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

acronym: SELECT-COMPARE

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

ReferenceType: background

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

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

family: Yamaoka

full_name: Kunihiro Yamaoka

given: Kunihiro

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Kameda

full_name: Hideto Kameda

given: Hideto

family: Khan

full_name: Nasser Khan

given: Nasser

family: Sasaki

full_name: Nobuhito Sasaki

given: Nobuhito

family: Harigai

full_name: Masayoshi Harigai

given: Masayoshi

family: Song

full_name: Yanna Song

given: Yanna

family: Zhang

full_name: Ying Zhang

given: Ying

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

journal_name: Drug Safety

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

family: Cohen

full_name: Stanley B Cohen

given: Stanley B

family: van Vollenhoven

full_name: Ronald F van Vollenhoven

given: Ronald F

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

family: Zerbini

full_name: Cristiano A F Zerbini

given: Cristiano A F

family: Bessette

full_name: Louis Bessette

given: Louis

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

name: Clinical Pharmacology and Pharmacometrics AbbVie North Chicago Illinois USA

name: Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH & Co. KG Ludwigshafen am Rhein Germany

name: Immunology Clinical Development AbbVie North Chicago Illinois USA

title: Exposure–Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit–Risk Assessment in Rheumatoid Arthritis

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

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

location_facility: East Tallinn Central Hospital /ID# 142923

location_facility: Med Versorgungszentrum AGILOME /ID# 154975

location_facility: Centro Integral de Reumatologi /ID# 142845

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

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

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

location_facility: CHU Strasbourg Hautepierre Hos /ID# 144708

location_facility: Advanced Clin Res of Orlando /ID# 154617

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

location_facility: Seoul National University Hospital /ID# 142978

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

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

location_facility: AOU Citta della Salute Scienza /ID# 150070

location_facility: Instituto Portugues De Reumatologia /ID# 148316

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

location_facility: Zaporizhzhia Regional Clinical /ID# 143069

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

location_facility: Hanyang University Seoul Hospi /ID# 142979

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

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

location_facility: Timaru Medical Specialists Ltd /ID# 143000

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

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

location_facility: Diagnostic Group Integrated He /ID# 148356

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

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

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

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

location_facility: Centrum Medyczne AMED Warszawa Targowek /ID# 157621

location_facility: Odessa National Medical Univ /ID# 143072

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

location_facility: Klinicki bolnicki centar Rijeka /ID# 160232

location_facility: Clinical Center of Vojvodina /ID# 143033

location_facility: City Clinical Hospital Botkina /ID# 145628

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

location_facility: Consultora Integral de Salud S /ID# 144856

location_facility: General Hospital of Athens Laiko /ID# 142934

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

location_facility: Riga East Clinical Univ Hosp /ID# 142981

location_facility: NSC-Strazhesko Ist Cardiology /ID# 152030

location_facility: Tver Regional Clinical Hosp. /ID# 143026

location_facility: Rheumatology Ctr of San Diego /ID# 153747

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 143135

location_facility: AZ Arthritis & Rheuma Research /ID# 143131

location_facility: Karaganda State Medical Univ /ID# 153433

location_facility: China Medical University Hosp /ID# 143058

location_facility: Rheumatology Clinic of Houston /ID# 150921

location_facility: Hopital Universitaire Purpan /ID# 144707

location_facility: AZ Arthritis and Rheum Assoc /ID# 143130

location_facility: Rheumatology Consultants, PLLC /ID# 153731

location_facility: Semey State Medical University /ID# 152659

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

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 143055

location_facility: AZ Arthritis & Rheum Research /ID# 156093

location_facility: Klinicki bolnicki centar Split /ID# 152530

location_facility: Clinical Research Ctr Reading /ID# 143133

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

location_facility: Albuquerque Clinical Trials, Inc /ID# 143083

location_facility: Orenburg State Medical Academy /ID# 143018

location_facility: Taipei Veterans General Hosp /ID# 157940

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

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 142954

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

location_facility: Lviv Municipal City Clinical /ID# 143068

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

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

location_facility: Daugavpils Regional Hospital /ID# 142982

location_facility: Kyungpook National Univ Hosp /ID# 162073

location_facility: Centro Peninsular de Investiga /ID# 148159

location_facility: Chungnam National University Hospital /ID# 142977

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

location_facility: Centro Hospitalar De Vila Nova /ID# 143010

location_facility: Clinical Research Solutions, LLC /ID# 154619

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

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

location_facility: Kazan State Medical University /ID# 144871

location_facility: Coastal Carolina Health Care /ID# 148359

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

location_facility: Royal Prince Alfred Hospital /ID# 144857

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 142966

location_facility: Istanbul Universitesi Cerrahpa /ID# 156088

location_facility: First City Clinical Hospital /ID# 158011

location_facility: Rheumatology and Immunotherapy Center /ID# 145646

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

location_facility: Investigaciones Medicas SSMSO /ID# 151686

location_facility: Aprillus Asistencia e Investig /ID# 148406

location_facility: Kaohsiung Medical University /ID# 143059

location_facility: North Mississippi Med Clinics /ID# 145636

location_facility: Revita Reumatologiai Rendelo /ID# 142950

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

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

location_facility: Warrington + Halton Hosp NHS /ID# 143075

location_facility: Chung Shan Medical University /ID# 143060

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

location_facility: Inst. Rheumatologic Strusberg /ID# 145601

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

location_facility: Invest y Biomed de Chihuahua /ID# 142996

location_facility: Far Eastern Memorial Hospital /ID# 143061

location_facility: Consultorio Reumatologic Pampa /ID# 144853

location_facility: Lviv Regional Clinical Hospita /ID# 154450

location_facility: Chonnam National University Hospital /ID# 142975

location_facility: Clinical Pharmacology Study Gr /ID# 143082

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

location_facility: Arthritis Center of North GA /ID# 155258

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

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

location_facility: Kiskunhalasi Semmelweis Korhaz /ID# 151944

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

location_facility: Ulyanovsk Regional Clin Hosp /ID# 143030

location_facility: Joint & Muscle Research Instit /ID# 143119

location_facility: Innovative Clinical Research /ID# 145637

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

location_facility: General Hospital of Athens Ippokratio /ID# 142935

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

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 144709

location_facility: The Center for Rheumatology & /ID# 151356

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

location_facility: Centro Integral de Reumatologi /ID# 142897

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 145618

location_facility: Reg. Clinical Hosptial Concepcion /ID# 151271

location_facility: Cliniques Universitaires Saint Luc /ID# 142858

location_facility: Clinical Center University of Sarajevo /ID# 142865

location_facility: Arthritis & Osteoporosis Assoc /ID# 147364

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

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

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

location_facility: Hospital Universitario Reina S /ID# 153566

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

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

location_facility: LMU Klinikum der Universität München /ID# 142931

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

location_facility: SunValley Arthritis Center, Lt /ID# 143123

location_facility: Hospital Raja Perempuan Zainab II /ID# 157862

location_facility: Arthritis Clinical Research Tr /ID# 144874

location_facility: Achieve Clinical Research, LLC /ID# 143136

location_facility: Linkou Chang Gung Memorial Ho /ID# 143057

location_facility: Jakaranda Hosp, Emmed Research /ID# 143046

location_facility: Houston Institute for Clin Res /ID# 144879

location_facility: Accurate Clinical Management /ID# 145644

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

location_facility: Physician Res. Collaboration /ID# 143087

location_facility: Markusovszky Egyetemi Oktatókórház /ID# 145621

