title: A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

summary: This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

location_country:
Germany
Ireland
New Zealand
Australia
Croatia
Canada
France
Denmark
United States
Belgium
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Israel

location_facility: Cary Gastroenterology Assoc PA /ID# 108198

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 144213

location_facility: Medical University of South Carolina /ID# 113439

location_facility: Duplicate_Bierwirth, Cranston, RI /ID# 113435

location_facility: Baylor Scott & White Medical Center- Temple /ID# 103639

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 157949

location_facility: Universitaetsklinikum Leipzig /ID# 98116

location_facility: Israelitisches Krankenhaus Hamburg /ID# 98197

location_facility: Moores Cancer Center at UC San Diego /ID# 133722

location_facility: Yale Univ Digestive Diseases /ID# 141987

location_facility: Complejo Hospitalario Universitario Ourense /ID# 128349

location_facility: Gastroenterologie Studien -CED /ID# 98205

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 137945

location_facility: Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 127798

location_facility: Kingston Hospital NHS Foundation Trust /ID# 164109

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 141396

location_facility: Universitaetsmedizin Rostock /ID# 128396

location_facility: Weill Cornell Medical College /ID# 135052

location_facility: Hospital Universitario y Politecnico La Fe /ID# 98597

location_facility: Ehehalt/Helmstadter, Heidelber /ID# 125211

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 217142

location_facility: Precision Research Institute - San Diego /ID# 103638

location_facility: Hospital Clinico Universitario San Carlos /ID# 98577

location_facility: University of Rochester Medical Center /ID# 126152

location_facility: Duplicate_Galway University Hospital /ID# 98763

location_facility: Klinicki bolnicki centar Osijek /ID# 127980

location_facility: Torre de Especialidades Medica /ID# 154276

location_facility: ProMedica Physicians Digestive Healthcare /ID# 156529

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 102058

location_facility: The University of Chicago Medical Center /ID# 114115

location_facility: Duplicate_A.O. Circolo e Fondazione Macc /ID# 141394

location_facility: The Royal Wolverhampton NHS Trust /ID# 164209

location_facility: Yeovil District Hospital NHS Foundation Trust /ID# 146042

location_facility: Hospital Universitario Virgen de Valme /ID# 129036

location_facility: Precision Research Institute - San Diego /ID# 113445

location_facility: Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 98196

location_facility: Emeritas Research Group, LLC /ID# 135537

location_facility: Klinikum Garmisch-Partenkirchen /ID# 127915

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 120557

location_facility: Hospital Universitario de Fuenlabrada /ID# 98591

location_facility: Centre des consultations spécialisées de la sauvegarde /ID# 98719

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 127394

location_facility: University Hospital Plymouth NHS Trust /ID# 157432

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 130321

location_facility: Stadtisches Klinikum Braunschweig /ID# 98123

location_facility: Hospital Universitario Reina Sofia /ID# 98586

location_facility: Dr. Everett Chalmers Reg Hosp. /ID# 135408

location_facility: NHS Greater Glasgow and Clyde /ID# 153818

location_facility: Mueller/Mueller-Ziehm, Hanover /ID# 130490

location_facility: County Durham and Darlington NHS Foundation Trust /ID# 145914

location_facility: Hospital Universitario Infanta Cristina /ID# 98635

location_facility: Hospital Universitario Dr. Negrin /ID# 98578

location_facility: Hospital Universitario de Galdakao /ID# 98618

location_facility: Duplicate_Adelaide and Meath Hosp,IE /ID# 117947

location_facility: Duplicate_Western States Clinical Research, Inc. /ID# 116237

location_facility: Hospital de Sant Joan Despi Moises Broggi /ID# 128347

location_facility: Royal Prince Alfred Hospital /ID# 157986

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 98592

location_facility: Research Associates of South Florida,LLC /ID# 148212

location_facility: GH Mutualiste Les Portes Du Sud /ID# 98722

location_facility: Klinicki bolnicki centar Split /ID# 127978

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 144089

location_facility: North Florida Gastro Research /ID# 128538

location_facility: Universitaetsklinikum Freiburg /ID# 98176

location_facility: Gastro Clinic of Acadiana, LA /ID# 119155

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust /ID# 164213

location_facility: Clinica de Higado & Gastroenterologia Integral SC /ID# 128376

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 144211

location_facility: The Chaim Sheba Medical Center /ID# 129281

location_facility: Hospital Universitario Basurto /ID# 129123

location_facility: St Vincent's University Hospital /ID# 116835

location_facility: Froedtert Memorial Lutheran Hospital /ID# 102066

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 98555

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 145912

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 144084

location_facility: Hospital Universitario Canarias /ID# 129037

location_facility: Commonwealth Clinical Studies /ID# 118597

location_facility: Ottawa Hospital Research Institute /ID# 128918

location_facility: General Hospital of Athens Laiko /ID# 129280

location_facility: Carle Foundation Hospital Digestive Health Research Center /ID# 117417

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 98121

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 137944

location_facility: A.O.U. Policlinico G. Martino /ID# 144212

location_facility: Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 120775

location_facility: AO Ordine Mauriziano Umberto I /ID# 137942

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 144080

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 129117

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 141716

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 103637

location_facility: Hospital General Universitario de Elche /ID# 129121

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 129124

location_facility: Graefin v.Waldersee&Partner, H /ID# 141607

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 130978

location_facility: Southern California Res. Ctr. /ID# 116898

location_facility: Investigacion y Biomedicina de Chihuahua /ID# 150115

location_facility: Southwoods Surgical Hospital /ID# 133038

location_facility: Guelph GI and Surgery Clinic /ID# 128917

location_facility: Theageneio Anticancer Hospital /ID# 141670

location_facility: University of Vermont Medical Center /ID# 102075

location_facility: Endoscopic Microsurgery Assoc /ID# 102065

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 133688

location_facility: The Royal Wolverhampton NHS Trust /ID# 98901

location_facility: Mobile Medical & Diagnostic Center, AL /ID# 102064

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 98756

location_facility: Washington University-School of Medicine /ID# 107156

location_facility: Percuro Clinical Research, Ltd /ID# 129996

location_facility: Hospital Universitario de Jaen /ID# 129035

location_facility: Duplicate_Clinical Research Solutions /ID# 207698

location_facility: Houston Digestive Dis Clinic /ID# 102076

location_facility: Nottingham University Hospitals NHS Trust /ID# 145678

location_facility: Hospital Clinico Universitario de Valencia /ID# 131749

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 98576

location_facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 137939

location_facility: Hospital Universitario de la Princesa /ID# 98580

location_facility: Duplicate_London Health Sciences Centre - University Hospital /ID# 128915

location_facility: Duplicate_Baruch-Padeh Poriya Medical /ID# 141671

location_facility: Louisana Research Center, LLC /ID# 102055

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 141381

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 129115

location_facility: Hospital Parc de Salut del Mar /ID# 126637

location_facility: Northwestern University Feinberg School of Medicine /ID# 126760

