title: A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

summary: This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

ReferenceCitation: Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, Warne C, Musselman D, Brockwell L, Shittu E, Klearman M, Fleming TR. Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):31-40. doi: 10.1002/art.41095.

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: The University of Glasgow - Enlighten: Publications

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Argentina
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Lithuania
Hungary
United States
Latvia
India
Romania
Belgium
Malaysia
Philippines
Italy
Ecuador
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel

location_facility: Rheumatology, P.C.; Medical Arts Building

location_facility: Centre for Arthritis and Rheumatic Diseases

location_facility: Hôpital Edouard Herriot; Service de Rhumatologie

location_facility: Hospital Central Dr. Ignacio Morones Prieto

location_facility: P. Stradins Clinical University Hospital

location_facility: Hospital Municipal Nuestra Sra. de Lujan

location_facility: Southend Hospital; Rheumatology Department

location_facility: University of Pittsburgh Medical Center Health System; Infectious Disease

location_facility: OrthoArkansas; Orthopedics & Sports Medicine

location_facility: Arthritis & Osteoporosis Medical Associates, Pllc

location_facility: Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Ospedale San Giovanni Bosco; Divisione di Reumatologia

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

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Arthritis Health Associates; Clinical Research

location_facility: University Clinical Center of the Republic of Srpska

location_facility: SEI of HPE "Altay State Medical University of Roszdrav"

location_facility: Hospital General de Agudos Dr. J. M. Ramos Mejia

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Arthritis Rheumatic & Back Disease Associates

location_facility: Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology

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

location_facility: Hospital Privado San Jose de Ciudad Obregon SA de CV

location_facility: Leading Edge Research, PA; Office of Dr. Burbano

location_facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C

location_facility: Landesklinikum Weinviertel Stockerau; Rheumatologie

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft

location_facility: Siauliai Republican Hospital Public Institution

location_facility: Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.

location_facility: Russells Hall Hospital; Rheumatology Department

location_facility: Jacksonville Center For Clinical Research

location_facility: Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A

location_facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

location_facility: Clinical Interventions Research Institute

location_facility: University Hospitals Case Medical Center

location_facility: Head Clinical Hospital of Internal Affair Ministry of Russia

location_facility: State institution of healthcare "Regional hospital for war veterans"

location_facility: Specialty Medical Clinic and Research Center

location_facility: Uni Of Alabama,Birmingham; Medicine - Rheumatology

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus

location_facility: Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny

location_facility: Hospital de Merida ;Servicio de Reumatologia

location_facility: Centro de Estudios Clinicos V Region Limitada

location_facility: Special Hospital for Medical Rehabilitation

location_facility: Cebu Doctors' University Hospital- North General Hospital

location_facility: Riga East Clinical University Hospital; Clinic Gailezers

location_facility: Royal London Hospital Outpatients Department

location_facility: University of Pretoria; Clinical Trial Unit

location_facility: Hospital Christus Muguerza del Parque; Reumatologia

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

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: Charité Universitaetsmedizin Berlin, Campus Charité Mitte

location_facility: Leningradskaya Regional Clinical Hospital; Rheumatology Dept

location_facility: Moscow State Medical Stomatological University

location_facility: Euromedica Kyanous Stavros General Hospital

location_facility: Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie

location_facility: University General Hospital of Larissa; Rheumatology Unit

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Shanahan Rheumatology & Immunology, PLLC

location_facility: Hospital de Cruces; Servicio de Reumatologia

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Inland Rheumatology; Clinical Trials, Inc.

location_facility: Whipps Cross Hospital; Rheumatology Dept

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Atencion Integral En Reumatologia Buenos Aires

location_facility: SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

location_facility: Hospital Infanta Sofia; Servicio de Reumatologia

location_facility: Southampton General Hospital; Rheumatology

location_facility: CHU d'Amiens Hôpital Nord; Pharmacie Clinique

location_facility: St. Joseph'S/Candler Health System, Inc.; Office of Research

location_facility: CEIM Consultorios Especializados en Investigaciones Médicas

location_facility: Memorial Medical Group Clinical Research

location_facility: Alytus Regional S. Kudirkos Hospital, Public Institution

location_facility: Groote Schuur Hospital; Rheumatology Unit

location_facility: Vilnius District Central Outpatient Clinic, Public Institution

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

location_facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie

location_facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Scientific and research medical complex Your Health

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

location_facility: Hôpital Saint-Antoine; Service de Psychiatrie

location_facility: Instituto Centralizado de Asistencia e Investigaci

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii

location_facility: Euroclinic of Athens; Internal Medicine & Immunology Dept.

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese

location_facility: Allergy & Rheumatology Medical Clinic, Inc

location_facility: CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie

location_facility: Chris Hani Baragwanath Hospital; Rheumatology Department

location_facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

location_facility: Hospital Clinico Pontificia Universidad Catolica de Chile

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Rheumatology Associates of North Alabama

location_facility: Hospital General de Castellon; Servicio de Reumatologia

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii

location_facility: St. Luke's Intermountain Research Center

location_facility: Arizona Arthritis & Rheumatology Research, Pllc

location_facility: Comite Mexicano Para la Prevencion de Osteoporosis AC

location_facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research

location_facility: Centro de Investigaciones Reumatologicas Tucuman

location_facility: Centro de Investigaciones Reumatologicas y Osteologicas

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Nashua Rheumatology - Foundation Medical Partners

location_facility: Klaipeda University Hospital; Public Institution

location_facility: FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Unidad de Atencion Medica e Investigacion en Salud S.C.

