ReferenceCitation: Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.

name: Department of Dermatology, George Washington University School of Medicine, Washington, DC

family: Silverberg

full_name: Jonathan I. Silverberg

given: Jonathan I.

name: Department of Dermatology, Oregon Health & Science University, Portland

family: Simpson

full_name: Eric L. Simpson

given: Eric L.

name: Department of Dermatology and Allergy, Ludwig Maximillian University, Munich, Germany

family: Wollenberg

full_name: Andreas Wollenberg

given: Andreas

name: Innovaderm Research, Montreal, Quebec, Canada

family: Bissonnette

full_name: Robert Bissonnette

given: Robert

name: Department of Dermatology, Kyoto University, Graduate School of Medicine, Kyoto, Japan

name: Skin Research Institute of Singapore and Singapore Immunology Network, A*Star, Singapore

family: Kabashima

full_name: Kenji Kabashima

given: Kenji

family: DeLozier

full_name: Amy M. DeLozier

given: Amy M.

family: Sun

full_name: Luna Sun

given: Luna

family: Cardillo

full_name: Tracy Cardillo

given: Tracy

name: now with Janssen, Titusville, New Jersey

name: at the time of the trial, Eli Lilly and Company, Indianapolis, Indiana

family: Nunes

full_name: Fabio P. Nunes

given: Fabio P.

name: Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

family: Reich

full_name: Kristian Reich

given: Kristian

journal_name: JAMA Dermatology

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

family: King

full_name: Brett King

given: Brett

family: Maari

full_name: Catherine Maari

given: Catherine

family: Lain

full_name: Edward Lain

given: Edward

family: Issa

full_name: Maher Issa

given: Maher

family: Holzwarth

full_name: Katrin Holzwarth

given: Katrin

family: Brinker

full_name: Dennis Brinker

given: Dennis

journal_name: American Journal of Clinical Dermatology

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.

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Taiwan

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Queen's Square Dermatology and Allergology

location_facility: Severance Hospital Yonsei University Health System

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: CRI Centro Regiomontano de Investigacion S.C.

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location_facility: Hallym University Kangnam Sacred Heart Hospital

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location_facility: KH Hietzing mit neurologischem Zentrum Rosenhügel

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location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: CHUV Centre Hospitalier Universitaire Vaudois

location_facility: Instituto de Neumonología y Dermatología

location_facility: Kyoto Prefectural University of Medicine

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: Russian state medical-stomatological university n.a. Evdokimov

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: All India Institue of Medical Sciences (AIIMS)

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Ordensklinikum Linz GmbH - Elisabethinen

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Aarhus Universitehospital Marselisborg Centret

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

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

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Dr. D. Y. Patil Medical College & Hospital

title: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

summary: The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.


title: A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane

acronym: CONTESSA

summary: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: Currently under evaluation by the organization

lead_sponsor: Odonate Therapeutics, Inc.

location_country:
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Austria
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Germany
France
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Poland
Thailand
Singapore
Hungary
Australia
Belgium
Russian Federation
Spain
Canada
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Taiwan
Ukraine

location_facility: Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie

location_facility: Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre

location_facility: Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center

location_facility: Royal Cornwall Hospital Oncology Trials, Sunrise Centre

location_facility: Clinique Sainte Anne - Strasbourg Oncologie Liberale

location_facility: University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

location_facility: California Cancer Associates for Research and Excellence

location_facility: Cancer Treatment Centers of America - Western Regional Medical Center

location_facility: Westside Surgical Hospital and Breast Center

location_facility: Forrest General Cancer Center/Hattiesburg Clinic

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Center Hospitalier de Montreal CHUM McPeak Sirois

location_facility: Hospital Teresa Herrera Materno-Infantil (CHUAC)

location_facility: Mammazentrum HH am Krankenhaus Jerusalem

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Stanford Cancer Center / Cancer Clinical Trials

location_facility: QEII Health Sciences Centre - Nova Scotia Cancer Centre

location_facility: Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad

location_facility: Hematology Oncology Associates of Central New York, P.C.

