title: A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

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, analyses plans, 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:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: University Hospitals of North Midlands NHS Trust /ID# 229202

location_facility: East Suffolk and North Essex NHS Foundation Trust /ID# 229056

location_facility: Nanfang Hospital of Southern Medical University /ID# 238436

location_facility: Hospital General Universitario Gregorio Maranon /ID# 239768

location_facility: National Cheng Kung University Hospital /ID# 226671

location_facility: Essentia Health DuLuth Clinic /ID# 228407

location_facility: Liverpool University Hospitals NHS Foundation Trust /ID# 229201

location_facility: Saint Peter's University Hospital /ID# 229471

location_facility: The Fifth Medical Center of PLA General Hospital /ID# 230941

location_facility: Szpital Wojewodzki w Opolu sp. z o.o. /ID# 229669

location_facility: West China Hospital, Sichuan University /ID# 233173

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542

location_facility: University of Oklahoma, Stephenson Cancer Center /ID# 225556

location_facility: ASST Spedali civili di Brescia /ID# 225549

location_facility: Fujian Provincial Cancer Hospital /ID# 238430

location_facility: CHU UCL Namur - site Godinne /ID# 225742

location_facility: Gabrail Cancer Center Research /ID# 226659

location_facility: Gloucestershire Hospitals NHS Foundation Trust /ID# 229067

location_facility: Novant Health Forsyth Medical Center /ID# 228339

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899

location_facility: Dokuz Eylul University Medical Faculty /ID# 225782

location_facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548

location_facility: Hospital Parc de Salut del Mar /ID# 225810

location_facility: Maastricht Universitair Medisch Centrum /ID# 225607

location_facility: Taichung Veterans General Hospital /ID# 226674

location_facility: Novant Health Presbyterian Medical Center /ID# 227753

location_facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 228292

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 225543

location_facility: Tel Aviv Sourasky Medical Center /ID# 225891

location_facility: Swedish Cancer Institute - Edmonds /ID# 226845

location_facility: Hospital Universitario Ramon y Cajal /ID# 241750

location_facility: The Fourth Hospital of Hebei Medical University /ID# 238656

location_facility: UCHSC Anschultz Cancer Pavilion /ID# 226040

location_facility: Tolna Megyei Balassa Janos Korhaz /ID# 250063

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360

location_facility: Universitaetsklinikum Tuebingen /ID# 229662

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 226102

location_facility: Saddleback Memorial Medical Center /ID# 229631

location_facility: Peking University Third Hospital /ID# 230975

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226048

location_facility: Centro di Riferimento Oncologico /ID# 225553

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 228191

location_facility: Hospital Clinico Universitario de Valencia /ID# 225818

location_facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065

location_facility: Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921

location_facility: The Cancer Institute Hospital Of JFCR /ID# 230269

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 228207

location_facility: University of Mississippi Medical Center /ID# 228045

location_facility: UW, Cancer Ctr ProHealth Care /ID# 228741

location_facility: Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 238730

location_facility: Gibbs Cancer Center & Research /ID# 229372

location_facility: Fakultni nemocnice Hradec Kralove /ID# 225955

location_facility: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141

location_facility: Haemalife Inc. Netcare Kuilsrivier Hospital /ID# 243391

location_facility: CCA Braga - Hospital de Braga /ID# 249112

location_facility: The First Hospital of Jilin University /ID# 239618

location_facility: General University Hospital of Thessaloniki AXEPA /ID# 225398

location_facility: Taipei Veterans General Hosp /ID# 226724

location_facility: Universitaetsklinikum Giessen /ID# 239181

location_facility: Ondokuz Mayis Universitesi Tip /ID# 251247

location_facility: East Carolina University Brody School of Medicine /ID# 225992

location_facility: Kagoshima University Hospital /ID# 250163

location_facility: Hokkaido University Hospital /ID# 250149

location_facility: VA Caribbean Healthcare System /ID# 230053

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225804

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 226130

location_facility: Bozeman Health Cancer Center /ID# 229368

location_facility: Assuta Tel Aviv Medical Center /ID# 226066

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 226148

location_facility: Tianjin Medical University Cancer Institute and Hospital /ID# 230974

location_facility: Kaiser Permanente - Northwest /ID# 225488

location_facility: IEO -Istituto Europeo di Oncologia /ID# 225545

location_facility: Icahn School of Medicine at Mount Sinai /ID# 225370

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 226838

location_facility: Sun Yat-Sen University Cancer Center /ID# 238371

location_facility: Theageneio Anticancer Hospital /ID# 225516

location_facility: University of Southern California /ID# 225443

location_facility: Albert Schweitzer Ziekenhuis /ID# 229560

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 229895

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228

location_facility: Intermountain Medical Center /ID# 231184

location_facility: KSW Kantonsspital Winterthur /ID# 241631

location_facility: Universitaetsklinikum Regensburg /ID# 231231

location_facility: University of Virginia Cancer Center - West Complex /ID# 225433

location_facility: CHU Grenoble - Hopital Michallon /ID# 226128

location_facility: Pan American Center for Oncology Trials, LLC /ID# 230052

location_facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 249113

location_facility: The First Affiliated Hospital of Soochow University /ID# 232569

location_facility: Multicare Institute for Research and Innovation /ID# 225432

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 245938

location_facility: Hospital Italiano de Buenos Aires /ID# 228270

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 231291

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 227798

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 225956

location_facility: Centrum Medyczne Pratia Poznan /ID# 227236

location_facility: Vrije Universiteit Medisch Centrum /ID# 225608

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379

location_facility: General Hospital of Athens Laiko /ID# 225399

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387

location_facility: Yamagata University Hospital /ID# 230003

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 225809

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 229773

location_facility: The Chaim Sheba Medical Center /ID# 225600

location_facility: Sutter Health Alta Bates Summit Medical Center /ID# 229427

location_facility: Hospital Universitario Vall d'Hebron /ID# 225811

location_facility: Hospital Privado Univesitario /ID# 228778

location_facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554

location_facility: Hospital Universitario Infanta Leonor /ID# 225816

location_facility: Walter Reed National Military Medical Center /ID# 231016

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 227117

location_facility: Univerzitna nemocnica Martin /ID# 240828

location_facility: Seoul National University Bundang Hospital /ID# 225763

location_facility: National Cancer Center Hospital /ID# 226089

location_facility: Baptist MD Anderson Cancer Center - Jacksonville /ID# 227040

location_facility: Roswell Park Comprehensive Cancer Center /ID# 239127

location_facility: Hospital Universitario Reina Sofia /ID# 225806

location_facility: CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 233509

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 227048

location_facility: CHU Amiens-Picardie Site Sud /ID# 238347

location_facility: University General Hospital Attikon /ID# 225401

location_facility: Inje University Busan Paik Hospital /ID# 232262

location_facility: Universitair Medisch Centrum Groningen /ID# 225602

location_facility: Loyola University Medical Ctr /ID# 227029

location_facility: University of Maryland School of Medicine /ID# 225421

location_facility: NJ Hematology Oncology Association /ID# 228058

location_facility: Kobe City Medical Center General Hospital /ID# 250597

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 229360

location_facility: Princess Margaret Cancer Centre /ID# 226080

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 229066

location_facility: Duplicate_The Affiliated Hospital of XuZhou Medical University /ID# 233174