location_facility: Duplicate_APHP - Groupe Hospitalier 1 /ID# 98736

location_facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 141397

location_facility: University of Iowa Hospitals and Clinics /ID# 134432

location_facility: Asklepios Westklinikum Hamburg /ID# 127492

location_facility: Digestive Health Spec of Tyler /ID# 138144

location_facility: Community Clinical Trials, CA /ID# 117335

location_facility: Advanced Research Institute, Inc /ID# 211335

location_facility: General University Hospital of Alexandroupolis /ID# 128636

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 145704

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 127897

location_facility: Northwest Gastroenterology Clinic /ID# 116896

location_facility: Atlanta Gastroenterology Spec /ID# 103619

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 102067

location_facility: Imperial College Healthcare NHS Trust /ID# 145916

location_facility: Bellini Medicine Professional /ID# 145706

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 98585

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 103616

location_facility: Attleboro Gastroenterology, PC /ID# 113899

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 128375

location_facility: Manchester University NHS Foundation Trust /ID# 145702

location_facility: University of Texas MD Anderson Cancer Center /ID# 144198

location_facility: Advanced Medical Research Center /ID# 116235

location_facility: AP-HP - Hopital Saint-Antoine /ID# 141611

location_facility: Iowa Digestive Disease Center /ID# 107159

location_facility: Paradise Clnical Research, LLC /ID# 212027

location_facility: Digestive Care Medical Center /ID# 122075

location_facility: University of Alabama at Birmingham - Main /ID# 131646

location_facility: Hospital Universitario Virgen Macarena /ID# 128346

location_facility: Stockport NHS foundation trust /ID# 144090

location_facility: The Gastro Group of S. Jersey /ID# 129902

location_facility: The Dudley Group NHS Foundation Trust /ID# 164119

location_facility: Morgantown Surgical Associates /ID# 123082

location_facility: Franciscus Gasthuis & Vlietland /ID# 127904

location_facility: University of Maryland School of Medicine /ID# 116897

location_facility: Hospital Universitario 12 de Octubre /ID# 98575

location_facility: King's College Hospital NHS Foundation Trust /ID# 145698

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 103636

location_facility: Concord Repatriation General /ID# 157983

location_facility: University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 129995

location_facility: Instituto de Salud Digestiva /ID# 157435

location_facility: Gastoenterology Group of Rochester /ID# 113438

location_facility: Fondazione Poliambulanza Istituto Ospedaliero /ID# 141593

location_facility: Hospital Universitario Principe de Asturias /ID# 131751

location_facility: North Shore University Hospital /ID# 127948

location_facility: The Royal Melbourne Hospital /ID# 157993

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 98645

location_facility: Shafran Gastroenterology Ctr /ID# 117839

location_facility: Medical Research Center of CT /ID# 102057

location_facility: Praxis Dres. Roesler und Lachma /ID# 128466

location_facility: Universitaetsklinik Heidelberg /ID# 98120

location_facility: Investigative Clinical Research /ID# 102056

location_facility: Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 148230

location_facility: CHU Toulouse - Hopital Purpan /ID# 148183

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 138142

location_facility: Hospitalier Germon et Gauthier /ID# 137874

location_facility: Digestive and Liver Disease Sp /ID# 125943

location_facility: University Hospitals Dorset NHS Foundation Trust /ID# 164108

location_facility: Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 98119

location_facility: Progressive Gastroenterology Consultants /ID# 105835

location_facility: LMU Klinikum Campus Grosshadern /ID# 98198

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 98115

location_facility: Hospital Universitario San Juan de Alicante /ID# 130167

location_facility: Karolinska University Hospital /ID# 171247

location_facility: Universitair Ziekenhuis Leuven /ID# 127984

location_facility: Temecula Valley Endoscopy Ctr /ID# 118660

location_facility: Houston Endoscopy and Research Center /ID# 206978

location_facility: Mater Misericordiae Univ Hospital /ID# 119054

location_facility: Biewer/Mohl, Saarbruecken, DE /ID# 98204

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 98124

location_facility: Universitaetsklinikum Erlangen /ID# 128179

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 98737

location_facility: Hospital Universitario Virgen de la Victoria /ID# 129038

location_facility: University of Arizona Cancer Center - North Campus /ID# 140387

location_facility: Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 141393

location_facility: Combined Research Orlando - Phase I-IV /ID# 141660

location_facility: NorthShore University HealthSystem /ID# 107165

location_facility: Huron Gastroenterology Assoc /ID# 132484

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 129318

location_facility: Hunter New England Local Health District /ID# 157999

location_facility: Akershus Universitetssykehus_MAIN /ID# 127159

location_facility: Digestive Health Assoc of TX /ID# 116215

location_facility: Allied Gastrointestinal Associates /ID# 107158

location_facility: Gastroenterologie Im Josephinu /ID# 123496

location_facility: CHU Grenoble - Hopital Michallon /ID# 98638

location_facility: ASST Spedali civili di Brescia /ID# 137943

location_facility: HCL - Hopital Edouard Herriot /ID# 155711

location_facility: University of Kansas Health Sy /ID# 134436

location_facility: Assaf Harofeh Medical Center /ID# 128996

location_facility: Hospital General de Castellon /ID# 128351

location_facility: Hospital Universitario Virgen del Rocio /ID# 98557

location_facility: Gastroenterology Clinic of San /ID# 113441

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 137946

location_facility: Internistische Praxisgemeinschaft /ID# 129000

location_facility: Carolina Digestive Health Associates /ID# 108199

location_facility: The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 145937

