title: A Phase 3b/4 Randomized, Double-blind, Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis (Flex-Up)

acronym: Flex-Up

summary:
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 6 arms. Non-responders will be placed in the Non-responder arm on or after Week 16 and will receive upadacitinib. After the last study visit, there is a 30-day follow-up visit. Approximately 600 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide.

The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Non-responders will be placed in the Non-responder arm on or after Week 16. Participants will receive upadacitinib oral tablets once daily for up to 36 weeks.

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

study_start_date_type: Anticipated

status: Not yet recruiting

location_country:
Poland
Taiwan
Portugal
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
New Zealand
Hungary
Korea, Republic of
France
Israel
China
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility: Dermatologie Quist - BAG Dres. Quist PartG /ID# 245628

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 246393

location_facility: The First Hospital of China Medical University /ID# 247686

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 246424

location_facility: KonKuk University Medical Center /ID# 245657

location_facility: CHU Toulouse - Hopital Larrey /ID# 245821

location_facility: Dermatology Research Institute Inc. /ID# 246703

location_facility: Seoul National University Hospital /ID# 245651

location_facility: Peking University People's Hospital /ID# 247841

location_facility: Soonchunhyang University Hospital Bucheon /ID# 245654

location_facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 246426

location_facility: Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 247668

location_facility: Fondazione Policlinico Universitario Agostino Gemelli /ID# 246633

location_facility: Azienda Ospedaliera di Perugia /ID# 246632

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 246241

location_facility: Hadassah Medical Center-Hebrew University /ID# 247244

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 246421

location_facility: Ospedale Fiorini di Terracina /ID# 246628

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 245748

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 245710

location_facility: Dermed Centrum Medyczne Sp. z o.o /ID# 246329

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 246320

location_facility: Dermatology Hospital of Southern Medical University /ID# 247951

