title: Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)

acronym: UPHOLD

summary:
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide.

Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months.

There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_country:
Italy
Austria
United Arab Emirates
Saudi Arabia
Switzerland
Mexico
Spain
Uruguay
France
Greece
Israel
Kuwait
Ireland
Argentina
Australia
Belgium
Russian Federation
Germany

location_facility: Omsk Regional Clinic Hospital /ID# 232029

location_facility: CHU de Rennes - Hospital Sud /ID# 222458

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 222452

location_facility: Pôle de Santé du Villeneuvois /ID# 222459

location_facility: CHR Orleans - Hopital de la Source /ID# 223591

location_facility: Cabinet de Rhumatologie Poincare /ID# 224755

location_facility: Departnent of Medicine-Rheumatology Al Baraha Hospital and Al Qasmi Hospital Min /ID# 223178

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 239164

location_facility: Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 224360

location_facility: A.0.Ordine Mauriziano/Ospedale Umberto I di Torino /ID# 228888

location_facility: Groupe Médical Spécialisé - Le Premium /ID# 223719

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 229086

location_facility: Hôpital d'instruction des armées Bégin /ID# 222440

location_facility: Private practice Sint-Niklaas /ID# 224123

location_facility: Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Trento /ID# 228553

location_facility: Praxis fuer Rheumatologie und Innere Medizin /ID# 225222

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 222449

location_facility: Praxis internistische Rheumatologie /ID# 239226

location_facility: Republican hospital named after V.A. Baranov /ID# 227661

location_facility: Helios Fachklinik Vogelsang-Gommern /ID# 222949

location_facility: Hospital Santa Creu i Sant Pau /ID# 231821

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 228807

location_facility: Drt Sulaiman Al Habib Hospital /ID# 226575

location_facility: Voronezh State Medical Univers /ID# 224854

location_facility: Hospital Universitario Virgen del Rocio /ID# 231836

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 229965

location_facility: MVZ Ambulantes Rheumazentrum Erfurt /ID# 224812

location_facility: Centre Hospitalier d'Angouleme /ID# 226064

location_facility: 251 Airforce General Hospital /ID# 225065

location_facility: Hopital de la Cavale Blanche /ID# 222462

location_facility: AP-HP - Hopital Saint-Antoine /ID# 222441

location_facility: CIER Centro de Investigaciones en Enfermedades Reumaticas /ID# 231769

location_facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228160

location_facility: CH Bigorre - Site de la Gespe /ID# 225141

location_facility: CHU Grenoble - Hopital Michallon /ID# 223211

location_facility: Azienda Ospedaliera Civico Di Cristina Benfratelli- P.O. Civico /ID# 228912

