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:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Lithuania
Slovakia
South Africa
Switzerland
Netherlands
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

acronym: RA-BRIDGE

location_facility: Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital

location_facility: Aintree University Hospital NHS Foundation Trust

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Private Practice - Dr. Christine J. Leehealey

location_facility: The Center for Rheumatology and Bone Research

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research

location_facility: Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Arthritis & Osteoporosis Clinic of Brazos Valley

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

location_facility: Nizhny Novgorod City Clinical Hospital Number 5

location_facility: St Luke's Clinic - Intermountain Orthopaedics

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi

location_facility: Università degli studi della Campania Luigi Vanvitelli

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim

location_facility: East Bay Rheumatology Medical Group, Inc

location_facility: Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Rheumatology Associates of South Florida

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: University Hospital Basel - Rheumatology

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: M. F. Vladimirskiy Moscow Regional Research Clinical Institute

location_facility: City Rheumatology Center (City Hospital #25)

location_facility: DM Clinical Research/Rheumatology Clinic of Houston

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: Rheuma Medicus- Zak��ad Opieki Zdrowotnej

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: North-Western State Med. Univ. n.a. I.I. Mechnikov of MoH of

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Ankara University Ibni Sina Hospital - Rheumatology

location_facility: Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka

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

location_facility: Hôpital Saint Joseph (Grand hôpital de Charleroi)

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Institut für Präventive Medizin & Klinische Forschung GbR

type: Other Identifier

title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

summary: This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.


design_allocation: Randomized

intervention_type: Other

status: Terminated

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Halozyme Therapeutics

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Belgium
Australia
Denmark
Taiwan
Croatia
France
Lithuania
Poland
Canada
Korea, Republic of
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Estonia
Latvia

location_facility: St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Fort Wayne Medical Oncology/Hematology, INC.

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Hospital de Clinicas de Porto Alegre - UFRGS

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Fundação Amaral Cravalho / Hospital Amaral Carvalho

location_facility: Sarah Cannon Research Institute UK (SCRI UK)

location_facility: East Tallinn Central Hospital Oncology Center

location_facility: Kaiser Permanente Franklin Medical Offices - Denver

location_facility: ICM Val d'Aurelle Saint Eloi - Departement Oncologie

location_facility: Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

location_facility: Memorial Healthcare System - Memorial Cancer Institute

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: Innovative Clinical Research Institution

location_facility: Mount Sinai School of Medicine - The Tisch Cancer Institute

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: Samuel Oschin Comprehensive Cancer Institute

location_facility: NYU Langone Medical Center - NYU Langone Arena Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Semmelweis Egyetem - Onkohaematológiai Osztály

location_facility: University of Wisconsin Health - UW Carbone Cancer Center

location_facility: Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Fundacao Pio XII Hospital De Câncer de Barretos

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Universitätsklinikum Halle-Universitätsklinik und Poliklinik

location_facility: CENANTRON - Centro Avançado de Tratamento Oncologico

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Seoul National University Bundang Hospital

location_facility: SIA "Rigas Austrumu Kliniska Universitates Slimnica"

location_facility: The Royal Marsden NHS Foundation Trust - Chelsea

location_facility: North Estonian Medical Centre Foundation Clinic of Oncology

location_facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

location_facility: David Geffen School of Medicine (DGSOM) at UCLA

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: The Catholic University of Korea, Seoul St.Mary's Hospital

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: Nemocnice Na Bulovce (Hospital Na Bulovce)

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro

location_facility: Penn State Milton S. Hershey Medical Center

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

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: Klinicki bolnički centar Sestre milosrdnice

location_facility: Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Keimyung University Dongsan Medical Center

location_facility: AZ Maria Middelares - Campus Maria Middelares

location_facility: The Chaim Sheba Medical Center [Oncology]

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Klinikum der Universität München - Campus Grosshadern

location_facility: University of Washington (UW) - Seattle Cancer Care Alliance

location_facility: The Royal Marsden NHS Foundation - Sutton

location_facility: The Sidney Kimmel Comprehensive Cancer Center

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase III Double-blind, Randomised, Parallel-Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human IFN Beta-1a) and Placebo in the Treatment of Patients With Moderate or Severe Acute Respiratory Distress Syndrome

acronym: INTEREST

summary: In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.

ReferenceType: derived

ReferenceCitation: Ranieri VM, Pettilä V, Karvonen MK, Jalkanen J, Nightingale P, Brealey D, Mancebo J, Ferrer R, Mercat A, Patroniti N, Quintel M, Vincent JL, Okkonen M, Meziani F, Bellani G, MacCallum N, Creteur J, Kluge S, Artigas-Raventos A, Maksimow M, Piippo I, Elima K, Jalkanen S, Jalkanen M, Bellingan G; INTEREST Study Group. Effect of Intravenous Interferon β-1a on Death and Days Free From Mechanical Ventilation Among Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2020 Feb 25;323(8):725-733. doi: 10.1001/jama.2019.22525.

name: Alma Mater Studiorum–Università di Bologna, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant’Orsola, Bologna, Italy

family: Ranieri

full_name: V. Marco Ranieri

given: V. Marco

sequence: first

name: Division of Intensive Care, Department of Anesthesiology, Intensive Care, and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

family: Pettilä

full_name: Ville Pettilä

given: Ville

sequence: additional

name: Faron Pharmaceuticals Ltd, Turku, Finland

family: Karvonen

full_name: Matti K. Karvonen

given: Matti K.

family: Jalkanen

full_name: Juho Jalkanen

given: Juho

name: Manchester University NHS Foundation Trust, Wythenshawe Hospital, Manchester, United Kingdom

family: Nightingale

full_name: Peter Nightingale

given: Peter

name: Critical Care, University College London Hospitals, NHS Foundation Trust and National Institute for Health Research Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London, London, United Kingdom

family: Brealey

full_name: David Brealey

given: David

name: Department of Intensive Care, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

name: Department of Intensive Care/SODIR Research Group–VHIR Hospital Universitari Vall d’Hebron UCI, Barcelona, Spain

family: Ferrer

full_name: Ricard Ferrer

given: Ricard

name: Médecine Intensive-Réanimation CHU d’Angers, Université d’Angers, Angers, France

family: Mercat

full_name: Alain Mercat

given: Alain

name: Dipartimento di scienze diagnostiche e integrate, Università degli studi di Genova, Genova, Italy

family: Patroniti

full_name: Nicolò Patroniti

given: Nicolò

name: Anesthesiology and Operative Intensive Care Medicine, Universitätsmedizin Göttingen, Göttingen, Germany

family: Quintel

full_name: Michael Quintel

given: Michael

name: Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

family: Okkonen

full_name: Marjatta Okkonen

given: Marjatta

name: Université de Strasbourg (UNISTRA), Faculté de Médecine, Hôpitaux universitaires de Strasbourg, Nouvel Hôpital Civil, Service de réanimation, Strasbourg, France