location_facility: Virginia Piper Cancer Institute, Allina Health

location_facility: Mercy Hospital St. Louis, David C. Pratt Cancer Center

location_facility: University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation

location_facility: Hospices Civils de Lyon Sud Oncologie Medicale

location_facility: CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital

location_facility: UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Onkologicka Klinika (Fakultni Nemocnice v Motole)

location_facility: Cancer Research Collaboration and Breast Link

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: NH Hospital a.s. Nemocnice Hořovice Onkologie

location_facility: St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum

location_facility: Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde

location_facility: New Jersey Hematology Oncology Associates

location_facility: Oncology Hematology West, P.C. dba Nebraska Cancer Specialists

location_facility: New Mexico Cancer Care Alliance - Southwest Gynecology Oncology

location_facility: Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )

location_facility: Florida Cancer Specialists and Research Institute - Panhandle Region

location_facility: S.C. Oncologia/Az. Osp.Ra. S Maria Terni

location_facility: Sarah Cannon Research Institute - Florida Cancer Specialists

location_facility: Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut

location_facility: Washington University School of Medicine

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Hospital Universitario Ramon y Cajal Servicio de Oncologia

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: InVO - Institut für Versorgungsforschung

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

location_facility: Centre Hospitalier Regional et Universitaire de Tours CHRU

location_facility: Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik

location_facility: Regional Cancer Care Associates, LLC-Sparta

location_facility: Centre François Baclesse Service the Recherche Clinique

location_facility: Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: LMU Klinikum der Universität München Breast Cancer

location_facility: University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)

location_facility: Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie

location_facility: Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania

location_facility: Cancer Care - Torrance Memorial Physician Network

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

location_facility: Arzt der Studienzentrale Universitätsklinikum Erlangen

location_facility: Dnipropetrovsk City Multifield Clinical Hospital #4

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology"

location_facility: San Luis Obispo Oncology & Hematology Health Center

location_facility: Central City Clinical Hospital, City Oncology Center

location_facility: John Hopkins Singapore International Medical Centre

location_facility: University of Pécs Department of Oncotherapy

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Ospedale San Raffaele - Medical Oncology Dept.

location_facility: Cancer Treatment Centers of America - Philadelphia

location_facility: Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs

location_facility: Sarah Cannon Research Institute at Tennessee Oncology

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceType: derived

ReferenceCitation: Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Díaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.

name: From Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St...

family: Bhatt

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sequence: first

family: Szarek

full_name: Michael Szarek

given: Michael

sequence: additional

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full_name: Bertram Pitt

given: Bertram

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

family: McGuire

full_name: Darren K. McGuire

given: Darren K.

family: Lewis

full_name: Julia B. Lewis

given: Julia B.

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

family: Inzucchi

full_name: Silvio E. Inzucchi

given: Silvio E.

family: Kosiborod

full_name: Mikhail N. Kosiborod

given: Mikhail N.

family: Cherney

full_name: David Z.I. Cherney

given: David Z.I.

family: Dwyer

full_name: Jamie P. Dwyer

given: Jamie P.

family: Scirica

full_name: Benjamin M. Scirica

given: Benjamin M.

family: Bailey

full_name: Clifford J. Bailey

given: Clifford J.

family: Díaz

full_name: Rafael Díaz

given: Rafael

family: Ray

full_name: Kausik K. Ray

given: Kausik K.

family: Udell

full_name: Jacob A. Udell

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family: Lopes

full_name: Renato D. Lopes

given: Renato D.

family: Lapuerta

full_name: Pablo Lapuerta

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family: Steg

full_name: P. Gabriel Steg

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bso_classification: Medical research

datasource: user

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journal_name: New England Journal of Medicine

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repository_institution: Aston University - Aston Publications Explorer

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Cefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y. Review.

family: Cefalo

full_name: Chiara Maria Assunta Cefalo

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repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

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title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

summary:
Primary Objectives:

To compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in patients with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

Total occurrences of HHF and urgent visit for HF
Occurrences of cardiovascular death
Total occurrences of cardiovascular death, HHF, urgent HF visit, non-fatal stroke, and non-fatal myocardial infarction
Total occurrences of cardiovascular death, HHF, urgent HF visit, and HF while hospitalized
First occurrence of a sustained ≥50% decrease in estimated glomerular filtration rate (eGFR) from baseline (for ≥30 days), chronic dialysis, renal transplant or sustained eGFR <15 mL/min/1.73m2 (for ≥30 days)
All-cause mortality
Total occurrences of cardiovascular death, non-fatal stroke, and non-fatal myocardial infarction


type: Other Identifier

type: EudraCT Number

title: A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma

summary: The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
France
Japan
Poland
Norway
Argentina
Canada
Sweden
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Instituto COI de Pesquisa, Educacao e Gestao

location_facility: Instituto Joinvilensse de Hematologia e Oncologia

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: National Hospital Organization Sendai Medical Center

location_facility: ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Hospital Das Clinicas Da Universidade Federal De Goias

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Hospital de Base de São José do Rio Preto

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia

location_facility: Semmelweis Egyetem, I. Belgyogyaszati Klinika

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik V

location_facility: Clinical Research Center sp. z o.o MEDIC-R s.k.