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986

location_facility: Imperial College Healthcare NHS Trust /ID# 242215

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809

location_facility: SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 229197

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran /ID# 228756

location_facility: Southern IL Univ School of Med /ID# 228999

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152

location_facility: Goshen Center for Cancer Care /ID# 225534

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 226127

location_facility: Royal Cornwall Hospitals NHS Trust /ID# 229827

location_facility: The First Affiliated Hospital of Xiamen University /ID# 238426

location_facility: Long Beach Memorial Medical Ct /ID# 228996

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229897

location_facility: The First Hospital of China Medical University /ID# 233201

location_facility: Jeonbuk National University Hospital /ID# 232263

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 226598

location_facility: Hospital Universitario 12 de Octubre /ID# 225815

location_facility: Universitaetsklinikum des Saarlandes /ID# 227051

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 226670

location_facility: Saint John Regional Hospital /ID# 233547

location_facility: China Medical University Hospital /ID# 226188

location_facility: Leids Universitair Medisch Centrum /ID# 225606

location_facility: Guangdong Provincial People's Hospital /ID# 230945

location_facility: Rush University Medical Center /ID# 225453

location_facility: Universitair Ziekenhuis Leuven /ID# 225951

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063

location_facility: Portsmouth Hospitals University NHS Trust /ID# 233400

location_facility: Harbin Medical University Cancer Hospital /ID# 241755

location_facility: Matsuyama Red Cross Hospital /ID# 251068

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 225920

location_facility: Centre Hospitalier de la Cote /ID# 249143

location_facility: Norton Cancer Institute - St Matthews /ID# 225420

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 226074

location_facility: The First Affiliated Hospital of Nanchang University /ID# 230399

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 225396

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 225796

location_facility: Medical University of South Carolina /ID# 225427

location_facility: Inonu University Medical Faculty /ID# 226572

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249111

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773

location_facility: NHS Greater Glasgow and Clyde /ID# 229463

location_facility: Universitaetsmedizin Goettingen /ID# 227120

location_facility: Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 225952

location_facility: Centre Antoine Lacassagne - Nice /ID# 238339

location_facility: Centro de Investigacion Clínica Chapultepec S.A. de C.V. /ID# 228613

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 225761

location_facility: Thompson Cancer Survival Ctr /ID# 227123

location_facility: University of Texas Southwestern Medical Center /ID# 225492

location_facility: Medizinische Universitaet Innsbruck /ID# 228364

location_facility: South Tyneside and Sunderland NHS Foundation Trust /ID# 229458

location_facility: University of Arkansas for Medical Sciences /ID# 225703

location_facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 226101

location_facility: University General Hospital of Ioannina /ID# 225400

location_facility: Klinikum Mutterhaus der Borromäerinnen /ID# 233434

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 226690

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 227393

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 226821

location_facility: Hospital Santa Creu i Sant Pau /ID# 225813

location_facility: Joe Arrington Cancer Research /ID# 227217

location_facility: Linkoping University Hospital /ID# 233521

location_facility: Seoul National University Hospital /ID# 225760

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino /ID# 225775

location_facility: National Cancer Center Hospital East /ID# 250151

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 225551

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582

location_facility: Hematology and Oncology Institute /ID# 230054

location_facility: University of Alabama at Birmingham - Main /ID# 225373

location_facility: Dana-Farber Cancer Institute /ID# 225506

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 228752

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 226026

location_facility: Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 228950

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 226125

location_facility: Univerzitna nemocnica L. Pasteura Kosice /ID# 240174

location_facility: Ankara Universitesi Fakultesi /ID# 227331

location_facility: Hospital de Clinicas da Universidade Federal do Parana /ID# 226027

location_facility: Millennium Research & Clinical Development /ID# 228284

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 226846

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 226726

location_facility: Augusta University Georgia Cancer Center /ID# 227131

location_facility: Aichi Cancer Center Hospital /ID# 226090

location_facility: Karolinska Universitetssjukhuset, Solna /ID# 229284

location_facility: Skane University Hospital Lund /ID# 227285

location_facility: Chongqing University Cancer Hospital /ID# 233187

location_facility: Christiana Care Health Service /ID# 228266

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462

location_facility: University of Arizona Cancer Center - North Campus /ID# 227463

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 226687

location_facility: Gazi University Medical Faculty /ID# 226571

location_facility: Universitaetsklinikum Wuerzburg /ID# 227113

location_facility: Keimyung University Dongsan Medical Center /ID# 232264

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 225575

location_facility: Fukushima Medical University Hospital /ID# 250869


status: Completed

primary_purpose: Treatment

acronym: AVATAXHER

intervention_type: Radiation

title: An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer

study_completion_date_type: Actual

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Coudert B, Pierga JY, Mouret-Reynier MA, Kerrou K, Ferrero JM, Petit T, Kerbrat P, Dupré PF, Bachelot T, Gabelle P, Giard S, Coeffic D, Bougnoux P, Prevost JB, Paintaud G, Thibault G, Hernandez J, Coudert M, Arnould L, Berriolo-Riedinger A. Use of [(18)F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [(18)F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1493-1502. doi: 10.1016/S1470-2045(14)70475-9. Epub 2014 Oct 30.

enrollment_type: Actual

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Ch De Montlucon; Sce Med Interne Hemato Onco

location_facility: Centre Henry S Kaplan - CHU Bretonneau ; service oncologie

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

summary: This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.

lead_sponsor_type: industriel

status_simplified: Completed


title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

summary: Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boehringer Ingelheim

location_facility: Boehringer Ingelheim Investigational Site 46

location_facility: Boehringer Ingelheim Investigational Site 21

location_facility: Boehringer Ingelheim Investigational Site 26

location_facility: Boehringer Ingelheim Investigational Site 18

location_facility: Boehringer Ingelheim Investigational Site 23

location_facility: Boehringer Ingelheim Investigational Site 20

location_facility: Boehringer Ingelheim Investigational Site 35

location_facility: Boehringer Ingelheim Investigational Site 37

location_facility: Boehringer Ingelheim Investigational Site 45

location_facility: Boehringer Ingelheim Investigational Site 13

location_facility: Boehringer Ingelheim Investigational Site 47

location_facility: Boehringer Ingelheim Investigational Site 25

location_facility: Boehringer Ingelheim Investigational Site 17

location_facility: Boehringer Ingelheim Investigational Site 40

location_facility: Boehringer Ingelheim Investigational Site 32

location_facility: Boehringer Ingelheim Investigational Site 22

location_facility: Boehringer Ingelheim Investigational Site 43

location_facility: Boehringer Ingelheim Investigational Site 9

location_facility: Boehringer Ingelheim Investigational Site 11

location_facility: Boehringer Ingelheim Investigational Site 6

location_facility: Boehringer Ingelheim Investigational Site 39

location_facility: Boehringer Ingelheim Investigational Site 36

location_facility: Boehringer Ingelheim Investigational Site 19

location_facility: Boehringer Ingelheim Investigational Site 33

location_facility: Boehringer Ingelheim Investigational Site 53

location_facility: Boehringer Ingelheim Investigational Site 44

location_facility: Boehringer Ingelheim Investigational Site 7

location_facility: Boehringer Ingelheim Investigational Site 50

location_facility: Boehringer Ingelheim Investigational Site 30

location_facility: Boehringer Ingelheim Investigational Site 10

location_facility: Boehringer Ingelheim Investigational Site 42

location_facility: Boehringer Ingelheim Investigational Site 34

location_facility: Boehringer Ingelheim Investigational Site 24

location_facility: Boehringer Ingelheim Investigational Site 16

location_facility: Boehringer Ingelheim Investigational Site 51

location_facility: Boehringer Ingelheim Investigational Site 41

location_facility: Boehringer Ingelheim Investigational Site 52

location_facility: Boehringer Ingelheim Investigational Site 49

location_facility: Boehringer Ingelheim Investigational Site 38

location_facility: Boehringer Ingelheim Investigational Site 8

location_facility: Boehringer Ingelheim Investigational Site 29

location_facility: Boehringer Ingelheim Investigational Site 48

location_facility: Boehringer Ingelheim Investigational Site 14

location_facility: Boehringer Ingelheim Investigational Site 31

location_facility: Boehringer Ingelheim Investigational Site 27

location_facility: Boehringer Ingelheim Investigational Site 12

location_facility: Boehringer Ingelheim Investigational Site 28

location_facility: Boehringer Ingelheim Investigational Site 15


title: Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

acronym: PHACS

summary:
This is a biomedical study of interventional type, multicenter, inter-regional.

Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.

ReferenceCitation: Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roché H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.

lead_sponsor: Institut Claudius Regaud

location_facility: Clinique Pasteur - Département d'Oncologie Médicale

location_facility: Clinique Pasteur - Département de Radiothérapie

location_facility: Centre Hospitalier Intercommunal de Castres-Mazamet

intervention_type: Drug


title: A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

summary: This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

ReferenceCitation: de Jong TD, Sellam J, Agca R, Vosslamber S, Witte BI, Tsang-A-Sjoe M, Mantel E, Bijlsma JW, Voskuyl AE, Nurmohamed MT, Verweij CL, Mariette X. A multi-parameter response prediction model for rituximab in rheumatoid arthritis. Joint Bone Spine. 2018 Mar;85(2):219-226. doi: 10.1016/j.jbspin.2017.02.015. Epub 2017 Mar 28.

ReferenceCitation: Sellam J, Rivière E, Courties A, Rouzaire PO, Tolusso B, Vital EM, Emery P, Ferraccioli G, Soubrier M, Ly B, Hendel Chavez H, Taoufik Y, Dougados M, Mariette X. Serum IL-33, a new marker predicting response to rituximab in rheumatoid arthritis. Arthritis Res Ther. 2016 Dec 13;18(1):294. Erratum in: Arthritis Res Ther. 2017 Jan 23;19(1):11.

ReferenceCitation: Sellam J, Rouanet S, Hendel-Chavez H, Miceli-Richard C, Combe B, Sibilia J, Le Loët X, Tebib J, Jourdan R, Dougados M, Taoufik Y, Mariette X. CCL19, a B cell chemokine, is related to the decrease of blood memory B cells and predicts the clinical response to rituximab in patients with rheumatoid arthritis. Arthritis Rheum. 2013 Sep;65(9):2253-61. doi: 10.1002/art.38023.

ReferenceCitation: Mariette X, Rouanet S, Sibilia J, Combe B, Le Loët X, Tebib J, Jourdan R, Dougados M. Evaluation of low-dose rituximab for the retreatment of patients with active rheumatoid arthritis: a non-inferiority randomised controlled trial. Ann Rheum Dis. 2014 Aug;73(8):1508-14. doi: 10.1136/annrheumdis-2013-203480. Epub 2013 May 30.

ReferenceCitation: Sellam J, Rouanet S, Hendel-Chavez H, Abbed K, Sibilia J, Tebib J, Le Loët X, Combe B, Dougados M, Mariette X, Taoufik Y. Blood memory B cells are disturbed and predict the response to rituximab in patients with rheumatoid arthritis. Arthritis Rheum. 2011 Dec;63(12):3692-701. doi: 10.1002/art.30599.

ReferenceCitation: Sellam J, Hendel-Chavez H, Rouanet S, Abbed K, Combe B, Le Loët X, Tebib J, Sibilia J, Taoufik Y, Dougados M, Mariette X. B cell activation biomarkers as predictive factors for the response to rituximab in rheumatoid arthritis: a six-month, national, multicenter, open-label study. Arthritis Rheum. 2011 Apr;63(4):933-8. doi: 10.1002/art.30233.


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

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

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Lynde CW, Alam MS, Ohson K, Gagné-Henley A, Avadisian M, Vender RB. Enhanced Effectiveness of Adalimumab Compared to Topical/Traditional Systemic Agents in the Treatment of Moderate to Severe Plaque Psoriasis: Results from a Canadian Observational Epidemiologic Study (COMPLETE-PS). Dermatol Ther (Heidelb). 2022 Apr;12(4):921-931. doi: 10.1007/s13555-022-00703-3. Epub 2022 Mar 14.

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

lead_sponsor: AbbVie

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

location_facility: Duplicate_University Hospital St. Polten /ID# 22842

location_facility: Duplicate_Univ Hosp, Plzen, CZ /ID# 27924

location_facility: Tzaneio general hospital of Piraeus /ID# 28237

location_facility: Rush University Medical Center /ID# 47604

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 17543

location_facility: Alliance Dermatology and MOHs /ID# 17087

location_facility: Dermatology Associates of Seattle /ID# 19802

location_facility: Center for Dermatology Clinical Research /ID# 20722

location_facility: Advanced Dermatology & Cosmetic Care /ID# 20511

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

location_facility: Universitaetsklinikum Leipzig /ID# 20604

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

location_facility: Dermatology Research Associates /ID# 17158

location_facility: Hospital Universitario de la Princesa /ID# 18867

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

location_facility: Premiere Clinical Research,LLC /ID# 44719

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

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

location_facility: General Hospital Andreas Syggros /ID# 22848

location_facility: Duplicate_Hospital Errikos Ntynan /ID# 28272

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

location_facility: Duplicate_Vseobecna fakultni nemoc Praze /ID# 25907

location_facility: Medizinische Universitaet Wien /ID# 18364

location_facility: Dermatology Medical Group of Oxnard /ID# 17102

location_facility: Panzer Dermatology & Cosmetic /ID# 17131

location_facility: University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 24223

location_facility: Tidewater Skin Care/Pathology /ID# 71674

location_facility: Dartmouth-Hitchcock Medical Center /ID# 20502

location_facility: Pinnacle Dermatology - Grand Blanc /ID# 40196

location_facility: NewLab Clinical Research Inc. /ID# 18360

location_facility: The Indiana Clinical Trials Center /ID# 17153

location_facility: Dermatology Associates of San Antonio /ID# 17150

location_facility: Dermatology & Laser Center NW /ID# 18324

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 37067

location_facility: Belleville Dermatology Center /ID# 17067

location_facility: CHRU de Besancon - Site Saint-Jacques /ID# 24202

location_facility: CHU Reims - Hôpital Robert Debre /ID# 37064

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

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

location_facility: The Royal Free London NHS Foundation Trust /ID# 40205

location_facility: NHS Greater Glasgow and Clyde /ID# 27956

location_facility: Duplicate_Duplicate_Oosterschelde Ziekenhuis /ID# 20462

location_facility: Northwest Georgia Dermatology /ID# 28162

location_facility: General Hospital Andreas Syggros /ID# 22847

location_facility: Allied Dermatology and Skin Surgery /ID# 28154

location_facility: Skin Physicians & Surgeons Med /ID# 40265

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 27936

location_facility: Solano Dermatology Associates /ID# 20727

location_facility: Kepler Universitaetsklinikum GmbH /ID# 27922

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

location_facility: Suncoast Dermatology and Skin Surgery Center /ID# 23067

location_facility: Gary L. Heller - Dermatology Research Cosmetic Center /ID# 17083