location_facility: Houma Digestive Health Special /ID# 125711

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 131390

location_facility: Hospital Universitario Miguel Servet /ID# 131188

location_facility: Biocentric Healthcare Research /ID# 213980

location_facility: Hampshire Hospitals NHS Foundation Trust /ID# 98900

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 105836

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 144673

location_facility: Krankenhaus Martha-Maria Halle-Doelau /ID# 122935

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 107163

location_facility: Ctr Gastro & Hepatology Stade /ID# 98206

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 127988

location_facility: CHU Toulouse - Hopital Rangueil /ID# 147755

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 98556

location_facility: Universitatsklinikum Mannheim /ID# 129279

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 98122

location_facility: Hospital Universitario La Paz /ID# 98582

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 129002

location_facility: DM Clinical Research/Southwest /ID# 120635

location_facility: University General Hospital of Ioannina /ID# 127390

location_facility: Kaiser Perm Riverside Med Ctr /ID# 146043

location_facility: Manhattan Clinical Research, LLC /ID# 113442

location_facility: Asociacion Mexicana para la Investigacion Clinica /ID# 128387

location_facility: GIRI Gastrointestinal Research Institute /ID# 129095

location_facility: Universitaetsklinikum Regensburg /ID# 141606

location_facility: London North West University Healthcare NHS Trust /ID# 145953

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 117838

location_facility: Detroit Clinical Research Center /ID# 123235

location_facility: Hospital General Universitario Gregorio Maranon /ID# 98558

location_facility: Atlantic Gastroenterology, PA /ID# 135536

location_facility: Emory Midtown Infectious Disease Clinic /ID# 133724

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 98761

location_facility: GZA St. Vincentiusziekenhuis /ID# 127398

location_facility: Cooper Digestive Health Instit /ID# 103615

location_facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 128467

location_facility: Premier Medical Group - GI Division /ID# 140384

location_facility: Precision Research Institute, LLC /ID# 211340

location_facility: Hospital Comarcal Santa Ana de Motril /ID# 129040

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 98581

location_facility: Ctr for Advanced Gastroenterol /ID# 116236

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 107157

location_facility: Royal Brisbane and Women's Hospital /ID# 158086

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 98641

location_facility: Rapid City Medical Center - GI Research /ID# 201191

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 141392

location_facility: Birmingham Gastroenterology Associates P.C /ID# 102063

location_facility: General Hospital of Athens Ippokratio /ID# 128638

location_facility: Guardian Angels Health Center /ID# 209706

location_facility: Leids Universitair Medisch Centrum /ID# 127402

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 127400

location_facility: Cabinet Médical - Dr THEVENIN /ID# 98720

location_facility: Azienda Ospedaliera di Padova /ID# 137941

location_facility: Gastroenterology Group Naples /ID# 105837

location_facility: Santa Monica Research Institut /ID# 118675

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 130049

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 145676

location_facility: Gastroenterology Institute, Division of Medicine /ID# 132530

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 130318

location_facility: Vega Fonseca, San Luis Potosi /ID# 128380

location_facility: Ospedale Policlinico San Martino /ID# 137947

location_facility: Hospital General Universitario de Valencia /ID# 98616

location_facility: Hospital Universitari Son Espases /ID# 148214

location_facility: Hospital General La Mancha Centro /ID# 98588

location_facility: Consultants in Gastroenterology - Columbia NE /ID# 126517

location_facility: Gastro-Hepato & Geriatric Ctr /ID# 113135

location_facility: Univ of Mississippi Med Ctr,US /ID# 132981

location_facility: South Florida Ctr Gastro, P.A. /ID# 166784

location_facility: Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 138113

location_facility: James Paget University Hospitals NHS Foundation Trust /ID# 164106

location_facility: Henry A. Rodriguez Ginorio, MD /ID# 113448

location_facility: Cleveland Clinic Main Campus /ID# 108055

location_facility: St. Marien- und Annastiftskrankenhaus /ID# 98235

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 98899

location_facility: Atrium Health Carolinas Medical Center /ID# 126970

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 128354

location_facility: Rush University Medical Center /ID# 132979

location_facility: Hospital Universitario de Jerez de la Frontera /ID# 128345

location_facility: QE II Health Sciences Centre /ID# 128916

location_facility: CHU Reims - Hôpital Robert Debre /ID# 98640

location_facility: Georgetown University Hospital /ID# 113437

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 98619

location_facility: Connolly Hospital Blanchardstown /ID# 98895

location_facility: Hospital San Pedro de Alcantara /ID# 98579

location_facility: Krankenhaus der Barmherzigen Brueder Salzburg /ID# 120776

location_facility: Erlanger Institute for Clinical Research /ID# 126151

location_facility: Sahlgrenska University Hospital /ID# 141672

location_facility: Hospital Universitario Ramon y Cajal /ID# 98596

location_facility: Klinicki bolnicki centar Rijeka /ID# 127979

location_facility: Universitair Ziekenhuis Antwerpen /ID# 142757

location_facility: Hospital General de Mostoles /ID# 130319

location_facility: Hospital Universitario de Bellvitge /ID# 98584

location_facility: Duplicate_Seconda Universita' di Napoli /ID# 141717

location_facility: Perez Jimenz Gastroenterologo /ID# 110135

location_facility: Ctr Digest, Allergic & Imm Dis /ID# 125502

location_facility: Hospital Universitario Central de Asturias /ID# 98617

location_facility: Hospital General Universitario Santa Lucia /ID# 129125


type: EudraCT Number

title: TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

acronym: TRANSFORM

summary: The primary objective of this study is to evaluate the effect of setanaxib on biochemical response at Week 52 in participants with primary biliary cholangitis (PBC) and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Calliditas Therapeutics Suisse SA

location_country:
Germany
Italy
Poland
New Zealand
Hungary
Israel
United Kingdom
Australia
Sweden
Switzerland
Austria
Belgium
United States
Spain
Greece
Czechia
Canada
France

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Consorci Hospital General Universitari de València

location_facility: Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: St. Joseph's Healthcare Hamilton - Charlton Campus

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Kansas Medical Clinic - Gastroenterology

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Froedtert and Medical College of Wisconsin

location_facility: Queen Elizabeth II Health Sciences Centre - Victoria General

location_facility: New York University Hepatology Associates

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: University of California Davis Medical Center

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Summit - Southern Therapy and Advanced Research

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Centre Hospitalier Universitaire Brugmann - Site Victor Horta

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Semmelweis Egyetem - I. Sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika

location_facility: University General Hospital of Heraklion (PAGNI)

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centricity Research (LMC Manna Research) - London

location_facility: Wake Forest University Baptist Medical Center

location_facility: Università degli Studi di Napoli Federico II

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Miami Leonard M. Miller School of Medicine

location_facility: Gastroenterology Associates - Crystal River

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

location_facility: Hospital General Universitari d'Alicante

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

summary: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Yes

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.

lead_sponsor: AbbVie

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Romania
Belgium
China
Malaysia
Estonia
Puerto Rico
Egypt
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 165460