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

name: Azienda Ospedaliera San Gerardo, Milan, Italy

family: Bellani

full_name: Giacomo Bellani

given: Giacomo

family: MacCallum

full_name: Niall MacCallum

given: Niall

family: Creteur

full_name: Jacques Creteur

given: Jacques

name: Department of Intensive Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

family: Kluge

full_name: Stefan Kluge

given: Stefan

name: Corporacion Sanitaria Universitaria Parc Tauli CIBER Enfermedades Respiratorias Autonomous University of Barcelona, Sabadell, Spain

family: Artigas-Raventos

full_name: Antonio Artigas-Raventos

given: Antonio

family: Maksimow

full_name: Mikael Maksimow

given: Mikael

family: Piippo

full_name: Ilse Piippo

given: Ilse

name: Medicity research Laboratory, University of Turku, Turku, Finland

family: Elima

full_name: Kati Elima

given: Kati

full_name: Sirpa Jalkanen

location_country:
Italy
Finland
France
Czechia
Belgium
Spain
Germany
United Kingdom

location_facility: Universitätsmedizin Göttingen Klinik für Anästhesiologie

location_facility: Charing Cross Hospital Imperial College Healthcare NHS Trust

location_facility: Azienda Ospedaliera Universitaria Sant' Anna

location_facility: Universitätsklinik Leipzig Klinik und Poliklinik für Anäesthesiologie und Intensivtherapie

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Charing Cross Hospital St Mary's Hospital, Imperial College Healthcare NHS Trust

location_facility: Bristol Royal Infirmary University Hospitals, Bristol Foundation Trust

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Universitätsklinikum Carl Gustav Carus Klinik für Anästhesiologie und Intensivmedizin

location_facility: Hospital Universitario de Gran Canaria Dr Negrin

location_facility: Universitätsklinikum Bonn Klinik und Poliklinik für Anästhesiologie

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Intesivmedizin

location_facility: Hôpital Cochin, Réanimation Médicale Hospitalisation

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hammersmith Hospital Imperial College Healthcre NHS Trust

location_facility: Kliniken der Stadt Köln Klinikum Merheim

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: CHU Charleroi Site Hôpital Civil Marie Curie

location_facility: Universita degli Studi di Roma "La Sapienza"

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Klinikum Augsburg Klinik für Anästhesiologie

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

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

location_facility: Lancashire Treaching Hospitals NHS Foundation Trust

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: St George's University Hospitals, NHS Foundation Trust


title: Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study

summary: The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier de Châlons-en-Champagne

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Bichat Claude Bernard

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire d'Orléans

location_facility: Centre Hospitalier Universitaire Lariboisiere

location_facility: Centre Hospitalier Mémorail France Etats Unis Saint Lo

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire Antoine Beclere

location_facility: Centre Hospitalier Universitaire de Grenoble

lead_sponsor_type: academique

status_simplified: Completed


title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK)-Inhibitor

summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are refractory to Janus Kinase (JAK)-Inhibitor treatment.

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Geron Corporation

location_country:
Malaysia
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Poland
Argentina
Korea, Republic of
Colombia
Switzerland
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Georgia
Spain
Turkey

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl

location_facility: Hospital de Clinicas de Porto Alegre - UFRGS

location_facility: CCA-Braga. Centro Clínico Académico - Hospital Braga

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Instituto Português de Oncologia de Lisboa

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András

location_facility: Institut de cancérologie du Gard - Hematologie clinique

location_facility: Pusan National University Hospital - Hematology and Oncology

location_facility: University of California-San Diego/Moores UCSD Cancer Center

location_facility: Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)

location_facility: Hospital A.C.Camargo Cancer Center - Clinical Oncology

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA

location_facility: Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre

location_facility: Hopital Avicenne - HÃ©matologie Clinique

location_facility: Deenanath Mangeshkar Hospital & Research Center

location_facility: Seoul National University Hospital - Department of Internal

location_facility: CHU - HÃ´pital Saint Louis - Centre D'Investigations Cliniq

location_facility: CEPON Centro de Pesquisas Oncologicas SC

location_facility: Marmara university pendik training and research hospital

location_facility: GOU VPO Saratov State Medical University n.a. V.I. Razumovsk

location_facility: National University Cancer Institute (NCIS)

location_facility: Specialized Hospital for Active Therapy of Hematological dis

location_facility: All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)

location_facility: Centre Hospitalier Du Mans - Cancérologie Médicale

intervention_type: Drug

status_simplified: Ongoing


ReferenceCitation: Kelly RJ, Shepherd FA, Krivoshik A, Jie F, Horn L. A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Ann Oncol. 2019 Jul 1;30(7):1127-1133. doi: 10.1093/annonc/mdz128.

family: Kelly

full_name: R.J. Kelly

family: Shepherd

full_name: F.A. Shepherd

family: Krivoshik

full_name: A. Krivoshik

given: A.

family: Jie

full_name: F. Jie

given: F.

family: Horn

full_name: L. Horn

given: L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Vanderbilt University - Discover Archive

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing_description:
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com

:

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Peru
Malaysia
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Thailand
Canada
Korea, Republic of
Chile
Netherlands
Singapore
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Spain

acronym: SOLAR

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Site PT35101
Site ES34010
Site MY60002
Site GB44003
Site HU36001
Site UA38001
Site AU61003
Site UA38006
Site JP81022
Site TH66012
Site US10021
Site DE49008

ipd_sharing: Yes

title: An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations

summary:
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.


title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

summary:
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).

The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Optional Sub-Study:

The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.