location_facility: Malopolskie Centrum Kliniczne /ID# 152782

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

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

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

location_facility: Perm Clinical Center of FMBA /ID# 145627

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

location_facility: Vital Medical Center Orvosi es /ID# 145950

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

location_facility: Lovelace Scientific Resources /ID# 143106

location_facility: Diagnostic Consultative Center /ID# 142875

location_facility: ClinicMed Badurski i wspolnicy SJ /ID# 163300

location_facility: Arthritis Rheumatic Back Disorder /ID# 143102

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

location_facility: Quality Clinical Research Inc. /ID# 156394

location_facility: North Georgia Rheumatology Grp /ID# 147170

location_facility: Spitalul Clinic de Recuperare /ID# 144867

location_facility: Arthritis Research of Florida /ID# 143125

location_facility: Daegu Catholic University Med /ID# 142973

location_facility: International Medical Research /ID# 143132

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

location_facility: Revmatologicka a interni ambul /ID# 142907

location_facility: University General Hospital Attikon /ID# 142933

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

location_facility: Arthritis Care and Diagnostic /ID# 150677

location_facility: Synexus Helderberg Clinical Tr /ID# 148322

location_facility: Russian National Research Medi /ID# 143028

location_facility: AZ Arthritis and Rheum Researc /ID# 143121

location_facility: Nuselská poliklinika, Revmatologie /ID# 144862

location_facility: Jakaranda Hosp, Emmed Research /ID# 145968

location_facility: Hevizgyogyfurdo es Szent Andra /ID# 142949

location_facility: AZ Arthritis and Rheum Researc /ID# 143080

location_facility: Hosp Lithuanian Univ Health Sc /ID# 142986

location_facility: Centro Medico de Reumatologia /ID# 148402

location_facility: Ryazan State Medical Universit /ID# 143031

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

location_facility: Reumatologicka ambulancia, LER /ID# 143044

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

location_facility: Accurate Clinical Management /ID# 143089

location_facility: Healthcare Research Consultant /ID# 143129

location_facility: Centro Inter Estud Clin CIEC /ID# 144777

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

location_facility: Winelands Medical Research Ctr /ID# 143048

location_facility: Revmatologie MUDr. Klara Sirov /ID# 142908

location_facility: Republican clinical hospital n /ID# 145626

location_facility: Mautalen Salud e Investigacion /ID# 142843

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

location_facility: North Estonian Medical Centre /ID# 145454


type: EudraCT Number

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

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

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

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

family: Greener

full_name: Tomer Greener

given: Tomer

sequence: first

family: Boland

full_name: Karen Boland

given: Karen

sequence: additional

family: Milgrom

full_name: Raquel Milgrom

given: Raquel

family: Ben-Bassat

full_name: Ofer Ben-Bassat

given: Ofer

family: Steinhart

full_name: A. Hillary Steinhart

given: A. Hillary

family: Silverberg

full_name: Mark. S. Silverberg

given: Mark. S.

family: Narula

full_name: Neeraj Narula

given: Neeraj

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Gastroenterology & Hepatology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn’s disease patients

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

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

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

location_facility: Gastroenterologicka Ambulancia /ID# 125632

location_facility: Hadassah University Hospital /ID# 127211

location_facility: Medizinische Universitat Wien /ID# 127186

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

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

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

location_facility: Asklepios Westklinikum Hamburg /ID# 127198

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

location_facility: Kitasato University Hospital /ID# 137694

location_facility: Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322

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

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

location_facility: Gastroenterology Group Naples /ID# 127806

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

location_facility: Magyar Elhizastudomanyi KKft. /ID# 126589

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

location_facility: Hospital Clinic de Barcelona /ID# 138147

location_facility: Complejo Hospitalario Universitario de Ferrol /ID# 127840

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 127216

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

location_facility: Norfolk and Norwich Univ Hosp /ID# 127139

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

location_facility: London Health Sciences Centre /ID# 127055

location_facility: Hidaka Clinic of Coloproctology /ID# 125477

location_facility: New River Valley Research Inst /ID# 127801

location_facility: Tel Aviv Sourasky Medical Center /ID# 201365

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

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

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

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

location_facility: Hiroshima University Hospital /ID# 124496

location_facility: KH der Elisabethinen Linz GmbH /ID# 127184

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

location_facility: University of Maryland Med Ctr /ID# 169734

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

location_facility: University of Michigan Hospitals /ID# 122240

location_facility: Soroka University Medical Center /ID# 127213

location_facility: Consultants for Clinical Res /ID# 122304

location_facility: Erlanger Institute for Clinica /ID# 129009

location_facility: Centrum Diagnostyczno Lecznicze Barska /ID# 170304

location_facility: Austin Center for Clinical Research /ID# 125396

location_facility: Universitatsklinikum Magdeburg /ID# 127200

location_facility: Wake Research Associates, LLC /ID# 122157

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

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

location_facility: Kitasato Univ Kitasato Inst Ho /ID# 127001

location_facility: Pannonia Maganorvosi Centrum Kft. /ID# 127207

location_facility: Hospital Univ de la Princesa /ID# 135828

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

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

location_facility: Fukuoka University Chikushi Hospital /ID# 124155

location_facility: Shafran Gastroenterology Ctr /ID# 122320

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

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

location_facility: Hospital General Universitario de Alicante /ID# 129261

location_facility: Universitatsklinikum Frankfurt /ID# 170300

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

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

location_facility: Hospital Universitario La Paz /ID# 127223

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

location_facility: Municipal Clinical Hospital #8 /ID# 127235

location_facility: Nagoya City University Hospital /ID# 124517

location_facility: The Royal Wolverhampton NHS Tr /ID# 127227

location_facility: Rocky Mountain Clinical Resear /ID# 122180

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

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

location_facility: Universitaetsklinik fuer Innere Medizin 1 /ID# 125944

location_facility: Winnipeg Regional Health Autho /ID# 125712

location_facility: Toronto Digestive Disease Asso /ID# 127075

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

location_facility: Policlinico Univ Tor Vergata /ID# 129321

location_facility: Hospital General Universitario Gregorio Maranon /ID# 127224

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

location_facility: Biopharma Informatic Research /ID# 171150

location_facility: Osaka Medical College Hospital /ID# 126451

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

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

location_facility: Universitatsklinik Regensburg /ID# 201265

location_facility: Toho University Sakura Medical Center /ID# 124497

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

location_facility: Dayton Gastroenterology, Inc. /ID# 127804

location_facility: Texas Digestive Disease Consul /ID# 141677

location_facility: Policlinico Agostino Gemelli /ID# 127217

location_facility: Texas Digestive Disease Consul /ID# 141678

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 125418

location_facility: Ordination Hainburg an der Don /ID# 127185

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

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

location_facility: Azienda Ospedaliera Spedali Civili /ID# 127236

location_facility: Southampton General Hospital /ID# 127228

location_facility: Centrum Medyczne LukaMed Joanna Luka /ID# 170302

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

location_facility: Centrum Medyczne Pratia Gdynia /ID# 170301

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

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


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

acronym: STRIVE

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

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Brunner HI, Nanda K, Toth M, Foeldvari I, Bohnsack J, Milojevic D, Rabinovich CE, Kingsbury DJ, Marzan K, Chalom E, Horneff G, Kuester RM, Dare JA, Trachana M, Jung LK, Olson J, Minden K, Quartier P, Bereswill M, Kalabic J, Kupper H, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation, and the Pediatric Rheumatology Collaborative Study Group. Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. Arthritis Care Res (Hoboken). 2020 Oct;72(10):1420-1430. doi: 10.1002/acr.24044.