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 168041

location_facility: Southern Star Research Institute, LLC /ID# 169754

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 203908

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546

location_facility: Advanced Research - Coral Springs /ID# 218020

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719

location_facility: Allegiance Research Specialists /ID# 165321

location_facility: Nagoya City University Hospital /ID# 165956

location_facility: City Clinical Hospital No. 31 /ID# 208870

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943

location_facility: East View Medical Research, LLC /ID# 171133

location_facility: Vanderbilt University Medical Center /ID# 164846

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 164830

location_facility: HonorHealth Research Institute - Shea /ID# 164734

location_facility: Crystal Pharmacology Research /ID# 166101

location_facility: University of Michigan Health Systems /ID# 164844

location_facility: The First Hospital of Jilin University /ID# 206867

location_facility: General Hospital of Athens Ippokratio /ID# 167036

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 203495

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 165318

location_facility: Toyama Prefectural Central Hospital /ID# 217833

location_facility: Tzaneio general hospital of Piraeus /ID# 206432

location_facility: Gastro Health & Nutrition - Victoria /ID# 167813

location_facility: Stockport NHS foundation trust /ID# 208718

location_facility: United Medical Doctors - Murrieta /ID# 164845

location_facility: Asahikawa Medical University Hospital /ID# 167133

location_facility: Taunton and Somerset NHS Foundation Trust /ID# 209664

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 206993

location_facility: Omega Research Maitland, LLC /ID# 203480

location_facility: Air Force Specialized Hospital /ID# 170995

location_facility: Niigata University Medical & Dental Hospital /ID# 170044

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 168176

location_facility: Medizinische Universitaet Wien /ID# 169462

location_facility: Universitatsklinikum Mannheim /ID# 168778

location_facility: Toho University Sakura Medical Center /ID# 165949

location_facility: Wakayama Medical University Hospital /ID# 169481

location_facility: Atlanta Gastroenterology Spec /ID# 164780

location_facility: Pauls Stradins Clinical University Hospital /ID# 169493

location_facility: Southern California Res. Ctr. /ID# 169654

location_facility: The Second Hospital Central South University /ID# 204075

location_facility: Coral Sea Clinical Research institute /ID# 212987

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720

location_facility: Inje University Haeundae Hospital /ID# 202629

location_facility: The Sixth Affiliated Hosp Sun /ID# 204049

location_facility: Lahey Hospital and Medical Center /ID# 214725

location_facility: Universitaetsklinikum Halle (Saale) /ID# 207454

location_facility: Inonu Universitesi Turgut Ozal /ID# 201267

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078

location_facility: Kazan State Medical University /ID# 169574

location_facility: P.A. Bayandin Murmansk Regiona /ID# 169575

location_facility: Japanese Red Cross Wakayama Medical Center /ID# 200638

location_facility: Complejo Hospitalario de Navarra /ID# 202038

location_facility: Hadassah Medical Center-Hebrew University /ID# 169927

location_facility: Osaka City University Hospital /ID# 166007

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740

location_facility: Nara Medical University Hospital /ID# 169216

location_facility: The Jikei University Hospital /ID# 167142

location_facility: Soroka University Medical Center /ID# 169912

location_facility: Mustafa Kemal University Medic /ID# 171318

location_facility: Hospital Privado Univesitario /ID# 169228

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663

location_facility: Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571

location_facility: Yamagata University Hospital /ID# 200156

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280

location_facility: Tyler Research Institute, LLC /ID# 168681

location_facility: National Taiwan University Hospital /ID# 169789

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 168174

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 169080

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085

location_facility: University of Chicago Medicine /ID# 165472

location_facility: Kyungpook National Univ Hosp /ID# 207015

location_facility: Medical Research Center of CT /ID# 164829

location_facility: Toyohashi Municipal Hospital /ID# 200174

location_facility: Cleveland Clinic Main Campus /ID# 208220

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420

location_facility: Lenasia Clinical Trial Centre /ID# 205144

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 171018

location_facility: Indianapolis Gastroenterology /ID# 164837

location_facility: Inselspital, Universitätsspital Bern /ID# 171006

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 171009

location_facility: Texas Digestive Disease Consultants /ID# 209952

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 165948

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096

location_facility: Options Health Research, LLC /ID# 164737

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 217963

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 206539

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072

location_facility: Immanuel Kant Baltic Federal University /ID# 202128

location_facility: Nanfang Hospital of Southern Medical University /ID# 204074

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 170985

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208050

location_facility: Clinical Research of West Florida, Inc /ID# 208117

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069

location_facility: Faculdade de Medicina do ABC /ID# 208327

location_facility: Gastroenterologie am Mexikoplatz /ID# 203573

location_facility: Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841

location_facility: Policlinico San Martino/Univer /ID# 168177

location_facility: Virginia Mason - Seattle Orthapedics /ID# 164680

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 224300

location_facility: Kaiser Clinica e Hospital Dia /ID# 166873

location_facility: Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565

location_facility: Private Practice Dr MN Rajabally /ID# 169852

location_facility: South Eastern Health and Social Care Trust /ID# 205322

location_facility: The First Affiliated Hospital of Nanchang University /ID# 204070

location_facility: Healthcare Research Consultant /ID# 166228

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779

location_facility: Duplicate_Care Access Research /ID# 164853

location_facility: Malopolskie Centrum Kliniczne /ID# 202166

location_facility: Hospital Nossa Senhora das Graças /ID# 166869

location_facility: Cabinet Particular Policlinic Algomed /ID# 167827

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 168170

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085

location_facility: Assaf Harofeh Medical Center /ID# 204870

location_facility: Gazi Universitesi Tip Fakultes /ID# 217443

location_facility: Linkou Chang Gung Memorial Ho /ID# 169788

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172

location_facility: Washington Gastroenterology Associates /ID# 164721

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 206324

location_facility: Hayang University GuriHospital /ID# 167578

location_facility: King's College Hospital NHS Foundation Trusts /ID# 169082

location_facility: Mentahaz Maganorvosi Kozpont /ID# 201890

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 171190

location_facility: Clinical Hosp Center Zvezdara /ID# 168221

location_facility: Hyogo College of Medicine College Hospital /Id# 200173

location_facility: Johns Hopkins University School of Medicine /ID# 211940

location_facility: Duplicate_Hopital Saint Eloi /ID# 170646

location_facility: Wake Forest Baptist Medical Center /ID# 201225

location_facility: Universitaetsklinikum Erlangen /ID# 203551

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 164863

location_facility: The Royal Wolverhampton NHS Trust /ID# 171387

location_facility: Clinical Research of West Florida, Inc /ID# 205825

location_facility: Erciyes University Medical Fac /ID# 171321

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995

location_facility: Carl R. Meisner Medical Clinic /ID# 201060

location_facility: University of Iowa Hospitals and Clinics /ID# 165330

location_facility: CHU UCL Namur - site Godinne /ID# 200300

location_facility: Hospital Universitario y Politecnico La Fe /ID# 201988

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 207414

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388

location_facility: Hospital Italiano de Buenos Aires /ID# 215543

location_facility: UCSF Center for Colitis and Crohn's Disease /ID# 202373

location_facility: Digestive Disease Center Gastro /ID# 169517

location_facility: Gastroenterology Consultants PC - Roswell /ID# 218219

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037

location_facility: Richmond University Medical Center /ID# 201855

location_facility: Univ of California San Francis /ID# 164843

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212422

location_facility: Atrium Health Carolinas Medical Center /ID# 164834

location_facility: Aichi Medical University Hospital /ID# 165957

location_facility: The Vancouver Clinic, INC. PS /ID# 164811

location_facility: Tokyo Women's Medical University Hospital /ID# 205981

location_facility: Montreal General Hospital - McGill University Health Center /ID# 170010

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 171566

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 164847

location_facility: Columbia Univ Medical Center /ID# 164870

location_facility: Radboud Universitair Medisch Centrum /ID# 166925

location_facility: Delsol Research Management, Ll /Id# 170179

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 168169

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 164880

location_facility: Digestive Health Associates (DHA) - Farmington Hills /ID# 206099

location_facility: The Dudley Group NHS Foundation Trust /ID# 169079

location_facility: Shiga University of Medical Science Hospital /ID# 167141

location_facility: Citrus Valley Gastroenterology /ID# 166201

location_facility: Universitaetsklinikum Frankfurt /ID# 203565

location_facility: Pusan National University Hospital /ID# 167580

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 201891

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168

location_facility: Riga East Clinical University Hospital /ID# 169496

location_facility: Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068

location_facility: Great Lakes Medical Research, LLC /ID# 202007

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891

location_facility: Clinical Research Trials of Florida, Inc. /ID# 203484

location_facility: Yonsei University Health System Severance Hospital /ID# 167581

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606

location_facility: Kanazawa University Hospital /ID# 169215

location_facility: CHU Amiens-Picardie Site Sud /ID# 171016

location_facility: CB Flock Research Corporation /ID# 166220

location_facility: Concord Repatriation General Hospital /ID# 171509

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887

location_facility: CHRU Tours - Hopital Trousseau /ID# 169786

location_facility: Republican hospital named after V.A. Baranov /ID# 206487

location_facility: Hospital Clinic de Barcelona /ID# 171242

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 200488

location_facility: Agaplesion Markus Krankenhaus /ID# 168777

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 167134

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143

location_facility: Montefiore Medical Center - Moses Campus /ID# 166226

location_facility: CHU Toulouse - Hopital Rangueil /ID# 169785

location_facility: Scott Shulman Medicine Professional Corporation /ID# 169064

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167

location_facility: Hometown Urgent Care and Resea /ID# 201290

location_facility: Sahlgrenska University Hospital /ID# 169031

location_facility: Zhongshan Hospital Xiamen University /ID# 204985

location_facility: AGA Clinical Research Associates, LLC /ID# 164883

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 205551

location_facility: Duplicate_Western States Clinical Research, Inc. /ID# 164895

location_facility: Hospital Provincial del Centenario /ID# 171254

location_facility: National Hospital Organization Takasaki General Medical Center /ID# 167136