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Columbia Arthritis Center (Partnership Practice)

location_facility: Centrul de Boli Reumatismale Dr. Ioan Stoia

location_facility: University General Hospital of Heraklion

location_facility: Arthritis and Rheumatic Disease Associates

location_facility: Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály

location_facility: MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant

location_facility: Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

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

location_facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: Universitätsklinikum Köln, Klinik I für Innere Medizin


title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes

acronym: LUMINOUS

summary: This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Holz FG, Minnella AM, Tuli R, Yoganathan P, Parikh S, Hamilton R; LUMINOUS study group. Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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: Università Cattolica del Sacro Cuore - PubliCatt

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;publicatt.unicatt.it

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Leys AM, Ramboer E, Favreau M, Denhaerynck K, MacDonald K, Abraham I, Brie H. Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study. Clin Ophthalmol. 2020 Jun 2;14:1473-1481. doi: 10.2147/OPTH.S242547. eCollection 2020.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Basel - edoc

version: acceptedVersion

repositories_concat: PubMed Central;edoc.unibas.ch

repositories_institution:
PubMed Central - Europe PMC
University of Basel - edoc

publisher_dissemination: Informa

ReferenceCitation: Pearce I, Clemens A, Brent MH, Lu L, Gallego-Pinazo R, Minnella AM, Creuzot-Garcher C, Spital G, Sakamoto T, Dunger-Baldauf C, McAllister IL; all the LUMINOUS study investigators. Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study. PLoS One. 2020 Jun 18;15(6):e0234739. doi: 10.1371/journal.pone.0234739. eCollection 2020.

repositories_concat: PubMed Central

ReferenceCitation: Mitchell P, Sheidow TG, Farah ME, Mahmood S, Minnella AM, Eter N, Eldem B, Al-Dhibi H, Macfadden W, Parikh S, Dunger-Baldauf C, Mahgoub MM, Schmidt-Erfurth U; LUMINOUS study investigators. Effectiveness and safety of ranibizumab 0.5 mg in treatment-naive patients with diabetic macular edema: Results from the real-world global LUMINOUS study. PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.

ReferenceCitation: Schmidt-Erfurth U, Chong V, Loewenstein A, Larsen M, Souied E, Schlingemann R, Eldem B, Mones J, Richard G, Bandello F; European Society of Retina Specialists. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014 Sep;98(9):1144-67. doi: 10.1136/bjophthalmol-2014-305702.

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Costa Rica
Japan
Turkey
Chile
Canada
France
Czech Republic
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Dominican Republic
Ukraine
India
Belgium
China
Malaysia
Peru
Egypt
Italy
Guatemala
Ecuador
Singapore
United Kingdom
Venezuela
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
Panama
Russian Federation
Israel


study_start_date_type: Actual

acronym: COSMOS

intervention_type: Drug

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

summary: The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.

ReferenceCitation: Coates LC, Gossec L, Theander E, Bergmans P, Neuhold M, Karyekar CS, Shawi M, Noel W, Schett G, McInnes IB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022 Mar;81(3):359-369. doi: 10.1136/annrheumdis-2021-220991. Epub 2021 Nov 24.

oa_colors: green hybrid

evidence: open (via page says license)

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

repository_normalized: HAL

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

location_facility: Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: Smolensk regional hospital on Smolensk railway station

location_facility: Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

location_facility: Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

location_facility: Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

location_facility: Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council

location_facility: SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS

location_facility: Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

location_facility: ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil'

location_facility: Kyiv Railway Station Clinical Hospital #2

location_facility: Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'

location_facility: Multiprofile Hospital for Active Treatment - Plovdiv

location_facility: Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Diagnostic - Consulting Center II-Pleven

location_facility: Hopital Pellegrin Tripode - CHU de Bordeaux

location_facility: Kyiv City Clinical Hospital #3, National Medical University

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Ryazan Regional Clinical Dermatovenerological Dispensary

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Mazowieckie Centrum Reumatologii i Osteoporozy

location_facility: VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

location_facility: Barts Health NHS Trust Whipps Cross University Hospital NHS Trust

location_facility: Rostov Regional Clinical Dermatovenerological Dispensary

location_facility: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Tula Regional Clinical Dermatovenerological Dispensary

location_facility: WroMedica I.Bielicka, A.Strzałkowska s.c.

location_facility: Krasnodar Clinical Dermatovenerologic Dispensary

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Municipal institution Central Clinical Hospital #1 Zhytomir

location_facility: Republican Clinical Hospital - G.G. Kuvatov

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Samara Regional Clinical Hospital Named After V.D.Seredavin

title: Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy

primary_purpose: Treatment

type: EudraCT Number

type: Other Identifier

source: euctr

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

design_allocation: Randomized

location_country:
Germany
Italy
Poland
Portugal
Hungary
Israel
United Kingdom
Belgium
Spain
Greece
Bulgaria
Ukraine
Russian Federation
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: Observational Study to Assess Clinical Management Patterns in Patients With Hospitalised Community-Acquired Pneumonia (CAP) or Complicated Skin and Skin Structure Infections (cSSSI)

acronym: REACH

summary: This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.

time_perspective: Retrospective

ReferenceCitation: Garau J, Blasi F, Medina J, McBride K, Ostermann H; REACH study group. Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study. BMC Infect Dis. 2015 Feb 19;15:78. doi: 10.1186/s12879-015-0822-2.