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Semmelweis Egyetem I.Belgyogyaszati Klinika

location_facility: On Dokuz Mayis University Medical Faculty Department of Hematology

location_facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

location_facility: Kobe City Medical Center General Hospital

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

location_facility: Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: Centro de Investigación Farmacéutica Especializada

location_facility: Tom Baker Cancer Center, University of Calgary

location_facility: Centro de Atención e Investigación Clínica en Oncología

status_simplified: Ongoing


ReferenceCitation: Iida S, Ishikawa T, Min CK, Kim K, Yeh SP, Usmani SZ, Mateos MV, Nahi H, Heuck C, Qin X, Parasrampuria DA, Gries KS, Qi M, Bahlis N, Ito S. Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study. Ann Hematol. 2021 Apr;100(4):1065-1077. doi: 10.1007/s00277-021-04405-2. Epub 2021 Feb 18.

family: Iida

full_name: Shinsuke Iida

given: Shinsuke

family: Ishikawa

full_name: Takayuki Ishikawa

given: Takayuki

family: Min

full_name: Chang Ki Min

given: Chang Ki

family: Kim

full_name: Kihyun Kim

given: Kihyun

family: Yeh

full_name: Su Peng Yeh

given: Su Peng

family: Usmani

full_name: Saad Z. Usmani

given: Saad Z.

family: Mateos

full_name: Maria-Victoria Mateos

given: Maria-Victoria

family: Nahi

full_name: Hareth Nahi

given: Hareth

family: Heuck

full_name: Christoph Heuck

given: Christoph

family: Qin

full_name: Xiang Qin

given: Xiang

family: Parasrampuria

full_name: Dolly A. Parasrampuria

given: Dolly A.

family: Gries

full_name: Katharine S. Gries

given: Katharine S.

family: Qi

full_name: Ming Qi

given: Ming

family: Bahlis

full_name: Nizar Bahlis

given: Nizar

family: Ito

full_name: Shigeki Ito

given: Shigeki

journal_name: Annals of Hematology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Usmani SZ, Mateos MV, Hungria V, Iida S, Bahlis NJ, Nahi H, Magen H, Cavo M, Hulin C, White D, De Stefano V, Fastenau J, Slavcev M, Heuck C, Qin X, Pei H, Masterson T, Lantz K, Gries KS. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.

family: Hungria

full_name: Vania Hungria

given: Vania

journal_name: Journal of Cancer Research and Clinical Oncology

ReferenceCitation: Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Bladé J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23. Erratum in: Lancet Haematol. 2020 Oct;7(10):e710.

location_country:
Italy
Brazil
United States
Sweden
France
Czechia
Greece
Israel
Japan
Poland
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Hospital Amaral Carvalho - Centro de Ensino e Pesquisa

location_facility: Instituto COI de Pesquisa, Educacao e Gestao

location_facility: Instituto Joinvilensse de Hematologia e Oncologia

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: St.-Petersburg City Clinical Hospital nr 31

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department

location_facility: Hospital de Base de São José do Rio Preto

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Hospital Do Cancer De Barretos - Fundacao Pio Xii

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: The Gordon & Leslie Diamond Health Care Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Centro de Pesquisa do Instituto do Câncer- Hospital São Vicente de Paulo

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Rambam Med.Center - Hematology Institute

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

location_facility: National Cancer Institute, Dept. of chemotherapy of hemoblastosis

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

location_facility: Karolinska University Hospital, Huddinge

location_facility: SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

location_facility: Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital

title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).


title: A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

acronym: SURPASS

summary: The purpose of this study is to demonstrate the impact of secukinumab on progression of structural damage in the spine, as measured by the mSASSS in patients with AS.

ReferenceCitation: Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804. Review.

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Poddubnyy

full_name: Denis Poddubnyy

given: Denis

journal_name: Current Opinion in Rheumatology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Baraliakos X, Østergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7.