location_facility: Plains Clinical Research Center, LLC /ID# 170184

location_facility: Digestive Disease Specialists /ID# 201062

location_facility: Hospital San Vicente de Paul /ID# 200028

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467

location_facility: Duplicate_Sjaellands Universitets Hospital /ID# 200783

location_facility: Hospital de Clinicas de Porto Alegre /ID# 166872

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 202039

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 200213

location_facility: Sisli Etfal Train & Res Hosp /ID# 171317

location_facility: Sapporo Medical University Hospital /ID# 167137

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175

location_facility: CliniCore International, LLC /ID# 164662

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010

location_facility: Klinicki bolnicki centar Zagreb /ID# 171201

location_facility: National Hepatology and Tropical Medicine Research Institute /ID# 170990

location_facility: Dayton Gastroenterology, Inc. /ID# 167624

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207465

location_facility: Tel Aviv Sourasky Medical Center /ID# 204876

location_facility: Hiroshima University Hospital /ID# 166006

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 168799

location_facility: Hospital Universitario Vall d'Hebron /ID# 171237

location_facility: London North West University Healthcare NHS Trust /ID# 169078

location_facility: Rapid City Medical Center - GI Research /ID# 201734

location_facility: Velocity Clinical Research - Salt Lake City /ID# 166095

location_facility: University Clinical Center Tuzla /ID# 210324

location_facility: East Tennessee Research Institute /ID# 203612

location_facility: TX Clinical Research Institute /ID# 164848

location_facility: Hospital Garcia de Orta, EPE /ID# 170234

location_facility: Consultants for Clinical Research /ID# 164855

location_facility: Hospital Universitari Son Espases /ID# 201997

location_facility: Hospital Universitario La Paz /ID# 171241

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 203285

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231

location_facility: Toronto Digestive Disease Asso /ID# 166961

location_facility: Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557

location_facility: Quality Clinical Research Inc. /ID# 170177

location_facility: Peak Gastroenterology Associates, PC /ID# 170181

location_facility: Froedtert Memorial Lutheran Hospital /ID# 202286

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316

location_facility: MediSphere Medical Research Center /ID# 166209

location_facility: Clinical Center University of Sarajevo /ID# 203885

location_facility: Centex Studies, Inc. - Houston /ID# 201213

location_facility: Ctr for Advanced Gastroenterol /ID# 165332

location_facility: University Clinical Center Serbia /ID# 168220

location_facility: CHA University Bundang Medical Center /ID# 167583

location_facility: University Clinical Center Kragujevac /ID# 205858

location_facility: QEII - Health Sciences Centre /ID# 169306

location_facility: Encore Borland-Groover Clinical Research /Id# 203498

location_facility: Advanced Research Institute, Inc /ID# 164814

location_facility: Hospital Universitario Dr. Negrin /ID# 171238

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002

location_facility: GIRI Gastrointestinal Research Institute /ID# 166964

location_facility: Clin Res Inst of Michigan, LLC /ID# 170178

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 202407

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015

location_facility: Louisana Research Center, LLC /ID# 164659

location_facility: Texas Digestive Disease Consultants /ID# 209802

location_facility: Yokkaichi Hazu Medical Center /ID# 167191

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 200008

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778

location_facility: Duplicate_Tokai University Hachioji Hospital /ID# 165951

location_facility: Universitair Ziekenhuis Leuven /ID# 200298

location_facility: Hospital Universitario Virgen Macarena /ID# 171240

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 167035

location_facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958

location_facility: Chung-Ang University Hostipal /ID# 207017

status_simplified: Completed


acronym: VIALE-M

summary: This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed.

ReferenceType: derived

ReferenceCitation: Ivanov V, Yeh SP, Mayer J, Saini L, Unal A, Boyiadzis M, Hoffman DM, Kang K, Addo SN, Mendes WL, Fathi AT. Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia. Future Oncol. 2022 Aug;18(26):2879-2889. doi: 10.2217/fon-2022-0450. Epub 2022 Jul 19.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ReferenceCitation: Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

sponsor_collaborators: AbbVie Roche-Genentech

location_facility: Seoul National University Hospital /ID# 213943

location_facility: Yamagata University Hospital /ID# 214698

location_facility: National Taiwan University Hospital /ID# 213939

location_facility: Hokkaido University Hospital /ID# 215938

location_facility: Prisma Health Cancer Institute-Faris Road /ID# 216066

location_facility: University General Hospital of Patras /ID# 213871

location_facility: Clinic of Immunopathology, SRIFCI /ID# 217937

location_facility: Tennessee Oncology-Nashville Centennial /ID# 218757

location_facility: University General Hospital Attikon /ID# 214298

location_facility: University of Texas MD Anderson Cancer Center /ID# 225201

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426

location_facility: Almazov National Medical Research Centre /ID# 214306

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 214933

location_facility: Universitaetsklinikum Giessen und Marburg /ID# 214734

location_facility: Erciyes University Medical Fac /ID# 214240

location_facility: Nagasaki University Hospital /ID# 214916

location_facility: Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156

location_facility: Princess Margaret Cancer Centre /ID# 214624

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715

location_facility: Shoalhaven District Memorial Hospital /ID# 221973

location_facility: Weill Cornell Medical College /ID# 214847

location_facility: Universitaetsklinikum Halle (Saale) /ID# 221109

location_facility: Guangdong Provincial People's Hospital /ID# 216284

location_facility: ASST Spedali civili di Brescia /ID# 214580

location_facility: Centre Hospitalier de Versailles André Mignot /ID# 215157

location_facility: Massachusetts General Hospital /ID# 217307

location_facility: University of Kentucky Markey Cancer Center /ID# 215048

location_facility: Saint Louis University Cancer Center /ID# 218164

location_facility: Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309

location_facility: Gibbs Cancer Center & Research /ID# 216192

location_facility: Gold coast University Hospital /ID# 214650

location_facility: Chinese PLA General Hospital /ID# 216286

location_facility: Tel Aviv Sourasky Medical Center /ID# 239698

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 217474

location_facility: University of Fukui Hospital /ID# 215283

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214713

location_facility: University Hospitals Bristol /ID# 215911

location_facility: London Health Sciences Center- University Hospital /ID# 216055

location_facility: Universitaetsklinikum Leipzig /ID# 214440

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558

location_facility: St. Alphonsus Regional Medical /ID# 216424

location_facility: Linkou Chang Gung Memorial Hospital /ID# 213951

location_facility: University of Alberta Hospital - Division of Hematology /ID# 215656

