Maertens

full_name: Johan Maertens

given: Johan

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
United States
Sweden
Germany
France
Japan
Belgium
Australia
Spain
Canada
Korea, Republic of
Taiwan

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