The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

status: Active, not recruiting

ReferenceCitation: Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaçi D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Oct 29. doi: 10.1007/s13555-021-00630-9. [Epub ahead of print]

family: Yosipovitch

full_name: Gil Yosipovitch

given: Gil

family: de Bruin-Weller

full_name: Marjolein de Bruin-Weller

given: Marjolein

family: Armstrong

full_name: April Armstrong

given: April

family: Wu

full_name: Jashin J. Wu

given: Jashin J.

family: Herranz

full_name: Pedro Herranz

given: Pedro

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

family: Delevry

full_name: Dimittri Delevry

given: Dimittri

family: Bagousse

full_name: Gaëlle Bégo-Le Bagousse

given: Gaëlle Bégo-Le

family: Zhang

full_name: Raymond Zhang

given: Raymond

family: Shumel

full_name: Brad Shumel

given: Brad

family: Rossi

full_name: Ana B. Rossi

given: Ana B.

family: Chao

full_name: Jingdong Chao

given: Jingdong

journal_name: Dermatology and Therapy

oa_host_type: publisher

evidence: oa journal (via doaj)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Beck LA, Thaçi D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2021 Feb 8:1-9. doi: 10.1080/09546634.2020.1871463. [Epub ahead of print]

name: Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA

family: Beck

full_name: Lisa A. Beck

given: Lisa A.

name: Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany

name: Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

family: Deleuran

full_name: Mette Deleuran

given: Mette

name: National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center, Utrecht, Netherlands

name: Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA

family: Chen

full_name: Zhen Chen

given: Zhen

family: Khokhar

full_name: Faisal A. Khokhar

given: Faisal A.

full_name: Meng Zhang

given: Meng

ReferenceCitation: Beck LA, Thaçi D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.

journal_name: American Journal of Clinical Dermatology

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
France
Japan
Lithuania
Poland
Slovakia
Canada
Korea, Republic of
Netherlands
Bulgaria
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Czechia
New Zealand
Spain
Estonia

location_facility:
Regeneron Study Site
Regeneron Study Site 3
Regeneron Study Site 6
Regeneron Study Site 4
Regeneron Study Site 1
Regeneron Study Site 7
Regeneron Study Site 8
Regeneron Study Site 2
Regeneron Study Site 5


title: EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs Investigator's Choice of Endocrine Therapy, in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

summary: The main purpose of this study is to measure how well LY3484356 works compared to hormone therapy in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Argentina
Korea, Republic of
Netherlands
China
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Willamette Valley Cancer Institute & Research Ctr.

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: The Fifth Medical Center of PLA General Hospital

location_facility: Instituto Argentino de Diagnóstico y Tratamiento (IADT)

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Centro de Investigación Clínica de Alta Especialidad

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: CIPREC-Centro de Investigacion y Prevencion Cardiovascular-

location_facility: Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Christus Muguerza Clinica Vidriera (Christus Muguerza Sistemas Hospitalarios S.A. de C.V.)

location_facility: Volgograd Regional Clinical Cancer Clinic No.1

location_facility: Rotkreuzklinikum München gemeinnützige GmbH

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: University of Health Sciences,Gulhane School of Medicine

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Texas Oncology - Methodist Charlton Cancer Center

location_facility: Jining Medical University - Affiliated Hospital

location_facility: Gynäkologisch-Onkologische Praxis am Pelikanplatz

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

location_facility: St Marianna University School of Medicine Hospital

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

location_facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

location_facility: Government Medical College And Hospital - Nagpur

location_facility: Harbin Medical University Cancer Hospital

location_facility: Evangelisches Krankenhaus Bethesda Mönchengladbach

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Banner MD Anderson Cancer Center at McKee Medical Center

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

location_facility: COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F.

location_facility: University General Hospital of Heraklion

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Xiangya Hospital Central South University

location_facility: The First People's Hospital of Changde City


title: A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.

ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.

In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28 days cycle.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
France
Japan
Israel
Australia
Spain
United States
Korea, Republic of
Taiwan

location_facility: National Cheng Kung University Hospital /ID# 225944

location_facility: Linkou Chang Gung Memorial Ho /ID# 225946

location_facility: National Cancer Center Hospital /ID# 225724

location_facility: Virginia Cancer Specialists - Fairfax /ID# 225693

location_facility: The Chaim Sheba Medical Center /ID# 225585

location_facility: Hospital Universitario 12 de Octubre /ID# 225977

location_facility: Centre Georges François Leclerc /ID# 226760

location_facility: Dana-Farber Cancer Institute /ID# 231209

location_facility: National Cancer Center Hospital East /ID# 225725

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225975

location_facility: Yonsei University Health System Severance Hospital /ID# 233774

location_facility: Carolina BioOncology Institute /ID# 225358

location_facility: AP-HM - Hopital de la Timone /ID# 225779

location_facility: Hospital Universitario Vall d'Hebron /ID# 225976

location_facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 226096

location_facility: South Texas Accelerated Research Therapeutics /ID# 225359

location_facility: Hospital Universitario Virgen de la Victoria /ID# 225978

location_facility: Washington University-School of Medicine /ID# 225698


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Brazil
Chile
South Africa
Mexico
Philippines
France
Korea, Republic of
Poland
Israel
Russian Federation
Spain
United States
United Kingdom
Canada
Colombia
Ukraine

acronym: MK-4482 Ph 2/3 Study in Hospitalized Adults with COVID-19

location_facility: Communal Non-Commercial Enterprise Central City Hospital ( Site 1615)

location_facility: Hospital Universitario La Paz ( Site 1300)

location_facility: University of Nebraska Medical Center ( Site 1835)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

location_facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0104)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)

location_facility: Hopital Bichat - Claude Bernard ( Site 0503)

location_facility: Servicio de Salud Sur Hospital Lucio Cordova ( Site 0305)

location_facility: University of California Davis Health ( Site 1809)

location_facility: Centre Hospitalier de Tourcoing ( Site 0502)

location_facility: Clinica Universidad de los Andes ( Site 0301)

location_facility: University Health Network - Toronto General Hospital ( Site 0201)

location_facility: North Manchester General Hospital ( Site 1701)

location_facility: Centrum Medyczne Pratia, Mazowiecki Szpital Specjalistyczny, Oddział Obserwacyjno - Zakaźny ( Site 1

location_facility: Clinical Projects Research Centre ( Site 1205)

location_facility: University of New Mexico, Health Sciences Center ( Site 1806)

location_facility: Complejo Hospitalario San Jose ( Site 0306)

location_facility: Сommunal non-com. Institution Oleksandrivska clinical hospital Kyiv ( Site 1600)