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

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

publisher_dissemination: Springer-Nature

ReferenceCitation: Blasi F, Ostermann H, Racketa J, Medina J, McBride K, Garau J; REACH study group. Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study. Respir Res. 2014 Jan 22;15(1):6. doi: 10.1186/1465-9921-15-6.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Springer

ReferenceCitation: Blasi F, Garau J, Medina J, Avila M, McBride K, Ostermann H; REACH study group. Current management of patients hospitalized with community-acquired pneumonia across Europe: outcomes from REACH. Respir Res. 2013 Apr 15;14(1):44. doi: 10.1186/1465-9921-14-44.

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

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Belgium
Spain
Greece
Turkey
France


acronym: NIAGARA

summary: A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

status: Active, not recruiting

title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.

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.

study_completion_date_type: Anticipated

location_country:
Germany
Poland
Australia
Brazil
Japan
Vietnam
Turkey
Chile
Czechia
Canada
France
United States
Belgium
Philippines
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

status_simplified: Ongoing


lead_sponsor: Incyte Corporation

summary: The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

location_facility: University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital

location_facility: AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin

location_facility: Great Ormond Street Hospital for Children

location_facility: Nemours/A.I. duPont Hospital for Children

location_facility: Central Manchester University Hospital - Royal Manchester Children's Hospital

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Azienda Ospedaliero Unversitatia Policlinico - Vittorio Emanuele - Presido Ospedaliero G. Rodolico

location_facility: Children's Hospital of Philadelphia - Center for Childhood Cancer Research

location_facility: Doernbecher Children's Hospital - Division of Pediatric Hematology

status: Terminated

title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

ipd_sharing: No

status_simplified: Unknown


title: A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy (D-LIVR)

acronym: D-LIVR

summary: Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

lead_sponsor: Eiger BioPharmaceuticals

location_country:
Germany
New Zealand
Turkey
Pakistan
Canada
France
Switzerland
United States
Ukraine
Romania
Belgium
Moldova, Republic of
Italy
United Kingdom
Mongolia
Sweden
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital of the state institution "National Institute of Therapy named after L.T. Maloi of the National Academy of Medical Sciences of Ukraine"

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

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

location_facility: Krasnodar specialized clinical infectious diseases hospital

location_facility: Municipal Enterprise "Poltava Regional Clinical Infectious Hospital of Poltava Regional Council"

location_facility: Universita di Modena e Reggio Emilia. Nuovo Ospedale civil

location_facility: Municipal non-profit enterprise " Vinnytsia city clinical hospital No. 1"

location_facility: ISMP Spitalul Clinic Republican "Timofei Mosneaga"

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: University Hospital of Sumy State University

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Kaiser Permanente Medical Center Sacramento

location_facility: Inselspital Bern, Hepatologie, Bauchzentrum, INO- A, Ms. Kathrin Husi

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: State Budgetary Educational Institution of Higher Profesional Education "Stavropol State Medical University" of MoH

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

location_facility: Clinic of the Ministry of health of the South Ural state medical UNIVERSITY Russia, 2 infectious diseases Department.

location_facility: Office for treatment of patients with viral hepatitis GBU Sakha (Yakutia) "Yakut Republican clinical hospital"

location_facility: University of California Davis Health System

location_facility: National medical research center Phthisiopulmonology and infectious diseases of the Ministry of health of the Russian Federation

location_facility: Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: University of Miami Schiff Center for Liver Disease


acronym: SUNSHINE

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

title: A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).

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:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Switzerland
United States
India
Belgium
Philippines
Italy
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


acronym: INFINITE

lead_sponsor: Trizell Ltd

summary:
This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.

Eligible patients will be randomized 1:1 to either:

Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine
Control group: Celecoxib followed by Gemcitabine

Patients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1.

The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM

sponsor_collaborators:
Trizell Ltd
University of Pennsylvania

location_facility: University of California, San Francisco (UCSF)

location_facility: Petrov National Medical Research Center of Oncology

location_facility: Budget Healthcare Institution of Omsk region Clinical Oncology Dispensary

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej - Curie, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Masonic Cancer Center - University of Minnesota

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: State Budget Educational Institution of Higher Professional Education Pavlov First Saint Petersburg State Medical University of Ministry of Healthcare of Russian Federation

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: New York University (NYU) Clinical Cancer Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliero Universitaria Senese, Cancer Immunotherapy

title: A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma

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


type: Registry Identifier

title: Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

acronym: PEDISTAD

summary:
Primary Objectives:

To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
To evaluate the time-course of AD and selected atopic comorbidities.

Secondary Objectives:

To characterize disease burden and unmet need.
To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
To document the real-world effectiveness and safety of treatments.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507.