name: Pediatric Rheumatology Collaborative Study Group Cincinnati Children’s Hospital Medical Center Cincinnati Ohio

family: Brunner

full_name: Hermine I. Brunner

given: Hermine I.

name: University of Washington School of Medicine and Seattle Children’s Hospital Seattle

family: Nanda

full_name: Kabita Nanda

given: Kabita

name: Nemours Children’s Hospital Orlando Florida

family: Toth

full_name: Mary Toth

given: Mary

name: Hamburg Centre for Pediatric and Adolescence Rheumatology Hamburg Germany

family: Foeldvari

full_name: Ivan Foeldvari

given: Ivan

family: Bohnsack

full_name: John Bohnsack

given: John

name: Johns Hopkins All Children’s Hospital St. Petersburg Florida

family: Milojevic

full_name: Diana Milojevic

given: Diana

name: Duke University Medical Center Durham North Carolina

family: Rabinovich

full_name: C. Egla Rabinovich

given: C. Egla

name: Randall Children’s Hospital at Legacy Emanuel Portland Oregon

family: Kingsbury

full_name: Daniel J. Kingsbury

given: Daniel J.

name: Children’s Hospital Los Angeles Los Angeles California

family: Marzan

full_name: Katherine Marzan

given: Katherine

family: Chalom

full_name: Elizabeth Chalom

given: Elizabeth

name: Asklepios Klinik Sankt Augustin, Sankt Augustin, and University Hospital of Cologne Cologne Germany

family: Horneff

full_name: Gerd Horneff

given: Gerd

name: Orthopaediezentrum Altona Hamburg Germany

family: Kuester

full_name: Rolf‐Michael Kuester

given: Rolf‐Michael

name: Arkansas Children’s Hospital Little Rock Arkansas

family: Dare

full_name: Jason A. Dare

given: Jason A.

name: Hippokration General Hospital Thessaloniki University School of Medicine Thessaloniki Greece

family: Trachana

full_name: Maria Trachana

given: Maria

name: Children’s National Medical Center Washington DC

family: Jung

full_name: Lawrence K. Jung

given: Lawrence K.

family: Olson

full_name: Judyann Olson

given: Judyann

name: Charite University Medicine Berlin and German Rheumatism Research Center Berlin Germany

family: Minden

full_name: Kirsten Minden

given: Kirsten

name: Université Paris‐Descartes Institut IMAGINE and Centre de Référence RAISE Hôpital Necker‐Enfants Malades Assistance Publique‐Hôpitaux de Paris Paris France

family: Quartier

full_name: Pierre Quartier

given: Pierre

name: AbbVie Deutschland GmbH and Co. KG Ludwigshafen Germany

family: Bereswill

full_name: Mareike Bereswill

given: Mareike

family: Kalabic

full_name: Jasmina Kalabic

given: Jasmina

family: Kupper

full_name: Hartmut Kupper

given: Hartmut

family: Lovell

full_name: Daniel J. Lovell

name: Istituto Giannina Gaslini Clinica Pediatrica e Reumatologia–PRINTO Genova Italy

family: Martini

full_name: Alberto Martini

given: Alberto

name: for the Paediatric Rheumatology International Trials Organisation, and the Pediatric Rheumatology Collaborative Study Group

title: Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven‐Year Interim Results

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

location_facility: Womens and Childrens Hospital /ID# 59182

location_facility: Nationwide Childrens Hospital /ID# 21963

location_facility: Kinder- & Jugendrheumatologie /ID# 39223

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

location_facility: Medizinische Universitat Wien /ID# 26127

location_facility: Azienda Ospedaliera Spedali Civili /ID# 39077

location_facility: Orszagos Reumatologiai es Fizi /ID# 95095

location_facility: AZ Arthritis and Rheum Researc /ID# 21023

location_facility: Asklepios Klinik St. Augustin /ID# 41622

location_facility: Arthritis Associates South FL /ID# 17001

location_facility: CHU NANCY - Hopital Brabois Adultes /ID# 25452

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

location_facility: Klinika detskeho a dorosto lek /ID# 47401

location_facility: Puerto Rico Children Hospital /ID# 47742

location_facility: Hospital Universitario Ramon y Cajal /ID# 41624

location_facility: Hopital Bretonneau - CHU Tours /ID# 27126

location_facility: Hospital Universitario Severo Ochoa /ID# 41751

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

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

location_facility: North Shore University Hospital /ID# 21022

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 42682

location_facility: Universita di Napoli Federico II /ID# 39078

location_facility: Legacy Emanuel Medical Center /ID# 14102

location_facility: Center Rheumatology Child&Adol /ID# 39069

location_facility: Universitair Medisch Centrum Utrecht /ID# 48842

location_facility: Hospital Garcia de Orta, E.P.E /ID# 37355

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

location_facility: Universita di Napoli Federico II /ID# 39072

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

location_facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 46402

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

location_facility: Univ degli Studi G D'Annunzio /ID# 37353

location_facility: Narodny ustav reumatickych chorob /ID# 38102

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 37360

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 95863

location_facility: Universitatsklinikum Tubingen /ID# 39070

location_facility: Azienda Ospedaliera Univ. Meyer /ID# 26123

location_facility: CHU Strasbourg Hautepierre Hos /ID# 25450

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 25454

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

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

location_facility: Rigshospitalet, Finsen Centre /ID# 25444

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 25447

location_facility: Duke University Medical Center /ID# 22904

location_facility: Charite Universitaetsmedizin Berlin /ID# 41623

location_facility: Methodist Medical Group Rheum /ID# 46343


title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

acronym: Verona

summary:
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be 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 and bone marrow tests, checking for side effects, and completing questionnaires.

status: Recruiting

enrollment_type: Anticipated

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

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 221231

location_facility: Cardiff & Vale University Health Board /ID# 221236

location_facility: Stauferklinikum Schwaebisch Gmuend /ID# 224917

location_facility: LUX MED Onkologia - Szpital Szamocka /ID# 222203

location_facility: University of Alabama at Birmingham /ID# 219151

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494

location_facility: Gold coast University Hospital /ID# 222606

location_facility: Ottawa Hospital Research Institute /ID# 219105

location_facility: Hospital Clinico Universitario de Salamanca /ID# 221297

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221667

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 219160

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 221703

location_facility: Tel Aviv Sourasky Medical Center /ID# 221896

location_facility: Fakultni nemocnice Hradec Kralove /ID# 221163

location_facility: City Clinical Hospital #40 of the Moscow City Health Department /ID# 221213