location_facility: Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 223866

location_facility: Azienda Ospedaliera Regionale San Carlo /ID# 228648

location_facility: St Vincent's University Hospital /ID# 224200

location_facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 227942

location_facility: ASST Spedali civili di Brescia /ID# 228970

location_facility: Centre Hospitalier de Boulogne Sur Mer /ID# 222991

location_facility: Organizacion Medica de Investigacion (OMI) /ID# 222187

location_facility: The Chaim Sheba Medical Center /ID# 222034

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 225787

location_facility: CHU Strasbourg - Hopital de Hautepierre /ID# 222450

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 223394

location_facility: University General Hospital Attikon /ID# 224136

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 228554

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 231818

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 228889

location_facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 228788

location_facility: cabinet liberal- Dr CORNILLE /ID# 227869

location_facility: CH Emile Roux Le Puy en Velay /ID# 223688

location_facility: ASL 3 Genovese - Ospedale la Colletta /ID# 228892

location_facility: Centre des Soins Ostéoarticulaires /ID# 224737

location_facility: GH Diaconesses Croix Saint-Simon /ID# 229126

location_facility: Nebbiolo Clinical Research Center /ID# 224900

location_facility: Tel Aviv Sourasky Medical Center /ID# 222117

location_facility: University General Hospital of Alexandroupolis /ID# 224880

location_facility: ELSAN - Clinique du Pont de Chaume /ID# 224898

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 229061

location_facility: Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 227852

location_facility: Private Practice - Scott Walter Graf /ID# 223958

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 229057

location_facility: General Hospital Asklepieio Voulas /ID# 224131

location_facility: Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 224364

location_facility: General University Hospital of Thessaloniki AXEPA /ID# 224879

location_facility: Cabinet liberal - Compiegne - Dr Banse /ID# 227099

location_facility: CHUV, Centre hospitalier universitaire vaudois /ID# 224161

location_facility: Fondazione IRCCS Policlinico /ID# 227937

location_facility: Hospital Universitario Virgen Macarena /ID# 231837

location_facility: Centre de rhumatologie d'Aubagne /ID# 240957

location_facility: Cabinet Rhumatologie St Michel Sur Orge /ID# 225176

location_facility: Rheumatologische-Immunologische Praxis Templin /ID# 226924

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 224361

location_facility: GBUZ TO Regional Clinical Hospital No. 1 /ID# 241113

location_facility: Dres. Teipel/Toussaint/Saech /ID# 226923

location_facility: Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 229065

location_facility: CH La Rochelle - Hopital Saint Louis /ID# 224240

location_facility: CHRU Tours - Hopital Trousseau /ID# 222445

location_facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 227853

location_facility: Hospital Universitario Virgen de las Nieves /ID# 231841

location_facility: Cabinet libéral du Dr PAUPIERE /ID# 238723

location_facility: Eisterhues, Braunschweig, DE /ID# 225186

location_facility: ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 228556

location_facility: General Hospital of Patras Agios Andreas /ID# 224132

location_facility: CHU de Besancon - Jean Minjoz /ID# 222463

location_facility: Hospital Universitario Virgen de Valme /ID# 231838

location_facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 240836

location_facility: Universitair Ziekenhuis Antwerpen /ID# 222795

location_facility: MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 226926

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 239921

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228551

location_facility: Algemeen Stedelijk Ziekenhuis /ID# 224121

location_facility: Tallaght University Hospital /ID# 231260

location_facility: CHU Amiens-Picardie Site Sud /ID# 222444

location_facility: Cabinet rhumatologie Dr NECTOUX /ID# 225828

location_facility: HOPITAUX DU LEMAN Site Georges PIANTA - THONON /ID# 229043

location_facility: Centre Hospitalier Jean Rougie /ID# 224242

location_facility: Inselspital, Universitätsspital Bern /ID# 224951

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 229063

location_facility: Centro Integral en Reumatologia S.A de C.V /ID# 224363

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 229440

location_facility: CH Roubaix - Hopital Victor Provo /ID# 225032

location_facility: Hospital Universitario de Jaen /ID# 231842

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 228580

location_facility: HFR Fribourg - Hôpital cantonal /ID# 224163

location_facility: Rheumapraxis Prof Dr Karin Manger /ID# 224086

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 224133

location_facility: CHU Lille - Hôpital Roger Salengro /ID# 223170

location_facility: CH Cannes - les Broussailles /ID# 226160

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 224837

location_facility: RM Pharma Specialists S.A de C.V /ID# 224359

location_facility: Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 227938

location_facility: The Lady Davis Carmel Medical Center /ID# 223851

location_facility: Integrated Rheumatology and Arthritis Center /ID# 223177

location_facility: Clinic of Samara State Medical University /ID# 241168

location_facility: King Abdulaziz University Hospital /ID# 222724

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 222456

location_facility: Hospital General de Granollers /ID# 238778

location_facility: Centre Hospitalier de CHOLET /ID# 222455

location_facility: Yaroslavl State Medicat University /ID# 224851

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 228014

location_facility: General Hospital of Athens Gennimatas /ID# 225064

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 228550

location_facility: CHU UCL Namur - site Godinne /ID# 222797

location_facility: CHU Toulouse - Hopital Purpan /ID# 223150

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 224852

location_facility: General Hospital of Athens Ippokratio /ID# 224164

location_facility: Hospital Universitario Reina Sofia /ID# 231843

location_facility: Rheumatologisches Versorgungszentrum Weinfelden /ID# 222346

location_facility: Nort-Western State Medical University n.a. Mechnikov /ID# 223419


design_allocation: Non-Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Guatemala
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Singapore
Hungary
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032)

location_facility: Universitaetsklinikum Essen ( Site 2404)

location_facility: Sotiria Regional Chest Diseases Hospital of Athens ( Site 1850)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0012)

location_facility: Canterbury Regional Cancer & Blood Service ( Site 1500)

location_facility: Universitaetsklinikum des Saarlandes ( Site 2411)

location_facility: Medizinische Hochschule Hannover ( Site 2402)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 2807)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1501)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 2805)

location_facility: National Cancer Center Hospital East ( Site 3121)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 2403)

location_facility: National Cancer Institute-Chemotherapy departament with day care unit ( Site 3301)

location_facility: Odessa Regional Oncology Center ( Site 3655)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 0802)

location_facility: Instituto de Oncologia de Rosario ( Site 1350)

location_facility: Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 2905)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0851)

location_facility: Centre Hopitalier Intercommunal Creteil ( Site 2514)

location_facility: Yamaguchi University Hospital ( Site 3114)

location_facility: Oslo Universitetssykehus Ullevål-Avdeling for kreftbehandling, Ullevål ( Site 1452)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 1958)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 3203)

location_facility: Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 2522)

location_facility: National Taiwan University Hospital ( Site 3200)

location_facility: Aichi Cancer Center Hospital ( Site 3101)

location_facility: Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0

location_facility: Melanoma Institute Australia ( Site 3001)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0863)

location_facility: The Angeles Clinic and Research Institute ( Site 0005)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 3109)

location_facility: Klaipeda University Hospital-Oncology chemotherapy ( Site 3302)

location_facility: Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 1964)

location_facility: Administradora Country S.A. ( Site 2701)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1000)

location_facility: Istituto di Candiolo - IRCCS ( Site 1960)

location_facility: Hyogo College of Medicine Hospital ( Site 3100)

location_facility: National Cancer Center Hospital ( Site 3130)

location_facility: James Graham Brown Cancer Center ( Site 0058)

location_facility: National Cancer Centre Singapore ( Site 2200)

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525)

location_facility: Transcarpathian Regional Clinical Oncology Center-Chemotherapy dept. ( Site 3652)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 3452)

location_facility: Universitatsklinikum Carl Gustav Carus ( Site 2407)

location_facility: IRCCS CRO Aviano, Hematology/Oncology ( Site 1957)

location_facility: Azienda Ospedaliera Santa Maria ( Site 1962)

location_facility: Osaka International Cancer Institute-Gynecologic Oncology ( Site 3129)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 2058)

location_facility: National Hospital Organization Himeji Medical Center ( Site 3111)

location_facility: Nara Medical University Hospital ( Site 3110)

location_facility: Helse Bergen Haukeland universitetssykehus ( Site 1451)

location_facility: Princess Alexandra Hospital ( Site 3002)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 2515)

location_facility: Hadassah Ein Kerem Medical Center ( Site 2051)

location_facility: IRCCS A.O.U. San Martino - IST ( Site 1961)

location_facility: Hospital Clinico San Carlos ( Site 0857)

location_facility: West Cancer Center and Research Institute ( Site 0055)

location_facility: Austin Health-Austin Hospital ( Site 3004)

location_facility: Taipei Veterans General Hospital ( Site 3202)

location_facility: Georgetown University Medical Center ( Site 0023)

location_facility: CHA Bundang Medical Center CHA University ( Site 0957)

location_facility: UZ Leuven Gasthuisberg, Gynaecologie-Verloskunde ( Site 2907)

location_facility: Kaiser Permanente Moanalua Medical Center ( Site 0063)

location_facility: University of North Carolina at Chapel Hill ( Site 0040)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1401)

location_facility: Princess Margaret Cancer Centre ( Site 2803)

location_facility: St.Luke's International Hospital ( Site 3120)

location_facility: Wakayama Medical University Hospital ( Site 3124)

location_facility: Cancer Institute of New Jersey ( Site 0025)

location_facility: Hospital General Universitario 12 de Octubre ( Site 0856)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0513)

location_facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 1969)

location_facility: South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1300)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0007)

location_facility: University of Colorado Cancer Center ( Site 0021)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1403)

location_facility: The Cancer Institute Hospital of JFCR ( Site 3108)

location_facility: Hospital Clinico de Valencia ( Site 0858)

location_facility: Vanderbilt Ingram Cancer Center ( Site 0015)

location_facility: Osaka City General Hospital ( Site 3125)

location_facility: St John of God Subiaco Hospital ( Site 3013)

location_facility: Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1201)

location_facility: Sunnybrook Research Institute ( Site 2802)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 1205)

location_facility: Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 2906)

location_facility: Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031)

location_facility: Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3656)

location_facility: Royal Brisbane and Women s Hospital ( Site 3009)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: Sir Charles Gairdner Hospital ( Site 3006)

location_facility: Universitaetsspital Zuerich ( Site 0750)

location_facility: Istituto Europeo di Oncologia ( Site 1952)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1001)

location_facility: Gallipoli Medical Research Foundation ( Site 3011)

location_facility: Universitätsklinikum Erlangen ( Site 2408)

location_facility: Universitaetsklinik Muenchen ( Site 2406)