location_facility: Krasnogorsk City Hospital Number 1 ( Site 1119)

location_facility: Kaiser Foundation Hospital - South Bay ( Site 1832)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2103)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0100)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

location_facility: Moscow Clinical Hospital #52 ( Site 1103)

location_facility: Centrum Medyczne w Lancucie Sp.zo.o. ( Site 1000)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

location_facility: University of the Philippines-Philippine General Hospital ( Site 0900)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

location_facility: Wellstar Kennestone Hospital ( Site 1801)

location_facility: Hospital Universitario San Ignacio ( Site 0401)

location_facility: University of Mississippi Medical Center ( Site 1846)

location_facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1001)

location_facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

location_facility: C.H.U. de Toulouse. Hopital de Purpan ( Site 0501)

location_facility: Chungnam National University Hospital ( Site 2202)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 2205)

location_facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

location_facility: CHRISTUS Institute for Innovation & Advanced Clinical Care ( Site 1864)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0403)

location_facility: Lung Center of the Philippines ( Site 0902)

location_facility: Volyn Regional Clinical Hospital ( Site 1613)

location_facility: Hospital Universitari Vall d Hebron ( Site 1305)

location_facility: Cedars-Sinai Medical Center ( Site 1822)

location_facility: Groupe Hospitalier Pellegrin ( Site 0511)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1004)

location_facility: Royal Free London NHS Foundation Trust ( Site 1700)

location_facility: FSBI Central Hospital with Policlinics ( Site 1105)

location_facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

location_facility: CNPE of Kharkiv RC Regional Clinical Infectious Diseases Hospital ( Site 1606)

location_facility: Odesa City Clinical Infectious Hospital ( Site 1611)

location_facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0101)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1302)

location_facility: Hospital Sotero del Rio [Santiago, Chile] ( Site 0304)

location_facility: Wits Baragwanath Clinical Trial Site ( Site 1204)

type: Registry Identifier

title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Hospitalized Adults With COVID-19

summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.


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.

location_country:
United States
Netherlands
Germany
France
Japan
Australia
Spain
Canada

acronym: DETERMINED 1

location_facility: Nagoya City University Hospital /ID# 211155

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 212564

location_facility: University of the Ryukyus Hospital /ID# 211373

location_facility: Beth Israel Deaconess Medical Center /ID# 211794

location_facility: The Royal Melbourne Hospital /ID# 212436

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 212249

location_facility: Central Connecticut Dermatology /ID# 214479

location_facility: Montefiore Medical Center - Moses Campus /ID# 211800

location_facility: Oregon Medical Res Center PC /ID# 211796

location_facility: Hospital General Universitario Gregorio Maranon /ID# 212011

location_facility: Burke Pharmaceutical Research /ID# 211671

location_facility: Universitaetsklinikum Frankfurt /ID# 211913

location_facility: Penn State Hershey Medical Ctr /ID# 211659

location_facility: Hospital Universitario Virgen de las Nieves /ID# 212014

location_facility: Bakersfield Derma & Skin Cance /ID# 211684

location_facility: HCL - Hopital Edouard Herriot /ID# 218408

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 212563

location_facility: Virginia Clinical Research, Inc. /ID# 215959

location_facility: Staedtisches Klinikum Dessau /ID# 211914

location_facility: Integrative Skin Science and Research /ID# 212550

location_facility: Modern Research Associates, PL /ID# 215202

location_facility: Wiseman Dermatology Research /ID# 212243

location_facility: Hospital Santa Creu i Sant Pau /ID# 212009

location_facility: Hospital Universitario Virgen de la Victoria /ID# 212013

location_facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043

location_facility: California Dermatology Institute /ID# 211786

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912

location_facility: Minnesota Clinical Study Center /ID# 211979

location_facility: CHU Toulouse - Hopital Larrey /ID# 213581

location_facility: Hospital General Universitario Alicante /ID# 212010

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

summary: This study is to evaluate the safety and efficacy of 2 dose levels of risankizumab in adult participants with moderate to severe Hidradenitis Suppurativa (HS). This study includes two treatment periods. In Period A, participants are randomized to receive either risankizumab dose A, dose B, or placebo. In Period B, participants who received risankizumab dose A or placebo during Period A, will receive risankizumab dose B. Participants who received risankizumab dose B in Period A will remain on that dose in Period B.


ReferenceCitation: Strosberg JR, Caplin ME, Kunz PL, Ruszniewski PB, Bodei L, Hendifar A, Mittra E, Wolin EM, Yao JC, Pavel ME, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Mariani MF, Demange A, Mutevelic S, Krenning EP; NETTER-1 investigators. (177)Lu-Dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Nov 15. pii: S1470-2045(21)00572-6. doi: 10.1016/S1470-2045(21)00572-6. [Epub ahead of print]

ReferenceCitation: Strosberg J, Kunz PL, Hendifar A, Yao J, Bushnell D, Kulke MH, Baum RP, Caplin M, Ruszniewski P, Delpassand E, Hobday T, Verslype C, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Paganelli G, Severi S, Morse M, Metz DC, Ansquer C, Courbon F, Al-Nahhas A, Baudin E, Giammarile F, Taïeb D, Mittra E, Wolin E, O'Dorisio TM, Lebtahi R, Deroose CM, Grana CM, Bodei L, Öberg K, Polack BD, He B, Mariani MF, Gericke G, Santoro P, Erion JL, Ravasi L, Krenning E; NETTER-1 study group. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with (177)Lu-Dotatate: an analysis of the NETTER-1 study. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2372-2382. doi: 10.1007/s00259-020-04709-x. Epub 2020 Mar 2.

family: Strosberg

full_name: Jonathan Strosberg

given: Jonathan

family: Kunz

full_name: Pamela L. Kunz

given: Pamela L.

family: Hendifar

full_name: Andrew Hendifar

given: Andrew

family: Yao

full_name: James Yao

given: James

family: Bushnell

full_name: David Bushnell

given: David

family: Kulke

full_name: Matthew H. Kulke

given: Matthew H.

family: Baum

full_name: Richard P. Baum

given: Richard P.

family: Caplin

full_name: Martyn Caplin

given: Martyn

family: Ruszniewski

full_name: Philippe Ruszniewski

given: Philippe

family: Delpassand

full_name: Ebrahim Delpassand

given: Ebrahim

family: Hobday

full_name: Timothy Hobday

given: Timothy

family: Verslype

full_name: Chris Verslype

given: Chris

family: Benson

full_name: Al Benson

given: Al

family: Srirajaskanthan

full_name: Rajaventhan Srirajaskanthan

given: Rajaventhan

family: Pavel

full_name: Marianne Pavel

given: Marianne

family: Mora

full_name: Jaume Mora

given: Jaume

family: Berlin

full_name: Jordan Berlin

given: Jordan

family: Grande

full_name: Enrique Grande

given: Enrique

family: Reed

full_name: Nicholas Reed

given: Nicholas

family: Seregni

full_name: Ettore Seregni

given: Ettore

family: Paganelli

full_name: Giovanni Paganelli

given: Giovanni

family: Severi

full_name: Stefano Severi

given: Stefano

family: Morse

full_name: Michael Morse

given: Michael

family: Metz

full_name: David C. Metz

given: David C.

family: Ansquer

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

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

repository_institution: Uppsala University - Uppsala University Publications

repositories_institution: Vanderbilt University - Discover Archive

title: Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate: an analysis of the NETTER-1 study

ReferenceCitation: Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With (177)Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

name: Jonathan Strosberg, Moffitt Cancer Center, Tampa, FL; Edward Wolin, Montefiore Einstein Center for Cancer Care, Bronx, NY; Beth Chasen, University of Texas MD Anderson Cancer Center, Houston, TX; Matthew Kulke, Dana-Farber Cancer Institute, Boston, MA; David Bushnell, University of Iowa, Iowa City, IA; Martyn Caplin, Royal Free Hospital, London, United Kingdom; Richard P. Baum, Zentralklinik, Bad Berka, Germany; Pamela Kunz, Stanford University Medical Center, Stanford; Andrew Hendifar, Cedars Sinai...

publisher: American Society of Clinical Oncology (ASCO)

title: Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial

ReferenceCitation: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of (177)Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

title: Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors

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

location_country:
Italy
United States
Spain
France
Belgium
Portugal
Germany
United Kingdom

location_facility: Cedars-Sinai Medical Center Samuel Oschin Cancer Center

location_facility: Università "Sapienza" di Roma, Facoltà di Medicina e Psicologia, Ospedale S. Andrea-Roma

location_facility: Charité, Virchow-Klinikum, Gastroentrology, Hepatology & Endocrinology

location_facility: Digestive Oncology, Leuven Cancer Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Oncologico Romagnolo per lo Studio dei Tumori

location_facility: Excel Diagnostics and Nuclear Oncology Center

location_facility: Universitätsmedizin Mainz, Medizinische Klinik I Schwerpunkt Endokrinologie

location_facility: Imperial College Healthcare Trust, Hammersmith Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Azienda Ospedaliero - Universitaria Pisana (Presidio Ospedaliero S. Chiara)

location_facility: Centro Hospitalar e Universitario de Coimbra

title: A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.


title: A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH).

summary:
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population.

Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH.

In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes.

This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.

ReferenceCitation: Ratziu V, Harrison SA, Francque S, Bedossa P, Lehert P, Serfaty L, Romero-Gomez M, Boursier J, Abdelmalek M, Caldwell S, Drenth J, Anstee QM, Hum D, Hanf R, Roudot A, Megnien S, Staels B, Sanyal A; GOLDEN-505 Investigator Study Group. Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening. Gastroenterology. 2016 May;150(5):1147-1159.e5. doi: 10.1053/j.gastro.2016.01.038. Epub 2016 Feb 11. Erratum in: Gastroenterology. 2017 Jun;152(8):2084.

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

family: Francque

full_name: Sven Francque

given: Sven

family: Bedossa

full_name: Pierre Bedossa

given: Pierre

family: Lehert

full_name: Philippe Lehert

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

family: Romero-Gomez

full_name: Manuel Romero-Gomez

given: Manuel

family: Boursier

full_name: Jérôme Boursier

given: Jérôme

family: Abdelmalek

full_name: Manal Abdelmalek

given: Manal

family: Caldwell

full_name: Steve Caldwell

given: Steve

family: Drenth

full_name: Joost Drenth

given: Joost

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

family: Hum

full_name: Dean Hum

given: Dean

family: Hanf

full_name: Remy Hanf

given: Remy

family: Roudot

full_name: Alice Roudot

given: Alice

family: Megnien

full_name: Sophie Megnien

given: Sophie

family: Staels

full_name: Bart Staels

given: Bart

family: Sanyal

full_name: Arun Sanyal

given: Arun

family: Mathurin

full_name: P. Mathurin

given: P.

family: Gournay

full_name: J. Gournay

given: J.

family: Nguyen-Khac

full_name: E. Nguyen-Khac

given: E.

family: De Ledinghen

full_name: V. De Ledinghen

given: V.

family: Larrey

full_name: D. Larrey

given: D.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

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

title: Elafibranor, an Agonist of the Peroxisome Proliferator−Activated Receptor−α and −δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening

location_country:
Italy
United States
Netherlands
France
Romania
Belgium
Spain
Germany
United Kingdom

location_facility:
Site 911
Site 303
Site 917
Site 603
Site 701
Site 705
Site 913
Site 802
Site 107
Site 108
Site 101
Site 204
Site 109
Site 103
Site 205
Site 902
Site 920
Site 901
Site 602
Site 906
Site 706
Site 801
Site 808
Site 507
Site 916
Site 111
Site 302
Site 707
Site 114
Site 405
Site 102
Site 113
Site 927
Site 931
Site 803
Site 903
Site 201
Site 703
Site 921
Site 909
Site 923
Site 501
Site 503
Site 202
Site 106
Site 930
Site 112
Site 908
Site 601
Site 924
Site 104
Site 203
Site 404
Site 919
Site 504
Site 912


title: A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)

summary: The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

ReferenceCitation: Menter A, Thaçi D, Wu JJ, Abramovits W, Kerdel F, Arikan D, Guo D, Ganguli A, Bereswill M, Camez A, Valdecantos WC. Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry. Dermatol Ther (Heidelb). 2017 Sep;7(3):365-381. doi: 10.1007/s13555-017-0198-x. Epub 2017 Aug 16.

family: Menter

full_name: Alan Menter

given: Alan

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

family: Wu

full_name: Jashin J. Wu

given: Jashin J.