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 220810

location_facility: University Hospital Plymouth NHS Trust /ID# 222514

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221233

location_facility: Texas Oncology - Austin Midtown /ID# 223729

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221092

location_facility: University Hospitals Bristol NHS Foundation Trust /ID# 222510

location_facility: Torrance Memorial Physician Network Cancer Care /ID# 222702

location_facility: Consultants in Medical Oncology and Hematology - Broomall /ID# 233818

location_facility: Pan American Center for Oncology Trials, LLC /ID# 221010

location_facility: The Second Hospital of Hebei Medical University /ID# 222919

location_facility: Universitaetsklinikum Duesseldorf /ID# 221169

location_facility: Rocky Mountain Cancer Centers /ID# 223723

location_facility: University Hospitals Dorset NHS Foundation Trust /ID# 221237

location_facility: Tianjin Medical University General Hospital /ID# 226810

location_facility: Virginia Cancer Specialists - Gainesville /ID# 223726

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 223573

location_facility: VA Puget Sound Health Care System /ID# 221358

location_facility: Shengjing Hospital of China Medical University /ID# 222945

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 221386

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567

location_facility: Lanzhou University Second Hospital /ID# 225980

location_facility: Florida Cancer Specialists - Fort Myers /ID# 221319

location_facility: The Chaim Sheba Medical Center /ID# 221110

location_facility: Hospital Universitario Quironsalud Madrid /ID# 221275

location_facility: Hadassah Medical Center-Hebrew University /ID# 222006

location_facility: University of Fukui Hospital /ID# 221568

location_facility: Almazov National Medical Research Centre /ID# 221449

location_facility: The First Affiliated Hospital of Soochow University /ID# 221640

location_facility: Medizinische Hochschule Hannover /ID# 221173

location_facility: University College London Hospitals NHS Foundation Trust /ID# 221240

location_facility: Hospital General Universitario Gregorio Maranon /ID# 221271

location_facility: AP-HM - Hopital de la Conception /ID# 224882

location_facility: Universitaetsklinikum Leipzig /ID# 221168

location_facility: Ondokuz mayis University Facul /ID# 222091

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 219163

location_facility: St. Joseph Heritage Healthcare /ID# 222633

location_facility: MTZ Clinical Research SP. zoo /ID# 221354

location_facility: Hacettepe University Faculty of Medicine /ID# 222094

location_facility: CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973

location_facility: Liga Paranaense de Combate ao Câncer /ID# 221341

location_facility: Weill Cornell Medical College /ID# 222898

location_facility: Kobe City Medical Center General Hospital /ID# 221977

location_facility: Hospital Universitario Vall d'Hebron /ID# 221323

location_facility: Henan Provincial People's Hospital /ID# 225790

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003

location_facility: Novant Health Presbyterian Medical Center /ID# 222561

location_facility: Universitaetsmedizin Goettingen /ID# 221187

location_facility: Massachusetts General Hospital /ID# 225068

location_facility: Pusan National University Hospital /ID# 232353

location_facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816

location_facility: Rush University Medical Center /ID# 221007

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321

location_facility: Hospital Universitario y Politecnico La Fe /ID# 221270

location_facility: Hospital Universitario Virgen del Rocio /ID# 221276

location_facility: CHU UCL Namur - site Godinne /ID# 219064

location_facility: Zhongda Hospital Southeast University /ID# 221849

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784

location_facility: Northwestern University Feinberg School of Medicine /ID# 220843

location_facility: VA Caribbean Healthcare System /ID# 221012

location_facility: Nanfang Hospital of Southern Medical University /ID# 224566

location_facility: Medizinische Universitaet Wien /ID# 221446

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 221229

location_facility: Hospital Universitario Reina Sofia /ID# 221273

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 221702

location_facility: Erciyes University Medical Fac /ID# 222090

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 220991

location_facility: Tennessee Oncology-Nashville Centennial /ID# 220854

location_facility: Texas Oncology - Medical City Dallas /ID# 223725

location_facility: Universitatsklinikum Mannheim /ID# 221172

location_facility: Novant Health Forsyth Medical Center /ID# 221004

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818

location_facility: PIH Health Whittier Hospital /ID# 222647

location_facility: Hospital Israelita Albert Einstein/Farmacia da Oncologia /ID# 221370

location_facility: Yonsei University Health System Severance Hospital /ID# 233171

location_facility: Florida Cancer Specialists - North /ID# 221318

location_facility: Texas Oncology - San Antonio Medical Center /ID# 223728

location_facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819

location_facility: The Royal Marsden NHS Foundation Trust /ID# 221232

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475

location_facility: National Hospital Organization Mito Medical Center /ID# 222278

location_facility: Seoul National University Hospital /ID# 221226

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 222074

location_facility: Kaluga Regional Clinical Hospital /ID# 221211

location_facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727

location_facility: Univ Estad Rio de Janeiro UERJ /ID# 223080

location_facility: CHU Grenoble - Hopital Michallon /ID# 220988

location_facility: Helen F. Graham Cancer Center & Research Institute /ID# 223731

location_facility: West China Hospital, Sichuan University /ID# 221601

location_facility: Sunnybrook Health Sciences Ctr /ID# 219103

location_facility: Maryland Oncology Hematology /ID# 223776

location_facility: Yamagata University Hospital /ID# 221574

location_facility: Peking University International Hospital /ID# 222987

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 220989

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 221590

location_facility: The First Affiliated Hospital of Nanchang University /ID# 225983

location_facility: Fukushima Medical University Hospital /ID# 222015

location_facility: St Vincent's Hospital Melbourne /ID# 221809

location_facility: Hospital Universitario Walter Cantidio /ID# 223434

location_facility: Florida Cancer Specialists - East /ID# 221317

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221705

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 221339

location_facility: Akdeniz Universitesi Tip Fakul /ID# 222095

location_facility: Virginia Cancer Institute at Reynolds Crossing /ID# 221002

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 221274

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 227801

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 221387

location_facility: St. Luke's Mountain State Tumor Institute /ID# 220838

location_facility: Zhujiang Hospital of Southern Medical University /ID# 222071

location_facility: Florida Cancer Specialists - Panhandle /ID# 221315

location_facility: Ustav hematologie a krevni transfuze /ID# 221350

location_facility: VA Ann Arbor Healthcare System /ID# 221365

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982

location_facility: CHU de Nice - Hôpital Archet 1 /ID# 220992

location_facility: Dana-Farber Cancer Institute /ID# 219162

location_facility: New York Oncology Hematology - Albany Cancer Center /ID# 223778

location_facility: Willamette Valley Cancer Institute /ID# 223733

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 221474

location_facility: Fejer Megyei Szent Gyorgy Korhaz /ID# 222953

location_facility: Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635

location_facility: Hospital Universitario 12 de Octubre /ID# 221272

location_facility: Port Macquarie Base Hospital /ID# 234078

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 222069

location_facility: Texas Oncology - Forth Worth /ID# 223777

location_facility: McGill University Health Center Research Institute /ID# 222519

location_facility: Oncology Hematology Care, Inc - Kenwood /ID# 223724

location_facility: Beth Israel Deaconess Medical Center /ID# 225069

location_facility: University of California, Los Angeles /ID# 221760

location_facility: Tennessee Oncology - Chattanooga / McCallie /ID# 221311

location_facility: Baylor Scott & White Medical Center- Temple /ID# 221332

location_facility: Shaanxi Provincial people's Hospital /ID# 225728

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 221704

location_facility: National Cheng Kung University Hospital /ID# 218989

location_facility: Republican hospital named after V.A. Baranov /ID# 221214

location_facility: Seoul National University Bundang Hospital /ID# 221695

location_facility: Universitair Ziekenhuis Leuven /ID# 218905

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189

location_facility: Guangdong Provincial People's Hospital /ID# 221442

location_facility: Nagasaki University Hospital /ID# 222241

location_facility: Maastricht Universitair Medisch Centrum /ID# 221630

location_facility: Stony Brook University Hospital /ID# 224450

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221170

location_facility: Pontchartrain Cancer Center - Covington /ID# 221005

location_facility: Shanghai 6th People's Hospital /ID# 221546

location_facility: China Medical University Hospital /ID# 218987

intervention_type: Drug

status_simplified: Ongoing


ReferenceCitation: Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. doi: 10.1200/JCO.20.03318. Epub 2021 Aug 26.

location_country:
Finland
Greece
Australia
Russian Federation
Denmark
Ukraine
Spain
Croatia
France
Lithuania
Poland
Slovakia
Norway
Canada
Turkey
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Egypt
Belarus
Estonia
New Zealand
Latvia

location_facility: Texas Oncology - Austin Midtown /ID# 127477

location_facility: University Hospital Waterford /ID# 126178

location_facility: University of Vermont Medical Center /ID# 128064

location_facility: Hopital Larrey - CHU de Toulouse /ID# 128394

location_facility: Institute For Pulmonary Diseas /ID# 128737

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 126112

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228

location_facility: Hospital Universitario Virgen del Rocio /ID# 125207

location_facility: Bobruysk Interdistrict Onco. /ID# 128999

location_facility: Veszprem Megyei Tudogyogyintez /ID# 126121

location_facility: Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879

location_facility: Fundacion Instituto Valenciano Oncologia IVO /ID# 125205

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385

location_facility: Marmara University Medical Fac /ID# 126187

location_facility: Texas Oncology - South Austin /ID# 127476

location_facility: Azienda Ospedaliero Uni Parma /ID# 125703

location_facility: State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460

location_facility: Northwest Cancer Specialists, P.C. /ID# 127486

location_facility: Hadassah University Hospital /ID# 127077

location_facility: University of Texas MD Anderson Cancer Center /ID# 127946

location_facility: Hospital Angeles Centro Medico /ID# 127620

location_facility: Klinika za plucne bolesti Jordanovac /ID# 126537

location_facility: Northwest Cancer Specialists, P.C. /ID# 127488

location_facility: Gabrail Cancer Center Research /ID# 127415

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 128585

location_facility: Haukeland University Hospital /ID# 126338

location_facility: Southern Medical Day Care Ctr /ID# 125604

location_facility: Petz Aladar Megyei Oktato Korh /ID# 126110

location_facility: Akdeniz University Medical Fac /ID# 126997

location_facility: P. Stradins Clinical Univ Hosp /ID# 126322

location_facility: NZOZ Magodent Ctr. Med. Ostro /ID# 126545

location_facility: Guy's and St Thomas' NHS Found /ID# 125694

location_facility: Nebraska Hematology Oncology /ID# 127699

location_facility: Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699

location_facility: Parkland Health and Hosp Syste /ID# 128518

location_facility: VA Caribbean Healthcare System /ID# 124562

location_facility: North Devon District Hospital /ID# 125689

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 127815

location_facility: Goshen Center for Cancer Care /ID# 123875

location_facility: Fejer Megyei Szent Gyorgy Korh /ID# 126118

location_facility: University Hospital Bezanijska /ID# 128761

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218

location_facility: Comprehensive Cancer Ctrs Neva /ID# 127491

location_facility: Klinicki bolnicki centar Osijek /ID# 132214

location_facility: Virginia Oncology Associates /ID# 127458

location_facility: Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160

location_facility: The Queen Elizabeth Hospital /ID# 125607

location_facility: Betsi Cadwaladr Univ Health Bo /ID# 127177

location_facility: Appalachian Regional Healthcare, Inc (ARH) /ID# 128061

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736

location_facility: St. Luke's Mountain States Tumor Institute - Boise /ID# 124059

location_facility: Assaf Harofeh Medical Center /ID# 127076

location_facility: Smolensk Regional Onc Clin Dis /ID# 127144

location_facility: Hospital Universitario HM Sanchinarro /ID# 125162

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156

location_facility: Centro Estatal de Cancerologia /ID# 127583

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234

location_facility: Riga East Clinical Univ Hosp /ID# 125597

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 126353

location_facility: Bekes Megyei Pandy Kalman Korhaz /ID# 126117

location_facility: Istituto Oncologico del Medite /ID# 132844

location_facility: Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708

location_facility: Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737

location_facility: Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815

location_facility: Mazowiecki Szpital Onkologiczn /ID# 126546

location_facility: Naser Institute for Res & Dev /ID# 129263

location_facility: Belgorod Oncology Dispensary /ID# 129899

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120

location_facility: Ege University Medical Faculty /ID# 126189

location_facility: Nemocnice Kyjov, prispevkova organizace /ID# 125819

location_facility: Istituto Europeo di Oncologia /ID# 125702

location_facility: Vrije Universiteit Medisch Centrum /ID# 125578

location_facility: Cancercare Outeniqua Oncology Unit /ID# 126103

location_facility: CHRU de Brest - Hopital Morvan /ID# 127903

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 128221

location_facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 125755

location_facility: Franciscan St. Francis Health /ID# 126678

location_facility: Sunshine Coast University Hosp /ID# 125608

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 125876

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176

location_facility: Norfolk and Norwich Univ Hosp /ID# 125697

location_facility: Oslo Universitetssykehus, Radiumhospitalet /ID# 126335

location_facility: Cairo Uni Hosp Al Kasr El Ainy /ID# 128338

location_facility: Centre Hosp Intercommunal de Creteil /ID# 125922

location_facility: The Clatterbridge Cancer Ctr /ID# 125695

location_facility: Hospital Universitario Vall d'Hebron /ID# 125159

location_facility: Helsinki Univ Central Hospital /ID# 125897

location_facility: Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738

location_facility: Stavanger University Hospital /ID# 126336

location_facility: Princess Margaret Cancer Centre /ID# 126155

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548

location_facility: Debreceni Egyetem Klinikai Központ /ID# 126119

location_facility: Barwon Health University Hospital Geelong /ID# 125606

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217

location_facility: Northeast Arkansas Clinical Ch /ID# 128071

location_facility: Volgograd Regional Clinical Oncology Dispensary /ID# 126350

location_facility: Odense Universitets Hospital /ID# 125996

location_facility: UT Southwestern Medical Center /ID# 127876

location_facility: Sverdlovsk Regional Oncology Center Dispensary /ID# 128457

location_facility: Cairo Uni Hosp Al Kasr El Ainy /ID# 128340

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458

location_facility: University Hospital Limerick /ID# 126175

location_facility: University Hospital Linkoping /ID# 126443

location_facility: Flinders Centre for Innovation /ID# 125605

location_facility: Minnesota Oncology Hematology, PA /ID# 127473

location_facility: Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 126676

location_facility: University of Florida - Archer /ID# 126476

location_facility: Netcare Oncology Intervent Ctr /ID# 126100

location_facility: Tudogyogyintezet Toeroekbalint /ID# 126111

location_facility: Winship Cancer Institute of Emory University /ID# 124061

location_facility: The Royal Bournemouth Hospital /ID# 125690

location_facility: East Kent Hosp Univ NHS Trust /ID# 125698

location_facility: VA Eastern Colorado Healthcare System /ID# 128065

location_facility: North Estonian Medical Centre /ID# 128215

location_facility: Dartmouth-Hitchcock Medical Center /ID# 128075

location_facility: Instituto COI de Educacao e Pesquisa /ID# 127739

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 125877

location_facility: Opca bolnica Dr. Josip Bencevi /ID# 126539

location_facility: Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 125875

location_facility: Inselspital, Universitaetsklinik /ID# 126347

location_facility: Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704

location_facility: Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143

location_facility: Mogilev Reg Clin Oncology Dis /ID# 128639

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309

location_facility: Cancerologia de Queretaro S.C. /ID# 125920

location_facility: Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219

location_facility: CCA Braga - Hospital de Braga /ID# 125837

location_facility: Orenburg Regional Clinical Onc /ID# 137474

location_facility: Univerzitna Nemocnica Bratislava /ID# 126342

location_facility: Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710

location_facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461

location_facility: SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477

location_facility: Institute for Oncology and Rad /ID# 128721

source: euctr

title: Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).


title: InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial

acronym: InSaKa

summary:
Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly.

the primary objective of our trial is to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.

ReferenceCitation: Montassier E, Lemoine L, Hardouin JB, Rossignol P, Legrand M. Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA). BMJ Open. 2020 Aug 26;10(8):e039277. doi: 10.1136/bmjopen-2020-039277.

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Lemoine

full_name: Loic Lemoine

given: Loic

family: Hardouin

full_name: Jean Benoit Hardouin

given: Jean Benoit

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Legrand

full_name: Matthieu Legrand

given: Matthieu

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_normalized: HAL

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

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

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing_description: Trial data are not publicly available owing to data privacy, but access to the anonymised dataset can be obtained from the corresponding author on reasonable request.

lead_sponsor: Nantes University Hospital

location_facility: La Pitié Salpêtrière University Hospital

lead_sponsor_type: academique


title: A Phase 3, Multicenter, Open-Label 52-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

summary: This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

lead_sponsor: Allergan

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

location_facility: Karolinska university hospital, Huddinge /ID# 228985

location_facility: Tri-Service General Hospital /ID# 228998

location_facility: Alpine Clinical Research Center /ID# 226203

location_facility: Taipei Veterans General Hospital /ID# 226206

location_facility: Albany Medical Center Rheumatology /ID# 228212

location_facility: Austin Clinical Trial Partners /ID# 228391

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 228435

location_facility: Vall d'Hebron University Hospital /ID# 226338

location_facility: Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 229994

location_facility: FutureSearch Trials of Neurology /ID# 226424

location_facility: Diex Recherche Sherbrooke Inc. /ID# 226427

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 231202

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 226301

location_facility: Northwest Clinical Research Center /ID# 226240

location_facility: Schuster Medical Research Institute /ID# 226246

location_facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456

location_facility: Queen Elizabeth University Hospital /ID# 226419

location_facility: Neurology Department, Raigmore Hospital, NHS Highlands /ID# 226332

location_facility: Barrow Neurological Institute /ID# 228217

location_facility: Hospital Santa Creu i Sant Pau /ID# 226337

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412

location_facility: Bashkir State Medical University /ID# 228634

location_facility: Clinical Research Institute, Inc /ID# 226232

location_facility: FutureSearch Trials of Dallas, LP /ID# 226511

location_facility: Re:Cognition Health - Guildford /ID# 231203

location_facility: Klinische Forschung Dresden GmbH /ID# 226314

location_facility: Duplicate_Sentara Family Medicine Physicians /ID# 226448

location_facility: Accel Research Sites-Maitland Clinical Research Unit /ID# 226225

location_facility: Yonsei University Health System Severance Hospital /ID# 226265

location_facility: State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 226428

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625

location_facility: Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 228623

location_facility: Ospedale Ss. Filippo e Nicola /ID# 228627

location_facility: Nowon Eulji Medical Center, Eulji University /ID# 226261

location_facility: Aggarwal and Associates Limited /ID# 226452

location_facility: Stortorgets Neurologmottagning /ID# 226236

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 228631

location_facility: Dongtan Sacred Heart Hospital /ID# 226264

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 226336

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 229986

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 226537

location_facility: MedStar Georgetown Neurology /ID# 226460

location_facility: Vancouver Island Health Authority /ID# 226255

location_facility: Ottawa Headache Centre Research Inc /ID# 226451

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 226458

location_facility: J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328

location_facility: Hospital Universitario y Politecnico La Fe /ID# 226300

location_facility: Josephson-Wallack-Munshower Neurology - NE /ID# 226295

location_facility: CHU de Quebec-Université Laval hôpital CHUL /ID# 226392

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 229790

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226433

location_facility: Department of Neurology, University of Szeged /ID# 228430

location_facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 226252

location_facility: CTI Clinical Research Center /ID# 226278

location_facility: Narsjukvardskliniken Hassleholms Sjukhus /ID# 231175

location_facility: J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228418

location_facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226305

location_facility: Hospital Clinico Universitario San Carlos /ID# 228635

location_facility: Hospital Clinico Universitario de Valladolid /ID# 226330

location_facility: AP-HM - Hopital de la Timone /ID# 226407

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 229993

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571

location_facility: Beth Israel Deaconess Medical Center /ID# 228214

location_facility: Montreal Neurological Institut /ID# 226274

location_facility: LMU Klinikum Campus Grosshadern /ID# 226303

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 228624

location_facility: Albuquerque Clinical Trials, Inc /ID# 226523

location_facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226390

location_facility: King's College Hospital NHS Foundation Trusts /ID# 226524

location_facility: Hospital Universitario Virgen del Rocio /ID# 226333

location_facility: St Pancras Clinical Research /ID# 231201

location_facility: Kazan State Medical University /ID# 228632

location_facility: Stetson-University of Cincinnati /ID# 226326

location_facility: Re:Cognition Health - London /ID# 231205

location_facility: CH Annecy Genevois Site Annecy /ID# 226269

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 226410

location_facility: California Headache and Balance Center /ID# 226241

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 228630

location_facility: Universitaetsmedizin Rostock /ID# 226311

location_facility: AP-HP - Hopital Lariboisière /ID# 226220

location_facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389

location_facility: Abington Neurological Associates - Abington /ID# 226449

location_facility: Centrum Medyczne CLW-Med Aneta Cichomska i Joanna Luka-Wendrowska /ID# 226414

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226409

location_facility: Hospital Clinico Universitario de Valencia /ID# 226471

location_facility: Gabinet Lekarski Jacek Rozniecki /ID# 226418

location_facility: Mount Vernon Clinical Research /ID# 226249

location_facility: Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991

location_facility: Seoul National University Hospital /ID# 226199

location_facility: Deaconess Clinic - Gateway Health Center /ID# 226479

location_facility: Pusan National University Hospital /ID# 231416

location_facility: Centrum Medyczne Pratia Gdynia /ID# 226431

location_facility: Headache Neurology Research Institute /ID# 226234

location_facility: Amici Clinical Research - Raritan /ID# 226450

location_facility: The Royal Melbourne Hospital /ID# 233484

location_facility: Preferred Primary Care Physicians, Inc. /ID# 226447

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 228629

location_facility: CHU Nice - Hopital de Cimiez /ID# 228419

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404


ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22. Erratum in: Gastroenterology. 2020 Sep;159(3):1192.

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

location_facility: Duplicate_Shanghai Tenth People's Hospital /ID# 150460

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 151821

location_facility: Centro de Investigaciones Clínicas Viña del Mar /ID# 150212

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821

location_facility: Moonshine Research Center, Inc /ID# 152533

location_facility: Clinical Center University of Sarajevo /ID# 150208

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125

location_facility: Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785

location_facility: Vanderbilt University Medical Center /ID# 153355

location_facility: Universitatsklinikum Mannheim /ID# 150173

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607

location_facility: Yamanashi Prefectural Central Hospital /ID# 151908

location_facility: Plains Clinical Research Center, LLC /ID# 170290

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 152606

location_facility: Klinicki bolnicki centar Rijeka /ID# 150708

location_facility: Universitetssykehuset Nord-Norge /ID# 152835

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 217216

location_facility: Macquarie University Hospital /ID# 211951

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 170712

location_facility: Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204499

location_facility: Kitasato University Kitasato Institute Hospital /ID# 152686

location_facility: Hospital Universitario Reina Sofia /ID# 151066

location_facility: Tyler Research Institute, LLC /ID# 169146

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 151360

location_facility: Digestive Disease Specialists /ID# 201056

location_facility: St. Marianna University School of Medicine Hospital /ID# 208654

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100

location_facility: Helsinki Univ Central Hospital /ID# 150407

location_facility: National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 210117

location_facility: Clinical Hosp Center Zvezdara /ID# 150427

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080

location_facility: Montefiore Medical Center - Moses Campus /ID# 150543

location_facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206940

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 150349

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207422

location_facility: Duplicate_Stavropol State Medical Univ /ID# 150387

location_facility: Consultants for Clinical Res /ID# 151679

location_facility: Hospital Universitario de San /ID# 155387

location_facility: Carl R. Meisner Medical Clinic /ID# 171061

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334

location_facility: NYU Langone Long Island Clinical Research Association /ID# 155272

location_facility: Indianapolis Gastroenterology /ID# 162901

location_facility: Huddersfield Royal Infirmary /ID# 217658

location_facility: The Sixth Affiliated Hosp Sun /ID# 150456

location_facility: Universitair Medisch Centrum Utrecht /ID# 152775

location_facility: Shengjing Hospital of China Medical University /ID# 166920

location_facility: Huron Gastroenterology Assoc /ID# 152710

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 201533

location_facility: CliniCore International, LLC /ID# 152062

location_facility: University Clinical Hospital Mostar /ID# 150705

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 150541

location_facility: University Clinical Centre of the Republic of Srpska /ID# 150706

location_facility: Universitaetsklinikum Tuebingen /ID# 150767

location_facility: West Tallinn Central Hospital /ID# 150419

location_facility: Private Practice Dr MN Rajabally /ID# 155144

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564

location_facility: Shimane University School of Medicine /ID# 208899

location_facility: Kaiser Clinica e Hospital Dia /ID# 152483

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 150912

location_facility: Kazan State Medical University /ID# 166042

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357

location_facility: Hospital Britanico de Buenos Aires /ID# 209495

location_facility: The First Affiliated Hospital of Nanchang University /ID# 211750

location_facility: Niigata University Medical & Dental Hospital /ID# 218048

location_facility: Chung Shan Medical University /ID# 150573

location_facility: Duplicate_Marmara University Medical Fac /ID# 213969

location_facility: Nature Coast Clinical Research - Inverness /ID# 154064

location_facility: University Clinical Centre of the Republic of Srpska /ID# 150209

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 203411

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 201260

location_facility: M y F Estudios Clínicos Ltda. /ID# 200107

location_facility: Southern Star Research Institute, LLC /ID# 169396

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 152335

location_facility: Univ of California San Francis /ID# 164581

location_facility: Asahikawa Medical University Hospital /ID# 170289

location_facility: Complesso integrato Columbus /ID# 150333

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610

location_facility: National Taiwan University Hospital /ID# 150574

location_facility: University of Iowa Hospitals and Clinics /ID# 157058

location_facility: Showa University Fujigaoka Hospital /ID# 208222

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523

location_facility: Premier Medical Group - GI Division /ID# 153357

location_facility: University Clinical Center Serbia /ID# 150428

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868

location_facility: Newport Huntington Medical Group /ID# 217005

location_facility: P. Stradins Clinical Univ Hosp /ID# 151409

location_facility: East View Medical Research, LLC /ID# 171183

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606

location_facility: Juntendo University Urayasu Hospital /ID# 208781

location_facility: University Clinical Center of Nis /ID# 151903

location_facility: MediSphere Medical Research Center /ID# 152064

location_facility: Hospital Universitario La Paz /ID# 214539

location_facility: Hyogo College of Medicine Hospital /ID# 152434

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386

location_facility: Clin Res Inst of Michigan, LLC /ID# 153027

location_facility: Hamamatsu University Hospital /ID# 205708

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575

location_facility: Bekes Megyei Kozponti Korhaz /ID# 151572

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 209267

location_facility: Medical Research Center of CT /ID# 150482

location_facility: Encore Borland-Groover Clinical Research /Id# 170912

location_facility: Universal Axon Clinical Research /ID# 213461

location_facility: University of Michigan Health Systems /ID# 151140

location_facility: University of Mississippi Medical Center /ID# 213139

location_facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256

location_facility: Klinicki bolnicki centar Zagreb /ID# 150709

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201790

location_facility: Percuro Clinical Research, Ltd /ID# 150367

location_facility: Atlanta Gastroenterology Spec /ID# 150548

location_facility: North Estonia Medical Centre /ID# 160870

location_facility: Atrium Health Carolinas Medical Center /ID# 156971

location_facility: Kobe Home Clinic of Neurology /ID# 152049

location_facility: Hospital Universitario y Politecnico La Fe /ID# 150611

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545

location_facility: Yeungnam University Medical Center /ID# 150345

location_facility: Trinity College Dublin - St. J /ID# 150320

location_facility: Emeritas Research Group, LLC /ID# 150258

location_facility: Osaka City University Hospital /ID# 152682

location_facility: Ctr for Gastrointestinal Healt /ID# 153360

location_facility: CHA Bundang Medical center CHA University /ID# 159479

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212424

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811

location_facility: Atlantic Gastroenterology Clinical Research /ID# 151899

location_facility: Shin-Yurigaoka General Hospital /ID# 206024

location_facility: Hospital Clinic de Barcelona /ID# 150612

location_facility: Immanuel Kant Baltic Federal University /ID# 200719

location_facility: University General Hospital of Ioannina /ID# 164248

location_facility: Sapporo Medical University Hospital /ID# 206492

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822

location_facility: Slovak Research Center Team Me /ID# 150257

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 207135

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815

location_facility: Medical Center of the "Health /ID# 151274

location_facility: Klinicki bolnicki centar Zagreb /ID# 150225

location_facility: Hospital Nossa Senhora das Graças /ID# 152480

location_facility: Pusan National University Hospital /ID# 159481

location_facility: Hospital Garcia de Orta, EPE /ID# 151613

location_facility: East Tallinn Central Hospital /ID# 150417

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710

location_facility: University Clinical Center Tuzla /ID# 150211

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574

location_facility: Univ Hospitals Birmingham NHS Foundation trust /ID# 150382

location_facility: St.Luke's International Hospital /ID# 208074

location_facility: Healthcare Research Consultant /ID# 163100

location_facility: Atlantic Digestive Health Inst /ID# 150447

location_facility: University of New Mexico Department of Internal Medicine /ID# 214396

location_facility: CHU de Saint-Etienne, Hopital Nord /ID# 154453

location_facility: Japanese Red Cross Osaka Hospital /ID# 209476

location_facility: Columbia Univ Medical Center /ID# 163410

location_facility: Toyohashi Municipal Hospital /ID# 171457

location_facility: Republican hospital named after V.A. Baranov /ID# 206506

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305

location_facility: Umraniye Training and Res Hosp /ID# 162659

location_facility: National University Hospital /ID# 150453

location_facility: Hometown Urgent Care and Resea /ID# 200065

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610

location_facility: Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275

location_facility: Medical centre of CONSILIUM MEDICAL LLC /ID# 217446

location_facility: Tokai University Hachioji Hospital /ID# 152587

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 151065

location_facility: Mentahaz Maganorvosi Kozpont /ID# 205884

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 150338

location_facility: General Hospital of Athens Laiko /ID# 208669

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 152016

location_facility: Medical College of Wisconsin /ID# 151843

location_facility: St Vincent's Hospital Melbourne /ID# 152472

location_facility: Dartmouth-Hitchcock Medical Center /ID# 150549

location_facility: Kanazawa University Hospital /ID# 205099

location_facility: Utah Gastroenternology - St. Mark's Office /ID# 163101

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 152607

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 209130

location_facility: Gazi Universitesi Tip Fakultes /ID# 150127

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602

location_facility: Fukuoka University Chikushi Hospital /ID# 152628

location_facility: Birmingham Gastroenterology Associates O.C /ID# 151276

location_facility: Digestive Health Partners, P.A /ID# 167237

location_facility: Agaplesion Markus Krankenhaus /ID# 161982

location_facility: Hospital de Clinicas de Porto Alegre /ID# 153743

location_facility: CHU Amiens-Picardie Site Sud /ID# 163456

location_facility: Hospital Privado Univesitario /ID# 164185

location_facility: Mautalen Salud e Investigacion /ID# 171173

location_facility: Klaipeda University Hospital /ID# 158862

location_facility: Aurora Medical Center - Grafto /ID# 151717

location_facility: Basingstoke & North Hampshire /ID# 150380

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 150313

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580

location_facility: Queen Elizabeth University Hos /ID# 163787

location_facility: Hiroshima University Hospital /ID# 151951

location_facility: Western Connecticut Medical Group /ID# 169210

location_facility: Advanced Research Institute, Inc /ID# 163098

location_facility: Aichi Medical University Hospital /ID# 151993

location_facility: Montreal General Hospital - McGill University Health Centre /ID# 170012

location_facility: Kitakyushu Municipal Med Ctr /ID# 152588

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088

location_facility: The First Hospital of Jilin University /ID# 209986

location_facility: South Denver Gastroenterology /ID# 151223

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 167182

location_facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359

location_facility: Universitatsklinikum Munster /ID# 150158

location_facility: Ohio Clinical Research Partner /ID# 154068

location_facility: Texas Digestive Disease Consultants /ID# 209804

location_facility: Gastro Health & Nutrition - Victoria /ID# 167761

location_facility: National Hospital Organization Sendai Medical Center /ID# 209527

location_facility: Tianjin Medical University General Hospital /ID# 170604

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 151100

location_facility: Options Health Research, LLC /ID# 150554

location_facility: CCA Braga - Hospital de Braga /ID# 151608

location_facility: Washington Gastroenterology Associates /ID# 163629

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 150250

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461

location_facility: Dayton Gastroenterology, Inc. /ID# 167631

location_facility: Xiangya Hospital Central South University /ID# 167229

location_facility: Yamagata University Hospital /ID# 171454

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609

location_facility: Hadassah Medical Center-Hebrew University /ID# 165118

location_facility: Louisana Research Center, LLC /ID# 150446

location_facility: Erciyes University Medical Fac /ID# 150129

location_facility: Taipei Veterans General Hosp /ID# 151748

location_facility: Next Innovative Clinical Research - Chicago /ID# 216060

location_facility: Lviv Regional Clinical Hospital /ID# 150375

location_facility: NW State Medical Univ na Mechn /ID# 169322

location_facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 209479

location_facility: Vitebsk Regional Advanced Clin /ID# 169612

location_facility: Inland Empire Clinical Trials, LLC /ID# 216038

location_facility: Delsol Research Management, Ll /Id# 170131

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 203911

location_facility: Shoyukai Fujita Gastroenterological Hospital /ID# 216492

location_facility: Tokyo Women's Medical University Hospital /ID# 205977

location_facility: Theageneio Anticancer Hospital /ID# 163896

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 165782

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216297

location_facility: Radboud Universitair Medisch Centrum /ID# 151700

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 211325

location_facility: Massachusetts General Hospital /ID# 165676

location_facility: Virginia Mason - Seattle Orthapedics /ID# 153026

location_facility: Toho University Medical Center Sakura Hospital /ID# 151936

location_facility: National Hospital Organization Mito Medical Center /ID# 152631

location_facility: Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723

location_facility: Medical University of Vienna /ID# 150614

location_facility: Centex Studies, Inc. - Houston /ID# 201216

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766

location_facility: Riga East Clinical Univ Hosp /ID# 150354

location_facility: Citrus Valley Gastroenterology /ID# 151914

location_facility: Yokkaichi Hazu Medical Center /ID# 214347

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 216620

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689

location_facility: Hospital Universitario Dr. Negrin /ID# 203937

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770

location_facility: Washington University-School of Medicine /ID# 150485

location_facility: Nagoya City University Hospital /ID# 151950

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 150455

location_facility: Klinicki bolnicki centar Split /ID# 213988

location_facility: Lenasia Clinical Trial Centre /ID# 214344

location_facility: Akershus universitetssykehus /ID# 150317

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 150426

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 150372

location_facility: NorthShore University HealthSystem /ID# 150555

location_facility: Great Lakes Gastroenterology Research LLC /ID# 201772

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078

location_facility: CB Flock Research Corporation /ID# 165980

location_facility: The Vancouver Clinic, INC. PS /ID# 162333

location_facility: Wake Forest Baptist Medical Center /ID# 150448

location_facility: Universitair Ziekenhuis Leuven /ID# 150332

location_facility: Inselspital, Universitätsspital Bern /ID# 152590

location_facility: Yokohama City University Medical Center /ID# 169899

location_facility: Northwest Health Care Associates /ID# 151590

location_facility: Leids Universitair Medisch Centrum /ID# 152624

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 150337

location_facility: InSite Digestive Health Care - Oxnard /ID# 163414

location_facility: University of Maryland Med Ctr /ID# 150449

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221

location_facility: Northwest Gastroenterology Clinic /ID# 152527

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208487

location_facility: Revival Research Institute, LLC /ID# 207280

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347

location_facility: West China Hospital, Sichuan University /ID# 167040

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 211168

location_facility: Faculdade de Medicina do ABC /ID# 152481

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 213539

location_facility: Velocity Clinical Research/ Gut Whisperer /ID# 163181

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484

location_facility: East Tennessee Research Institute /ID# 203610

location_facility: Hanyang University Guri Hospital /ID# 150344

location_facility: Hospital Universitario Ramon y Cajal /ID# 151067

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 150486

location_facility: Houma Digestive Health Special /ID# 151844

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725

location_facility: St Vincent's University Hosp /ID# 150318

location_facility: University Clinical Center Kragujevac /ID# 150430

location_facility: AGA Clinical Research Associates, LLC /ID# 153040

location_facility: Shin-Yurigaoka General Hospital /ID# 227134

location_facility: Toronto Digestive Disease Asso /ID# 150363

location_facility: China Medical University Hosp /ID# 150571

location_facility: Fakultna nemocnica s poliklini /ID# 211370

location_facility: Klinicki bolnicki centar Osijek /ID# 150216

location_facility: Richmond University Medical Center /ID# 201859

location_facility: Hospital Clinico Universitario de Salamanca /ID# 150509

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358

location_facility: United Medical Doctors - Murrieta /ID# 151211

location_facility: Texas Digestive Disease Consultants /ID# 209947

location_facility: TX Clinical Research Institute /ID# 151526

location_facility: Crystal Pharmacology Research /ID# 151841

location_facility: Minnesota Gastroenterology PA /ID# 151678

location_facility: National Cheng Kung University Hospital /ID# 151749

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission in order to identify the induction dose of upadacitinib for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.