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 213946

location_facility: Pan American Center for Oncology Trials, LLC /ID# 214953

location_facility: General Hospital of Athens Laiko /ID# 213869

location_facility: Hadassah Medical Center-Hebrew University /ID# 239700

location_facility: Providence Portland Medical Ct /ID# 216231

location_facility: General University Hospital of Alexandroupolis /ID# 213870

location_facility: Peking University International Hospital /ID# 217439

location_facility: National Hospital Organization Mito Medical Center /ID# 214699

location_facility: West China Hospital, Sichuan University /ID# 216606

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425

location_facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 214841

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680

location_facility: Nanfang Hospital of Southern Medical University /ID# 215565

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948

location_facility: Cardiff & Vale University Health Board /ID# 215906

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 215644

location_facility: Aichi Cancer Center Hospital /ID# 215284

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953

location_facility: Colorado Blood Cancer Institute /ID# 214280

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826

location_facility: Hospital Santa Creu i Sant Pau /ID# 214714

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 214422

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173

location_facility: Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393

location_facility: Oncology Hematology Associates (OHA) - Springfield /ID# 216351

location_facility: Hospital Universitario Reina Sofia /ID# 214786

location_facility: Hospital Universitario Infanta Leonor /ID# 214843

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525

location_facility: Ustav hematologie a krevni transfuze /ID# 215137

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 215910

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 214278

location_facility: Regional Clinical Hospital of Yaroslavl /ID# 214318

location_facility: McGill University Health Center Research Institute /ID# 215984

location_facility: Hospital Universitario Ramon y Cajal /ID# 214684

location_facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283

location_facility: Hospital Universitario 12 de Octubre /ID# 214789

location_facility: Centre Hospitalier de la Cote Basque /ID# 216185

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944

location_facility: Osaka Metropolitan University Hospital /ID# 215225

location_facility: Seoul National University Bundang Hospital /ID# 215549

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 216456

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 214075

location_facility: CHRU Tours - Hopital Bretonneau /ID# 216186

location_facility: Ottawa Hospital Research Institute /ID# 214627

location_facility: P. Hertsen Moscow Oncology Research Institute /ID# 214312

location_facility: University of California, Los Angeles /ID# 219149

location_facility: China Medical University Hospital /ID# 213952

location_facility: Hospital Universitario de Navarra /ID# 214788

location_facility: University College London Hospitals NHS Foundation Trust /ID# 215921

location_facility: Rutgers Cancer Institute of New Jersey /ID# 239708

location_facility: Rush University Medical Center /ID# 218815

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505

location_facility: CHU de Nice - Hôpital Archet 1 /ID# 217368

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 214583

location_facility: Pusan National University Hospital /ID# 213941

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046

location_facility: Tulane Medical Center - New Orleans /ID# 218166

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 215908

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872

location_facility: Saitama Medical University International Medical Center /ID# 214823

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 215150

status: Active, not recruiting

title: A Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

source: euctr

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

design_allocation: Non-Randomized

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


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 untill 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.

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

location_facility: Oncology Hematology Care, Inc. /ID# 222556

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

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

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

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

location_facility: Florida Cancer Specialists - East /ID# 221728

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

location_facility: Leningrad Regional Clinical Hospital /ID# 221028

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 219185

location_facility: Kawasaki Medical School Hospital /ID# 221481

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

location_facility: OncoResearch Lerchenfeld GmbH /ID# 230867

location_facility: United Lincolnshire Hospitals NHS Trust /ID# 231471

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

location_facility: Rush University Medical Center /ID# 221581

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

location_facility: Juntendo University Shizuoka Hospital /ID# 221782

location_facility: Seoul National University Hospital /ID# 219055

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

location_facility: Hospital Clinico Universitario de Valencia /ID# 220875

location_facility: Hacettepe University Medical Faculty /ID# 230759

location_facility: Gabrail Cancer Center Research /ID# 230488

location_facility: Kanazawa University Hospital /ID# 238424

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

location_facility: Ege University Medical Faculty /ID# 230753

location_facility: Universitatsklinikum Mannheim /ID# 221523

location_facility: Medizinische Universitaet Wien /ID# 220906

location_facility: Pusan National University Hospital /ID# 222087

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

location_facility: Dana-Farber Cancer Institute /ID# 218010

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867

location_facility: Minnesota Oncology Hematology /ID# 227357

location_facility: National Taiwan University Hospital /ID# 218976

location_facility: Seoul National University Bundang Hospital /ID# 219053

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

location_facility: Trakya University Medical Facu /ID# 230754

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220813

location_facility: Gachon University Gil Medical Center /ID# 222089

location_facility: Radboud Universitair Medisch Centrum /ID# 218948

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

location_facility: Assaf Harofeh Medical Center /ID# 222957

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

location_facility: Universitair Medisch Centrum Groningen /ID# 218947

location_facility: The Chaim Sheba Medical Center /ID# 219137

location_facility: Hospital Universitario 12 de Octubre /ID# 229691

location_facility: Skane University Hospital Lund /ID# 220835

location_facility: Taipei Veterans General Hosp /ID# 221146

location_facility: Universitaetsklinikum Aachen /ID# 221519

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 219086

location_facility: Fujita Health University Hospital /ID# 221537

location_facility: University of Miyazaki Hospital /ID# 221483

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

location_facility: University Clinical Center Serbia /ID# 230854

location_facility: University of Yamanashi Hospital /ID# 221701

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

location_facility: University General Hospital Attikon /ID# 230784

location_facility: Medical Corporation Seijinkai Ikeda Hospital /ID# 242172

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

location_facility: Almazov National Medical Research Centre /ID# 221033

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

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 230757

location_facility: Tel Aviv Sourasky Medical Center /ID# 219134

location_facility: Juntendo University Hospital /ID# 221405

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

location_facility: Townsville University Hospital /ID# 229794

location_facility: Texas Oncology - Northeast Texas /ID# 241813

location_facility: General Hospital of Athens Laiko /ID# 230785

location_facility: Hospital Universitario Dr. Negrin /ID# 220897

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218984

location_facility: Klinicki bolnicki centar Zagreb /ID# 230793

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

location_facility: University of Kansas Cancer Center /ID# 218144

location_facility: ASST Spedali civili di Brescia /ID# 241273

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

location_facility: Klinicki bolnicki centar Split /ID# 230796

location_facility: Linkou Chang Gung Memorial Hospital /ID# 218983

location_facility: Thompson Cancer Survival Ctr /ID# 231689

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

location_facility: Nippon Medical School Hospital /ID# 221674

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 220901

location_facility: Providence Medical Foundation /ID# 241646

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

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

location_facility: Inje University Busan Paik Hospital /ID# 231667

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

location_facility: Indiana Blood & Marrow Transpl /ID# 221586

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

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

location_facility: Hospital Universitario Ramon y Cajal /ID# 220877

location_facility: Beth Israel Deaconess Medical Center /ID# 224261

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

location_facility: National Cancer Center Hospital East /ID# 226093

location_facility: Augusta University Georgia Cancer Center /ID# 221551

location_facility: Centre Hospitalier de CHAMBERY /ID# 224506

location_facility: Kyungpook National University Hospital /ID# 231666

location_facility: Highlands Oncology Group, PA /ID# 221824

location_facility: Weill Cornell Medical College /ID# 220933

location_facility: Sahlgrenska University Hospital /ID# 218776

location_facility: Virginia Cancer Specialists - Fairfax /ID# 242682

location_facility: Florida Cancer Specialist - South /ID# 221726

location_facility: Universitair Ziekenhuis Leuven /ID# 218806

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

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 231161

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 221961

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

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

location_facility: Tula Regional Clinical Hospital /ID# 221027

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

location_facility: Moscow State budget healthcare /ID# 221025

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

location_facility: Medizinische Universitaet Graz /ID# 220910

location_facility: Orebro Universitetssjukhuset /ID# 220829

location_facility: Columbus Regional Research Institute /ID# 227272

location_facility: Kansai Medical University Hospital /ID# 221482

location_facility: University Clinical Center Kragujevac /ID# 230855

location_facility: Albert Schweitzer Ziekenhuis /ID# 224015

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 242806

location_facility: China Medical University Hospital /ID# 218978

location_facility: Hokkaido University Hospital /ID# 242667

location_facility: Fukushima Medical University Hospital /ID# 222752

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

location_facility: CHU NIMES - Hopital Caremeau /ID# 219114

location_facility: Universitair Medisch Centrum Utrecht /ID# 218949

location_facility: Inonu University Medical Faculty /ID# 230758

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

location_facility: Florida Cancer Specialists - North /ID# 221727

location_facility: Massachusetts General Hospital /ID# 221559

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230946

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

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

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

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

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

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


summary: The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

ReferenceCitation: D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.