family: Abramovits

full_name: William Abramovits

given: William

family: Kerdel

full_name: Francisco Kerdel

given: Francisco

family: Arikan

full_name: Dilek Arikan

given: Dilek

family: Guo

full_name: Dianlin Guo

given: Dianlin

family: Ganguli

full_name: Arijit Ganguli

given: Arijit

family: Bereswill

full_name: Mareike Bereswill

given: Mareike

family: Camez

full_name: Anne Camez

given: Anne

family: Valdecantos

full_name: Wendell C. Valdecantos

given: Wendell C.

oa_colors: green gold

license: cc-by

license_normalized: cc-by

license: implied-oa

license_normalized: implied-oa

ipd_sharing: Undecided

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Austria
Sweden
Netherlands
Germany
France
Czechia
Greece
Ireland
Puerto Rico
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 20723

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 19763

location_facility: Arlington Research Center, Inc /ID# 23063

location_facility: Camelback Derm & Skin Surgery /ID# 18901

location_facility: Genl Hospital Andreas Syggros /ID# 22848

location_facility: Rush University Medical Center /ID# 47604

location_facility: Skin Physicians & Surgeons Med /ID# 40265

location_facility: Great Plains Dermatology, P.A. /ID# 23079

location_facility: Pinnacle Dermatology - Grand Blanc /ID# 40196

location_facility: NewLab Clinical Research Inc. /ID# 18360

location_facility: Vseobecna fakultni nemoc Praze /ID# 28269

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center /ID# 24268

location_facility: Northwest Georgia Dermatology /ID# 28162

location_facility: Mountain State Clinical Resear /ID# 28146

location_facility: Derm Med Grp Oxnard/Camarillo /ID# 17102

location_facility: Derm & Laser Ctr of Charleston /ID# 18353

location_facility: Dermatology Assoc San Antonio /ID# 17150

location_facility: Tzaneio general hospital of Piraeus /ID# 28237

location_facility: Oregon Health and Science University /ID# 28143

location_facility: Florida Academic Centers Research and Education /ID# 24273

location_facility: Center for Dermatology Clin Res /ID# 20722

location_facility: The Dermatology Center PSC - New Albany /ID# 20501

location_facility: Metro Hypertension and Kidney /ID# 40184

location_facility: Centre de Dermatologie Maizerets /ID# 20515

location_facility: Fakultni Nemocnice u SvateAnny /ID# 37062

location_facility: Vseobecna fakultni nemoc Praze /ID# 27933

location_facility: UMDNJ R. W. Johnson Med School /ID# 24326

location_facility: Iacobelli, Clinton Twnshp, MI /ID# 38290

location_facility: Allied Dermatology and Skin Surgery /ID# 28154

location_facility: Entralogix Clinical Research, /ID# 79194

location_facility: University Hospital St. Polten /ID# 22842

location_facility: NW GA Derm & Skin Cancer Spec /ID# 17089

location_facility: The Indiana Clinical Trials Center /ID# 17153

location_facility: Central Dermatology Center, PA /ID# 17070

location_facility: Psoriasis Treatment Ctr of Central NJ /ID# 17148

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 28232

location_facility: Skin and Laser Surgery Center /ID# 40182

location_facility: Dartmouth-Hitchcock Medical Center /ID# 20502

location_facility: Dr. Reinaldo Rosario Med Offic /ID# 24328

location_facility: Total Skin and Beauty Derm Ctr /ID# 17156

location_facility: Krankenanstalt Rudolfstiftung /ID# 20603

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 37063

location_facility: Hospital Universitario 12 de Octubre /ID# 18365

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 27944

location_facility: Tulsa Dermatology Clinic, Inc. /ID# 71675

location_facility: Entralogix Clinical Research, /ID# 79197

location_facility: Fernandez-Obregon, Hoboken, NJ /ID# 23073

location_facility: Hospital Universitario de la Princesa /ID# 18867

location_facility: Duke University Medical Center /ID# 24324

location_facility: Premiere Clinical Research,LLC /ID# 44719

location_facility: Universitaetsklinik Heidelberg /ID# 20601

location_facility: The Dermatology Inst of S. TX /ID# 38288

location_facility: Flebologisch Centrum Oosterwal /ID# 18349

location_facility: Alliance Dermatology and MOHs /ID# 17087

location_facility: Loyola University Medical Ctr /ID# 23065

location_facility: CHRU Tours - Hopital Trousseau /ID# 28271

location_facility: Universitaetsklinikum Leipzig /ID# 20604

location_facility: Winnipeg Clinic, Manitoba, CA /ID# 37046

location_facility: Hudklinik / Clinic Dermatology /ID# 20729

location_facility: General Hospital of Giannitsa /ID# 27951

location_facility: Eastern Washington Dermatology /ID# 17542

location_facility: Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 22844

location_facility: Skin Cancer & Cosmetic Derm Ct /ID# 23313

location_facility: Northwestern University Feinberg School of Medicine /ID# 28169

location_facility: Genl Hospital Andreas Syggros /ID# 25905

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 27954

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 17152

location_facility: Hospital Universitari Sagrat Cor - Grupo Quiron Salud /ID# 19767

location_facility: Academisch Medical center Amsterdam /ID# 22850

location_facility: Ft. Lauderdale Derm & Cosmetic /ID# 23071

location_facility: Panzer Dermatology & Cosmetic /ID# 17131

location_facility: Austin Dermatology Associates /ID# 38296

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 27942

location_facility: Genl Hospital Andreas Syggros /ID# 22847

location_facility: The Dermatology Center, PSC - Bayside NY /ID# 28170

location_facility: Radboud Universitair Medisch Centrum /ID# 24265

location_facility: Guildford Derm. Specialists,CA /ID# 40199

location_facility: Universitätsklinikum Frankfurt /ID# 19801

location_facility: RI Dermatology & Cosmetic Ctr /ID# 40270

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 22846

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 18361

location_facility: Hospital General Universitario Alicante /ID# 20730

location_facility: Vseobecna fakultni nemoc Praze /ID# 25907

location_facility: Panzer Dermatology & Cosmetic /ID# 17146

location_facility: Saint Louis University School of Medicine /ID# 28150

location_facility: Dermatology & Laser Center NW /ID# 18324

location_facility: Univ California, San Francisco /ID# 28267

location_facility: Dermatologic Surgery Specialis /ID# 17149

location_facility: Assoc. Derm & Skin Cancer Clin /ID# 24303

location_facility: Solano Dermatology Associates /ID# 20727

location_facility: Cent Florida Dermatology Assoc /ID# 20508

location_facility: Belleville Dermatology Center /ID# 17067

location_facility: Medizinische Universitat Wien /ID# 18364

location_facility: McLain Medical Associates, PC /ID# 18351

location_facility: Tidewater Skin Care/Pathology /ID# 71674

location_facility: Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 27923

location_facility: Guy's and St Thomas' NHS Found /ID# 28273

location_facility: Brigham Dermatology Associates /ID# 28207

location_facility: Mercy Woodstock Medical Center /ID# 40186


title: A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

summary: A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

location_country:
Italy
United States
Sweden
Spain
Germany
France
Czechia
Greece
Israel
Japan
Singapore
Australia
Russian Federation
China
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 222879