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Østergaard

full_name: Mikkel Østergaard

given: Mikkel

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

family: Lee

full_name: Eun Young Lee

given: Eun Young

family: Kiltz

full_name: Uta Kiltz

given: Uta

family: Martin

full_name: Ruvie Martin

given: Ruvie

family: Sawata

full_name: Hiroshi Sawata

given: Hiroshi

family: Readie

full_name: Aimee Readie

given: Aimee

family: Porter

full_name: Brian Porter

given: Brian

journal_name: Clinical Drug Investigation

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Netherlands
Philippines
Portugal
United States
Germany
United Kingdom
Mexico
Czechia
Israel
Spain
Turkey

intervention_type: Biological


ReferenceCitation: Fangusaro J, Cefalo MG, Garré ML, Marshall LV, Massimino M, Benettaib B, Biserna N, Poon J, Quan J, Conlin E, Lewandowski J, Simcock M, Jeste N, Hargrave DR, Doz F, Warren KE. Phase 2 Study of Pomalidomide (CC-4047) Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors. Front Oncol. 2021 Jun 8;11:660892. doi: 10.3389/fonc.2021.660892. eCollection 2021.

family: Fangusaro

full_name: Jason Fangusaro

given: Jason

family: Cefalo

full_name: Maria Giuseppina Cefalo

given: Maria Giuseppina

family: Garré

full_name: Maria Luisa Garré

given: Maria Luisa

family: Marshall

full_name: Lynley V. Marshall

given: Lynley V.

family: Massimino

full_name: Maura Massimino

given: Maura

family: Benettaib

full_name: Bouchra Benettaib

given: Bouchra

family: Biserna

full_name: Noha Biserna

given: Noha

family: Poon

full_name: Jennifer Poon

given: Jennifer

family: Quan

full_name: Jackie Quan

given: Jackie

family: Conlin

full_name: Erin Conlin

given: Erin

family: Lewandowski

full_name: John Lewandowski

given: John

family: Simcock

full_name: Mathew Simcock

given: Mathew

family: Jeste

full_name: Neelum Jeste

given: Neelum

family: Hargrave

full_name: Darren R. Hargrave

given: Darren R.

family: Doz

full_name: François Doz

given: François

family: Warren

full_name: Katherine E. Warren

given: Katherine E.

currency_apc_doaj: USD

journal_name: Frontiers in Oncology

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Fangusaro J, Mitchell DA, Kocak M, Robinson GW, Baxter PA, Hwang EI, Huang J, Onar-Thomas A, Dunkel IJ, Fouladi M, Warren KE. Phase 1 study of pomalidomide in children with recurrent, refractory, and progressive central nervous system tumors: A Pediatric Brain Tumor Consortium trial. Pediatr Blood Cancer. 2021 Feb;68(2):e28756. doi: 10.1002/pbc.28756. Epub 2020 Oct 7.

name: Children's Healthcare of Atlanta and Emory University Medical School  Atlanta Georgia

name: Preston A. Wells Jr. Center for Brain Tumor Therapy University of Florida Brain Tumor Immunotherapy Program  Gainesville Florida

name: University of Tennessee Health Science Center  Memphis Tennessee

name: St Jude Children's Research Hospital  Memphis Tennessee

name: Texas Children's Cancer Center Baylor College of Medicine  Houston Texas

name: Children's National Health System  Washington District of Columbia

name: Memorial Sloan Kettering Cancer Center  New York New York

name: Nationwide Children's Hospital  Columbus Ohio

name: Dana‐Farber Cancer Institute and Harvard Medical School  Boston Massachusetts

location_country:
Italy
France
Spain
United States
United Kingdom

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie

location_facility: Istituto G. Gaslini Ospedale Pediatrico IRCCS

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

title: A PHASE 2 CLINICAL STUDY OF POMALIDOMIDE (CC-4047) MONOTHERAPY FOR CHILDREN AND YOUNG ADULTS WITH RECURRENT OR PROGRESSIVE PRIMARY BRAIN TUMORS

summary: This study will assess the efficacy, safety and tolerability of pomalidomide in children and young adults aged 1 to < 21 years with recurrent or progressive primary brain tumors in one of four primary brain tumor types: high-grade glioma (HGG), medulloblastoma, ependymoma and diffuse intrinsic pontine glioma (DIPG).


ReferenceCitation: Viklicky O, Slatinska J, Novotny M, Hruba P. Developments in immunosuppression. Curr Opin Organ Transplant. 2021 Feb 1;26(1):91-96. doi: 10.1097/MOT.0000000000000844. Review.

family: Viklicky

full_name: Ondrej Viklicky

given: Ondrej

family: Slatinska

full_name: Janka Slatinska

given: Janka

family: Novotny

full_name: Marek Novotny

given: Marek

family: Hruba

full_name: Petra Hruba

given: Petra

journal_name: Current Opinion in Organ Transplantation

title: Developments in immunosuppression

lead_sponsor: CSL Behring

location_country:
United States
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: Centre Regional Hospitalier Universitaire de Lille

location_facility: University of Alabama Hospital (at Birmingham)

ipd_sharing: No

source: euctr

title: A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients

summary: This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).


title: An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

acronym: STELARA

summary: The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Janssen-Cilag International NV

location_country:
Austria
Switzerland
Netherlands
France
Norway
Belgium
Russian Federation
Denmark
Germany
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Moscow Research-Practical Center of Dermatovenerology and Cosmetology

location_facility: FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Groupe Hospitalier Pellegrin CHU de Bordeaux

location_facility: Klinikum der Johann Wolfgang Goethe -Universitaet

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Saint-Petersburg State Pediatric Medical Academy of RosZdrav

location_facility: Oslo universitetssykehus HF, Rikshospitalet

location_facility: Centre hospitalier universitaire vaudois


location_country:
Italy
Brazil
France
Bulgaria
Poland
Hungary
Belgium
Spain
United States

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

location_facility: IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

location_facility: Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy

location_facility: Hospital Infantil Pequeno Príncipe - Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Johns Hopkins Hospital, Child and Adolescent Psychiatry

location_facility: Hospital Universitario Professor Edgar Santos

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego

location_facility: University of Iowa, Carver College of Medicine

location_facility: University North Carolina at Chapel Hill

location_facility: Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD

location_facility: Vadaskert Gyermek- és Ifjúságpszichiátriai Kórház és Szakambulancia

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS

location_facility: Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego, Oddział Psychiatryczny Dzieci i Młodzieży

location_facility: Bioserv SMO - HSVP ( Hospital São Vicente de Paulo)

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: University of Texas Southwestern Medical Center

title: A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

summary: The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.


title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy

summary: This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months.

lead_sponsor: Helsinn Healthcare SA

location_country:
Italy
Austria
Brazil
Germany
France
Czechia
Poland
Romania
Hungary
Argentina
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Fondazione IRCCS policlinico San Matteo Pavia

location_facility: "Fakultni nemocnice Kralovske Vinohrady,

location_facility: Hosp.Universitario A Coruña-Hospital Teresa Herrera

location_facility: Hospital Universitario y Politecnico de La Fe

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: CHU de Nice, Archet 1 Hospital-Hematology department

location_facility: Ce ntro de Pesquisas Hospital Amara l Ca rvalh o

location_facility: Marien Hospital Herne-Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Austin Hospital, Clinical Trial Pharmacy

location_facility: Specjalistyc:my Szpi tal im. dra Alfreda Sokolowskiego

location_facility: Saint alphonsus Regional medical center-cancer care center

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Duke University Medical Center-2400 Pratt Street

location_facility: Liga Paranaense de Com bate ao Cancer - Hospital Erasto Gaertner

location_facility: Charité-Universitätsmedizin - 1. Campus Mitte

location_facility: Centro de Pesquisa Clinica do Hospital Santa Marcelina

location_facility: VA North texas Health Care sytem,Dallas VA Medical Center div. Hematology Oncology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Seoul National University Hospital, Div.Hematology/Oncology

location_facility: Pontchartrain Cancer Center (Research Location)

location_facility: Gachon University Gil medical center, div hematology

location_facility: UMass Memorial medical center-university campus

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Dep. Of Haematology

location_facility: CHU Amiens Picardie-Site Sud-Service d'Hematologie

location_facility: The Northern hospital Pharmacy Department, Ground Floor

location_facility: Bradford Teaching Hospitals NHS Foundation trust

location_facility: koo-Foundation Sun Yat-Sen Cancer Center

location_facility: Oklahoma cancer specialist and research institute

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Ospedale la Maddalena, UO Oncoematologia e TMO

location_facility: Division of Hematology, National Taiwan University Hospital

location_facility: Hospital Santa Casa de Belo Horizonte -Serviyo de Oncologia Clinica

location_facility: Institute Nacional de Cancer Jose de Alencar Gomes da Silva-INCA

location_facility: 10666 N.Torrey Pines-Scripps Cancer Center

location_facility: Wojewodzkie Wielospecjalistyczne Centrum onkologii I traumatologii

location_facility: University Hospital Cleveland Medical Center

location_facility: Haut-Leveque-Service d'hématologie clinique et de thérapie cellular

location_facility: Ospedale San Raffaele-U.O. Ematologia e TMO

location_facility: Hematology and Oncology, Changhwa Christian Hospital

location_facility: Arizona Oncology Associates, East Valley Cancer Center

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Barwon Health, University Hospital Geelong

location_facility: University of Arizona cancer center-north campus

location_facility: Royal Devon & Exeter Hospital (Wonford site)

location_facility: Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz â€" Josa Andras Oktatokorhaz, Hematologiai Osztaly

location_facility: Seoul St.Mary Hospital, div hemato-oncology

location_facility: St. Istvan & St. Laszlo Hospital, Deapartment of Hematology and Stem Cell Transplantation


status: Completed

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
United States
France

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: Charite Paediatric Pulmonology Department

location_facility: Wake Forest University Baptist Medical Center

location_facility: The University of Tennessee Medical Center

location_facility: Centre Hospitalier Universitaire De Grenoble - Hopital Michallon

location_facility: Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center

location_facility: Centre hospitalier universitaire de Nice, Pulmonology

location_facility: Tampa General Hospital Cardiac and Lung Transplant Clinic

location_facility: Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: UCSF - Fresno, Community Regional Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Children's Hospital of Richmond at VCU, Children's Pavilion

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Dell Children's Medical Center of Central Texas

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: The University of Iowa Hospitals and Clinics

location_facility: Klinikum Innenstadt, University of Munich

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Children's Hospital of the King's Daughters

location_facility: Children's Speciality Services at North Druid Hills

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Massachusetts General Hospital Cystic Fibrosis Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Centre Hospitalier Universitaire - Hopitaux de Rouen

location_facility: University of Utah / Primary Children's Medical Center

title: Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation

summary: Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).

status_simplified: Completed


title: Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

acronym: SMART CRT

summary: The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United States
Switzerland
Netherlands
France
Japan
Ireland
Spain
Germany
United Kingdom
Canada

location_facility: Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle

location_facility: Novant Health Heart and Vascular Institute

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Trinity Health Michigan d/b/a Michigan Heart

location_facility: The International Heart Institute on Montana Foundation

location_facility: Virginia Commonwealth University Medical Center

location_facility: Affinity Hospital, LLC d/b/a Granview Medical Center

location_facility: Cardiovascular Associates of the Delaware Valley

location_facility: Azienda Sanitaria Universtitaria Integrata di Trieste

location_facility: Salinas Valley Memorial Healthcare System

location_facility: University of Arizona Sarver Heart Center

location_facility: Foundation for Advancing Veterans' Health Research

location_facility: University of Berlin, Charite Virchow Standort

location_facility: The Ohio Health Research Institute- Grant Medical Center

intervention_type: Device


ReferenceCitation: Dam T, Boxer AL, Golbe LI, Höglinger GU, Morris HR, Litvan I, Lang AE, Corvol JC, Aiba I, Grundman M, Yang L, Tidemann-Miller B, Kupferman J, Harper K, Kamisoglu K, Wald MJ, Graham DL, Gedney L, O'Gorman J, Haeberlein SB; PASSPORT Study Group. Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial. Nat Med. 2021 Aug;27(8):1451-1457. doi: 10.1038/s41591-021-01455-x. Epub 2021 Aug 12.

family: Dam

full_name: Tien Dam

given: Tien

family: Boxer

full_name: Adam L. Boxer

given: Adam L.

family: Golbe

full_name: Lawrence I. Golbe

given: Lawrence I.

family: Höglinger

full_name: Günter U. Höglinger

given: Günter U.

family: Morris

full_name: Huw R. Morris

given: Huw R.

family: Litvan

full_name: Irene Litvan

given: Irene

family: Lang

full_name: Anthony E. Lang

given: Anthony E.

family: Corvol

full_name: Jean-Christophe Corvol

given: Jean-Christophe

family: Aiba

full_name: Ikuko Aiba

given: Ikuko

family: Grundman

full_name: Michael Grundman

given: Michael

family: Yang

full_name: Lili Yang

given: Lili

family: Tidemann-Miller

full_name: Beth Tidemann-Miller

given: Beth

family: Kupferman

full_name: Joseph Kupferman

given: Joseph

family: Harper

full_name: Kristine Harper

given: Kristine

family: Kamisoglu

full_name: Kubra Kamisoglu

given: Kubra

family: Wald

full_name: Michael J. Wald

given: Michael J.

family: Graham

full_name: Danielle L. Graham

given: Danielle L.

family: Gedney

full_name: Liz Gedney

given: Liz

family: O’Gorman

full_name: John O’Gorman

family: Haeberlein

full_name: Samantha Budd Haeberlein

given: Samantha Budd

journal_name: Nature Medicine

lead_sponsor: Biogen

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

acronym: PASSPORT

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy

summary:
The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities.

The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.


ReferenceType: result

ReferenceCitation: Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csőszi T, Cheema PK, Rodriguez-Abreu D, Wollner M, Yang JC, Mazieres J, Orlandi FJ, Luft A, Gümüş M, Kato T, Kalemkerian GP, Luo Y, Ebiana V, Pietanza MC, Kim HR; KEYNOTE-604 Investigators. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020 Jul 20;38(21):2369-2379. doi: 10.1200/JCO.20.00793. Epub 2020 May 29.

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

family: Rudin

full_name: Charles M. Rudin

given: Charles M.

name: Dana-Farber Cancer Institute, Boston, MA

family: Awad

full_name: Mark M. Awad

given: Mark M.

name: Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain

family: Navarro

full_name: Alejandro Navarro

given: Alejandro

family: Gottfried

full_name: Maya Gottfried

given: Maya

name: Lausanne University Hospital, Lausanne, Switzerland

family: Peters

full_name: Solange Peters

given: Solange

name: Hetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary

family: Csőszi

full_name: Tibor Csőszi

given: Tibor

name: William Osler Health System, University of Toronto, Brampton, Ontario, Canada

family: Cheema

full_name: Parneet K. Cheema

given: Parneet K.

name: Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

family: Rodriguez-Abreu

full_name: Delvys Rodriguez-Abreu

given: Delvys

family: Wollner

full_name: Mirjana Wollner

given: Mirjana

name: National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

name: Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France

family: Mazieres

full_name: Julien Mazieres

given: Julien

name: Oncología-Health and Care, Santiago, Chile

family: Orlandi

full_name: Francisco J. Orlandi

given: Francisco J.

name: Leningrad Regional Clinical Hospital, St Petersburg, Russia

family: Luft

full_name: Alexander Luft

given: Alexander

name: Istanbul Medeniyet University Hospital, Istanbul, Turkey

family: Gümüş

full_name: Mahmut Gümüş

given: Mahmut

family: Kato

full_name: Terufumi Kato

given: Terufumi

family: Kalemkerian

full_name: Gregory P. Kalemkerian

given: Gregory P.

family: Luo

full_name: Yiwen Luo

given: Yiwen

family: Ebiana

full_name: Victoria Ebiana

given: Victoria

family: Pietanza

full_name: M. Catherine Pietanza

given: M. Catherine

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

family: Kim

full_name: Hye Ryun Kim

given: Hye Ryun

name: on behalf of the KEYNOTE-604 Investigators

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
United States
Chile
Switzerland
Spain
Germany
France
Japan
Poland
Israel
Hungary
Australia
Ireland
New Zealand
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Phase 3 trial of first line etoposide/platinum with or without pembrolizumab in ES-SCLC(KEYNOTE-604)

location_facility: Duke University Medical Center ( Site 1214)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)

location_facility: Inje University Haeundae Paik Hospital ( Site 0905)

location_facility: Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0617)

location_facility: National Cheng Kung University Hospital ( Site 1004)

location_facility: Hiroshima University Hospital ( Site 0604)

location_facility: Chaim Sheba Medical Center. ( Site 0501)

location_facility: Taipei Veterans General Hospital ( Site 1002)

location_facility: Birmingham Heartlands Hospital ( Site 1162)

location_facility: Taichung Veterans General Hospital ( Site 1007)

location_facility: Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0803)

location_facility: National Cancer Center Hospital East ( Site 0613)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 0454)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0457)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)

location_facility: SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)

location_facility: Osaka International Cancer Institute ( Site 0616)

location_facility: Sunnybrook Research Institute ( Site 0151)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0958)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)

location_facility: Beth Israel Deaconess Medical Center ( Site 1206)

location_facility: North Shore University Health System ( Site 1216)

location_facility: Massachusetts General Hospital ( Site 1203)

location_facility: China Medical University Hospital. ( Site 1003)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0615)

location_facility: Orszagos Onkologiai Intezet ( Site 0453)

location_facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)

location_facility: Bon Secours St. Francis Health Sytem ( Site 1212)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)

location_facility: Dana-Farber Cancer Institute [Boston] ( Site 1201)

location_facility: Philipps-Universitat Marburg ( Site 0414)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0955)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1059)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0614)

location_facility: Minnesota Oncology Hematology, PA ( Site 8001)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0161)

location_facility: St Vincents Hospital Melbourne ( Site 0005)

location_facility: CISSS-CA Hotel Dieu de Levis ( Site 0154)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1211)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0206)

location_facility: Hospital Universitari Vall d Hebron ( Site 0951)

location_facility: St. Jerome Medical Research Inc. ( Site 0160)

location_facility: CHRU de Lille - Hopital Albert Calmette ( Site 0353)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0203)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0460)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0354)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0606)

location_facility: Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 1210)

location_facility: CISSS de la Monteregie-Centre ( Site 0152)

location_facility: Evangelische Lungenklinik Berlin ( Site 0403)

location_facility: Ege Universitesi Tıp Fakultesi ( Site 1052)

location_facility: Wakayama Medical University Hospital ( Site 0612)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)

location_facility: Southern Medical Day Care Centre ( Site 0001)

location_facility: Clinica Universidad Catolica del Maule ( Site 0208)

location_facility: Complejo Hospitalario Universitario de A Coruna ( Site 0953)

location_facility: Canterbury Regional Cancer & Blood Services ( Site 0701)

location_facility: Universitaetsspital Zuerich ( Site 1404)

location_facility: Baptist Health Medical Group Oncology, LLC ( Site 8000)

location_facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)

location_facility: Instituto Nacional del Cancer ( Site 0207)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)

location_facility: Institut de Cancerologie Jean-Godinot ( Site 0351)

location_facility: Belgorod Regional Oncology Dispensary ( Site 0804)

location_facility: Rush University Medical Center ( Site 1215)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)

location_facility: Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)

location_facility: Nova Scotia Health Authority ( Site 0157)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)

location_facility: Municipal Clinical Oncology Center ( Site 0802)

location_facility: Severance Hospital Yonsei University Health System ( Site 0903)

location_facility: Medical Park Izmir Hospital ( Site 1051)

location_facility: National Taiwan University Hospital ( Site 1001)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)

location_facility: Florence Nightingale Krankenhaus ( Site 0413)

location_facility: SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)

location_facility: Kingston Health Sciences Centre ( Site 0155)

location_facility: St Vincents University Hospital ( Site 1456)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0952)

location_facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 0757)

location_facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)

location_facility: St James s University Hospital ( Site 1161)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8004)

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1061)

location_facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1229)

location_facility: Chi Mei Medical Center Liuying ( Site 1006)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)

location_facility: Universitaetsklinikum Tuebingen ( Site 0404)

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)

location_facility: CHU Nantes - Hopital Laennec ( Site 0363)

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)

location_facility: Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)

location_facility: Niigata Cancer Center Hospital ( Site 0610)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)

title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy.

The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.


lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Finland
Greece
Romania
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Chile
Sweden
Switzerland
Netherlands
Singapore
Hungary
China
United States
Germany
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Instituto Nacional De Enfermedades Neoplasicas

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Washington University School OF Medicine-Siteman Cancer Center

location_facility: Centro Internacional de Estudios Clinicos

location_facility: Klinikum Nuernberg Nord, Urologische Klinik

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: NYU Winthrop Hospital Dept of Oncology/Hematology

location_facility: Nova Scotia Health Authority QEII Health Sciences Centre

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Centro de Pesquisas Oncologicas de Santa Catarina-CEPON

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

location_facility: Dana Farber Cancer Institute-Parent Account

location_facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital

location_facility: VA of Central California Health Care System

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Hospital De Base Da Faculdade De Medicina De Rio Preto

title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

summary: The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.