publisher_dissemination: Elsevier

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534

location_facility: Clinical Research of West Florida, Inc /ID# 208127

location_facility: Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431

location_facility: Health Pharma Professional Research S.A de C.V /ID# 170763

location_facility: Duplicate_Transcarpathian Regional Clin. /ID# 167958

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 158039

location_facility: United Medical Doctors - Murrieta /ID# 158278

location_facility: Tzaneio general hospital of Piraeus /ID# 206441

location_facility: Hospital Clinic de Barcelona /ID# 157533

location_facility: Velocity Clinical Research - Salt Lake City /ID# 161775

location_facility: Phoenix VA Health Care System /ID# 162261

location_facility: King's College Hospital NHS Foundation Trusts /ID# 158758

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 161307

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 163218

location_facility: Texas Digestive Disease Consultants /ID# 209945

location_facility: Rapid City Medical Center - GI Research /ID# 163835

location_facility: Digestive Disease Specialists /ID# 170772

location_facility: Agaplesion Markus Krankenhaus /ID# 159334

location_facility: East Tennessee Research Institute /ID# 168735

location_facility: Intercity Advanced Gastroentertology Center /ID# 215204

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453

location_facility: Pauls Stradins Clinical University Hospital /ID# 159616

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202772

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267

location_facility: University Multiprofile Hospit /ID# 165697

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 158759

location_facility: Pusan National University Hospital /ID# 163376

location_facility: National Hepatology and Tropical Medicine Research Institute /ID# 157875

location_facility: Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 211241

location_facility: Zagazig University Hospitals /ID# 164018

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 154753

location_facility: Rocky Mountain Pediatric Gastroenterology /ID# 207171

location_facility: Hanyang University Guri Hospital /ID# 163351

location_facility: Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434

location_facility: Omega Research Maitland, LLC /ID# 171080

location_facility: Acibadem City Clinic UMHAT Tokuda /ID# 165698

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 157577

location_facility: University of Calgary - Heritage Medical Research Clinic /ID# 157156

location_facility: Southern California Res. Ctr. /ID# 211989

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 157720

location_facility: Stadtisches Klinikum Braunschweig /ID# 163673

location_facility: Soroka University Medical Center /ID# 157789

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 158037

location_facility: Southern Star Research Institute, LLC /ID# 168772

location_facility: Medical University of South Carolina /ID# 212859

location_facility: Peak Gastroenterology Associates, PC /ID# 165832

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691

location_facility: North Shore University Hospital /ID# 168734

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362

location_facility: Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213

location_facility: Clinical Hosp Center Zvezdara /ID# 156956

location_facility: University Multiprofile Hospit /ID# 167576

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656

location_facility: West Tallinn Central Hospital /ID# 157073

location_facility: Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 211965

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798

location_facility: HonorHealth Research Institute - Shea /ID# 165825

location_facility: CliniCore International, LLC /ID# 158191

location_facility: Scott Shulman Medicine Professional Corporation /ID# 165910

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892

location_facility: Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079

location_facility: National University Hospital /ID# 160662

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534

location_facility: Duplicate_LKH-Univ. Klinikum Graz /ID# 158134

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 154865

location_facility: Hospital Provincial del Centenario /ID# 170904

location_facility: East Tallinn Central Hospital /ID# 157072

location_facility: Vitebsk Regional Advanced Clin /ID# 204807

location_facility: Hometown Urgent Care and Resea /ID# 170447

location_facility: Tel Aviv Sourasky Medical Center /ID# 157787

location_facility: Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479

location_facility: Second Multiprofile Hospital f /ID# 165699

location_facility: Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 215146

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 200700

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584

location_facility: Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433

location_facility: Medizinische Hochschule Hannover /ID# 162027

location_facility: Krankenhaus der Barmherzigen Brueder Wien /ID# 211418

location_facility: Columbia Univ Medical Center /ID# 167545

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732

location_facility: Northwestern University Division of GI/Hepatology /ID# 158250

location_facility: 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984

location_facility: Great Lakes Medical Research, LLC /ID# 201774

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338

location_facility: The University of Chicago Medical Center /ID# 157113

location_facility: Centex Studies, Inc. - Houston /ID# 201218

location_facility: Kuzbass Regional Clinical Hospital /ID# 200707

location_facility: Tver Regional Clinical Hospital /ID# 206586

location_facility: Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959

location_facility: Louisana Research Center, LLC /ID# 162239

location_facility: Universitaetsklinikum Muenster /ID# 159333

location_facility: Cabinet Particular Policlinic Algomed /ID# 170889

location_facility: NorthShore University HealthSystem /ID# 158254

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418

location_facility: The Sixth Affiliated Hosp Sun /ID# 210783

location_facility: University General Hospital of Ioannina /ID# 157415

location_facility: Washington Gastroenterology Associates /ID# 162101

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527

location_facility: Universitaetsklinikum Tuebingen /ID# 159341

location_facility: GIRI Gastrointestinal Research Institute /ID# 157097

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 157100

location_facility: Private Practice Dr MN Rajabally /ID# 171159

location_facility: Duplicate_Dong-A University Hospital /ID# 163370

location_facility: South Florida Research Ph I-IV, Inc. /ID# 161825

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 162547

location_facility: Hospital Clinico Universitario de Valencia /ID# 209699

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 212400

location_facility: Northwest Gastroenterology Clinic /ID# 158255

location_facility: CHU Grenoble - Hopital Michallon /ID# 211980

location_facility: Hospital Universitario Virgen Macarena /ID# 159966

location_facility: Duplicate_Centrul Medical Tuculanu SRL /ID# 170892

location_facility: Centro de Investigaciones Clínicas Viña del Mar /ID# 203585

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706

location_facility: Hospital Universitario y Politecnico La Fe /ID# 157537

location_facility: Odense Universitets Hospital /ID# 155536

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058

location_facility: QEII - Health Sciences Centre /ID# 157089

location_facility: Hospital Universitario Basurto /ID# 205188

location_facility: Sjællands Universitetshospital, Roskilde /ID# 155537

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302

location_facility: Hadassah Medical Center-Hebrew University /ID# 171062

location_facility: Western Connecticut Medical Group /ID# 165874

location_facility: Clinical Center University of Sarajevo /ID# 165132

location_facility: Duplicate_Atria Clinical Research /ID# 164504

location_facility: Seffner Premier Health Care, PA /ID# 162259

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024

location_facility: Digestive Disease Associates, LTD /ID# 208296

location_facility: Riga East Clinical University Hospital /ID# 159615

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742

location_facility: Duplicate_Gastro-Praxis Wiesbaden /ID# 159335

location_facility: University of Nebraska Medical Center /ID# 210056

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 162545

location_facility: Evangelisches Krankenhaus Kalk /ID# 212724

location_facility: Toronto Digestive Disease Asso /ID# 157159

location_facility: Taichung Veterans General Hosp /ID# 160134

location_facility: Advanced Research Institute, Inc /ID# 161973

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040

location_facility: Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169766

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657

location_facility: West China Hospital, Sichuan University /ID# 210888

location_facility: St Vincent's University Hospital /ID# 157569

location_facility: Universitaetsklinikum Magdeburg /ID# 211840

location_facility: Children's Hospital of Pittsburgh of UPMC /ID# 212543

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 163620

location_facility: The First Affiliated Hospital of Nanchang University /ID# 211035