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

repositories_concat: PubMed Central;www.lenus.ie

lead_sponsor: Sanofi

location_country:
Argentina
Australia
Brazil
Japan
Canada
France
Colombia
Portugal
Denmark
United States
China
Italy
Norway
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Dermatology Associates of Mid-Ohio Site Number : 8400052

location_facility: NorthShore University HealthSystem Site Number : 8400064

location_facility: Cyn3rgy Research & Development Site Number : 8400023

location_facility: The Indiana Clinical Trials Center, PC Site Number : 8400007

location_facility: Children's Mercy Hospital and Clinics Site Number : 8400020

location_facility: Pediatric Center Of Excellence Site Number : 8400072

location_facility: Amedica Research Institute, Inc. Site Number : 8400067

location_facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004

location_facility: Dermatology Associates PC Site Number : 8400049

location_facility: Tiga Pediatrics, PC Site Number : 8400037

location_facility: C2 Research Center, LLC Site Number : 8400071

location_facility: Allergic Disease and Asthma Research Center, PA Site Number : 8400048

location_facility: Michael W. Simon, M.D., PSC Site Number : 8400073

location_facility: Family Allergy and Asthma Research Site Number : 8400060

location_facility: Hospital Sao Paulo Site Number : 0760006

location_facility: C Squared Research Center Site Number : 8400068

location_facility: VAMA Medical Health Center Site Number : 8400083

location_facility: The Dermatology Institute of South Texas Site Number : 8400076

location_facility: Phoenix Children's Hospital, Inc. Site Number : 8400015

location_facility: Michigan Dermatology Institute Site Number : 8400059

location_facility: Carey Chronis, MD, FAAP Site Number : 8400033

location_facility: Amarillo Center for Clinical Research Site Number : 8400055

location_facility: Madera Family Medical Group Site Number : 8400054

location_facility: Medical College Of Wisconsin Site Number : 8400008

location_facility: Philip Fried, M.D., PLLC Site Number : 8400029

location_facility: Universidade Federal do Paraná Site Number : 0760003

location_facility: Cincinnati Children's Hospital Medical Center Site Number : 8400017

location_facility: Pediatric & Adult Research Center Site Number : 8400040

location_facility: Eastern Research, Inc. Site Number : 8400032

location_facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002

location_facility: Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057

location_facility: Tokunbo T. Dada, MD PA Site Number : 8400079

location_facility: Allervie Clinical Research Site Number : 8400012

location_facility: Clínica de Alergia Martti Antila Site Number : 0760001

location_facility: Heights Dermatology and Aesthetic Center Site Number : 8400065

location_facility: Vista Health Research, LLC Site Number : 8400034

location_facility: Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056

location_facility: Northwestern University Feinberg School of Medicine Site Number : 8400001

location_facility: Green Dermatology and Cosmetic Center. Site Number : 8400078

location_facility: Immunoe Research Centers Site Number : 8400026

location_facility: Axis Clinical Trials Site Number : 8400025

location_facility: 2G Clinical Research Services Site Number : 8400031

location_facility: Clinical Research of Gastonia Site Number : 8400041

location_facility: Pediatric Dermatology of North Texas Site Number : 8400003

location_facility: Premier Dermatology Partners Site Number : 8400075

location_facility: Providence Medical Center Site Number : 8400081

location_facility: Family Pediatrics Iwuozo L Obilo Md Site Number : 8400077

location_facility: Cahaba Dermatology Site Number : 8400046

location_facility: Orange County Research Institute Site Number : 8400028

location_facility: Viable Research Management Site Number : 8400027

intervention_type: Other


acronym: CIRRUS I

summary:
The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients.

This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

title: A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)

location_country:
Germany
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Hungary
Switzerland
United States
Latvia
Belgium
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Sweden


title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

evidence: open (via crossref license)

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_concat: PubMed Central;eprint.ncl.ac.uk

ReferenceCitation: Valenzuela F, Paul C, Mallbris L, Tan H, Papacharalambous J, Valdez H, Mamolo C. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1753-1759. doi: 10.1111/jdv.13702. Epub 2016 Jun 7.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wiley

ReferenceCitation: Bachelez H, van de Kerkhof PC, Strohal R, Kubanov A, Valenzuela F, Lee JH, Yakusevich V, Chimenti S, Papacharalambous J, Proulx J, Gupta P, Tan H, Tawadrous M, Valdez H, Wolk R; OPT Compare Investigators. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015 Aug 8;386(9993):552-61. doi: 10.1016/S0140-6736(14)62113-9. Epub 2015 Jun 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Pfizer

location_country:
Germany
Poland
Argentina
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
Belgium
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Bulgaria
Russian Federation
Israel

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika

location_facility: North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department

location_facility: State Research Center of Dermatovenerology, Department of dermatology

location_facility: Tsentar za kozhno-venericheski zaboliavania" EOOD

location_facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

location_facility: Hospital Clinico Universidad de Chile, Departamento Dermatologia

location_facility: Severance Hospital, Yonsei University College of Medicine/Department of Dermatology

location_facility: LKH Salzburg, Landesklinik fuer Dermatologie

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: Ryazan regional clinical dermatovenerologic dispensary

location_facility: Clinical hospital of emergency care N.V. Soloviev

location_facility: Dres.Kirsten Prepeneit und Volker Streit

location_facility: Centro de Investigaciones Dermatologicas

location_facility: Dermatovenerologic dispensary #10 of Vyborg region

location_facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

location_facility: State Research Center of Dermatovenerology, Department of clinical dermatology

location_facility: Department for skin and venerial diseases, Clinical Center University of Sarajevo

location_facility: Hôpital de Brabois / Bâtiment Philippe Canton

location_facility: MBAL na Voennomeditsinska akademia- Sofia

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Novum Instytut Dermatologii Leczniczej i Estetycznej

location_facility: Samsung Medical Center / Department of Dermatology

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel

location_facility: Hautklinik der Ruprecht-Karls-Universitaet Heidelberg

location_facility: Department of dermatovenerology, University Hospital Center Zagreb