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1968)

location_facility: Queen Mary Hospital-Department of Medicine (Respiratory) ( Site 1900)

location_facility: University of Iowa Hospital and Clinics ( Site 0026)

location_facility: Seoul National University Bundang Hospital ( Site 0951)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1301)

location_facility: St. Luke's University Health Network ( Site 0017)

location_facility: Tampere University Hospital [Tampere Finland] ( Site 0600)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0043)

location_facility: MedStar Franklin Square Medical Center ( Site 0046)

location_facility: Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060)

location_facility: Medizinische Universitaet Wien, Universitaetsklinik fuer Dermatologie ( Site 2953)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1203)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2808)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0864)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0510)

location_facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 1308)

location_facility: Seattle Cancer Care Alliance ( Site 0024)

location_facility: Fakultni nemocnice v Motole ( Site 0700)

location_facility: Tasman Oncology Research Pty Ltd ( Site 3012)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0506)

location_facility: London Regional Cancer Program - LHSC ( Site 2806)

location_facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 0062)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 3116)

location_facility: University of Arizona Cancer Center ( Site 0018)

location_facility: Dana-Farber Cancer Institute ( Site 0006)

location_facility: UPR Comprehensive Cancer Center ( Site 1150)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056)

location_facility: Odense Universitetshospital ( Site 0650)

location_facility: Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016)

location_facility: Seoul National University Hospital ( Site 0953)

location_facility: University Malaya Medical Centre ( Site 0626)

location_facility: Peter MacCallum Cancer Centre ( Site 3008)

location_facility: Mater Misercordiae University Hospital ( Site 1800)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0867)

location_facility: Massachusetts General Hospital ( Site 0041)

location_facility: Kansai Medical University Hospital ( Site 3126)

location_facility: China Medical University Hospital ( Site 3204)

location_facility: Universitaetsklinikum Tuebingen ( Site 2405)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 3300)

location_facility: Ogarev Mordovia State University ( Site 1206)

location_facility: Hospital Clinic de Barcelona ( Site 0852)

location_facility: Clinica Universitaria de Navarra ( Site 0855)

location_facility: Norrlands Universitetssjukhus ( Site 0800)

location_facility: Hospital General Universitario de Valencia ( Site 0854)

location_facility: Saitama Medical University International Medical Center ( Site 3118)

location_facility: Mayo Clinic in Rochester, Minnesota-Medical Oncology ( Site 0002)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004)

location_facility: Okayama University Hospital ( Site 3107)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 1967)

location_facility: CHRU Lille Hospital Claude Huriez ( Site 2506)

location_facility: Hospital Universitario La Paz ( Site 0853)

location_facility: Municipal institution of Lviv regional council Lviv Oncology-Chemotherapy ( Site 3653)

location_facility: St James University Hospital ( Site 0509)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 1450)

location_facility: Medizinische Universitaet Innsbruck ( Site 2951)

location_facility: Universitair Medisch Centrum Groningen ( Site 1550)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 1965)

location_facility: Providence Saint John's Health Center ( Site 0059)

location_facility: Chaim Sheba Medical Center. ( Site 2052)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 2412)

location_facility: Blod och Tumorssjukdomar. Akademiska sjukhuset ( Site 0801)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 1208)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1400)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 2504)

location_facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1551)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 2750)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0061)

location_facility: University of Virginia Health System ( Site 0035)

location_facility: Providence Portland Medical Center ( Site 0051)

location_facility: National Cheng Kung University Hospital ( Site 3201)

location_facility: UCLA Medical Center Hematology Oncology ( Site 0009)

location_facility: CHU Toulouse - Hopital Rangueil ( Site 2518)

location_facility: Sapporo Medical University Hospital ( Site 3113)

location_facility: Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022)

location_facility: Korea University Anam Hospital ( Site 0956)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 2521)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0860)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1750)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1204)

location_facility: Hospital Universitario Quiron Madrid ( Site 0868)

location_facility: California Cancer Associates for Research & Excellence ( Site 0016)

location_facility: Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 0859)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 3119)

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

type: Registry Identifier

source: euctr

title: A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

summary:
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study.

This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.

Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

summary:
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Aghemo A, Horsmans Y, Bourgeois S, Bondin M, Gschwantler M, Hofer H, Semmo N, Negro F, Zhang Z, Marcinak J, Veitsman E, Hazzan R, Mimidis K, Goulis I, Marques N, Flisiak R, Mazur W, Roncero C, Marra F, Pageaux GP, Asselah T, Lampertico P. Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. Infect Dis Ther. 2021 Dec;10(4):2203-2222. doi: 10.1007/s40121-021-00455-1. Epub 2021 Jun 14. Erratum in: Infect Dis Ther. 2021 Sep 16;:.

family: Aghemo

full_name: Alessio Aghemo

given: Alessio

sequence: first

family: Horsmans

full_name: Yves Horsmans

given: Yves

sequence: additional

family: Bourgeois

full_name: Stefan Bourgeois

given: Stefan

family: Bondin

full_name: Mark Bondin

given: Mark

family: Gschwantler

full_name: Michael Gschwantler

given: Michael

family: Hofer

full_name: Harald Hofer

given: Harald

family: Semmo

full_name: Nasser Semmo

given: Nasser

family: Negro

full_name: Francesco Negro

given: Francesco

family: Zhang

full_name: Zhenzhen Zhang

given: Zhenzhen

family: Marcinak

full_name: John Marcinak

given: John

family: Veitsman

full_name: Ella Veitsman

given: Ella

family: Hazzan

full_name: Rawi Hazzan

given: Rawi

family: Mimidis

full_name: Konstantinos Mimidis

given: Konstantinos

family: Goulis

full_name: Ioannis Goulis

given: Ioannis

family: Marques

full_name: Nuno Marques

given: Nuno

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: Mazur

full_name: Wlodzimierz Mazur

given: Wlodzimierz

family: Roncero

full_name: Carlos Roncero

given: Carlos

family: Marra

full_name: Fiona Marra

given: Fiona

family: Pageaux

full_name: Georges Philippe Pageaux

given: Georges Philippe

family: Asselah

full_name: Tarik Asselah

given: Tarik

family: Lampertico

full_name: Pietro Lampertico

given: Pietro

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Infectious Diseases and Therapy