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 202213

location_facility: VA Puget Sound Health Care System /ID# 222708

location_facility: Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904

location_facility: The Jikei University Kashiwa Hospital /ID# 223031

location_facility: Khmelnytskyi Regional Hospital /ID# 223942

location_facility: Cleveland Clinic Main Campus /ID# 202247

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 223097

location_facility: Instituto Catalan de Oncologia (ICO) Girona /ID# 171311

location_facility: Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943

location_facility: Barbara Ann Karmanos Cancer In /ID# 201377

location_facility: Tel Aviv Sourasky Medical Center /ID# 169437

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213

location_facility: Kobe City Medical Center General Hospital /ID# 170992

location_facility: Hospital Universitario 12 de Octubre /ID# 171288

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952

location_facility: Yonsei University Health System Severance Hospital /ID# 202709

location_facility: Seoul National University Hospital /ID# 202711

location_facility: Hospital Universitario Virgen del Rocio /ID# 171286

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989

location_facility: Hospital Universitario Vall d'Hebron /ID# 218106

location_facility: Portsmouth Hospitals University NHS Trust /ID# 171444

location_facility: Ege University Medical Faculty /ID# 222697

location_facility: Medical Park Izmir Hastanesi /ID# 201954

location_facility: The First Hospital of China Medical University /ID# 215996

location_facility: Royal Berkshire NHS Foundation Trust /ID# 217835

location_facility: The First Affiliated Hospital of Soochow University /ID# 216094

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 170952

location_facility: National Hospital Organization Mito Medical Center /ID# 171187

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498

location_facility: Moscow State budget healthcare /ID# 169685

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941

location_facility: Iwate Medical University Hospital /ID# 222849

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 215495

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956

location_facility: National University Hospital /ID# 203988

location_facility: Assuta Ashdod Medical Center /ID# 222968

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 238646

location_facility: Istanbul University Istanbul Medical Faculty /ID# 201953

location_facility: The Jikei University Hospital /ID# 239014

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850

location_facility: University of California, Los Angeles /ID# 171524

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950

location_facility: Gazi University Medical Faculty /ID# 222698

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 222914

location_facility: Fairview Hospital - Moll Pavilion /ID# 208919

location_facility: University of Arizona Cancer Center - North Campus /ID# 218407

location_facility: West China Hospital, Sichuan University /ID# 216647

location_facility: CHU Grenoble - Hopital Michallon /ID# 223182

location_facility: Duplicate_Universitetssjukhuset Linköping /ID# 200789

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962

location_facility: Tula Regional Clinical Hospital /ID# 223226

location_facility: CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887

location_facility: Universitaetsklinikum Wuerzburg /ID# 200055

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041

location_facility: CHU Reims - Hôpital Robert Debre /ID# 233907

location_facility: Columbia University Medical Center /ID# 200715

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 223945

location_facility: Azienda Ospedaliera Santa Maria Terni /ID# 170948

location_facility: Japanese Red Cross Osaka Hospital /ID# 171493

location_facility: Peking University Third Hospital /ID# 216371

location_facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 218953

location_facility: University College London Hospitals NHS Foundation Trust /ID# 171428

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051

location_facility: Hospital Universitario La Paz /ID# 218107

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 200060

location_facility: Shengjing Hospital of China Medical University /ID# 223435

location_facility: Soroka University Medical Center /ID# 218768

location_facility: University Gen Hosp of Patra /ID# 201691

location_facility: Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 200099

location_facility: Manchester University NHS Foundation Trust /ID# 171440

location_facility: Univ Maryland School Medicine /ID# 217422

location_facility: Odense Universitets Hospital /ID# 223217

location_facility: Nottingham University Hospitals NHS Trust /ID# 223292

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 171304

location_facility: Complejo Hospitalario Universitario Ourense /ID# 222876

location_facility: Leningrad Regional Clinical Hospital /ID# 202776

location_facility: Hospital Universitario y Politecnico La Fe /ID# 234019

location_facility: VA Central California Health Care System /ID# 200047

location_facility: Beijing Chaoyang Hospital,Capital Medical University /ID# 216014

location_facility: Centre Antoine Lacassagne - Nice /ID# 234155

location_facility: Beijing Chaoyang Hospital,Capital Medical University(xiyuan campus) /ID# 234033

location_facility: Almazov National Medical Research Centre /ID# 169681

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 201076

location_facility: Hospital Universitari Son Espases /ID# 222889

location_facility: Nagoya City University Hospital /ID# 170880

location_facility: Guangdong Provincial People's Hospital /ID# 215860

location_facility: Tokushima University Hospital /ID# 202571

location_facility: QE II Health Sciences Centre /ID# 218883

location_facility: The Queen Elizabeth Hospital /ID# 202432

location_facility: Gachon University Gil Medical Center /ID# 202827

location_facility: Hospital Clinico Universitario de Salamanca /ID# 171294

location_facility: Research Institute of Fundamental and Clinical Immunology /ID# 223594

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045

location_facility: Cukurova Universitesi Tip Fakultesi /ID# 201955

location_facility: The Lady Davis Carmel Medical Center /ID# 222969

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 201692

location_facility: NHS Greater Glasgow and Clyde /ID# 202199

location_facility: The First Affiliated Hospital of Nanchang University /ID# 216954

location_facility: Peking Union Medical College Hospital /ID# 216040

location_facility: Ospedale Civile di Legnano - ASST Ovest Milanese /ID# 222989

location_facility: Hospital Universitario Canarias /ID# 238452

location_facility: The Chaim Sheba Medical Center /ID# 169778

location_facility: Tianjin Medical University Cancer Institute & Hospital /ID# 223550

location_facility: University Hospitals of North Midlands NHS Trust /ID# 218355

location_facility: Moscow Cancer Research Institute n.a. P. A. Herzen /ID# 233328