location_facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

location_facility: Amphia Hospital Location Molengracht / Department Dermatology

location_facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

location_facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

location_facility: Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne

location_facility: Rostov-on-Don regional dermatovenerologic dispensary

location_facility: Skanes Universitetssjukhus i Malmo, Hudkliniken

location_facility: Istanbul university Istanbul Medical Faculty

location_facility: Hospital General Universitario de Alicante

location_facility: Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Department of Dermatology, Aarhus University Hospital

location_facility: Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"

location_facility: Centro Integral de Reumatología del Caribe Circaribe S.A

location_facility: LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie

location_facility: Hopital Ambroise Pare, Service de Dermatologie

location_facility: LKH Feldkirch Abteilung fuer Dermatologie und Venerologie

location_facility: Department of Dermatovenerology, University Hospital Center Osijek

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

location_facility: Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling

location_facility: Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven

location_facility: IMAI (Instituto Medico de Asistencia e Investigaciones)

location_facility: Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Centro de Investigacion Clinica de la Universidad del Rosario

location_facility: Kralska zdravotni a.s., Masarykovy nemocnice o.z.

location_facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

location_facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali


acronym: ROSiA

summary: This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

ReferenceCitation: Oza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, Gonzalez-Martin A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836.

title: Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma

location_country: Macedonia, The Former Yugoslav Republic of


title: Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

summary: This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

ReferenceCitation: Schymik G, Lefevre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Edwards Lifesciences

location_country:
Finland
Germany
Italy
Poland
Israel
Norway
Denmark
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
South Africa
Czechia
Canada
France

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: The Cardinal Stefan Wyszyński Institute of Cardiology

location_facility: KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: Klinikum der Universität München - Großhadern

location_facility: King's College Hospital NHS Foundation Trust

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve

location_facility: St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

location_facility: Centre Hospitalier De Universite of Montreal

location_facility: Azienda Ospedaliera Policlinico Universitario

intervention_type: Device


title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

acronym: PROTECT

summary: This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

ReferenceType: background

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Motzer RJ, Russo P, Haas N, Doehn C, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Lim HY, Melichar B, Zemanova M, Rini B, Choueiri TK, Wood L, Reaume MN, Stenzl A, Chowdhury S, McDermott R, Michael A, Izquierdo M, Aimone P, Zhang H, Sternberg CN; PROTECT study investigators. Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial. Eur Urol. 2021 Mar;79(3):334-338. doi: 10.1016/j.eururo.2020.12.029. Epub 2021 Jan 15.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

location_country:
Germany
Ireland
Poland
Argentina
Japan
Brazil
Luxembourg
Turkey
Chile
Czechia
Canada
France
Slovakia
Hungary
Denmark
United States
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

summary: This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Finland
Germany
Ireland
Italy
Portugal
Slovakia
Hungary
Norway
Denmark
United Kingdom
Netherlands
Switzerland
Belgium
Greece
France

location_facility: "Agios Savas" Anticancer-Oncology Hospital of Athens

location_facility: "G. Gennimtas" General Hospital of Thessaloniki

location_facility: 2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki

location_facility: Azienda Sanitaria Regionale del Molise (ASREM)

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Centre Hospitalier d'Athis Mons site Caron

location_facility: Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona

location_facility: Azienda Ospedaliera Mater Domini di Catanzaro

location_facility: Vestre Viken HF, Sykehuset Asker og Baerum

location_facility: CENTRUM UROLOGIE Povazska Bystrica s.r.o

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: Aghios Andreas General Hospital of Patras

location_facility: Amalia Fleming General Hospital of Athens

location_facility: Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft

location_facility: General Hospital of Athens "Ag. Olga" - Konstantopouleion

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Olso Universitetssykehus HF, Radiumhospitalet

location_facility: Gemeinschaftspraxis Dres Effert und Benedic

location_facility: Helse Nordmore og Romsdal HF, Kristiansund Sykehus

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: "G. Gennimtas" General Hospital of Athens

location_facility: General Hospital of Volos "Achillopouleio"


title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

summary: The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

ReferenceType: result

ReferenceCitation: Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, Saunders MP, Gilbert DC, Jensen LH, Samalin E, Spindler KL, Tamberi S, Demols A, Guren MG, Arnold D, Fakih M, Kayyal T, Cornfeld M, Tian C, Catlett M, Smith M, Spano JP. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529. doi: 10.1016/j.esmoop.2022.100529. Epub 2022 Jul 8.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Oslo - Duo Research Archive

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Belgium
United States
Spain
France

location_facility: A.O.U. Policlinico V. Emanuele G. Rodolico

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: Centre Hospitalier Universitaire de Besancon


acronym: Measure Up 1

lead_sponsor: AbbVie

summary: The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

ReferenceCitation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repositories_concat: HAL

ReferenceCitation: Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaci D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21. Erratum In: Lancet. 2021 Jun 5;397(10290):2150.