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Müllhaupt B, Semela D, Ruckstuhl L, Magenta L, Clerc O, Torgler R, Negro F, Semmo N. Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland. Swiss Med Wkly. 2021 Jan 19;151:w20399. doi: 10.4414/smw.2021.20399. eCollection 2021 Jan 18.

name: Division of Gastroenterology and Hepatology, University Hospital Zurich, Switzerland

name: Division of Gastroenterology, Kantonsspital St. Gallen, Switzerland

name: Fondazione Epatocentro Ticino, Lugano, Switzerland

name: Infectious Diseases Department, Hospital Pourtalès, Neuchâtel, Switzerland

name: Divisions of Gastroenterology and Hepatology and of Clinical Pathology, University Hospital, Geneva, Switzerland

name: Hepatology, Department of BioMedical Research, University of Bern, Switzerland

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country: Italy Austria Switzerland France Poland Greece Israel Belgium Portugal

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604

location_facility: CHR Orleans - Hopital de la Source /ID# 202360

location_facility: CH Annecy Genevois Site Annecy /ID# 202804

location_facility: AOU Citta della Salute Scienza /ID# 168142

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414

location_facility: NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449

location_facility: Hopital Bichat-Claude Bernard /ID# 202513

location_facility: NZOZ Przychodnia Specjalistycz /ID# 208334

location_facility: Universita degli Studi della /ID# 168135

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 207980

location_facility: Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463

location_facility: Assaf Harofeh Medical Center /ID# 169370

location_facility: Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931

location_facility: MED-FIX Centrum Medyczne Sp. z /ID# 208453

location_facility: CHU NANCY - Hopital Brabois Adultes /ID# 202570

location_facility: Azienda Ospedaliera di Padova /ID# 168125

location_facility: AOU di Cagliari - Presidio di /ID# 168132

location_facility: Hopital de la Cavale Blanche /ID# 202640

location_facility: Algemeen Stedelijk Ziekenhuis /ID# 170876

location_facility: General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930

location_facility: Centre Hosp Intercommunal de Creteil /ID# 202566

location_facility: Azienda Ospedaliero - Universi /ID# 168130

location_facility: Azienda Universitaria Ospedali /ID# 168129

location_facility: Wojewodzki Szpit Bieganskiego /ID# 208445

location_facility: Gen Univ Hosp Alexandroupolis /ID# 206416

location_facility: CHU de Besancon - Jean Minjoz /ID# 208502

location_facility: Fondazione Epatocentro Ticino /ID# 201024

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 168712

location_facility: Wojewodzki Szpital Obserwacyjn /ID# 209345

location_facility: Universitair Ziekenhuis Leuven /ID# 170921

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957

location_facility: Ctre Hospitalier de Tourcoing /ID# 202358

location_facility: Cabinet Medical, Dr. Constant, /ID# 202361

location_facility: Università Cattolica Sacro Cuore /ID# 168781

location_facility: Centre Hospitalier PERPIGNAN /ID# 205762

location_facility: Centro Hospitalar do Porto EPE /ID# 207733

location_facility: Cabinet Medical, Boyer Darrigr /ID# 202050

location_facility: KH der Elisabethinen Linz GmbH /ID# 169915

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137

location_facility: Klinikum Wels - Grieskirchen /ID# 169916

location_facility: Azienda Ospedaliera Maggiore d /ID# 168710

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910

location_facility: Azienda Ospedaliera di Rilievo /ID# 168141

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 168138

location_facility: Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195

location_facility: Hospital Garcia de Orta, E.P.E /ID# 207717

location_facility: Ospedale Sant Orsola Malpighi /ID# 168127

location_facility: Azienda Ospedaliera di Padova /ID# 168126

location_facility: General Hospital of Athens Laiko /ID# 206421

location_facility: Wojewodzki Szpit Bieganskiego /ID# 209608

location_facility: University Hospital St. Polten /ID# 169918

location_facility: Szpital Specjalistyczny W Chorzowie /Id# 209129

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451

location_facility: Centro Hospitalar Barreiro Montijo, EPE /ID# 211267

location_facility: Centre Hospitalier de Béziers /ID# 202948

location_facility: Gastroenterology Institute, Division of Medicine /ID# 169360

location_facility: Tzaneio general hospital of Piraeus /ID# 208828

location_facility: Hopitaux Universitaires de Geneve /ID# 203435

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862

location_facility: Wilhelminenspital der Stadt Wien /ID# 169914

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 168136

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 168140

location_facility: Inselspital, Universitaetsklinik /ID# 201022

location_facility: General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420

location_facility: Ctre Hospitalier de Tourcoing /ID# 202805

location_facility: Medizinische Universität Graz /ID# 169932

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 168709

location_facility: A.O.U. Policlinico G. Martino /ID# 168139

location_facility: Wojewódzki Szpital Zespolony w Kielcach /ID# 210569

location_facility: Centre Hospitalier de Wallonie Picarde /ID# 200822

location_facility: AOU OO. RR. San Giovanni di Di /ID# 168715


title: Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.

acronym: PANORAMA

summary:
This is an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer).

Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.

status: Terminated

lead_sponsor: AstraZeneca

location_country:
France
Spain
China
Canada
United Kingdom
Taiwan

intervention_type: Other

status_simplified: Unknown


title: A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

summary: This Registry will enroll participants with cirrhosis with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

status: Active, not recruiting

ReferenceCitation: Younossi ZM, Racila A, Muir A, Bourliere M, Mangia A, Esteban R, Zeuzem S, Colombo M, Manns M, Papatheodoridis GV, Buti M, Chokkalingam A, Gaggar A, Nader F, Younossi I, Henry L, Stepanova M. Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response. Clin Gastroenterol Hepatol. 2021 Jan 22. pii: S1542-3565(21)00076-8. doi: 10.1016/j.cgh.2021.01.026. [Epub ahead of print]

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

family: Racila

full_name: Andrei Racila

given: Andrei

family: Muir

full_name: Andrew Muir

given: Andrew

family: Bourliere

full_name: Marc Bourliere

given: Marc

family: Mangia

full_name: Alessandra Mangia

given: Alessandra

family: Esteban

full_name: Rafael Esteban

given: Rafael

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Colombo

full_name: Massimo Colombo

given: Massimo

family: Manns

full_name: Michael Manns

given: Michael

family: Papatheodoridis

full_name: George V. Papatheodoridis

given: George V.

family: Buti

full_name: Maria Buti

given: Maria

family: Chokkalingam

full_name: Anand Chokkalingam

given: Anand

family: Gaggar

full_name: Anuj Gaggar

given: Anuj

family: Nader

full_name: Fatema Nader

given: Fatema

full_name: Issah Younossi

given: Issah

family: Henry

full_name: Linda Henry

given: Linda

family: Stepanova

full_name: Maria Stepanova

journal_name: Clinical Gastroenterology and Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
Germany
France
Australia
Puerto Rico
New Zealand
Spain
Canada
United Kingdom

location_facility: University of Pennsylvania Health System

location_facility: Asheville Gastroenterology Associates, PA

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: The North Texas Clinical Research Institute

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: London Health Sciences Centre - University Campus

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

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

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Bon Secours St. Mary's Hospital of Richmond

location_facility: Community Research Initiative of New England

location_facility: University of California at San Francisco Medical Center

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: South Florida Center of Gastroenterology

location_facility: University of California, Davis Medical Center

location_facility: University of Miami Miller School of Medicine

location_facility: Binghamton Gastroenterology Associates, PC

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Nashville Gastrointestinal Specialists, Inc.

location_facility: Gastroenterology Center of the MidSouth, P.C.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

acronym: Bridalveil

summary:
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

design_allocation: Randomized

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

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

location_facility: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Spedali Civili Di Brescia Azienda Ospedaliera

location_facility: North Shore Hematology/Oncology Associates

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim

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

location_facility: N. N. Blokhin Russian Cancer Research Center

location_facility: University College London Hospitals National Health Society Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte

location_facility: FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"

location_facility: Gemeinschaftspraxis Dres. Söling Und Siehl

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Hadassah Medical Organization, Ein Kerem

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Kaiser Permanente Vallejo Medical Center

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Comprehensive Blood and Cancer Center (Bakersfield)

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku

location_facility: Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Centre Hospitalier Affilie Universitaire de Quebec

location_facility: Centre Hospitalier Départmental La Roche sur Yon

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau

location_facility: Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research

location_facility: Haematology and Oncology Clinics of Australia Gold Coast

location_facility: State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"

location_facility: Klinikum der Ludwig-Maximilians-Universität München

location_facility: Joliet Oncology Hematology Associates Ltd.

location_facility: Saint Petersburg I.P. Pavlov State Medical University

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Hospital Universitari i Politecnic La Fé de Valencia


title: A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

summary: The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

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

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Isaacs

full_name: John D. Isaacs

given: John D.

family: Chen

full_name: Lea Ann Chen

given: Lea Ann

family: Wang

full_name: Wenjin Wang

given: Wenjin

family: Marren

full_name: Amy Marren

given: Amy

family: Kwok

full_name: Kenneth Kwok

given: Kenneth

full_name: Lisy Wang

given: Lisy

family: Chan

full_name: Gary Chan

given: Gary

family: Su

full_name: Chinyu Su

given: Chinyu

journal_name: Digestive Diseases and Sciences

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: Newcastle Univesity - Newcastle University ePrints

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_institution: Newcastle Univesity - Newcastle University ePrints

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13.

name: Department of Dermatology; University of Chile Clinical Hospital; Santiago Chile

name: Probity Medical Research; Santiago Chile

family: Valenzuela

full_name: F. Valenzuela

given: F.

name: University Hospitals Case Medical Center; Cleveland OH U.S.A.

family: Korman

full_name: N.J. Korman

family: Bissonnette

full_name: R. Bissonnette

given: R.

family: Bakos

full_name: N. Bakos

given: N.

name: Department of Dermatology; National Taiwan University Hospital; Taipei Taiwan

family: Tsai

full_name: T.-F. Tsai

family: Harper

full_name: M.K. Harper

family: Ports

full_name: W.C. Ports

family: Tan

full_name: H. Tan

given: H.

family: Tallman

full_name: A. Tallman

given: A.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Puerto Rico
Germany
United States
United Kingdom
Austria
Bosnia and Herzegovina
Brazil
Serbia
Mexico
Czechia
Spain

location_facility: Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego

location_facility: The Guenther Dermatology Research Centre

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

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

location_facility: Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly

location_facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling

location_facility: Novum Instytut Dermatologii Leczniczej i Estetycznej

location_facility: Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

location_facility: Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary

location_facility: Regional Municipal Dermatovenerologic Dispensary

location_facility: Michigan Center for Research Corporation dba Michigan Center for Skin Care Research

location_facility: Deaconess Clinic Downtown Research Institute

location_facility: University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease

location_facility: CHU Limoges - Hôpital Dupuytren - Pharmacie

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: Atlanta Dermatology, Vein & Research Center, P.C.

location_facility: University Hospitals Case Medical Center/Dept. of Dermatology

location_facility: SI 'Institute for Dermatology and Venerology of AMS of Ukraine'

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: Ryazan regional clinical dermatovenerologic dispensary

location_facility: International Dermatology Research, Inc.

location_facility: North-Western State Medical University I.I. Mechnikov

location_facility: CENIT Centro de Neurociencias Investigacion y Tratamiento

location_facility: Centro Integral de Reumatologia del Caribe Cicaribe S.A.S

location_facility: University Dermatology Clinic "Andreas Syggros" Hospital

location_facility: Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny

location_facility: Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Baker Allergy Asthma and Dermatology Research Center, LLC

location_facility: Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

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

location_facility: Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"

location_facility: Saint Louis University - Department of Dermatology

location_facility: Facharzt fuer Dermatologie und Allergologie

location_facility: Dept of Dermatology and Venerology of Lugansk State Medical University,

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa

location_facility: Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,

location_facility: Colegio Mayor de Nuestra Señora del Rosario

location_facility: IP ONLY: University Hospitals Case Medical Center

location_facility: Dept of Dermatology and Venerology of ONMU

location_facility: Hud kliniken- Skanes Universitetssjukhus i Malmo

location_facility: "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika

location_facility: NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit

location_facility: Centro Internacional de Estudios Clinicos, CIEC

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia

location_facility: Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

location_facility: Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)

location_facility: Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn

location_facility: University of Pittsburgh Medical Center - Department of Dermatology

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

location_facility: State Research Center of Dermatovenerology

location_facility: Eastern Canada Cutaneous Research Associates Ltd.

location_facility: University of North Carolina at Chapel Hill

location_facility: CRCMRGilbert Inc., Centre de Dermatologie Maizerets

location_facility: Oddelenie biologickej liecby, Narodny ustav reumatickych chorob

location_facility: University Hospitals Case Medical Center

location_facility: Rivergate Dermatology Clinical Research Center, PLLC

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: NorthShore University Health System - Division of Dermatology

location_facility: Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

location_facility: Hospital General Universitario de Alicante

location_facility: Dr. Tuppal's Privat Practice, Oshawa Clinic

location_facility: Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: University General Hospital of Ioannina / Dermatology and Venereology Department

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly

location_facility: Nemocnice Ceske Budejovice, a.s. Ustavni lekarna

location_facility: Specjalistyczne Gabinety Lekarskie "Dermed"

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Office of Dr. Paul Adam (back-up location)

location_facility: Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat

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

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: University of North Carolina at Chapel Hill- Hospital

location_facility: Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

location_facility: State Research Center of Dermatovenerology,

location_facility: Rostov-on-Don regional dermatovenerologic dispensary

location_facility: Leavitt Medical Associates of Florida dba Ameriderm Research

location_facility: Dr. Zohair Tomi PMC Inc. Paton Medical Centre

location_facility: Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika

location_facility: Mexico Centre for Clinical Research S.A. de C.V.

location_facility: Centre de Recherche Dermatologique du Québec Métropolitain

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck

location_facility: Tampere Univeristy Hospital, Department of Dermatology and Venereology

location_facility: Centro De Investigaciones Dermatologicas

location_facility: UMHAT "Dr. Georgi Stranski" - II clinical base

location_facility: North Florida Dermatology Associates, PA

location_facility: Chang Gung Medical Foundation Kaohsiung Branch

location_facility: Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter

location_facility: Centennial Center-Comprehensive Clinical Research

location_facility: Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin

location_facility: Tsentar za kozhno venericheski zaboliavania EOOD

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

location_facility: Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles

location_facility: Hopital Larrey Departement de Dermatologie

location_facility: Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ

location_facility: LKH Salzburg, Landesklinik fuer Dermatologie

location_facility: Dres. Kirsten Prepeneit und Volker Streit

location_facility: Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"

location_facility: Hopital de Brabois / Batiment Philippe Canton

location_facility: MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"

location_facility: Dermatovenerologic dispensary #10 of Vyborg region


title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Finland
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Slovakia
Argentina
Canada
Korea, Republic of
Bulgaria
Hungary
China
United States
United Kingdom
Italy
Spain
Turkey

location_facility: Providence Cancer Institute Newberg Clinic

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

location_facility: Moscow Research Oncology Institute n.a P.A. Gertsen (MROI n.a P.A. Gertsen)

location_facility: State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary"

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

location_facility: MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia

location_facility: Providence Cancer Institute Clackamas Clinic

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: BHI of Omsk region "Clinical Oncological Dispensary"

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Complex Oncology Center - Stara Zagora Ltd.

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Mid-Illinois Hematology & Oncology Associates, Ltd

location_facility: Investigational Drug Services, Advent Health Orlando

location_facility: Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of

location_facility: Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)

location_facility: Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntr

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

location_facility: Holston Valley Hospital and Medical Center

location_facility: AZ (Algemeen Ziekenhuis) Maria Middelares

location_facility: SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino SA

location_facility: University Health Network-Princess Margaret Cancer Centre

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: The Second Hospital of Tianjin Medical University

location_facility: AdventHealth Medical Group Hematology and Oncology

location_facility: Gallipoli Medical Research Foundation, Greenslopes Private Hospital

location_facility: Centre of Applied Urology Research, Nova Scotia Health Authority

location_facility: State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: Seoul National University Bundang Hospital

location_facility: Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")

location_facility: Sahyadri Clinical Research & Development Centre

location_facility: Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"

location_facility: Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)

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

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

location_facility: Providence Cancer Institute Franz Clinic

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Branch of the Limited Liability Company "Hadassah Medical Ltd."

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

location_facility: FundaciÃ³n Instituto Valenciano de OncologÃ-a

location_facility: Huntsman Cancer Institute - University of Utah

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: National Hospital Organization Tokyo Medical Center

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

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: Netaji Subhas Chandra Bose Cancer Hospital

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"

location_facility: Private Medical Institution "Euromedservice"

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Providence Oncology and Hematology Care Clinic - Westside


intervention_type: Radiation

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
China
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

location_facility: Aichi Cancer Center Hospital ( Site 4190)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 4181)

location_facility: Medizinische Universitaet Innsbruck ( Site 2001)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)

location_facility: LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)

location_facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)

location_facility: Cukurova Uni. Tip Fakultesi ( Site 2353)

location_facility: Bialostockie Centrum Onkologii ( Site 2483)

location_facility: University of Iowa Hospital and Clinics ( Site 3046)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

location_facility: C.I.U. Hopital Ambroise Pare ( Site 2039)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)

location_facility: Medipol Universite Hastanesi ( Site 2352)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 4091)

location_facility: Medizinische Universitat Graz ( Site 2004)

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)

location_facility: Hospital Britanico de Buenos Aires ( Site 1002)

location_facility: Gunma Prefectural Cancer Center ( Site 4183)

location_facility: Instituto de Oncologia de Rosario ( Site 1004)

location_facility: National Cancer Center Hospital East ( Site 4197)

location_facility: Universitair Ziekenhuis Gent ( Site 2037)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 1092)

location_facility: Hospital Clinic i Provincial ( Site 2185)

location_facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)

location_facility: Women s Hospital School of Medicine Zhejiang University ( Site 4032)

location_facility: Hôpital Privé Des Côtes d'Armor ( Site 2063)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)

location_facility: Athens University Hospital ATTIKON ( Site 2424)

location_facility: Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)

location_facility: University of the Ryukyus Hospital ( Site 4184)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 3058)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2220)

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)

location_facility: Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)

location_facility: Clinica Universitaria de Navarra ( Site 2181)

location_facility: Lviv State Regional Oncological Center ( Site 2361)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 2637)

location_facility: Medical Park Izmir Hastanesi ( Site 2356)

location_facility: Jiangxi Maternal and Child Health Hospital ( Site 4051)

location_facility: Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)

location_facility: Osaka International Cancer Institute ( Site 4188)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 2354)

location_facility: Soerlandet sykehus HF Kristiansand ( Site 2152)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)

location_facility: Centro Oncologico Riojano Integral ( Site 1007)

location_facility: Saitama Medical University International Medical Center ( Site 4182)

location_facility: Institut De Cancerologie De Lorraine ( Site 2072)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)

location_facility: Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)

location_facility: University of Alabama - Birmingham ( Site 3061)

location_facility: Sanford Gynecology Oncology ( Site 3045)

location_facility: WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)

location_facility: McGill University Health Centre ( Site 3005)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 2069)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2151)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 3070)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2303)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 2368)

location_facility: IRCCS Ospedale San Raffaele ( Site 2130)

location_facility: Rigshospitalet University Hospital ( Site 2515)

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)

location_facility: The First Bethune Hospital of Jilin University ( Site 4057)

location_facility: Hospital Clinico San Carlos ( Site 2187)

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)

location_facility: General Hospital of Patras. St Andrews ( Site 2421)

location_facility: Edith Wolfson Medical Center ( Site 2306)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)

location_facility: Instituto Nacional de Cancerología E.S.E ( Site 1094)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 4193)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)

location_facility: Ege University Medical Faculty ( Site 2351)

location_facility: Azienda Ospedaliera Universitaria Federico II ( Site 2123)

location_facility: Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1096)

location_facility: Hokkaido University Hospital ( Site 4194)

location_facility: Taipei Veterans General Hospital ( Site 4093)

location_facility: Tampere University Hospital ( Site 2541)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 2241)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 3049)

location_facility: MNE "Khmelnytskyi regional antitumor center" ( Site 2365)

location_facility: Iwate Medical University Hospital ( Site 4189)

location_facility: Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)

location_facility: Legacy Good Samaritan Medical Center ( Site 3033)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)

location_facility: Arizona Oncology Associates, PC- HAL ( Site 3043)

location_facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)

location_facility: SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 2068)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)

location_facility: Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 2393)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2391)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2248)

location_facility: The First Affiliated Hospital ( Site 4043)

location_facility: Peking Union Medical College Hospital ( Site 4036)

location_facility: Universitetssjukhuset i Linkoping. ( Site 2222)

location_facility: Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)

location_facility: The Cancer Institute Hospital of JFCR ( Site 4196)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)

location_facility: Changhua Christian Hospital ( Site 4095)

location_facility: Niigata Cancer Center Hospital ( Site 4185)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1061)

location_facility: University Hospital of North Norway ( Site 2153)

location_facility: Hospital Universitario Reina Sofia ( Site 2183)

location_facility: Xiangya Hospital Central-South University ( Site 4035)

location_facility: Nanjing Drum Tower Hospital ( Site 4037)

location_facility: Taichung Veterans General Hospital ( Site 4094)

location_facility: Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)

location_facility: National Research Ogarev Mordovia State University ( Site 2648)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)

location_facility: Severance Hospital Yonsei University Health System ( Site 4062)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)

location_facility: Istituto di Candiolo - IRCCS ( Site 2125)

location_facility: Odense Universitetshospital ( Site 2512)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)

location_facility: The Christie Hospital NHS Foundation Trust ( Site 2243)

location_facility: Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)

location_facility: Castle Hill Hospital-Academic Oncology ( Site 2252)

location_facility: Norton Cancer Institute - St. Matthews ( Site 3056)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 1062)

location_facility: Centre Hospitalier Lyon Sud ( Site 2064)

location_facility: Seoul National University Bundang Hospital ( Site 4063)

location_facility: Aalborg Universitetshospital ( Site 2511)

location_facility: Hospital Universitario La Paz ( Site 2186)

title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.


lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Spain

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Hanusch Krankenhaus Wiener Gebietskrankenkasse

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: John Theurer Cancer Center at Hackensack

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST

location_facility: Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Spitalul Clinic Judetean de Urgenta Tirgu-Mures

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: University Hospitals Monarch Medical Center

location_facility: Azienda Ospedaliera Ospedale di Busto Arsizio

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD

location_facility: Universitätsklinikum Frankfurt Goethe Universität

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

title: A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

status_simplified: Completed


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:
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Bulgaria
Germany
United States
United Kingdom
Italy
Austria
Serbia
Israel
New Zealand
Spain
Turkey

location_facility: Princess Margaret Cancer Centre /ID# 233768

location_facility: Hospital Clinico Universitario de Valencia /ID# 220875

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 220867

location_facility: Augusta University Georgia Cancer Center /ID# 221551

location_facility: MNI Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council /ID# 230831