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 161303

location_facility: Revival Research Institute, Inc /ID# 210986

location_facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070

location_facility: Hospital Clinico Universitario de Salamanca /ID# 157539

location_facility: Montreal General Hospital - McGill University Health Center /ID# 157086

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339

location_facility: Duplicate_Northern Care Alliance NHS Group /ID# 207765

location_facility: Houma Digestive Health Special /ID# 158253

location_facility: Baylor Scott & White Medical Center- Temple /ID# 204129

location_facility: Univerzitna nemocnica Martin /ID# 163205

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578

location_facility: Clinical Research of West Florida, Inc /ID# 205864

location_facility: Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434

location_facility: Universitaetsklinikum Regensburg /ID# 163812

location_facility: Duplicate_Institutul Clinic Fundeni /ID# 170888

location_facility: Hospital Garcia de Orta, EPE /ID# 160688

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 160676

location_facility: Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018

location_facility: University Clinical Center Serbia /ID# 156957

location_facility: Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970

location_facility: Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857

location_facility: Theageneio Anticancer Hospital /ID# 163922

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980

location_facility: Hospital General Universitario Gregorio Maranon /ID# 161144

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 162549

location_facility: Duplicate_Medical University of Vienna /ID# 158135

location_facility: Yeungnam University Medical Center /ID# 163366

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 163219

location_facility: Aalborg Universitets Hospital /ID# 160685

location_facility: University Children's Hospital 'Tirsova' /ID# 211480

location_facility: Duplicate_Rambam Medical Center /ID# 171056

location_facility: National Taiwan University Hospital /ID# 162189

location_facility: Universitatsklinikum Mannheim /ID# 162026

location_facility: PennState Milton S.Hershey Med /ID# 154894

location_facility: Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630

location_facility: Universitaetsklinikum Frankfurt /ID# 212977

location_facility: China Medical University Hosp /ID# 160130

location_facility: Cleveland Clinic Main Campus /ID# 209225

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453

location_facility: Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 158194

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 162527

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604

location_facility: Percuro Clinical Research, Ltd /ID# 161635

location_facility: Tyler Research Institute, LLC /ID# 166795

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 210758

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 171130

location_facility: Vinius University Hospital Santaros Klinikos /ID# 162524

location_facility: Medizinisches Versorgunszentrum Dachau /ID# 211550

location_facility: Klinicki bolnicki centar Zagreb /ID# 157703

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 205736

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806

location_facility: Virginia Mason - Seattle Orthapedics /ID# 155577

location_facility: Asklepios Westklinikum Hamburg /ID# 159336

location_facility: South Lake Pain Institute, Inc /ID# 162798

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626

location_facility: National Cheng Kung University Hospital /ID# 160129

location_facility: City Clinical Hospital No. 31 /ID# 208865

location_facility: Hospital Universitario La Paz /ID# 159232

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 163365

location_facility: Hospital Universitario Miguel Servet /ID# 157538

location_facility: TX Clinical Research Institute /ID# 159396

location_facility: Taipei Veterans General Hosp /ID# 212711

location_facility: Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438

location_facility: Hospital Privado Univesitario /ID# 168080

location_facility: Duplicate_Long Island Clinical Research /ID# 154843

location_facility: Inje University Haeundae Hospital /ID# 202516

location_facility: University of Kentucky Chandler Medical Center /ID# 157109

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 162550

location_facility: Precision Research Institute, LLC /ID# 201072

location_facility: Gastroenterology Group Naples /ID# 165192

location_facility: Regional Clinical Hospital #1 /ID# 200708

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846

location_facility: Atrium Health Carolinas Medical Center /ID# 158364

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 154919

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 157417

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 210925

location_facility: CHA Bundang Medical center CHA University /ID# 163377

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 162546

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889

location_facility: Alliance Biomedical Ural Group /ID# 200703

location_facility: University Clinical Centre of the Republic of Srpska /ID# 165018

location_facility: Universal Axon Clinical Research /ID# 165426

location_facility: Adult Gastroenterology Associates - Gen 1 Research /ID# 208857

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655

location_facility: Duplicate_Universitaetsklinikum Freiburg /ID# 162025

location_facility: Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017

location_facility: Gastro Health & Nutrition - Victoria /ID# 164284

location_facility: Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121

location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 212458

location_facility: Centro Hosp de Tondela-Viseu /ID# 160731

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766

location_facility: University Clinical Centre of the Republic of Srpska /ID# 157710

location_facility: Klinicki bolnicki centar Split /ID# 157705

location_facility: Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169383

location_facility: NHS Greater Glasgow and Clyde /ID# 202314

location_facility: London Health Sciences Center /ID# 157162

location_facility: CHU Amiens-Picardie Site Sud /ID# 165056

location_facility: University Clinical Center Kragujevac /ID# 156961

location_facility: Texas Digestive Disease Consultants /ID# 209781

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 159977

location_facility: Unidad de Atencion Medica e Investigacion en Salud /ID# 170765

location_facility: Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 203975

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423

location_facility: Universitaetsklinikum Erlangen /ID# 159332

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 158023

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 155660

location_facility: Vanderbilt University Medical Center /ID# 157110

location_facility: Praxis fuer Gastroenterologie /ID# 166148

location_facility: Hospital Britanico de Buenos Aires /ID# 168081

location_facility: Instituto de Coloproctologia /ID# 158740

location_facility: Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201606

location_facility: Universitaetsklinikum St. Poelten /ID# 166423

location_facility: Vidant Multispecialty Clinic - Kinston /ID# 161109

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910

location_facility: Plains Clinical Research Center, LLC /ID# 169712

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Bosnia and Herzegovina
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
China
Malaysia
Estonia
Egypt
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


lead_sponsor: Ariad Pharmaceuticals

summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).

ReferenceCitation: Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11.

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2027-2039. doi: 10.1056/NEJMoa1810171. Epub 2018 Sep 25.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: Imperial College London - Spiral

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Istituto Oncologico di Bari Giovanni Paolo II

location_facility: Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner

location_facility: Kaiser Permanente Bellflower Medical Offices

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: USOR - Arizona Oncology Associates - Sedona

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Amphia Ziekenhuis - Locatie Langendijk Breda

location_facility: Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas

location_facility: Centre Hospitalier de Luxembourg - Hopital Municipal

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Hospital General Universitario de Alicante

location_facility: Virginia Cancer Specialists - Fairfax Office

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita

location_facility: Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia

location_facility: Seoul National University Bundang Hospital

location_facility: Istituto Tumori Napoli Fondazione G. Pascale

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: Hospital Teresa Herrera - Materno Infantil

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim

location_facility: Azienda Unita Sanitaria Locale di Ravenna

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

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Centre Hospitalier Universitaire Hopital Nord

location_facility: Centre Hospitalier Intercommunal de Creteil

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

location_facility: Centro di Riferimento Oncologico di Aviano

title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

type: Other Identifier

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Australia
Luxembourg
Canada
France
Hong Kong
Denmark
Switzerland
United States
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden