ReferenceCitation: Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frías JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Cheng

full_name: Alice Cheng

given: Alice

family: Ritzel

full_name: Robert Ritzel

given: Robert

family: Bosnyak

full_name: Zsolt Bosnyak

given: Zsolt

family: Devisme

full_name: Christine Devisme

given: Christine

family: Cali

full_name: Anna M.G. Cali

given: Anna M.G.

family: Sieber

full_name: Jochen Sieber

given: Jochen

family: Stella

full_name: Peter Stella

given: Peter

family: Wang

full_name: Xiangling Wang

given: Xiangling

family: Frías

full_name: Juan P. Frías

given: Juan P.

family: Roussel

full_name: Ronan Roussel

given: Ronan

family: Bolli

full_name: Geremia B. Bolli

given: Geremia B.

evidence: open (via free pdf)

lead_sponsor: Sanofi

location_country:
Italy
Sweden
Serbia
Switzerland
Croatia
Czechia
Bulgaria
France
Greece
Israel
Hungary
Romania
Slovakia
Denmark
United States
United Kingdom

acronym: BRIGHT

location_facility:
Investigational Site Number 840075
Investigational Site Number 376003
Investigational Site Number 380013
Investigational Site Number 380016
Investigational Site Number 840061
Investigational Site Number 250005
Investigational Site Number 840053
Investigational Site Number 840016
Investigational Site Number 840063
Investigational Site Number 840088
Investigational Site Number 840077
Investigational Site Number 642004
Investigational Site Number 100002
Investigational Site Number 376004
Investigational Site Number 703001
Investigational Site Number 840031
Investigational Site Number 100003
Investigational Site Number 642012
Investigational Site Number 840085
Investigational Site Number 840038
Investigational Site Number 840058
Investigational Site Number 840011
Investigational Site Number 191003
Investigational Site Number 840056
Investigational Site Number 642014
Investigational Site Number 642010
Investigational Site Number 752102
Investigational Site Number 840008
Investigational Site Number 380005
Investigational Site Number 840076
Investigational Site Number 840033
Investigational Site Number 703006
Investigational Site Number 840084
Investigational Site Number 208004
Investigational Site Number 208002
Investigational Site Number 840057
Investigational Site Number 840060
Investigational Site Number 840082
Investigational Site Number 840043
Investigational Site Number 840007
Investigational Site Number 208003
Investigational Site Number 840093
Investigational Site Number 642015
Investigational Site Number 380015
Investigational Site Number 380008
Investigational Site Number 840080
Investigational Site Number 840045
Investigational Site Number 642006
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 840009
Investigational Site Number 203009
Investigational Site Number 250001
Investigational Site Number 826005
Investigational Site Number 840020
Investigational Site Number 376006
Investigational Site Number 840023
Investigational Site Number 300001
Investigational Site Number 191002
Investigational Site Number 203007
Investigational Site Number 840095
Investigational Site Number 840040
Investigational Site Number 642013
Investigational Site Number 250003
Investigational Site Number 840097
Investigational Site Number 840001
Investigational Site Number 756003
Investigational Site Number 376009
Investigational Site Number 203001
Investigational Site Number 840036
Investigational Site Number 840018
Investigational Site Number 840052
Investigational Site Number 840010
Investigational Site Number 840071
Investigational Site Number 703003
Investigational Site Number 840072
Investigational Site Number 250007
Investigational Site Number 826002
Investigational Site Number 348003
Investigational Site Number 826004
Investigational Site Number 840048
Investigational Site Number 380012
Investigational Site Number 380011
Investigational Site Number 840041
Investigational Site Number 703002
Investigational Site Number 756001
Investigational Site Number 840046
Investigational Site Number 642003
Investigational Site Number 752101
Investigational Site Number 840091
Investigational Site Number 300005
Investigational Site Number 840021
Investigational Site Number 203005
Investigational Site Number 300002
Investigational Site Number 840064
Investigational Site Number 642009
Investigational Site Number 840096
Investigational Site Number 840070
Investigational Site Number 840054
Investigational Site Number 380007
Investigational Site Number 376007
Investigational Site Number 380010
Investigational Site Number 840051
Investigational Site Number 203006
Investigational Site Number 840039
Investigational Site Number 840032
Investigational Site Number 840002
Investigational Site Number 703005
Investigational Site Number 300003
Investigational Site Number 826008
Investigational Site Number 203004
Investigational Site Number 380002
Investigational Site Number 840024
Investigational Site Number 348004
Investigational Site Number 840022
Investigational Site Number 203002
Investigational Site Number 826006
Investigational Site Number 191001
Investigational Site Number 840027
Investigational Site Number 376001
Investigational Site Number 826001
Investigational Site Number 642008
Investigational Site Number 840004
Investigational Site Number 840030
Investigational Site Number 840026
Investigational Site Number 840081
Investigational Site Number 840087
Investigational Site Number 250006
Investigational Site Number 642005
Investigational Site Number 840094
Investigational Site Number 376008
Investigational Site Number 826009
Investigational Site Number 840086
Investigational Site Number 376002
Investigational Site Number 642007
Investigational Site Number 688002
Investigational Site Number 840017
Investigational Site Number 840098
Investigational Site Number 840029
Investigational Site Number 348001
Investigational Site Number 840006
Investigational Site Number 840066
Investigational Site Number 840101
Investigational Site Number 380009
Investigational Site Number 203008
Investigational Site Number 688003
Investigational Site Number 840079
Investigational Site Number 840065
Investigational Site Number 642001
Investigational Site Number 380014
Investigational Site Number 840025
Investigational Site Number 840069
Investigational Site Number 840044
Investigational Site Number 208001
Investigational Site Number 348002
Investigational Site Number 840012
Investigational Site Number 688001
Investigational Site Number 100001

title: A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

summary:
Primary Objective:

To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.

Secondary Objectives:

Change From Baseline in HbA1c to Week 12

To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:

Change in Fasting plasma glucose (FPG);
Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
Percentage of participants reaching HbA1c targets <7% or ≤6.5%;
Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia
Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.

To assess the safety in each treatment group.

To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).

Percentage of participants requiring rescue therapy.


ReferenceType: derived

ReferenceCitation: Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.

family: Lathouwers

full_name: Erkki Lathouwers

given: Erkki

sequence: first

family: De La Rosa

full_name: Guy De La Rosa

given: Guy

sequence: additional

family: Van de Casteele

full_name: Tom Van de Casteele

given: Tom

family: Baeten

full_name: Benny Baeten

given: Benny

family: Tomaka

full_name: Frank Tomaka

given: Frank

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

family: Picchio

full_name: Gaston Picchio

given: Gaston

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Tibotec Pharmaceuticals, Ireland

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Austria
Brazil
Chile
Guatemala
South Africa
Germany
France
Malaysia
Panama
Thailand
Romania
Hungary
Argentina
Australia
Puerto Rico
Spain
United States
United Kingdom
Taiwan

acronym: ODIN

study_completion_date_type: Actual

type: Other Identifier

type: EudraCT Number

source: euctr

title: A Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects

summary: The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

summary: This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodríguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
United States
Germany
France
Australia
Puerto Rico
Spain
Canada


ReferenceCitation: Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Gossec

full_name: Laure Gossec

given: Laure

family: Pournara

full_name: Effie Pournara

given: Effie

family: Jeka

full_name: Slawomir Jeka

given: Slawomir

family: Mera-Varela

full_name: Antonio Mera-Varela

given: Antonio

family: D'Angelo

full_name: Salvatore D'Angelo

given: Salvatore

family: Schulz

full_name: Barbara Schulz

given: Barbara

family: Rissler

full_name: Michael Rissler

given: Michael

family: Nagar

full_name: Kriti Nagar

given: Kriti

family: Perella

full_name: Chiara Perella

given: Chiara

family: Coates

full_name: Laura C Coates

given: Laura C

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central
ora.ox.ac.uk

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

study_start_date_type: Actual

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Switzerland
Spain
Finland
France
Czechia
Bulgaria
Greece
Israel
Poland
Hungary
Belgium
Ireland
Romania
Russian Federation
Estonia
Germany
United Kingdom

acronym: MAXIMISE

ipd_sharing: Undecided

title: MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

summary: The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).


title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies

summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

ReferenceCitation: Lal P, Su Z, Holweg CT, Silverman GJ, Schwartzman S, Kelman A, Read S, Spaniolo G, Monroe JG, Behrens TW, Townsend MJ. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment. Arthritis Rheum. 2011 Dec;63(12):3681-91. doi: 10.1002/art.30596.

family: Lal

full_name: Preeti Lal

given: Preeti

family: Su

full_name: Zheng Su

given: Zheng

family: Holweg

full_name: Cecile T. J. Holweg

given: Cecile T. J.

family: Silverman

full_name: Gregg J. Silverman

given: Gregg J.

family: Schwartzman

full_name: Sergio Schwartzman

given: Sergio

family: Kelman

full_name: Ariella Kelman

given: Ariella

family: Read

full_name: Simon Read

given: Simon

family: Spaniolo

full_name: Greg Spaniolo

given: Greg

family: Monroe

full_name: John G. Monroe

given: John G.

family: Behrens

full_name: Timothy W. Behrens

given: Timothy W.

family: Townsend

full_name: Michael J. Townsend

given: Michael J.

journal_name: Arthritis & Rheumatism

oa_host_type: publisher

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.

family: Keystone

full_name: E. Keystone

given: E.

family: Burmester

full_name: G. R. Burmester

given: G. R.

family: Furie

full_name: R. Furie

given: R.

family: Loveless

full_name: J. E. Loveless

given: J. E.

family: Emery

full_name: P. Emery

given: P.

family: Kremer

full_name: J. Kremer

given: J.

family: Tak

full_name: P. P. Tak

given: P. P.

family: Broder

full_name: M. S. Broder

given: M. S.

family: Yu

title: Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti–tumor necrosis factor therapy

location_country:
Italy
United States
Netherlands
Germany
France
Israel
Norway
Ireland
Belgium
Canada
United Kingdom


title: Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy (Bronchodilation) and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (4 Doses) Delivered by the Respimat® Inhaler in Patients With Asthma

summary: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

ReferenceCitation: O'Byrne PM, D'Urzo T, Beck E, Fležar M, Gahlemann M, Hart L, Blahova Z, Toorawa R, Beeh KM. Dose-finding evaluation of once-daily treatment with olodaterol, a novel long-acting β2-agonist, in patients with asthma: results of a parallel-group study and a crossover study. Respir Res. 2015 Aug 18;16:97. doi: 10.1186/s12931-015-0249-8.

family: O’Byrne

full_name: Paul M. O’Byrne

given: Paul M.

family: D’Urzo

full_name: Tony D’Urzo

given: Tony

family: Beck

full_name: Ekkehard Beck

given: Ekkehard

family: Fležar

full_name: Matjaž Fležar

given: Matjaž

family: Gahlemann

full_name: Martina Gahlemann

given: Martina

family: Hart

full_name: Lorna Hart

given: Lorna

family: Blahova

full_name: Zuzana Blahova

given: Zuzana

family: Toorawa

full_name: Robert Toorawa

given: Robert

family: Beeh

full_name: Kai-Michael Beeh

given: Kai-Michael

currency_apc_doaj: GBP

journal_name: Respiratory Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
United States
Canada
France

location_facility: 1222.6.3302A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.064 Arthur F. Gelb Medical Corporation, Lakewood

location_facility: 1222.6.032 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3305A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.008 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.002 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.015 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.006 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.031 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.017 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.066 Allergy & Asthma Medical Group and Rsrch Ctr, APC

location_facility: 1222.6.007 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.072 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.067 Northeast Medical Research Associates, Inc

location_facility: 1222.6.3304A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.069 Allergy Associates Medical Group

location_facility: 1222.6.011 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.004 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.009 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.073 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.038 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.034 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3308A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.003 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.012 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3306A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3301A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.005 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.016 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.068 National Jewish Medical Center

location_facility: 1222.6.013 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.062 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.036 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3303A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.037 Boehringer Ingelheim Investigational Site


title: A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy

summary: A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Switzerland
Netherlands
United Kingdom
Germany
France
Hungary
Belgium
Spain
Canada
Czech Republic


title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

acronym: CONFIRM

summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.

name: Department of Neurology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany

family: Gold

full_name: Ralf Gold

given: Ralf

name: Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, QC, Canada

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

name: Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Fox

full_name: Robert J. Fox

given: Robert J.

name: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Chen

full_name: Chongshu Chen

given: Chongshu

family: Parks

full_name: Becky Parks

given: Becky

name: Biogen, 225 Binney Street, Cambridge, MA 02142, USA

family: Miller

full_name: Catherine Miller

given: Catherine

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Neurological Disorders

title: Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

family: Mehta

full_name: Devangi Mehta

given: Devangi

family: Bame

full_name: Eris Bame

given: Eris

family: Hanna

full_name: Jerome Hanna

given: Jerome

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.

ReferenceCitation: Fernández Ó, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.

ReferenceCitation: Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.

name: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA;

name: Department of Neurology, University Hospital Bern and University of Bern, Bern, Switzerland;

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

title: Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing–Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies

ReferenceCitation: Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.

title: Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis–related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies

ReferenceCitation: Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22. Review.

name:
Mellen Center for Multiple Sclerosis Treatment and Research
Cleveland Clinic, Cleveland, OHUSA

name:
Virginia Mason Medical Center,
Seattle, WA, USA

name:
Providence Multiple Sclerosis Center, Providence Brain and Spine Institute
Portland, ORUSA

name:
Swedish Neuroscience Institute
Issaquah, WAUSA

name:
Multiple Sclerosis Program, Baylor Institute for Immunology Research
Dallas, TXUSA

ReferenceCitation: Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. Erratum in: N Engl J Med. 2012 Oct 25;367(17):1673.

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.

summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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


title: A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

summary: The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

ReferenceCitation: Crown JP, Diéras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.

name: John P. Crown, Irish Cooperative Oncology Research Group, Dublin, Ireland; Véronique Diéras, Institut Curie, Paris; Thomas Bachelot, Centre Léon Bérard, Lyon; Olivier Capitain, Centre Paul Papin, Angers; Gilles Romieu, Regional Centre for the Fight Against Cancer Val d'Aurelle Paul-Lamarque, Montpellier, France; Elzbieta Staroslawska, Centrum Onkologii Ziemi Lubelskiej, Lublin; Maria Blasinska-Morawiec, Wojewodzki Szpital Specjalistyczny, im M. Kopernika, Lodz, Poland; Denise A. Yardley, Sarah Cannon...

family: Crown

full_name: John P. Crown

given: John P.

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Staroslawska

full_name: Elzbieta Staroslawska

given: Elzbieta

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Davidson

full_name: Neville Davidson

given: Neville

family: Wildiers

full_name: Hans Wildiers

given: Hans

family: Fasching

full_name: Peter A. Fasching

given: Peter A.

family: Capitain

full_name: Olivier Capitain

given: Olivier

family: Ramos

full_name: Manuel Ramos

given: Manuel

family: Greil

full_name: Richard Greil

given: Richard

family: Cognetti

full_name: Francesco Cognetti

given: Francesco

family: Fountzilas

full_name: George Fountzilas

given: George

family: Blasinska-Morawiec

full_name: Maria Blasinska-Morawiec

given: Maria

family: Liedtke

full_name: Cornelia Liedtke

given: Cornelia

family: Kreienberg

full_name: Rolf Kreienberg

given: Rolf

full_name: Wilson H. Miller

given: Wilson H.

suffix: Jr

family: Tassell

full_name: Vanessa Tassell

given: Vanessa

family: Huang

full_name: Xin Huang

given: Xin

family: Paolini

full_name: Jolanda Paolini

given: Jolanda

family: Kern

full_name: Kenneth A. Kern

given: Kenneth A.

family: Romieu

full_name: Gilles Romieu

given: Gilles

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Trial of Sunitinib in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Patients With Pretreated Metastatic Breast Cancer

location_country:
Italy
Austria
United States
United Kingdom
Netherlands
Germany
France
Poland
Greece
Norway
Ireland
Belgium
Romania
Russian Federation
Spain
Denmark
Canada
Czech Republic


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

summary: The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

ReferenceType: result

ReferenceCitation: Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

family: Wohl

full_name: David Wohl

given: David

family: Clarke

full_name: Amanda Clarke

given: Amanda

family: Maggiolo

full_name: Franco Maggiolo

given: Franco

family: Garner

full_name: Will Garner

given: Will

family: Laouri

full_name: Marianne Laouri

given: Marianne

family: Martin

full_name: Hal Martin

given: Hal

family: Quirk

full_name: Erin Quirk

given: Erin

journal_name: The Patient - Patient-Centered Outcomes Research

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories:
2f75rf68h
PubMed Central
RePEc

ReferenceCitation: Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.

full_name: David A Wohl

given: David A

family: Yazdanpanah

full_name: Yazdan Yazdanpanah

given: Yazdan

family: Baumgarten

full_name: Axel Baumgarten

given: Axel

family: Thompson

full_name: Melanie A Thompson

given: Melanie A

family: Brinson

full_name: Cynthia Brinson

given: Cynthia

family: Hagins

ReferenceCitation: Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5). pii: e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.

name: Gilead Sciences, Foster City, California, USA

ReferenceCitation: Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in art-naïve participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.

ReferenceCitation: Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.

ReferenceCitation: White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.

ReferenceCitation: Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

ReferenceCitation: Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.

repository_institution: Queen Mary University of London - Queen Mary Research Online

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

location_country:
Italy
United States
Germany
Dominican Republic
France
Belgium
Puerto Rico
Spain
Canada
United Kingdom

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Southampton Clinical Research Group, Inc.

location_facility: North Manchester General Hospital - PPDS

location_facility: Louisiana State University Health Sciences Center

location_facility: Medical University of South Carolina PPDS

location_facility: Instituto Dominicano de Estudios Virologicos IDEV

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

location_facility: Hospital General Universitario de Alicante

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Wake Forest Baptist Medical Center - PPDS

location_facility: Multicare Rockwood HIV Critical Care Clinic

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: North Texas Infectious Diseases Consultants PA

location_facility: Diagnostic Clinic of Longview Center For Clinical Research (DCOL)

location_facility: Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center

location_facility: Alameda Health System- Highland Hospital

location_facility: Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research

location_facility: Infectious Disease Specialists of Atlanta

location_facility: The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

location_facility: North Shore University Hospital-(Manhasset)

location_facility: St. Joseph's Comprehensive Research Institute


title: A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3

summary: The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country: Canada France

status_simplified: Unknown


ReferenceCitation: Furie RA, Aroca G, Cascino MD, Garg JP, Rovin BH, Alvarez A, Fragoso-Loyo H, Zuta-Santillan E, Schindler T, Brunetta P, Looney CM, Hassan I, Malvar A. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2021 Oct 6. pii: annrheumdis-2021-220920. doi: 10.1136/annrheumdis-2021-220920. [Epub ahead of print]

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10.

family: Dossier

full_name: Claire Dossier

given: Claire

family: Hogan

full_name: Julien Hogan

given: Julien

bso_classification: Social sciences

journal_name: Pediatric Nephrology

title: Response to Majeranowski

intervention_type: Other

status: Active, not recruiting

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
Brazil
Peru
Costa Rica
Mexico
France
Panama
Israel
Argentina
Spain
United States
Colombia

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Suny Downstate Medical Center; Rheumatology

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia

location_facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

location_facility: Hospital General De Mexico; Rheumatology

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: Ohio State University; Division of Nephrology

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology

location_facility: Hopital europeen Marseille; Service de medecine interne

location_facility: Centro de Investigación Delgado; Clinica Delgado

location_facility: Hospital Nacional Cayetano Heredia; Rheumatology

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

location_facility: Centro de Investigación Clínica de Morelia S.C.

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia

location_facility: Hopital Bichat Claude Bernard; Nephrologie

location_facility: Ospedale San Giovanni Bosco; entro di Ricerche di Immunopatologia e Documentazione su Malattie Rare

location_facility: Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

ipd_sharing: No

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

summary: This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

status_simplified: Ongoing


title: An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in Patients With Muscle Invasive Bladder Cancer (MIBC) Who Have Progressed on Prior Treatment (BISCAY).

acronym: BISCAY

summary:
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents.

The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination.

ReferenceCitation: Powles T, Carroll D, Chowdhury S, Gravis G, Joly F, Carles J, Fléchon A, Maroto P, Petrylak D, Rolland F, Cook N, Balar AV, Sridhar SS, Galsky MD, Grivas P, Ravaud A, Jones R, Cosaert J, Hodgson D, Kozarewa I, Mather R, McEwen R, Mercier F, Landers D. An adaptive, biomarker-directed platform study of durvalumab in combination with targeted therapies in advanced urothelial cancer. Nat Med. 2021 May;27(5):793-801. doi: 10.1038/s41591-021-01317-6. Epub 2021 May 3.

family: Powles

full_name: Thomas Powles

given: Thomas

family: Carroll

full_name: Danielle Carroll

given: Danielle

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Joly

full_name: Florence Joly

given: Florence

family: Carles

full_name: Joan Carles

given: Joan

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Maroto

full_name: Pablo Maroto

given: Pablo

family: Petrylak

full_name: Daniel Petrylak

given: Daniel

family: Rolland

full_name: Frédéric Rolland

given: Frédéric

family: Cook

full_name: Natalie Cook

given: Natalie

family: Balar

full_name: Arjun V. Balar

given: Arjun V.

family: Sridhar

full_name: Srikala S. Sridhar

given: Srikala S.

family: Galsky

full_name: Matthew D. Galsky

given: Matthew D.

family: Grivas

full_name: Petros Grivas

given: Petros

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Jones

full_name: Robert Jones

given: Robert

family: Cosaert

full_name: Jan Cosaert

given: Jan

family: Hodgson

full_name: Darren Hodgson

given: Darren

family: Kozarewa

full_name: Iwanka Kozarewa

given: Iwanka

family: Mather

full_name: Richard Mather

given: Richard

family: McEwen

full_name: Robert McEwen

family: Mercier

repository_institution: The University of Glasgow - Enlighten: Publications

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
France
Spain
United States
United Kingdom
Canada


ReferenceType: background

ReferenceCitation: Shah MA, Bodoky G, Starodub A, Cunningham D, Yip D, Wainberg ZA, Bendell J, Thai D, He J, Bhargava P, Ajani JA. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol. 2021 Mar 20;39(9):990-1000. doi: 10.1200/JCO.20.02755. Epub 2021 Feb 12.

lead_sponsor: Gilead Sciences

location_country:
Italy
Chile
Peru
Germany
France
Czechia
Poland
Romania
Hungary
Belgium
Australia
Spain
Turkey
United States
United Kingdom
Colombia

location_facility: Hacettepe Universitesi Tip Facultesi Cocuk Saligi ve Hastaklikleri Anabilim Dali

location_facility: Staedtisches Klinikum Muenchen Bogenhausen

location_facility: Hospital Regional Universitario de Malaga

location_facility: Peterborough City Hospital Peterborough and Stamford Hospitals NHS Foundation Trust

location_facility: University Hospital Gent Department of Gastroenterology

location_facility: Klinka Gastroenterologii Okologicznej Centrum Okologii Instytut

location_facility: Kliniken Essen Mitte Studiensekretariat Onkologie Evang. Huyssens-Stiftung

location_facility: Klinikum rechts der Isar Technical University of Ismaninger

location_facility: Zala Megyei Korhaz Pozva Diabetes Kulsokorhaz

location_facility: Mrukmed Lekarz Beata Madej Mruk i Partner Spolka Partnerska Oddzial Nr 1 w Rzeszowie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Ankara University Medical Faculty Ibni Sina Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Treviglio Caravaggio U.O. Oncologia Medica

location_facility: SC Centrul de Oncologie Euroclinic SRL, Oncologie

location_facility: Dundacion Oftalmologica de Santander Clinica Ardila Lulle La Foscal

location_facility: Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

location_facility: Istanbul Universitesi Onkoloji Enstitusu Medikal Onkoloji Bilim Dali

location_facility: Zentrum fur Innere Medizin Stauferklinikum Schwab

location_facility: Indiana University Goshen Center for Cancer Care

location_facility: Van Yuzuncu Yil Universitesi Tip Kaultesi Ic Hastaliklari Anabilim Dali Tibbi Okoloji Bilim Dali

location_facility: Clinica Anglo Americana Calle Alfredo Salazar

location_facility: Charleston Hematology Oncology Associates

location_facility: Human Klinikai Vizsgalatok Regisztracios Kozpont - HKVRK

location_facility: Krankenhaus Nordwest gGmbH Institut für Klinisch Onkologische Med Klinik II

location_facility: Borsod County Hospital Clinical Oncological and Radiotheraputic Center

location_facility: DRK Klinken Berlin Abteilungsleiter Chiurgische Okologie

location_facility: Cancer Center Heilbronn-Franken, SLK-Kliniken

location_facility: CHRU de Brest, Hopital Morvan, Institut de Cancerologie et d'Hematologie

location_facility: Spitalul Judetean De Urgenta Sf Ion Cel Nou Suceava Sectia Oncologie Medicala Bdul

location_facility: S.C. Oncologia Medica Azienda Ospedaliera Valtellina e Valchiavenna Presidio Ospedaliero di Sondrio

location_facility: Izmir Universitesi Hastanesi Yeni Girne Vulvari

location_facility: Centrul de Oncologie Sfantul Nectarie SRL, Oncologie

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Egyesített Szent István és Szent László Kórház -Rendelőintézet

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi Elazi

location_facility: Wojewodzki Szpital Zespolony w Elblagu Oddzial Onkologiczny

location_facility: Centro de Investigacion Instituto de oncologia y Radiotherpia de la Clinica

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Regional Cancer Care Associates LLC - Sparta

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.


title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).

summary: To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Austria
Switzerland
Spain
Germany
France
Czechia
Lithuania
Poland
Slovakia
Hungary
Portugal
Canada
United Kingdom


title: An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients With Relapsed/Refractory Multiple Myeloma

summary:
Primary Objective:

Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM).
Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab.

Secondary Objectives:

Part A:
To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM.
Part B:
To evaluate the safety of SAR650984 (isatuximab).
To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS).
To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline.
To evaluate the immunogenicity of SAR650984 (isatuximab).

ReferenceCitation: Mikhael J, Belhadj-Merzoug K, Hulin C, Vincent L, Moreau P, Gasparetto C, Pour L, Spicka I, Vij R, Zonder J, Atanackovic D, Gabrail N, Martin TG, Perrot A, Bensfia S, Weng Q, Brillac C, Semiond D, Macé S, Corzo KP, Leleu X. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab. Blood Cancer J. 2021 May 12;11(5):89. doi: 10.1038/s41408-021-00478-4.

family: Mikhael

full_name: Joseph Mikhael

given: Joseph

family: Belhadj-Merzoug

full_name: Karim Belhadj-Merzoug

given: Karim

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Vincent

full_name: Laure Vincent

given: Laure

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Gasparetto

full_name: Cristina Gasparetto

given: Cristina

family: Pour

full_name: Ludek Pour

given: Ludek

family: Spicka

full_name: Ivan Spicka

given: Ivan

family: Vij

full_name: Ravi Vij

given: Ravi

family: Zonder

full_name: Jeffrey Zonder

given: Jeffrey

family: Atanackovic

full_name: Djordje Atanackovic

given: Djordje

family: Gabrail

full_name: Nashat Gabrail

given: Nashat

family: Martin

full_name: Thomas G. Martin

given: Thomas G.

family: Perrot

full_name: Aurore Perrot

given: Aurore

family: Bensfia

full_name: Samira Bensfia

given: Samira

family: Weng

full_name: Qilong Weng

given: Qilong

family: Brillac

full_name: Claire Brillac

given: Claire

family: Semiond

full_name: Dorothée Semiond

given: Dorothée

family: Macé

full_name: Sandrine Macé

given: Sandrine

family: Corzo

full_name: Kathryn P. Corzo

given: Kathryn P.

family: Leleu

full_name: Xavier Leleu

given: Xavier

journal_name: Blood Cancer Journal

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_facility:
Investigational Site Number 840004
Investigational Site Number 840015
Investigational Site Number 840001
Investigational Site Number 840003
Investigational Site Number 840013
Investigational Site Number 840006
Investigational Site Number 250005
Investigational Site Number 250008
Investigational Site Number 203001
Investigational Site Number 840005
Investigational Site Number 250002
Investigational Site Number 840002
Investigational Site Number 203002
Investigational Site Number 250004
Investigational Site Number 250006
Investigational Site Number 840010
Investigational Site Number 250001
Investigational Site Number 840011


title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

summary: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: Allergan

location_country:
United States
Philippines
Germany
France
Poland
Israel
Australia
Russian Federation
New Zealand
Denmark
Canada
United Kingdom

location_facility: Arizona Advanced Eye Research Institute /ID# 234947

location_facility: Samara State Medical University /ID# 236997

location_facility: Manchester University NHS Foundation Trust /ID# 237318

location_facility: Advanced Glaucoma Specialists /ID# 234799

location_facility: Albemarle Clinical Trials LLC /ID# 235144

location_facility: Cardinal Santos Medical Center /ID# 235325

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 238315

location_facility: University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875

location_facility: Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966

location_facility: Peregrine Eye and Laser Institute /ID# 236220

location_facility: Clayton Eye Clinical Research, LLC /ID# 236678

location_facility: Carolinas Centers for Sight,PC /ID# 237017

location_facility: CHU Strasbourg - Hopital Civil /ID# 237837

location_facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041

location_facility: Wolstan & Goldberg Eye Associates /ID# 235166

location_facility: Levenson Eye Associates Inc. /ID# 235021

location_facility: Dr. Andrew Gardner Logan, FL /ID# 236946

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 236806

location_facility: Ophthalmology Clinic Bellevue /ID# 234631

location_facility: Clinique Honore Cave - Pharmacie /ID# 235925

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929

location_facility: California Eye Specialists Medical Group Inc. /ID# 235999

location_facility: Imperial College Healthcare NHS Trust /ID# 234777

location_facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879

location_facility: Speciality Eye Care Medical Group /ID# 236001

location_facility: Universitaetsklinikum Magdeburg /ID# 237284

location_facility: West Virginia University Eye Institute /ID# 235174

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129

location_facility: Scott and Christie and Associates /ID# 234594

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 237705

location_facility: Eye Associates of New Mexico /ID# 235115

location_facility: Tel Aviv Sourasky Medical Center /ID# 237211

location_facility: Epsom & St Helier University Hospital NHS Trust /ID# 236902

location_facility: California Center for Clin Res /ID# 237412

location_facility: Emerson Clinical Research Institute /ID# 235977

location_facility: Northern New Jersey Eye Institute PA /ID# 234944

location_facility: Cincinnati Eye Institute- Edgewood /ID# 236714

location_facility: CHU de Nice - Hospital Pasteur 2 /ID# 235844

intervention_type: Procedure


title: An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

summary: This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

status: Recruiting

design_allocation: Non-Randomized

lead_sponsor: Genentech, Inc.

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

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Monash Health Clinical Trial Pharmacy department

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: University of California San Diego Moores Cancer Center

location_facility: Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores

location_facility: Hôpital St Louis - Service de Dermatologie II

location_facility: CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: BC Cancer Agency Vancouver Centre - PARENT

location_facility: Universitatsklinikum Koln; Apotheke Uniklinik Koln

location_facility: University of Pennsylvania; School of Medicine

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Willamette Valley Cancer Insitute and Research Center

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie


title: A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)

acronym: Open PRIDE-HD

summary: The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).

status: Terminated

ReferenceCitation: Cohen S, Waks Z, Elm JJ, Gordon MF, Grachev ID, Navon-Perry L, Fine S, Grossman I, Papapetropoulos S, Savola JM. Characterizing patient compliance over six months in remote digital trials of Parkinson's and Huntington disease. BMC Med Inform Decis Mak. 2018 Dec 20;18(1):138. doi: 10.1186/s12911-018-0714-7.

family: Cohen

full_name: Shani Cohen

given: Shani

family: Waks

full_name: Zeev Waks

given: Zeev

family: Elm

full_name: Jordan J. Elm

given: Jordan J.

family: Gordon

full_name: Mark Forrest Gordon

given: Mark Forrest

family: Grachev

full_name: Igor D. Grachev

given: Igor D.

family: Navon-Perry

full_name: Leehee Navon-Perry

given: Leehee

family: Fine

full_name: Shai Fine

given: Shai

family: Grossman

full_name: Iris Grossman

given: Iris

family: Papapetropoulos

full_name: Spyros Papapetropoulos

given: Spyros

family: Savola

full_name: Juha-Matti Savola

given: Juha-Matti

journal_name: BMC Medical Informatics and Decision Making

title: Characterizing patient compliance over six months in remote digital trials of Parkinson’s and Huntington disease

lead_sponsor: Prilenia

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Poland
Australia
Russian Federation
Canada
United Kingdom

location_facility:
Teva Investigational Site 30080
Teva Investigational Site 35121
Teva Investigational Site 35125
Teva Investigational Site 53150
Teva Investigational Site 53149
Teva Investigational Site 12198
Teva Investigational Site 50214
Teva Investigational Site 33027
Teva Investigational Site 32408
Teva Investigational Site 12208
Teva Investigational Site 34058
Teva Investigational Site 78058
Teva Investigational Site 12206
Teva Investigational Site 34055
Teva Investigational Site 12196
Teva Investigational Site 50215
Teva Investigational Site 34057
Teva Investigational Site 34056
Teva Investigational Site 11036
Teva Investigational Site 12210
Teva Investigational Site 33021
Teva Investigational Site 32410
Teva Investigational Site 35123
Teva Investigational Site 50213
Teva Investigational Site 12209
Teva Investigational Site 32407
Teva Investigational Site 30083
Teva Investigational Site 12203
Teva Investigational Site 78057
Teva Investigational Site 78055
Teva Investigational Site 53148
Teva Investigational Site 12200
Teva Investigational Site 34054
Teva Investigational Site 34059
Teva Investigational Site 35124
Teva Investigational Site 53151
Teva Investigational Site 34061
Teva Investigational Site 35122
Teva Investigational Site 32409
Teva Investigational Site 38059
Teva Investigational Site 12204
Teva Investigational Site 30081
Teva Investigational Site 12201
Teva Investigational Site 35165
Teva Investigational Site 12211
Teva Investigational Site 30082


ReferenceCitation: McCrae C, Olsson M, Gustafson P, Malmgren A, Aurell M, Fagerås M, Da Silva CA, Cavallin A, Paraskos J, Karlsson K, Wingren C, Monk P, Marsden R, Harrison T. INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics. Clin Exp Allergy. 2021 Feb;51(2):273-283. doi: 10.1111/cea.13765. Epub 2020 Nov 3.

name: Translational Science and Experimental Medicine, Research and Early Development Respiratory & Immunology, BioPharmaceuticals R&D AstraZeneca Gaithersburg Maryland USA

name: Krefting Research Centre Department of Internal Medicine and Clinical Nutrition Institute of Medicine University of Gothenburg Gothenburg Sweden

family: McCrae

full_name: Christopher McCrae

given: Christopher

name: Early Biometrics and Statistical Innovation Data Science and AI, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden

family: Olsson

full_name: Marita Olsson

given: Marita

name: BioPharmaceutical Medical AstraZeneca Gothenburg Sweden

family: Gustafson

full_name: Per Gustafson

given: Per

name: Early Respiratory & Immunology Projects Department BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden

family: Malmgren

full_name: Anna Malmgren

given: Anna

name: Early Respiratory & Immunology Clinical Development BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden

family: Aurell

full_name: Malin Aurell

given: Malin

family: Fagerås

full_name: Malin Fagerås

family: Da Silva

full_name: Carla A. Da Silva

given: Carla A.

name: Translational Science and Experimental Medicine Early Cardiovascular, Renal and Metabolism (CVRM) BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden

family: Cavallin

full_name: Anders Cavallin

given: Anders

name: Point of Care Diagnostics, Precision Medicine Oncology R&D AstraZeneca Cambridge UK

family: Paraskos

full_name: Jonathan Paraskos

given: Jonathan

family: Karlsson

full_name: Karin Karlsson

given: Karin

family: Wingren

full_name: Cecilia Wingren

given: Cecilia

name: Synairgen Research Ltd Southampton University Hospital Southampton UK

family: Monk

full_name: Phillip Monk

given: Phillip

family: Marsden

full_name: Richard Marsden

given: Richard

name: Nottingham NIHR Biomedical Research Centre University of NottinghamNottingham City Hospital Nottingham UK

family: Harrison

full_name: Tim Harrison

given: Tim

journal_name: Clinical & Experimental Allergy

evidence: open (via crossref license)

title: INEXAS: A Phase 2 Randomized Trial of On‐demand Inhaled Interferon Beta‐1a in Severe Asthmatics

lead_sponsor: AstraZeneca

primary_purpose: Prevention

location_country:
France
Argentina
Australia
Spain
United Kingdom
Korea, Republic of
Colombia

acronym: INEXAS

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Phase IIa Study in Asthma Patients Comparing the Efficacy and Safety of Once Daily Inhaled Interferon Beta-1a to Placebo, Administered for 14 Days After the Onset of Symptoms of an Upper Respiratory Tract Infection for the Prevention of Severe Exacerbations

summary: A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza


location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Korea, Republic of
Chile
Switzerland
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: Smilow Cancer Hospital. At Yale New Haven

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: Klinika Nowotworow Pluca i Klatki Piersiowej

location_facility: University Hospitals Cleveland Medical Center

location_facility: Washington University School Of Medicine

location_facility: Azienda Ospedaliera - Nuovo Ospedale San Gerardo

title: An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

summary: The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.


title: A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.

ReferenceCitation: Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536. Review.

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

journal_name: The Cancer Journal

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

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

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

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

lead_sponsor: Acerta Pharma BV

location_country:
Italy
Netherlands
Germany
France
Poland
Israel
Hungary
Belgium
Australia
New Zealand
Spain
Turkey
Denmark
United States
United Kingdom


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus

summary: This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).

lead_sponsor: Sage Therapeutics

location_country:
Italy
Austria
Sweden
Serbia
Netherlands
Germany
Finland
France
Israel
Hungary
Spain
Estonia
Denmark
United States
United Kingdom
Canada

location_facility:
Sage investigational Site
Sage Investigational Site


title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)

acronym: CEDAR

summary: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

location_country:
Austria
Chile
Hong Kong
Switzerland
Philippines
Germany
France
Czechia
Israel
Singapore
Argentina
New Zealand
Spain
United States
Latvia
Korea, Republic of
Colombia

location_facility: TASMC (The Tel-Aviv Sourasky Medical Centre)

location_facility: Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg

location_facility: Clinic and policlinic of ophthalmology, University of Regensburg

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Medizinische Universitat Innsbruck, Univ.

location_facility: Atlantis Retina Institute (Atlantis Eyecare)

location_facility: Pauls Stradins Clinical University Hospital Opthalmology Clinic

location_facility: Hopital de la Croix Rousse, Service d'Opthalmologie

location_facility: Northern California Retina Vitreous Associates Medical Group, INC.

location_facility: Instituto Clínico Quirúrgico de Oftalmología (ICQO)

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: The Bert M Glaser National Retina Institute

location_facility: Carmel Medical Center Ophthalmology Clinic

location_facility: The Catholic Univ. Of Seoul St. Mary's Hospital

location_facility: The Chinese University of Hong Kong Hongkong eye hospital

location_facility: Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas

location_facility: Clinica Universidad de Navarra Servicio de Oftalmologia

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

location_facility: Kellog Eye Center - University of Michigan Health System

location_facility: Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)

location_facility: Stiftung für wissenschaftliche Forschung am Stadtspital Triemli

location_facility: Hospital General de Valencia Unidad de Investigacion Clinica

location_facility: Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona

location_facility: Instituto Oftalmologico de Buenos Aires - Oftalmos

location_facility: Houston Eye Associates (HEA) - Gramercy Location

location_facility: Seoul National University Bundang Hospital

location_facility: Konventhospital Barmherzige Brueder Linz

location_facility: Instituto Oftalmologica Profesor Arentsen

location_facility: Vseobecna fakultni nemocnice v Praze Ocni Klinika

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: University of Virginia - Department of Ophthalmology

location_facility: Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica

location_facility: Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology

location_facility: Fundacion Oftalmologica Nacional - FUNDONAL

location_facility: Yonsei University Health System Serverance Hospital

location_facility: Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie

location_facility: Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika

location_facility: University Retina and Macula Associates, PC

location_facility: Universitatsklinik fur Augenheilkunde, Inselspital

location_facility: Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde


title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

acronym: MYSTIC

summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

ReferenceCitation: Garon EB, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, Robinet G, Le Moulec S, Natale R, Schneider J, Shepherd FA, Garassino MC, Geater SL, Szekely ZP, Van Ngoc T, Liu F, Scheuring U, Patel N, Peters S, Rizvi NA. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). Clin Lung Cancer. 2021 Jul;22(4):301-312.e8. doi: 10.1016/j.cllc.2021.02.010. Epub 2021 Feb 19.

family: Garon

full_name: Edward B. Garon

given: Edward B.

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

family: Lee

full_name: Ki Hyeong Lee

given: Ki Hyeong

family: Luft

full_name: Alexander Luft

given: Alexander

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: Robinet

full_name: Gilles Robinet

given: Gilles

family: Le Moulec

full_name: Sylvestre Le Moulec

given: Sylvestre

family: Natale

full_name: Ronald Natale

given: Ronald

family: Schneider

full_name: Jeffrey Schneider

given: Jeffrey

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

family: Garassino

full_name: Marina Chiara Garassino

given: Marina Chiara

family: Geater

full_name: Sarayut Lucien Geater

given: Sarayut Lucien

family: Szekely

full_name: Zsolt Papai Szekely

given: Zsolt Papai

family: Van Ngoc

full_name: Tran Van Ngoc

given: Tran

family: Liu

full_name: Feng Liu

given: Feng

family: Scheuring

full_name: Urban Scheuring

given: Urban

family: Patel

full_name: Nikunj Patel

given: Nikunj

family: Peters

full_name: Solange Peters

given: Solange

family: Rizvi

full_name: Naiyer A. Rizvi

given: Naiyer A.

journal_name: Clinical Lung Cancer

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

title: Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer (MYSTIC)

ReferenceCitation: Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. doi: 10.1001/jamaoncol.2020.0237. Erratum in: JAMA Oncol. 2020 Nov 1;6(11):1815.

name: Division of Hematology/Oncology, Columbia University Medical Center, New York, New York

name: Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea

name: Asklepios Lung Clinic, Munich-Gauting, Germany

name: Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea

name: Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St Petersburg, Russia

name: Department of Hematology and Oncology, Samsung Medical Center, Seoul, South Korea

name: Nederlands Kanker Instituut–Antoni van Leeuwenhoekziekenhuis, Amsterdam, the Netherlands

name: Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain

name: Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain

name: Department of Radiology, Burdenko Main Military Clinical Hospital, Moscow, Russia

name: Oncological Clinical Research Center, St Petersburg, Russia

name: H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

name: Department of Medical Oncology, Institut Bergonié, Bordeaux, France

name: Service de Pneumologie, Centre Hospitalier Régional Universitaire de Brest–Hôpital Morvan, Brest, France

name: Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California

name: Department of Hematology and Oncology, NYU Winthrop Hospital, Mineola, New York

name: Princess Margaret Cancer Centre and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada

name: Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand

name: David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles

name: Levine Cancer Institute, Atrium Health, Charlotte, North Carolina

name: Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut

name: Faculty of Medicine, Department of Medical Oncology, Kindai University, Osaka, Japan

name: Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland

title: Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non–Small Cell Lung Cancer

location_country:
Italy
United States
Switzerland
Netherlands
Vietnam
Germany
France
Japan
Thailand
Hungary
Belgium
Australia
Russian Federation
Spain
Canada
Korea, Republic of
Taiwan


title: Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study

acronym: PROMIZING

summary: For adult patients with acute respiratory failure requiring invasive mechanical ventilation, does a ventilation strategy using proportional assist ventilation with load-adjustable gain factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a ventilation strategy using pressure support ventilation (PSV)?

primary_purpose: Supportive Care

lead_sponsor: Lawson Health Research Institute

location_country: Italy France Greece Spain Canada

location_facility: Hôpital Henri Mondor (Assistance Publique-Hôpitaux de Paris)

location_facility: San Giovanni Battista University Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Angers

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire (CHU) de Rouen

location_facility: Centre Hospitalier Universitaire (CHU) de Nice

location_facility: Institut Universitaire de cardiologie et de pneumologie de Quebec

location_facility: London Health Sciences Centre - University Hospital


ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
France
Poland
Slovakia
Romania
Hungary
Argentina
Australia
New Zealand
Russian Federation
Turkey
United States
United Kingdom

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

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

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: University of Texas MD Anderson Cancer Center

title: Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second-Line Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior chemotherapy.


ReferenceCitation: Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.

name: Department of Neurology, Mayo Clinic, Phoenix, AZ, USA

family: Dodick

full_name: David W Dodick

given: David W

name: NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK

name: Department of Neurology, University of California, San Francisco, CA, USA

family: Goadsby

full_name: Peter J Goadsby

given: Peter J

name: Pain Clinic, Department of Neurosurgery, Hôpital Salengro, CHU de Lille, Lille, France

family: Lucas

full_name: Christian Lucas

given: Christian

name: Danish Headache Center, Rigshospitalet-Glostrup, Glostrup, Denmark

family: Jensen

full_name: Rigmor Jensen

given: Rigmor

name: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA

family: Bardos

full_name: Jennifer N Bardos

given: Jennifer N

family: Martinez

full_name: James M Martinez

given: James M

family: Zhou

full_name: Chunmei Zhou

given: Chunmei

family: Aurora

full_name: Sheena K Aurora

given: Sheena K

family: Yang

full_name: Jyun Yan Yang

given: Jyun Yan

name: University of Maryland School of Medicine, Baltimore, MD, USA

family: Conley

full_name: Robert R Conley

given: Robert R

family: Oakes

full_name: Tina Oakes

given: Tina

journal_name: Cephalalgia

location_country:
Italy
United States
Netherlands
Germany
Finland
France
Greece
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Klinikum der Universität München Campus Großhadern

location_facility: New England Institute for Clinical Research

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

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache

summary: The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

acronym: RANGE

summary: The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Necchi A, Nishiyama H, Matsubara N, Lee JL, Petrylak DP, de Wit R, Drakaki A, Liepa AM, Mao H, Bell-McGuinn K, Powles T. Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE). BMC Urol. 2020 Nov 7;20(1):181. doi: 10.1186/s12894-020-00752-w.

family: Necchi

full_name: Andrea Necchi

given: Andrea

family: Nishiyama

full_name: Hiroyuki Nishiyama

given: Hiroyuki

family: Matsubara

full_name: Nobuaki Matsubara

given: Nobuaki

family: Lee

full_name: Jae-Lyun Lee

given: Jae-Lyun

family: Petrylak

full_name: Daniel P. Petrylak

given: Daniel P.

family: de Wit

full_name: Ronald de Wit

given: Ronald

family: Drakaki

full_name: Alexandra Drakaki

given: Alexandra

family: Liepa

full_name: Astra M. Liepa

given: Astra M.

family: Mao

full_name: Huzhang Mao

given: Huzhang

family: Bell-McGuinn

full_name: Katherine Bell-McGuinn

given: Katherine

family: Powles

full_name: Thomas Powles

given: Thomas

journal_name: BMC Urology

repository_institution: Erasmus University, Rotterdam - RePub

version: submittedVersion

ReferenceCitation: Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain SA, Fléchon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Géczi L, Ou YC, Coskun HS, Su WP, Bedke J, Gakis G, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Garcia Del Muro X, Rodriguez-Vida A, Cicin I, Harputluoglu H, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Hamid O, Liepa AM, Wijayawardana S, Russo F, Walgren RA, Zimmermann AH, Hozak RR, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):105-120. doi: 10.1016/S1470-2045(19)30668-0. Epub 2019 Nov 18.

full_name: Daniel P Petrylak

given: Daniel P

family: Chi

full_name: Kim N Chi

given: Kim N

ReferenceCitation: Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain S, Fléchon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Géczi L, Ou YC, Coskun HS, Su WP, Hegemann M, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Del Muro XG, Rodriguez-Vida A, Cicin I, Harputluoglu H, Widau RC, Liepa AM, Walgren RA, Hamid O, Zimmermann AH, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial. Lancet. 2017 Nov 18;390(10109):2266-2277. doi: 10.1016/S0140-6736(17)32365-6. Epub 2017 Sep 12.

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Canada
Korea, Republic of
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain
Turkey

location_facility: University of California, Davis - Health Systems

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

location_facility: University of Maryland- Biological Sciences

location_facility: The Center for Cancer and Blood Disorders

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

location_facility: Central Coast Medical Oncology Corporation

location_facility: Inova Comprehensive Cancer Care & Research Institute

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: Scientific research oncology institute n.a. P. A. Herzen

location_facility: St Mary's Hospital Regional Cancer Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Ivanovo regional clinical oncology dispensary


ReferenceCitation: Mascarenhas J, Komrokji RS, Palandri F, Martino B, Niederwieser D, Reiter A, Scott BL, Baer MR, Hoffman R, Odenike O, Vannucchi AM, Bussolari J, Zhu E, Rose E, Sherman L, Dougherty S, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Kiladjian JJ. Randomized, Single-Blind, Multicenter Phase II Study of Two Doses of Imetelstat in Relapsed or Refractory Myelofibrosis. J Clin Oncol. 2021 Sep 10;39(26):2881-2892. doi: 10.1200/JCO.20.02864. Epub 2021 Jun 17.

name: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

family: Mascarenhas

full_name: John Mascarenhas

given: John

family: Komrokji

full_name: Rami S. Komrokji

given: Rami S.

name: Institute of Hematology “L. and A. Seràgnoli”, S. Orsola-Malpighi University Hospital, Bologna, Italy

family: Palandri

full_name: Francesca Palandri

given: Francesca

name: Grande Ospedale Metropolitano-G.O.M. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy

family: Martino

full_name: Bruno Martino

given: Bruno

name: University Hospital Leipzig, Leipzig, Germany

family: Niederwieser

full_name: Dietger Niederwieser

given: Dietger

name: University Hospital Mannheim, Mannheim, Germany

family: Reiter

full_name: Andreas Reiter

given: Andreas

name: Fred Hutchinson Cancer Research Center, Seattle, WA

family: Scott

full_name: Bart L. Scott

given: Bart L.

name: University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, MD

family: Baer

full_name: Maria R. Baer

given: Maria R.

family: Hoffman

full_name: Ronald Hoffman

family: Odenike

full_name: Olatoyosi Odenike

given: Olatoyosi

name: AOU Careggi, University of Florence, Florence, Italy

family: Vannucchi

full_name: Alessandro M. Vannucchi

given: Alessandro M.

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

family: Bussolari

full_name: Jacqueline Bussolari

given: Jacqueline

family: Zhu

full_name: Eugene Zhu

given: Eugene

family: Rose

full_name: Esther Rose

given: Esther

family: Sherman

full_name: Laurie Sherman

given: Laurie

family: Dougherty

full_name: Souria Dougherty

given: Souria

family: Sun

full_name: Libo Sun

given: Libo

family: Huang

full_name: Fei Huang

given: Fei

family: Wan

full_name: Ying Wan

given: Ying

family: Feller

full_name: Faye M. Feller

given: Faye M.

family: Rizo

full_name: Aleksandra Rizo

given: Aleksandra

name: Hôpital Saint-Louis, Université Paris, Paris, France

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Geron Corporation

location_country:
Italy
United States
Germany
France
Israel
Belgium
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

title: A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects With Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) Inhibitor

summary: The purpose of this study is to evaluate the efficacy and safety of 2 dose regimens of imetelstat in participants with intermediate-2 or high-risk myelofibrosis (MF) whose disease is relapsed after or is refractory to Janus Kinase (JAK) inhibitor treatment. Key secondary endpoint includes overall survival.