location_facility: Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 219185

location_facility: Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370

location_facility: Indiana Blood & Marrow Transpl /ID# 221586

location_facility: University of Miyazaki Hospital /ID# 221483

location_facility: Taipei Veterans General Hosp /ID# 221146

location_facility: Assaf Harofeh Medical Center /ID# 222957

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874

location_facility: Sahlgrenska University Hospital /ID# 218776

location_facility: Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204

location_facility: Dana-Farber Cancer Institute /ID# 218010

location_facility: Universitaetsklinikum Aachen /ID# 221519

location_facility: Klinicki bolnicki centar Zagreb /ID# 230793

location_facility: Hospital Universitario Ramon y Cajal /ID# 220877

location_facility: Ege University Medical Faculty /ID# 230753

location_facility: Radboud Universitair Medisch Centrum /ID# 218948

location_facility: Inonu University Medical Faculty /ID# 230758

location_facility: The Chaim Sheba Medical Center /ID# 219137

location_facility: Florida Cancer Specialist - South /ID# 221726

location_facility: Orebro Universitetssjukhuset /ID# 220829

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 219192

location_facility: Florida Cancer Specialists - North /ID# 221727

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 231161

location_facility: Niagara Health - St. Catherines Site /ID# 230994

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 222264

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221333

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056

location_facility: Leningrad Regional Clinical Hospital /ID# 221028

location_facility: University of Kansas Cancer Center /ID# 218144

location_facility: Hacettepe University Medical Faculty /ID# 230759

location_facility: University Clinical Center Serbia /ID# 230854

location_facility: CH Roubaix - Hopital Victor Provo /ID# 219116

location_facility: Fukushima Medical University Hospital /ID# 222752

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083

location_facility: Universitatsklinikum Mannheim /ID# 221523

location_facility: Minnesota Oncology Hematology /ID# 227357

location_facility: Townsville University Hospital /ID# 229794

location_facility: Moores Cancer Center at UC San Diego /ID# 218012

location_facility: VA Puget Sound Health Care System /ID# 231691

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 220901

location_facility: Hospital Parc de Salut del Mar /ID# 220913

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 230757

location_facility: ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978

location_facility: Moscow State budget healthcare /ID# 221025

location_facility: Centre Hospitalier de CHAMBERY /ID# 224506

location_facility: Seoul National University Bundang Hospital /ID# 219053

location_facility: Medizinische Universitaet Wien /ID# 220906

location_facility: Hospital Universitario Vall d'Hebron /ID# 229690

location_facility: Kansai Medical University Hospital /ID# 221482

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 232073

location_facility: Nippon Medical School Hospital /ID# 221674

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721

location_facility: OncoResearch Lerchenfeld GmbH /ID# 230867

location_facility: Weill Cornell Medical College /ID# 220933

location_facility: General Hospital of Athens Laiko /ID# 230785

location_facility: Universitair Medisch Centrum Groningen /ID# 218947

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 222518

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100

location_facility: National Taiwan University Hospital /ID# 218976

location_facility: Hospital Universitario Dr. Negrin /ID# 220897

location_facility: CHU NIMES - Hopital Caremeau /ID# 219114

location_facility: Hospital Universitario 12 de Octubre /ID# 229691

location_facility: Medizinische Universitaet Graz /ID# 220910

location_facility: Pusan National University Hospital /ID# 222087

location_facility: Juntendo University Hospital /ID# 221405

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230946

location_facility: Seoul National University Hospital /ID# 219055

location_facility: Albert Schweitzer Ziekenhuis /ID# 224015

location_facility: Trakya University Medical Facu /ID# 230754

location_facility: Skane University Hospital Lund /ID# 220835

location_facility: Massachusetts General Hospital /ID# 221559

location_facility: Thompson Cancer Survival Ctr /ID# 231689

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 219086

location_facility: Tula Regional Clinical Hospital /ID# 221027

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222333

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 219113

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220813

location_facility: Gabrail Cancer Center Research /ID# 230488

location_facility: China Medical University Hospital /ID# 218978

location_facility: Florida Cancer Specialists - East /ID# 221728

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 229936

location_facility: Universitair Ziekenhuis Leuven /ID# 218806

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 230832

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658

location_facility: Northwell Health - Monter Cancer Center /ID# 222996

location_facility: Gachon University Gil Medical Center /ID# 222089

location_facility: Linkou Chang Gung Memorial Ho /ID# 218983

location_facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029

location_facility: Kanazawa University Hospital /ID# 238424

location_facility: University General Hospital Attikon /ID# 230784

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720

location_facility: Inje University Busan Paik Hospital /ID# 231667

location_facility: Hadassah Medical Center-Hebrew University /ID# 219110

location_facility: Kyungpook National University Hospital /ID# 231666

location_facility: Universitair Medisch Centrum Utrecht /ID# 218949

location_facility: University Clinical Center Kragujevac /ID# 230855

location_facility: United Lincolnshire Hospitals NHS Trust /ID# 231471

location_facility: Rush University Medical Center /ID# 221581

location_facility: CHU UCL Namur - site Godinne /ID# 221127

location_facility: Republican hospital named after V.A. Baranov /ID# 221412

location_facility: Hospital Universitario Virgen de la Victoria /ID# 220878

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218984

location_facility: Tel Aviv Sourasky Medical Center /ID# 219134

location_facility: ASST Spedali civili di Brescia /ID# 241273

location_facility: Almazov National Medical Research Centre /ID# 221033

location_facility: Juntendo University Shizuoka Hospital /ID# 221782

location_facility: Columbus Regional Research Institute /ID# 227272

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347

location_facility: National Cancer Center Hospital East /ID# 226093

location_facility: Beth Israel Deaconess Medical Center /ID# 224261

location_facility: Klinicki bolnicki centar Split /ID# 230796

location_facility: Kawasaki Medical School Hospital /ID# 221481

location_facility: University of Yamanashi Hospital /ID# 221701

location_facility: Fujita Health University Hospital /ID# 221537

location_facility: University of Texas MD Anderson Cancer Center /ID# 217994

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754

location_facility: Oncology Hematology Care, Inc - Kenwood /ID# 222556

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

summary:
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.

Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide.

Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue till the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.


ReferenceType: background

ReferenceCitation: Trotman J, Folwer N, Auer R, Flowers C, Reed W, Stern JC, Huang J, Zinzani PL. Phase 2 Obinutuzumab Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Clinical Oncology, 2018.

ReferenceCitation: Fowler N, Trotman J, Auer R, Flowers C, Reed W, Marimpietri C, Huang J, Zinzani PL.Randomized phase 2 zanubrutinib (BGB-3111) + obinutuzumab (obi) vs obi monotherapy in patients (pts) with relapsed/refractory follicular lymphoma (R/R FL). American Society of Clinical Oncology. 2019

ReferenceCitation: Fowler NH, Trotman J, Auer R, Flowers CR, Reed WF, Ivanova E, Huang J, Zinzani PL.Randomized Phase 2 Zanubrutinib (BGB-3111) + Obinutuzumab vs Obinutuzumab Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Hematology. 2019

lead_sponsor: BeiGene

location_country:
Italy
United States
Spain
Germany
France
Bulgaria
Czechia
Poland
Australia
Russian Federation
New Zealand
Belarus
China
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: ROSEWOOD

location_facility: Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Institut Català d'Oncologia de l'Hospitalet de Llobregat

location_facility: N.N. Alexandrov National Cancer Centre of Belarus

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Centre Hospitalier Universitaire d'Amiens - Hopital Sud

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Nanfang Hospital,Southern Medical University

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie - Oddział w Gliwicach

location_facility: IRCCS Ospedale di Circolo e Fondazione Macchi

location_facility: State Budgetary Healthcare Institution. Volgograd

location_facility: Severance Hospital, Yonsei University Health System

location_facility: N. N. Blokhin Russian Cancer Research Center

location_facility: Tongji Hospital of Tongji Medical College Huazhong University of Science Technology

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Minsk City Clinical Oncological Dispensary

location_facility: Chonnam National University Hwasun Hospital

location_facility: Nizhniy Novgorod Regional Clinical Hospital N.A.

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev

location_facility: Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital)

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

location_facility: University of Illinois Hospital & Health Sciences System

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: University Multiprofile Hospital for Active Treatment Saint Ivan Rilski

location_facility: State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: Keimyung University Dongsan Medical Center

location_facility: Centre de Lutte Contre le Cancer - Institut Bergonie

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: The First Affiliated Hospital of Medical College of Zhejiang University

title: An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.