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

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 27934

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

location_facility: Austin Dermatology Associates /ID# 38296

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

location_facility: Eastern Washington Dermatology /ID# 17542

location_facility: Water's Edge Dermatology - Stuart /ID# 76114

location_facility: Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 22844

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 24271

location_facility: Medizinische Universitaet Wien /ID# 211020

location_facility: The Guenther Dermatology Research Centre /ID# 79196

location_facility: Arlington Research Center, Inc /ID# 23063

location_facility: Mercy Woodstock Medical Center /ID# 40186

location_facility: Universitaetsklinik Heidelberg /ID# 20601

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 28273

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

location_facility: Dermatology Treatment and Research Center, PA /ID# 17545

location_facility: Metro Hypertension and Kidney /ID# 40184

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

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

location_facility: Coastal Clinical Research Center of the Carolinas /ID# 18353

location_facility: Heights Dermatology & Aesthetic Center /ID# 28325

location_facility: Medizinische Universitaet Graz /ID# 24263

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

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 40199

location_facility: General Hospital Andreas Syggros /ID# 25905

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

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 28269

location_facility: Camelback Dermatology & Skin Surgery /ID# 18901

location_facility: Dermatologic Surgery Specialis /ID# 17149

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

location_facility: Private Practice- Dr. Tory Sullivan /ID# 17126

location_facility: Oregon Dermatology and Research Center /ID# 24327

location_facility: Skin and Laser Surgery Center /ID# 40182

location_facility: Epiphany Dermatology of Kansas LLC /ID# 19764

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 17148

location_facility: Universitaetsklinikum Frankfurt /ID# 19801

location_facility: Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 28232

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

location_facility: Texas Tech University Health Sciences Center - Lubbock /ID# 37050

location_facility: RI Dermatology & Cosmetic Ctr /ID# 40270

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 22846

location_facility: General Hospital of Giannitsa /ID# 27951

location_facility: CHRU Tours - Hopital Trousseau /ID# 28271

location_facility: Hospital General Universitario Alicante /ID# 20730

location_facility: Hospital Universitario 12 de Octubre /ID# 18365

location_facility: St Vincent's University Hospital /ID# 43149

location_facility: Univ California, San Francisco /ID# 28267

location_facility: PMG Research of Winston-Salem /ID# 17133

location_facility: Mountain State Clinical Research /ID# 28146

location_facility: Reflections Dermatology & Psoriasis canter /ID# 19781

location_facility: Fakultni nemocnice Hradec Kralove /ID# 40201

location_facility: Dermatology Associates of the Palm Beaches /ID# 17137

location_facility: Dermatology Associates of Indiana /ID# 24269

location_facility: Centre de Dermatologie Maizerets /ID# 20515

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

location_facility: Fakultni nemocnice u sv. Anny v Brne /ID# 37062

location_facility: NW GA Dermatology & Skin Cancer Specialists /ID# 17089

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 20723

location_facility: Central Dermatology Center, PA /ID# 17070

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 27942

location_facility: Duplicate_Vseobecna fakultni nemoc Praze /ID# 27933

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

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 40202

location_facility: George Washington University Hospital /ID# 24270

location_facility: Oregon Health and Science University /ID# 28143

location_facility: Panzer Dermatology & Cosmetic /ID# 17146

location_facility: Radboud Universitair Medisch Centrum /ID# 24265

location_facility: Northern Care Alliance NHS Group /ID# 40203

location_facility: Central Florida Dermatology Associates /ID# 20508

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

location_facility: Thessaloniki Hospital of Skin and Venereal Diseases /ID# 37068

location_facility: McLain Medical Associates, PC /ID# 18351

location_facility: Dermatology Associates of Seattle /ID# 18328

location_facility: Dr. Jensen Yeung Medicine Professional Corporation /ID# 28141

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 22843

location_facility: Loyola University Medical Ctr /ID# 23065

location_facility: Brigham Dermatology Associates /ID# 28207

location_facility: Cardiff & Vale University Health Board /ID# 40204

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 19763

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

location_facility: AP-HM - Hopital Sainte Marguerite /ID# 28270

location_facility: Academic Dermatology of Nevada /ID# 20513

status_simplified: Ongoing


title: Evaluation of the Effect of Probiotic Lactobacillus Paracasei Lp-33 for the Management of Rhinitis in People Sensitized to Allergens. A Double Blind Randomized Parallel Placebo Controlled Study. (GA2LEN STUDY) BIONATLANTA Project

acronym: BionAtlanta

summary: The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.

primary_purpose: Supportive Care

lead_sponsor: Merck Medication Familiale

location_facility:
Nathan ABENHAIM
Chantal MALZAC
Monique LESCOUTE
Luc ECHINARD
Bernard PRIJAC
Patrick VERDAVOINE
Sabine GRUTTER
Olivier BISCH
Sylvie CHABROL-RIVIERE
MONGIN
Dominique BLOT
Natacha HEITZ
Martine FERRE
Jacques GRAVES
Christian GIRARD
COSTA
Gérard DUGNY
Philippe BOISSON
François LE HINGRAT
Hervé MOREL
François BAYLE
Charles LOUSQUI
Judah TOLEDANO
Laurence DAGES
Sébastien CONVENT
Patrick VOGT
Reinhard RENNER
Joël ETIENNEZ
Claire PFRUNNER-SCHNEIDER
Maxime BOUMANDIL
Sylvie OLLIVIER
Florian KOMAC
Nicolas BRETON
Olivier BAISSAS
Olivier CHAIX
Maurice GAY
Baudoin PINSON
Catherine MERCEY
Gladys HAVARD
Jean Pierre CANO
Philippe PIAT
Thierry AUTARD
Guy BIRRY
Marcel RUETSCH
Christian DAUGENET
Léa ABOAF
Yves-Olivier SCHLECHT
Philippe HEUZE
Gregoire MARTOCQ
Michel CHASSAGNE
Jean Roch ALEA
Philippe CAYRON
Bernadette CHAUFFAILLE
Bruno DAUBIN
Chantal MARTIN
Robert COMBET
Catherine AYRAL
Michel AMOUYAL
Philippe MARMOR
Georgios MARKIDIS
Bernard GABBAI
Frédéric RENOU
Gabriel VENTURINI
Alain GIACOMINO
Gil MEYRAND
Gérard TELLIER
Marc BUR
Nasser GOUCHENE
Daniel FERET
Bernard CLARY
Jean-Louis WURTZ
Dominique GENOUD
Jean-Philippe RICHTER
Alain GUERRI
Jean DEFLAUX
Hélène STURCHLER
Jean Pascal SASTOURNE
Jean-Yves DOERR
Dominique EDET
Philippe GRUJARD
Stéphane BOURGHOL
Catherine BRUNET-CAZOT
Corinne SION
Philippe IMBERT
Gérard BOURREL
Hervé VILAREM
Jean Baptiste THIBERT
Jean-Baptiste DE LEMOS
Marie Pascale DEMOLY
Patrick DUTILLEUL
Pascal MABIRE
Irène LAFONT
Alain FAUDIN
Cécile BELIN-SAUGET
Raymond WESTERFELD
Georges BINET
Roland BENEDIC
Raymond ATTUIL
Claude BRUNAUD
Victor BASTIDE
Paul REGNIER-VIGOUROUX
Marie Christine BONS-GALLET
Jean François GUILLEM
Laurent TENNEZE
Thierry CANALI
Jacques RAMBAUD
Didier CADINOT
Geneviève DURANT
Christian FLAISSIER
Nicole FERRIER
Béatrice LOGNOS-FOLCO
Claire ROLLAND-JACQUEMIN
Patrick KORMANN
Véronique PEREZ
Thierry STEFANAGGI
Serge ELIE
Alain LION
Eric LIOTARD
Patrick OLOMBEL
Emmanuel DEJOUX
Claude BERNAT
Marc GARCIA
Yves MERCEY
Sophie ROSENBERG
Sonia COURTOIS

intervention_type: Dietary Supplement


acronym: Corti-TC

title: Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury

lead_sponsor: Nantes University Hospital

type: Other Identifier

ReferenceType: background

ReferenceCitation: Asehnoune K, Roquilly A, Sebille V; Corti-TC trial group. Corticotherapy for traumatic brain-injured patients--the Corti-TC trial: study protocol for a randomized controlled trial. Trials. 2011 Oct 14;12:228. doi: 10.1186/1745-6215-12-228.

ReferenceCitation: Asehnoune K, Seguin P, Allary J, Feuillet F, Lasocki S, Cook F, Floch H, Chabanne R, Geeraerts T, Roger C, Perrigault PF, Hanouz JL, Lukaszewicz AC, Biais M, Boucheix P, Dahyot-Fizelier C, Capdevila X, Mahe PJ, Le Maguet P, Paugam-Burtz C, Gergaud S, Plaud B, Constantin JM, Malledant Y, Flet L, Sebille V, Roquilly A; Corti-TC Study Group. Hydrocortisone and fludrocortisone for prevention of hospital-acquired pneumonia in patients with severe traumatic brain injury (Corti-TC): a double-blind, multicentre phase 3, randomised placebo-controlled trial. Lancet Respir Med. 2014 Sep;2(9):706-16. doi: 10.1016/S2213-2600(14)70144-4. Epub 2014 Jul 24. Erratum in: Lancet Respir Med. 2014 Sep;2(9):e15.

location_facility:
Saint Louis Hospital
University Hospital
Universtiy Hospital
University hospital
European Hospital Georges Pompidou

summary:
Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid insufficiency that is associated with a raise in the rate of pneumonia.

In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for prevention of post trauma pneumonia in a population of severe TBI patients.

lead_sponsor_type: academique


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

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

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: Yes

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

location_facility: The Jikei University Hospital /ID# 239014

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

location_facility: Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954

location_facility: Istanbul University Istanbul Medical Faculty /ID# 201953

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

location_facility: QE II Health Sciences Centre /ID# 218883

location_facility: Universitaetsklinikum Wuerzburg /ID# 200055

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

location_facility: Columbia University Medical Center /ID# 200715

location_facility: Hospital Universitario Canarias /ID# 238452

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

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

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

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

location_facility: Iwate Medical University Hospital /ID# 222849

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

location_facility: Icon Cancer Care - Townsville /ID# 206565

location_facility: Odense Universitets Hospital /ID# 223217

location_facility: Fakultni nemocnice Hradec Kralove /ID# 221291

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

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

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

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 221166

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

location_facility: Portsmouth Hospitals University NHS Trust /ID# 171444

location_facility: Seoul National University Hospital /ID# 202711

location_facility: CHU Grenoble - Hopital Michallon /ID# 223182

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

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

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

location_facility: Imperial College Healthcare NHS Trust /ID# 171446

location_facility: Soroka University Medical Center /ID# 218768

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

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

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

location_facility: Tula Regional Clinical Hospital /ID# 223226

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

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

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

location_facility: The Jikei University Kashiwa Hospital /ID# 223031

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

location_facility: Cukurova Universitesi Tip Fakultesi /ID# 201955

location_facility: Hospital Universitario de Salamanca /ID# 171294

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

location_facility: Almazov National Medical Research Centre /ID# 169681

location_facility: Hospital Universitario Virgen del Rocio /ID# 171286

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

location_facility: Hospital Universitario La Paz /ID# 218107

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

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

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

location_facility: Gazi University Medical Faculty /ID# 222698

location_facility: Duplicate_Universitetssjukhuset Linköping /ID# 200789

location_facility: Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445

location_facility: Tel Aviv Sourasky Medical Center /ID# 169437

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

location_facility: Japanese Red Cross Medical Center /ID# 171256

location_facility: Cleveland Clinic Main Campus /ID# 202247

location_facility: Tokushima University Hospital /ID# 202571

location_facility: Peking Union Medical College Hospital /ID# 216040

location_facility: Ege University Medical Faculty /ID# 222697

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

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

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

location_facility: Theageneio Anticancer Hospital /ID# 213983

location_facility: Nagoya City University Hospital /ID# 170880

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

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

location_facility: Leningrad Regional Clinical Hospital /ID# 202776

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 222914

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 171304

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

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

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

location_facility: Royal Berkshire NHS Foundation Trust /ID# 217835

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

location_facility: The Chaim Sheba Medical Center /ID# 169778

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

location_facility: Moscow State budget healthcare /ID# 169685

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

location_facility: Azienda Ospedaliera Santa Maria Terni /ID# 170948

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

location_facility: Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887

location_facility: Japanese Red Cross Osaka Hospital /ID# 171493

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

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952

location_facility: Fairview Hospital - Moll Pavilion /ID# 208919

location_facility: NHS Greater Glasgow and Clyde /ID# 202199

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

location_facility: Barbara Ann Karmanos Cancer In /ID# 201377

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

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

location_facility: Manchester University NHS Foundation Trust /ID# 171440

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

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

location_facility: Khmelnytskyi Regional Hospital /ID# 223942

location_facility: Peking University Third Hospital /ID# 216371

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

location_facility: Complejo Hospitalario Universitario Ourense /ID# 222876

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

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

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

location_facility: National University Hospital /ID# 203988

location_facility: Yamagata University Hospital /ID# 238329

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

location_facility: Universitaetsklinikum Tuebingen /ID# 238646

location_facility: University Gen Hosp of Patra /ID# 201691

location_facility: Gachon University Gil Medical Center /ID# 202827

location_facility: The Queen Elizabeth Hospital /ID# 202432

location_facility: Assuta Ashdod Medical Center /ID# 222968

location_facility: Hospital Universitario 12 de Octubre /ID# 171288

location_facility: University of Maryland School of Medicine /ID# 217422

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

location_facility: Hospital Universitari Son Espases /ID# 222889

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

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

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

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

location_facility: Nottingham University Hospitals NHS Trust /ID# 223292

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


title: Large Scale Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From Monoclonal Gammopathy of Undetermined Significance (MGUS) and Indolent Myeloma (SMM).

acronym: GENOMGUS

summary: The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.

status: Terminated

lead_sponsor: Rennes University Hospital

location_facility: Service de Médecine interne - Centre Hospitalier

location_facility: Service d'Hématologie - Hôpital de Brabois

location_facility: Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie

intervention_type: Genetic

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

acronym: SELECT-COMPARE

summary: The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

ReferenceCitation: Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 28.

ReferenceCitation: Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.

ReferenceCitation: Mysler E, Tanaka Y, Kavanaugh A, Aletaha D, Taylor PC, Song IH, Shaw T, Song Y, DeMasi R, Ali M, Fleischmann R. Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE. Rheumatology (Oxford). 2022 Aug 26. pii: keac477. doi: 10.1093/rheumatology/keac477. [Epub ahead of print]

ReferenceCitation: Peterfy CG, Strand V, Friedman A, Hall S, Mysler E, Durez P, Baraliakos X, Enejosa JV, Shaw T, Li Y, Chen S, Song IH. Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. Rheumatology (Oxford). 2022 Aug 3;61(8):3246-3256. doi: 10.1093/rheumatology/keab861.

ReferenceCitation: Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.

ReferenceCitation: Strand V, Tundia N, Bergman M, Ostor A, Durez P, Song IH, Enejosa J, Schlacher C, Song Y, Fleischmann R. Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. Rheumatology (Oxford). 2021 Dec 1;60(12):5583-5594. doi: 10.1093/rheumatology/keab158.

ReferenceCitation: Fleischmann RM, Blanco R, Hall S, Thomson GTD, Van den Bosch FE, Zerbini C, Bessette L, Enejosa J, Li Y, Song Y, DeMasi R, Song IH. Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis. Ann Rheum Dis. 2021 Apr;80(4):432-439. doi: 10.1136/annrheumdis-2020-218412. Epub 2020 Nov 4.

ReferenceCitation: Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum in: Ann Rheum Dis. 2021 May;80(5):e83.

ReferenceCitation: Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.

ReferenceCitation: Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Song IH. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. 2019 Nov;78(11):1454-1462. doi: 10.1136/annrheumdis-2019-215764. Epub 2019 Jul 30.

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:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
Kazakhstan
United States
Belgium
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Ireland
Estonia
Latvia
New Zealand
Korea, Republic of
France
Chile
Colombia

location_facility: The Vancouver Clinic, INC. PS /ID# 143107

location_facility: Centro Medico de Reumatologia /ID# 148402

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 144709

location_facility: China Medical University Hosp /ID# 143058

location_facility: Synexus Helderberg Clinical Tr /ID# 148322

location_facility: Doctor's Hosp at Renaissance /ID# 154616

location_facility: Accurate Clinical Management /ID# 145644

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 142966

location_facility: Achieve Clinical Research, LLC /ID# 143136

location_facility: Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062

location_facility: AZ Arthritis & Rheum Research /ID# 156093

location_facility: Daegu Catholic University Med /ID# 142973

location_facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 142954

location_facility: Consultora Integral de Salud S /ID# 144856

location_facility: Arthritis Clinical Research Tr /ID# 144874

location_facility: Kazan State Medical University /ID# 144871

location_facility: FL Med Ctr and Research, Inc. /ID# 143081

location_facility: JSC Nat Scientific Med Res Ctr /ID# 142971

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 143135

location_facility: St Vincent's University Hosp /ID# 142957

location_facility: Klinicki bolnicki centar Split /ID# 152530

location_facility: Lviv Municipal City Clinical /ID# 143068

location_facility: Chungnam National University Hospital /ID# 142977

location_facility: Rheumatology Clinic of Houston /ID# 150921

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 145618

location_facility: Kyungpook National Univ Hosp /ID# 162073

location_facility: Ctr for Arth and Rheum Disease /ID# 143113

location_facility: Arthritis & Osteoporosis Assoc /ID# 147364

location_facility: Semey State Medical University /ID# 152659

location_facility: Hospital Raja Perempuan Zainab II /ID# 157862

location_facility: North Georgia Rheumatology Grp /ID# 147170

location_facility: RM Pharma Specialists, S.A de C.V /ID# 142994

location_facility: Centro Integral de Reumatologi /ID# 142845

location_facility: Vital Medical Center Orvosi es /ID# 145950

location_facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091

location_facility: Aprillus Asistencia e Investig /ID# 148406

location_facility: NW State Med Univ NA Mechnikov /ID# 143022

location_facility: Reumatologicka ambulancia, LER /ID# 143044

location_facility: Coastal Carolina Health Care /ID# 148359

location_facility: Malopolskie Centrum Kliniczne /ID# 152782

location_facility: City Clinical Hospital Botkina /ID# 145628

location_facility: Clinical Research Ctr Reading /ID# 143133

location_facility: Chonnam National University Hospital /ID# 142975

location_facility: H. Un. Marques de Valdecilla /ID# 143050

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960

location_facility: Hevizgyogyfurdo es Szent Andra /ID# 142949

location_facility: The Center for Rheumatology & /ID# 151356

location_facility: Ulyanovsk Regional Clin Hosp /ID# 143030

location_facility: Spitalul Clinic Dr. I. Cantacuzino /ID# 143017

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 142976

location_facility: Jakaranda Hosp, Emmed Research /ID# 145968

location_facility: Centrum Medyczne AMED Warszawa Targowek /ID# 157621

location_facility: Accurate Clinical Management /ID# 143089

location_facility: NSC-Strazhesko Ist Cardiology /ID# 152030

location_facility: University of Arizona Cancer Center - North Campus /ID# 143114

location_facility: AZ Arthritis & Rheuma Research /ID# 143131

location_facility: C.V. Mehta MD, Med Corporation /ID# 143116

location_facility: Quality Clinical Research Inc. /ID# 156394

location_facility: Cliniques Universitaires Saint Luc /ID# 142858

location_facility: Kaohsiung Medical University /ID# 143059

location_facility: University Clinical Centre of the Republic of Srpska /ID# 142863

location_facility: Clinical Pharmacology Study Gr /ID# 143082

location_facility: AOU Citta della Salute Scienza /ID# 150070

location_facility: Arizona Research Center, Inc. /ID# 144877

location_facility: Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063

location_facility: Revita Reumatologiai Rendelo /ID# 142950

location_facility: University Clinical Centre of the Republic of Srpska /ID# 142862

location_facility: Karaganda State Medical Univ /ID# 153433

location_facility: Istanbul Universitesi Cerrahpa /ID# 156088

location_facility: Riga East Clinical Univ Hosp /ID# 142981

location_facility: ClinicMed Badurski i wspolnicy SJ /ID# 163300

location_facility: Republican clinical hospital n /ID# 145626

location_facility: North Estonian Medical Centre /ID# 145454

location_facility: Clinical Center of Vojvodina /ID# 143033

location_facility: Healthcare Research Consultant /ID# 143129

location_facility: Arthritis Care and Diagnostic /ID# 150677

location_facility: Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890

location_facility: AZ Arthritis and Rheum Researc /ID# 143121

location_facility: Lovelace Scientific Resources /ID# 143106

location_facility: Riesgo de Fractura S.A - CAYRE /ID# 142896

location_facility: Rheumatology and Immunotherapy Center /ID# 145646

location_facility: Warrington + Halton Hosp NHS /ID# 143075

location_facility: East Tallinn Central Hospital /ID# 142923

location_facility: Diagnostic Consultative Center /ID# 142875

location_facility: Spitalul Clinic de Recuperare /ID# 144867

location_facility: University General Hospital Attikon /ID# 142933

location_facility: CHU de Rennes - Hospital Sud /ID# 151957

location_facility: Mautalen Salud e Investigacion /ID# 142843

location_facility: Centro Integral de Reumatologi /ID# 142897

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898

location_facility: Arthritis Research of Florida /ID# 143125

location_facility: Arthritis Rheumatic Back Disorder /ID# 143102

location_facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 142992

location_facility: Solumed Sp. zoo Cent Medyczne /ID# 152783

location_facility: Taipei Veterans General Hosp /ID# 157940

location_facility: Investigaciones Medicas SSMSO /ID# 151686

location_facility: LMU Klinikum der Universität München /ID# 142931

location_facility: Kiskunhalasi Semmelweis Korhaz /ID# 151944

location_facility: Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138

location_facility: Albuquerque Clinical Trials, Inc /ID# 143083

location_facility: CCA Braga - Hospital de Braga /ID# 148317

location_facility: Klinicki bolnicki centar Rijeka /ID# 160232

location_facility: Ryazan State Medical Universit /ID# 143031

location_facility: Consultorio Reumatologic Pampa /ID# 144853

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 143055

location_facility: General Hospital of Athens Laiko /ID# 142934

location_facility: Winelands Medical Research Ctr /ID# 143048

location_facility: Clinical Res of West FL, Inc. /ID# 143112

location_facility: Timaru Medical Specialists Ltd /ID# 143000

location_facility: A.O.U.I. di Verona Policlinico /ID# 142963

location_facility: Zaporizhzhia Regional Clinical /ID# 143069

location_facility: Moscow State Univ Med and Dent /ID# 145623

location_facility: Ctr Int de Reum del Caribe SAS /ID# 142894

location_facility: TriWest Research Associates- La Mesa /ID# 143115

location_facility: General Hospital of Athens Ippokratio /ID# 142935

location_facility: Russian National Research Medi /ID# 143028

location_facility: Seoul National University Hospital /ID# 142978

location_facility: Physician Res. Collaboration /ID# 143087

location_facility: Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871

location_facility: Clinical Center University of Sarajevo /ID# 142865

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071

location_facility: Centro Peninsular de Investiga /ID# 148159

location_facility: Royal Prince Alfred Hospital /ID# 144857

location_facility: Comple Hosp Univ de A Coruna /ID# 143051

location_facility: Tver Regional Clinical Hosp. /ID# 143026

location_facility: Hosp Lithuanian Univ Health Sc /ID# 142986

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622

location_facility: Inst. Rheumatologic Strusberg /ID# 145601

location_facility: Clinical Research Solutions, LLC /ID# 154619

location_facility: Centro Hospitalar De Vila Nova /ID# 143010

location_facility: Invest y Biomed de Chihuahua /ID# 142996

location_facility: Nuselská poliklinika, Revmatologie /ID# 144862

location_facility: Advanced Clin Res of Orlando /ID# 154617

location_facility: Revmatologie MUDr. Klara Sirov /ID# 142908

location_facility: Chung Shan Medical University /ID# 143060

location_facility: Spitalul Clinic Dr. I. Cantacuzino /ID# 143012

location_facility: AZ Arthritis and Rheum Assoc /ID# 143130

location_facility: Centro Inter Estud Clin CIEC /ID# 144777

location_facility: Arthritis Center of North GA /ID# 155258

location_facility: Reg. Clinical Hosptial Concepcion /ID# 151271

location_facility: Rheumatology Ctr of San Diego /ID# 153747

location_facility: Arthritis and Rheum Clin N. CO /ID# 156094

location_facility: Hopital Universitaire Purpan /ID# 144707

location_facility: Slovak research center Team Member, Thermium s.r.o. /ID# 147614

location_facility: Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169

location_facility: Odessa National Medical Univ /ID# 143072

location_facility: Houston Institute for Clin Res /ID# 144879

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 151312

location_facility: Diagnostic Group Integrated He /ID# 148356

location_facility: Innovative Clinical Research /ID# 145637

location_facility: Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293

location_facility: Pioneer Research Solutions, Inc. /ID# 145640

location_facility: Markusovszky Egyetemi Oktatókórház /ID# 145621

location_facility: Unidade Local De Saude Do Alto Minho /ID# 143009

location_facility: Linkou Chang Gung Memorial Ho /ID# 143057

location_facility: Joint & Muscle Research Instit /ID# 143119

location_facility: Orenburg State Medical Academy /ID# 143018

location_facility: Jakaranda Hosp, Emmed Research /ID# 143046

location_facility: Hospital Universitario Reina S /ID# 153566

location_facility: Center of Clinical and Basic Research /ID# 142922

location_facility: Instituto Portugues De Reumatologia /ID# 148316

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 152871

location_facility: AZ Arthritis and Rheum Researc /ID# 143080

location_facility: Arthritis & Osteo Ctr of S. TX /ID# 143103

location_facility: First City Clinical Hospital /ID# 158011

location_facility: Family Outpatient clinic#4,LLC /ID# 148319

location_facility: Revmatologicka a interni ambul /ID# 142907

location_facility: International Medical Research /ID# 143132

location_facility: SunValley Arthritis Center, Lt /ID# 143123

location_facility: Far Eastern Memorial Hospital /ID# 143061

location_facility: Daugavpils Regional Hospital /ID# 142982

location_facility: CHU Strasbourg Hautepierre Hos /ID# 144708

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867

location_facility: SW FL Clin Res Ctr, Tampa, FL /ID# 143117

location_facility: North Mississippi Med Clinics /ID# 145636

location_facility: St. Anthony Comprehsve Res Ins /ID# 143095

location_facility: Arthritis Clinic of N. VA, P.C /ID# 143109

location_facility: Med Versorgungszentrum AGILOME /ID# 154975

location_facility: Lviv Regional Clinical Hospita /ID# 154450

location_facility: Perm Clinical Center of FMBA /ID# 145627

location_facility: Hanyang University Seoul Hospi /ID# 142979

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951

location_facility: Groupe de Recherche en Maladies Osseuses /ID# 142878

location_facility: Hospital de Clinicas de Porto Alegre /ID# 142870

location_facility: Rheumatology Consultants, PLLC /ID# 153731

location_facility: CIP - Centro Internacional de Pesquisa /ID# 142872


title: A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination With Induction Chemotherapy, or Azacitidine and Idarubicin as Salvage Therapy and Idarubicin With Cytarabine or Azacitidine as Maintenance Therapy in Older Patients With Acute Myeloblastic Leukemia (AML)

summary:
A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML).

To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

status: Withdrawn

lead_sponsor: Acute Leukemia French Association

location_facility:
Hopital Edouard Herriot
St Antoine Hospital
Hopital Pitie-Salpetriere
Necker Hospital
IGR
Hopital Henri Mondor
Ch Rene Dubos
Centre Antoine Lacassagne
Hopital Saint-Louis
Hopital Avicenne
Ch Sud Francilien
CHU
Ch Dunkerque
CNLCC
CH
Chu Amiens Sud
Hopital Percy
Chu Boulogne Sur Mer


title: A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

ReferenceCitation: Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250.

location_country:
Denmark
Poland
Romania
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Ukraine
Hungary
United States
France
Israel
Belgium
Japan
Germany
Slovakia
Czechia

location_facility: H-T.Centrum Medyczne-Endoterapia /ID# 170305

location_facility: Consultants for Clinical Res /ID# 122304

location_facility: Shiga University of Medical Science Hospital /ID# 127675

location_facility: Universitatsklinikum Magdeburg /ID# 127200

location_facility: GI National Institute of Therapy named by L.T. Malaya /ID# 127231

location_facility: Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233

location_facility: Policlinico Agostino Gemelli /ID# 127217

location_facility: Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199

location_facility: Icahn School of Med Mt. Sinai /ID# 127047

location_facility: The Oregon Clinic- Gastro West /ID# 135273

location_facility: Hepato-Gastroenterologie HK s.r.o. /ID# 127188

location_facility: Gastroenterology Group Naples /ID# 127806

location_facility: MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238

location_facility: COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423

location_facility: Ordination Hainburg an der Don /ID# 127185

location_facility: Ospedali Riuniti Villa Sofia-C /ID# 129323

location_facility: Medical Hospital of Tokyo Medical and Dental University /ID# 128315

location_facility: Kitasato Univ Kitasato Inst Ho /ID# 127001

location_facility: Tel Aviv Sourasky Medical Center /ID# 201365

location_facility: Kitasato University Hospital /ID# 137694

location_facility: Hadassah University Hospital /ID# 127211

location_facility: Hiroshima University Hospital /ID# 124496

location_facility: Policlinico Univ Tor Vergata /ID# 129321

location_facility: Ctr for Digest and Liver Dis /ID# 122182

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215

location_facility: Centrum Medyczne LukaMed Joanna Luka /ID# 170302

location_facility: Hospital Clinic de Barcelona /ID# 138147

location_facility: Toronto Digestive Disease Asso /ID# 127075

location_facility: Nagoya City University Hospital /ID# 124517

location_facility: Gastroenterologicka Ambulancia /ID# 125632

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 127216

location_facility: Municipal Clinical Hospital #8 /ID# 127235

location_facility: CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480

location_facility: Texas Digestive Disease Consul /ID# 141678

location_facility: Hospital General Universitario Gregorio Maranon /ID# 127224

location_facility: Hospital General Universitario de Alicante /ID# 129261

location_facility: Universitatsklinik Regensburg /ID# 201265

location_facility: Research Associates of South Florida,LLC /ID# 170309

location_facility: Pannonia Maganorvosi Centrum Kft. /ID# 127207

location_facility: Digestive Health Specialists of the Southeast /ID# 127844

location_facility: CHU NANCY - Hôpital Brabois Adultes /ID# 127196

location_facility: Hospital Univ de la Princesa /ID# 135828

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209

location_facility: Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324

location_facility: New River Valley Research Inst /ID# 127801

location_facility: Hyogo College of Medicine College Hospital /Id# 127539

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138

location_facility: Japanese Red Cross Kyoto Daiichi Hos /ID# 127540

location_facility: University of Michigan Hospitals /ID# 122240

location_facility: Azienda Ospedaliera Spedali Civili /ID# 127236

location_facility: Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002

location_facility: Biopharma Informatic Research /ID# 171150

location_facility: Fukuoka University Chikushi Hospital /ID# 124155

location_facility: KO-Med Centra Kliniczne Pulawy /ID# 127219

location_facility: KH der Elisabethinen Linz GmbH /ID# 127184

location_facility: Magyar Elhizastudomanyi KKft. /ID# 126589

location_facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203

location_facility: Northwestern University Feinberg School of Medicine /ID# 122183

location_facility: Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322

location_facility: Osaka Medical College Hospital /ID# 126451

location_facility: Soroka University Medical Center /ID# 127213

location_facility: Froedtert & the Medical College of Wisconsin /ID# 122261

location_facility: Hull and East Yorkshire Hospitals NHS Trust /ID# 127225

location_facility: Shafran Gastroenterology Ctr /ID# 122320

location_facility: CHU de Grenoble - Albet Michal /ID# 127195

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 134490

location_facility: University of Maryland Med Ctr /ID# 169734

location_facility: Complejo Hospitalario Universitario de Ferrol /ID# 127840

location_facility: The Royal Wolverhampton NHS Tr /ID# 127227

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 125418

location_facility: Norfolk and Norwich Univ Hosp /ID# 127139

location_facility: Erlanger Institute for Clinica /ID# 129009

location_facility: Southampton General Hospital /ID# 127228

location_facility: Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141

location_facility: Winnipeg Regional Health Autho /ID# 125712

location_facility: Medizinische Universitat Wien /ID# 127186

location_facility: Toho University Sakura Medical Center /ID# 124497

location_facility: Centrum Medyczne Pratia Gdynia /ID# 170301

location_facility: Dayton Gastroenterology, Inc. /ID# 127804

location_facility: C.M. Szpital Swietej Rodziny /ID# 127838

location_facility: Asklepios Westklinikum Hamburg /ID# 127198

location_facility: Universitaetsklinik fuer Innere Medizin 1 /ID# 125944

location_facility: Texas Digestive Disease Consul /ID# 141677

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322

location_facility: Wake Research Associates, LLC /ID# 122157

location_facility: Hospital Universitario La Paz /ID# 127223

location_facility: Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222

location_facility: Rocky Mountain Clinical Resear /ID# 122180

location_facility: London Health Sciences Centre /ID# 127055

location_facility: Universitatsklinikum Frankfurt /ID# 170300

location_facility: Lviv City Clinical Hospital NO.4 /ID# 127232

location_facility: Hidaka Clinic of Coloproctology /ID# 125477

location_facility: Centrum Diagnostyczno Lecznicze Barska /ID# 170304

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 127197

location_facility: Austin Center for Clinical Research /ID# 125396

intervention_type: Other


title: A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) - STRIVE

acronym: STRIVE

summary: This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years from the enrollment date into one of the treatment arms.

location_country:
Denmark
Portugal
Spain
Greece
Austria
Australia
Italy
Netherlands
Sweden
Hungary
Puerto Rico
United States
France
Norway
Germany
Slovakia
Czechia

location_facility: CHU Strasbourg - Hopital de Hautepierre /ID# 25450

location_facility: Children's Hosp P. A. Kyriakou /ID# 25448

location_facility: Center Rheumatology Child&Adol /ID# 39069

location_facility: Universitair Medisch Centrum Utrecht /ID# 48842

location_facility: Medizinische Universitaet Wien /ID# 26127

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 41623

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 42682

location_facility: Methodist Medical Group Rheum /ID# 46343

location_facility: Children's National Medical Center /ID# 23506

location_facility: Azienda Ospedaliero Universitaria Meyer /ID# 26123

location_facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966

location_facility: CHRU Tours - Hopital Bretonneau /ID# 27126

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 95863

location_facility: Catalina Pointe Clinical Research /ID# 40227

location_facility: Duplicate_Azienda Ospedaliera Spedali Civili /ID# 39077

location_facility: Duplicate_Universita di Catania /ID# 39075

location_facility: Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 39223

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 47401

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 25452

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 39072

location_facility: Duplicate_Rigshospitalet, Finsen Centre /ID# 25444

location_facility: Asklepios Klinik Sankt Augustin /ID# 41622

location_facility: Hospital Universitario Vall d'Hebron /ID# 37357

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 21023

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 39074

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 25454

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 26124

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 39081

location_facility: North Shore University Hospital /ID# 21022

location_facility: Puerto Rico Children Hospital /ID# 47742

location_facility: Hospital Universitario Severo Ochoa /ID# 41751

location_facility: Arthritis Associates of Kingsport /ID# 44462

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 37360

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 25449

location_facility: The University of Chicago Medical Center /ID# 21981

location_facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 46402

location_facility: Centro de Reumatologia Pediatrico de Puerto Rico /Id# 61047

location_facility: Narodny ustav reumatickych chorob /ID# 38102

location_facility: Kepler Universitaetsklinikum GmbH /ID# 39068

location_facility: Duplicate_Universita di Napoli Federico II /ID# 39078

location_facility: Universitaetsklinikum Tuebingen /ID# 39070

location_facility: Medizinische Universitaet Graz /ID# 26126

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 95095

location_facility: Children's Hospital Wisconsin - Milwaukee Campus /ID# 40226

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 25447

location_facility: Legacy Emanuel Medical Center /ID# 14102

location_facility: Nationwide Childrens Hospital /ID# 21963

location_facility: Hospital Universitario y Politecnico La Fe /ID# 37359

location_facility: Duplicate_Arthritis Associates South FL /ID# 17001

location_facility: Duplicate_Womens and Childrens Hospital /ID# 59182

location_facility: Hospital Universitario Ramon y Cajal /ID# 41624

location_facility: Duplicate_CHU de Rennes - Hospital Sud /ID# 27123

intervention_type: Biological


acronym: ALIAS

title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

lead_sponsor: Novartis

ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10:CD012569. doi: 10.1002/14651858.CD012569.pub2.

location_facility:
Novartis Investigative Site
Investigative Site
Novartis Investigator Site

summary: This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.


title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment

acronym: GRATSEC

summary:
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.

It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.

follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.

During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau

intervention_type: Procedure


primary_purpose: Prevention

title: A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

lead_sponsor: Pfizer

design_allocation: Non-Randomized

summary: This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.


title: A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA

summary: The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II study, the study assesses, duration of erythroid response, overall survival and time to progression as well as toxicity.

ReferenceCitation: Thépot S, Ben Abdelali R, Chevret S, Renneville A, Beyne-Rauzy O, Prébet T, Park S, Stamatoullas A, Guerci-Bresler A, Cheze S, Tertian G, Choufi B, Legros L, Bastié JN, Delaunay J, Chaury MP, Sanhes L, Wattel E, Dreyfus F, Vey N, Chermat F, Preudhomme C, Fenaux P, Gardin C; Groupe Francophone des Myélodysplasies (GFM). A randomized phase II trial of azacitidine +/- epoetin-β in lower-risk myelodysplastic syndromes resistant to erythropoietic stimulating agents. Haematologica. 2016 Aug;101(8):918-25. doi: 10.3324/haematol.2015.140988. Epub 2016 May 26.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Hôpital Boulogne Sur Mer
Hôpital Edouard Herriot
Hôpital Henri Becquerel
Hopital Clémenceau
Hôpital Cochin
Hôpital Versailles
Hôpital Hautepierre
Hôpital Maréchal Joffre
Hôpital de la Côte Basque
Hopital Avicenne
Hôpital le Bocage
Hôpital Saint Vincent
Hôpital Avignon
Hôpital Reims
Hôpital Saint Antoine
Hôpital Huriez
Hôpital Saint Louis
Hôpital Hôtel Dieu
Hôpital Jean-Bernard
Hôpital Paoli-Calmettes
Hôpital Lariboisière
Hôpital Purpan
CHU d'Amiens
Hôpital Limoges
Hôpital Archet1
Hôpital Brabois
Hôpital Angers
Hôpital kremlin Bicêtre
Hôpital La Source