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 200979

location_facility: Duplicate_George Washington Univ Med /ID# 200364

location_facility: Dermatology Ottawa Research Centre /ID# 200319

location_facility: Instituto de Neumonología y Dermatología /ID# 203444

location_facility: Klinicki bolnicki centar Rijeka /ID# 217423

location_facility: Dermdox Dermatology Centers, PC /ID# 213782

location_facility: Northwestern University Feinberg School of Medicine /ID# 201644

location_facility: UMHAT Professor Stoyan Kirkovich /ID# 201522

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741

location_facility: Ctr Int de Reum del Caribe SAS /ID# 201620

location_facility: Clear Dermatology & Aesthetics Center /ID# 201256

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554

location_facility: Bakersfield Derma & Skin Cance /ID# 200433

location_facility: Clin Res Inst of Michigan, LLC /ID# 208019

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746

location_facility: Clinical Research Puerto Rico /ID# 203309

location_facility: West Middlesex University Hospital /ID# 202273

location_facility: San Luis Derm and Laser Clinic /ID# 200372

location_facility: Inselspital, Universitätsspital Bern /ID# 201598

location_facility: CHU Toulouse - Hopital Larrey /ID# 201528

location_facility: Arlington Research Center, Inc /ID# 200391

location_facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 201523

location_facility: Herlev and Gentofte Hospital /ID# 200736

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 200750

location_facility: Aichi Medical University Hospital /ID# 202833

location_facility: CHUV, Centre hospitalier universitaire vaudois /ID# 200910

location_facility: Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996

location_facility: Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862

location_facility: National Medical Research Center for Children's Health /ID# 203440

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 200311

location_facility: Advanced Dermatology of the Midlands /ID# 201689

location_facility: Clinical Dermatovenerology Dispensary /ID# 203439

location_facility: Hopital Saint Vincent de Paul /ID# 218253

location_facility: Ponce Medical School Foundation /ID# 201821

location_facility: Forest Hills Dermatology Group /ID# 209244

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695

location_facility: Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043

location_facility: North Estonia Medical Centre /ID# 200951

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255

location_facility: Clinical Trials Management, LLC - Metairie /ID# 212659

location_facility: Alliance Dermatology and MOHs /ID# 200375

location_facility: University Clinical Centre of the Republic of Srpska /ID# 202667

location_facility: Psoriahue Med Interdisciplinar /ID# 202451

location_facility: Dermatology Specialists of Spokane /ID# 202068

location_facility: Modern Research Associates, PL /ID# 200705

location_facility: Universitaetsklinikum Frankfurt /ID# 202089

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201192

location_facility: Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239

location_facility: Center for Clinical Studies - Webster TX /ID# 203185

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 201521

location_facility: Integrated Clinical Research LLC /ID# 200900

location_facility: Oregon Health and Science University /ID# 200992

location_facility: University Clinical Centre of the Republic of Srpska /ID# 202666

location_facility: Hôpitaux Universitaires Genève /ID# 201600

location_facility: Confido Private Medical Clinic /ID# 200846

location_facility: Peking University People's Hospital /ID# 202549

location_facility: Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 201876

location_facility: Clinical Center University of Sarajevo /ID# 202669

location_facility: Dermatology Physicians of Connecticut /ID# 200928

location_facility: Klinicki bolnicki centar Zagreb /ID# 201879

location_facility: Hospital Raja Permaisuri Bainun /ID# 204375

location_facility: California Allergy and Asthma Medical Group /ID# 200727

location_facility: Dr. Wei Jing Loo Medicine Prof /ID# 206051

location_facility: Universitaetsklinikum Muenster /ID# 202085

location_facility: Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962

location_facility: Hacettepe University Faculty of Medicine /ID# 204099

location_facility: Holdsworth House Medical Practice /ID# 211236

location_facility: Erciyes University Medical Fac /ID# 204098

location_facility: Dr. David Gratton Dermat Inc. /ID# 200309

location_facility: Oregon Medical Res Center PC /ID# 200428

location_facility: Integrated Dermatology of Massachusetts, LLC /ID# 209468

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597

location_facility: Lynn Health Science Institute (LHSI) /ID# 212676

location_facility: Allergy & Asthma Associates of Southern California /ID# 200733

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200326

location_facility: CMS3 Company for Medical Study /ID# 205193

location_facility: North Eastern Health Specialists /ID# 205802

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100

location_facility: Gazi Universitesi Tip Fakultes /ID# 204176

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971

location_facility: Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087

location_facility: Dermatology Research Institute Inc. /ID# 200318

location_facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891

location_facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504

location_facility: Klinicki bolnicki centar Split /ID# 201527

location_facility: Peking University Third Hospital /ID# 202612

location_facility: Ural Research Institute of dermatovenerology and immunopathology /ID# 201593

location_facility: Huashan Hospital of Fudan University /ID# 205760

location_facility: Multi-Speciality Research Associates /ID# 213254

location_facility: Icahn School of Medicine at Mount Sinai /ID# 200370

location_facility: Clinical Trials Management, LLC - Covington /ID# 212658

location_facility: Leavitt Medical Associates of Florida /ID# 200880

location_facility: Clinical Center University of Sarajevo /ID# 202668

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313

location_facility: The First Hospital of China Medical University /ID# 202615

location_facility: Clinical Research Consortium /ID# 200734

location_facility: Klinika za dječje bolesti Zagreb /ID# 203151

location_facility: Medizinische Hochschule Hannover /ID# 202091

location_facility: The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548

location_facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 206377

location_facility: University of Yamanashi Hospital /ID# 204174

location_facility: Care Access Research - Walnut Creek /ID# 200940

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692

location_facility: Coastal Clinical Research Center of the Carolinas /ID# 200402

location_facility: CHUV, Centre hospitalier universitaire vaudois /ID# 206505

location_facility: Massachusetts General Hospital /ID# 200474

location_facility: Northern Care Alliance NHS Group /ID# 201194

location_facility: Wiseman Dermatology Research /ID# 200323

location_facility: The South Bend Clinic Center /ID# 200371

location_facility: Florida International Rsrch cr /ID# 218507

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 201136

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

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:
Finland
Germany
New Zealand
Argentina
Australia
Japan
Bosnia and Herzegovina
Turkey
Croatia
Canada
France
Colombia
Denmark
Switzerland
United States
Ukraine
Romania
China
Malaysia
Estonia
Puerto Rico
Italy
United Kingdom
Bulgaria
Russian Federation


lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

location_facility: University of North Carolina Dermatology and Skin Cancer Cen

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Shiga University of Medical Science Hosptial

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'

location_facility: University Hospitals Cleveland Medical Center

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: The South Bend Clinic Center for Research

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

location_facility: California Dermatology & Clinical Research Institute

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Eastern Canada Cutaneous Research Assoicates Ltd

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Presidio Ospedaliero Firenze Centro Piero Palagi

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Seoul National University Bundang Hospital

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Toho University School of Medicine, Sakura Hospital

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: Keck School of Medicine University of Southern California

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: National Taiwan University Hospital - Hsinchu branch

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Instituto de Neumonología Y Dermatología

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Tokai University Hospital- Isehara Campus

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

title: A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

design_allocation: Non-Randomized

location_country:
Germany
Poland
Argentina
Australia
Japan
Czechia
Canada
France
Hungary
United States
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


summary: The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

location_facility: University of North Carolina Dermatology and Skin Cancer Cen

location_facility: San Luis Dermatology & Laser Clinic, Inc

location_facility: Shiga University of Medical Science Hosptial

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Severance Hospital Yonsei University Health System

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

location_facility: University Hospitals Cleveland Medical Center

location_facility: Kyoto Prefectural University of Medicine

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: California Dermatology and Clinical Research Institute

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: The Guenther Dermatology Research Centre

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Eastern Canada Cutaneous Research Assoicates Ltd

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: Presidio Ospedaliero Firenze Centro Piero Palagi

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Instituto de Neumonología y Dermatología

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: CEDIC-Centro de Investigaciones Clinicas

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

location_facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2

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.

location_country:
Germany
Italy
Poland
Hungary
Argentina
Israel
Australia
Japan
United Kingdom
United States
Korea, Republic of
Spain
Czechia
Canada
Puerto Rico
France


acronym: POTOMAC

intervention_type: Biological

summary: This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer

title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients

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:
Germany
Poland
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
Spain
Canada
Russian Federation
France


title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
New Zealand
Israel
United Kingdom
Australia
Brazil
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: Vision Research Center Eye Associates of NM

location_facility: Radboud University Medical Center Oogheelkunde

location_facility: University of California, San Diego, Jacobs Retina

location_facility: New York Eye and Ear Infirmary of Mount Sinai

location_facility: Centre Ophtalmologique d'Imagerie et Laser

location_facility: Vitreous Retina Macula Consultants of NY

location_facility: Retina Vitreous Associates Medical Group

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Northwestern Feinberg School of Medicine

location_facility: Byers Eye Institute at Stanford, Stanford School of Medicine

location_facility: University of Utah - John A. Moran Center

location_facility: Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

location_facility: Blue Ocean Clinical Research / The Macula Center

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: National Ophthalmic Research Institute (Retina Consultants of Southwest Florida)


acronym: PEGASUS

summary: Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria

ReferenceCitation: de Latour RP, Szer J, Weitz IC, Roth A, Hochsmann B, Panse J, Usuki K, Griffin M, Kiladjian JJ, de Castro CM, Nishimori H, Ajayi T, Al-Adhami M, Deschatelets P, Francois C, Grossi F, Risitano AM, Hillmen P. Pegcetacoplan versus eculizumab in patients with paroxysmal nocturnal haemoglobinuria (PEGASUS): 48-week follow-up of a randomised, open-label, phase 3, active-comparator, controlled trial. Lancet Haematol. 2022 Sep;9(9):e648-e659. doi: 10.1016/S2352-3026(22)00210-1.

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Cella D, Sarda SP, Hsieh R, Fishman J, Hakimi Z, Hoffman K, Al-Adhami M, Nazir J, Cutts K, Lenderking WR. Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study. Ann Hematol. 2022 Sep;101(9):1905-1914. doi: 10.1007/s00277-022-04887-8. Epub 2022 Jul 23.

ReferenceCitation: Hakimi Z, Wilson K, McAughey E, Pochopien M, Wojciechowski P, Toumi M, Knight C, Sarda SP, Patel N, Wiseman C, de Castro NP, Nazir J, Kelly RJ. The cost-effectiveness, of pegcetacoplan compared with ravulizumab for the treatment of paroxysmal nocturnal hemoglobinuria, in a UK setting. J Comp Eff Res. 2022 Sep;11(13):969-985. doi: 10.2217/cer-2022-0076. Epub 2022 Jul 7.

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: Bhak RH, Mody-Patel N, Baver SB, Kunzweiler C, Yee CW, Sundaresan S, Swartz N, Duh MS, Krishnan S, Sarda SP. Comparative effectiveness of pegcetacoplan versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria previously treated with eculizumab: a matching-adjusted indirect comparison. Curr Med Res Opin. 2021 Nov;37(11):1913-1923. doi: 10.1080/03007995.2021.1971182. Epub 2021 Sep 3.

ReferenceCitation: Hillmen P, Szer J, Weitz I, Roth A, Hochsmann B, Panse J, Usuki K, Griffin M, Kiladjian JJ, de Castro C, Nishimori H, Tan L, Hamdani M, Deschatelets P, Francois C, Grossi F, Ajayi T, Risitano A, Peffault de la Tour R. Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2021 Mar 18;384(11):1028-1037. doi: 10.1056/NEJMoa2029073.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Pavlov First Saint Petersburg State Medical University of Russian Ministry of Health

location_facility: Hospital Universitario Politécnico La Fe

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Institution of Health Care of Tyumen Region

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Investigative Clinical Research of Indiana

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Winship Cancer Institute of Emory University

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: St. James' Institute of Oncology, Leeds Teaching Hospitals

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

title: A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

location_country:
Germany
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


title: A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer

acronym: FeDeriCa

summary: This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

ReferenceCitation: Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21. Erratum In: Lancet Oncol. 2021 Feb;22(2):e42.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Czechia
Canada
France
United States
Ukraine
Belgium
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: China Medical University Hospital; Surgery

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre

location_facility: Saitama Medical University International Medical Center

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: National Cancer Institute MOH of Ukraine

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Hospital de Cruces; Servicio de Oncología Médica

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.

ReferenceCitation: Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.

oa_colors: green other

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

location_facility: Istituto Nazionale Tumori Fondazione Pascale

title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Canada
France
Colombia
Denmark
United States
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Austria
Mexico
Spain
Greece
Russian Federation
Israel


lead_sponsor: Blueprint Medicines Corporation

summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

ReferenceCitation: Kang YK, George S, Jones RL, Rutkowski P, Shen L, Mir O, Patel S, Zhou Y, von Mehren M, Hohenberger P, Villalobos V, Brahmi M, Tap WD, Trent J, Pantaleo MA, Schoffski P, He K, Hew P, Newberry K, Roche M, Heinrich MC, Bauer S. Avapritinib Versus Regorafenib in Locally Advanced Unresectable or Metastatic GI Stromal Tumor: A Randomized, Open-Label Phase III Study. J Clin Oncol. 2021 Oct 1;39(28):3128-3139. doi: 10.1200/JCO.21.00217. Epub 2021 Aug 3.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
cris.unibo.it

repositories_concat: LIRIAS (KU Leuven);PubMed Central;cris.unibo.it

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Gebreyohannes YK, Wozniak A, Zhai ME, Wellens J, Cornillie J, Vanleeuw U, Evans E, Gardino AK, Lengauer C, Debiec-Rychter M, Sciot R, Schoffski P. Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors. Clin Cancer Res. 2019 Jan 15;25(2):609-618. doi: 10.1158/1078-0432.CCR-18-1858. Epub 2018 Oct 1.

evidence: oa repository (via page says license)

repositories_concat: LIRIAS (KU Leuven);aacr.figshare.com

publisher_dissemination: American Association for Cancer Research

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt

location_facility: Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii

location_facility: AOUC Azienda Ospedaliero - Universitaria Careggi

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Fujian Medical University Union Hospital

location_facility: Magyar Honvédség Egészségügyi Központ Onkológiai Osztály

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

location_facility: Shanghai Jiaotong University School of Medicine, Renji Hospital

location_facility: Onkologická klinika Fakultní nemocnice Olomouc

location_facility: Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis

location_facility: The First Affiliated Hospital of Nanchang Medical University

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: The Sixth Affiliated Hospital of Sun Yat-Sen University

location_facility: Dolnoslaskie Centrum Onkologii we Wrocawiu

location_facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology

location_facility: The University of Chicago Medical Center

location_facility: Azienda Ospedaliero Universitaria Sant'Orsola Malpighi

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO

location_facility: Fovarosi Onkormanyzat Szent Laszlo Korhaz

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

location_facility: Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia

location_facility: Washington Hospital Center - Oncology and Hematology

title: An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

location_country:
Germany
Italy
Poland
Hungary
Singapore
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
China
Korea, Republic of
Spain
Czechia
Canada
France


lead_sponsor: Celgene

summary: This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

ReferenceCitation: Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

location_facility: Hospital Universitario De Gran Canaria Dr. Negrin

location_facility: University Hospital Puerta de Hierro Majadajonda

location_facility: University Hospital Marques de Valdecilla (HUMV)

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: University of Pennsylvania Cancer Center

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: University Hospital of Girona Dr. Josep Trueta

title: Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

location_country:
Finland
Germany
Poland
Australia
Senegal
Turkey
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
United States
Ukraine
China
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


title: A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

summary: This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.

study_start_date_type: Anticipated

status: Withdrawn

location_country:
Germany
Italy
Australia
Brazil
Japan
Austria
Mexico
Switzerland
United States
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Czechia
Canada
France


title: A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

acronym: PRISM-MDR

summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.

lead_sponsor: Polyphor Ltd.

location_country:
Hungary
Israel
Brazil
Mexico
United States
Korea, Republic of
Spain
Thailand
Greece
Croatia
South Africa
Estonia
France

location_facility:
Research site 2
Research Site
Research Site 1
Research Site 3
Research site 1
Reasearch site
Research site
Research Site 2
Research site 3