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643

location_facility: Japanese Red Cross Medical Center /ID# 171256

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691

location_facility: Yamagata University Hospital /ID# 238329

location_facility: Theageneio Anticancer Hospital /ID# 213983

location_facility: Imperial College Healthcare NHS Trust /ID# 171446

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 221166

location_facility: Fakultni nemocnice Hradec Kralove /ID# 221291

location_facility: Sun Yat-Sen University Cancer Center /ID# 223828

location_facility: Icon Cancer Care - Townsville /ID# 206565


location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Japan
Norway
Canada
Sweden
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain

acronym: SELECT-GCA

location_facility: Medizinische Universitaet Innsbruck /ID# 201786

location_facility: Azienda Sanitaria dell'Alto Adige/Ospedale di Bolzano /ID# 200081

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 213529

location_facility: Hospital General Universitario Gregorio Maranon /ID# 201326

location_facility: Rush University Medical Center /ID# 224581

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 171200

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 171543

location_facility: Practicheskaya Medicina Clinic /ID# 224612

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040

location_facility: West Texas Clinical Research /ID# 204834

location_facility: West Tennessee Research Institute /ID# 209256

location_facility: Rheum Assoc of North Alabama /ID# 168668

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 202834

location_facility: University of Alberta Hospital - Division of Hematology /ID# 208629

location_facility: Hospital Clinico Universitario San Carlos /ID# 204871

location_facility: IRIS Research and Development, LLC /ID# 169406

location_facility: Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702

location_facility: The Queen Elizabeth Hospital /ID# 201939

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 171199

location_facility: Bedfordshire Hospitals NHS Foundation Trust /ID# 224020

location_facility: VA Long Beach Healthcare System /ID# 203833

location_facility: General Hospital of Athens Gennimatas /ID# 210129

location_facility: Japanese Red Cross Kumamoto Hospital /ID# 203507

location_facility: Torbay and South Devon Nhs Foundation Trust /Id# 224689

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 200079

location_facility: St. Marianna University School of Medicine Hospital /ID# 218692

location_facility: Sahlgrenska University Hospital /ID# 171405

location_facility: General Hospital of Athens Ippokratio /ID# 202181

location_facility: Hopital de la Cavale Blanche /ID# 171549

location_facility: St.Luke's International Hospital /ID# 200170

location_facility: Haukeland universitetssjukehus /ID# 201602

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761

location_facility: Karolinska University Hospital Solna /ID# 204945

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 201853

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 171544

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 204018

location_facility: Hospital Universitario Canarias /ID# 224928

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 171539

location_facility: Physician Research Collaboration, LLC /ID# 168610

location_facility: 424 General MILITARY Hospital /ID# 210973

location_facility: Hospital Clinic de Barcelona /ID# 201878

location_facility: Medallion Clinical Research Institute, LLC /ID# 168666

location_facility: Froedtert Memorial Lutheran Hospital /ID# 224557

location_facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 202946

location_facility: Universitair Medisch Centrum Groningen /ID# 201715

location_facility: Western Connecticut Health Network- Germantown Rd /ID# 205071

location_facility: Piedmont Arthritis Clinic, PA /ID# 212431

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 168667

location_facility: Lovelace Scientific Resources /ID# 169041

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 223854

location_facility: The Center for Rheumatology and Bone Research /ID# 168652

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 221643

location_facility: Omega Research Maitland, LLC /ID# 201903

location_facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 201781

location_facility: Hospital Universitario Basurto /ID# 224730

location_facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 204887

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 224266

location_facility: Liverpool University University Hospitals NHS Foundation Trust /ID# 240391

location_facility: HCL - Hopital de la Croix-Rousse /ID# 211184

location_facility: Duplicate_Jichi Medical University Hosp /ID# 200169

location_facility: Timaru Medical Specialists Ltd /ID# 201943

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208151

location_facility: Radboud Universitair Medisch Centrum /ID# 212925

location_facility: Duplicate_West Michigan Rheumatology /ID# 168647

location_facility: University Hospitals Dorset NHS Foundation Trust /ID# 202836

location_facility: Universitaetsklinikum Wuerzburg /ID# 213340

location_facility: Duplicate_Vastmanlands Sjukhus /ID# 171429

location_facility: Institute of Arthritis Research /ID# 168490

location_facility: Universitair Ziekenhuis Leuven /ID# 202779

location_facility: Portsmouth Hospitals University NHS Trust /ID# 225002

location_facility: Unidade Local de Saúde da Guarda, EPE /ID# 224878

location_facility: University of Vermont Medical Center /ID# 211179

location_facility: The Chaim Sheba Medical Center /ID# 241041

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 201604

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 203673

location_facility: Kemerovo State Medical University /ID# 203676

location_facility: CHU UCL Namur - site Godinne /ID# 224334

location_facility: CHU Toulouse - Hopital Purpan /ID# 171547

location_facility: Wayne State University Health Center /ID# 212755

location_facility: University Clinical Research Center /ID# 202504

location_facility: Precision Comprehensive Clinical Research Solutions /ID# 201798

location_facility: The Lady Davis Carmel Medical Center /ID# 240731

location_facility: Rheumatology Associates PA - Portland /ID# 225011

location_facility: University of Michigan Hospitals /ID# 168645

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 203530

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 201526

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205186

location_facility: Clinical Research of West Florida - Tampa /ID# 201899

location_facility: Inselspital, Universitätsspital Bern /ID# 201364

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 200082

location_facility: Arthritis Associates of Kingsport /ID# 212756

location_facility: HFR Fribourg - Hôpital cantonal /ID# 201114

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 211454

location_facility: Medizinische Versorgungszentren Burghausen Altoetting /ID# 208773

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 208950

location_facility: Hospital Universitario Virgen de las Nieves /ID# 224726

location_facility: Szent Imre Egyetemi Oktatokorhaz /ID# 201838

location_facility: Clinical Research of West Florida, Inc /ID# 201901

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 224731

location_facility: Centre de Recherche Musculo-Squelettique /ID# 201224

location_facility: Medizinische Hochschule Hannover /ID# 200632

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA

summary: This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved remission in Period 1.