location_facility: Universitair Medisch Centrum Groningen /ID# 245672

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741

location_facility: Hospital Universitario Ramon y Cajal /ID# 246273

location_facility: Korea University Ansan Hospital /ID# 245653

location_facility: Chung Shan Medical University Hospital /ID# 245707

location_facility: National Taiwan University Hospital /ID# 245711

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 249135

location_facility: Linkou Chang Gung Memorial Hospital /ID# 245709

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 246634

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 247843

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 246247

location_facility: Derma Study Center Friedrichshafen GmbH /ID# 245640

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395

location_facility: Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 247991

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 246635

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 248413

location_facility: ASST Spedali civili di Brescia /ID# 246631

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 247026

location_facility: West China Hospital, Sichuan University /ID# 247953

location_facility: North Eastern Health Specialists /ID# 246153

location_facility: Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 245636

location_facility: St George Dermatology & Skin Cancer Centre /ID# 246152

location_facility: Hospital General Universitario Alicante /ID# 246270

location_facility: Northern Care Alliance NHS Group /ID# 246243

location_facility: Hospital Universitario de Bellvitge /ID# 246326

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629

location_facility: Hospital Garcia de Orta, EPE /ID# 246262

location_facility: Diagnostic consultative center Focus-5 /ID# 246317

location_facility: Universitair Ziekenhuis Leuven /ID# 246860

location_facility: Universitaetsklinikum Frankfurt /ID# 245627

location_facility: Universitaetsklinik Heidelberg /ID# 247029

location_facility: Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701

location_facility: Hospital Universitario y Politecnico La Fe /ID# 246319

location_facility: Nemocnice Jihlava, prispevkova organizace /ID# 247985

location_facility: Univerzitna nemocnica L. Pasteura Kosice /ID# 248084

location_facility: Univerzitna nemocnica Martin /ID# 246948

location_facility: The Holy Family Hospital Nazareth /ID# 248132

location_facility: Hospital Universitario La Paz /ID# 246271

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 246425

location_facility: Huashan Hospital, Fudan University /ID# 247680

location_facility: CCA Braga - Hospital de Braga /ID# 247521

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 246323

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 246250

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 246700

location_facility: Chung-Ang University Hostipal /ID# 245655

location_facility: Universitaetsklinikum Muenster /ID# 245623

location_facility: Taipei Municipal Wan Fang Hospital /ID# 245712

location_facility: INTER CLINIC Piotr Adrian Klimiuk /ID# 246330

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 246428

location_facility: Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 247845

location_facility: Hospital Universitario Infanta Leonor /ID# 246272

location_facility: Universitaetsklinikum Halle (Saale) /ID# 245637

location_facility: Shanghai Skin Disease Hospital /ID# 247950

location_facility: Peking University Third Hospital /ID# 247842

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 245825

location_facility: Universita degli Studi Gabriele dAnnunzio /ID# 246629

location_facility: Centrum Medyczne Pratia Gdynia /ID# 245835

location_facility: Royalderm Agnieszka Nawrocka /ID# 245746

location_facility: NHS Greater Glasgow and Clyde /ID# 246253


title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Viracta Therapeutics, Inc.

location_country:
Taiwan
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
Singapore
Germany

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

location_facility: The University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: UCSF Hematology and Blood and Marrow Transplant

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Mid Florida Hematology and Oncology Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Sidney Kimmel Cancer Center - Jefferson Health

location_facility: University College London Hospitals NHS Foundation Trust

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

acronym: (R-HAD)

summary: The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

status: Unknown status

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Prof. Dr. M. Dreyling (co-chairman)

location_country: Germany France

location_facility: Kath. Krankenhaus Hagen gem. GmbH St.-Marien-Hospital

location_facility: Hôpital Bretonneau, Service hématologie, Bâtiment H. Kaplan

location_facility: CH de Bretagne Atlantique, Service Hématologie

location_facility: Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

location_facility: Diakonieklinikum Stuttgart, Medizinische Klinik II

location_facility: Klinikum der J.W. Goethe-Universtität Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie

location_facility: Universitätsklinikum Ulm, Innere Medizin III

location_facility: Clinique Victor Hugo, Service hématologie

location_facility: Vivantes Klinikum Neukölln, Medizinische Klinik I - Hämatologie und Onkologie

location_facility: Ammerland-Klinik GmbH, Klinik für innere Medizin

location_facility: Mutterhaus der Borromäerinnen, Medizinische Abteilung

location_facility: Universitätsklinik Essen, Klinik für Hämatologie

location_facility: Hôpital Haut Lévêque, Service hématologie

location_facility: Harz-Klinikum Wernigerode-Blankenburg GmbH, Innere Medizin, Hämato-Onkologie und Palliativmedizin

location_facility: LMU München - Klinikum Großhadern Medizinische Klinik III

location_facility: Klinikum d. Phillips-Universität, Klinik für Innere Medizin Hämatol./Onkologie/Immunologie

location_facility: Heinrich-Braun-Krankenhaus, Klinik für Innere Medizin III

location_facility: Hôpital Jean Bernard, Service hématologie

location_facility: Centre Hospitalier de la côte Basque, Service hématologie

location_facility: Hôpital Albert Michallon, Service hématologie

location_facility: CHU Necker, Service d'hématologie - adulte

location_facility: Asklepios Klinik St. Georg, Abteilung Hämatologie

location_facility: Westpfalz-Klinikum GmbH, I. Medizinische Klinik

location_facility: Schlossberg Klinik, Oberstaufen Internistische Onkologie

location_facility: CH Sud Francilien de Corbeil, Service hématologie

location_facility: Hôpital Henri Mondor, Service hématologie

location_facility: Klinikum Nord Nürnberg, 5. Med. Klinik, Onkologie/Hämatologie

location_facility: UKSH im Städt. Krankenhaus Kiel, II. Med. Klinik und Poliklinik im SSK

location_facility: Kreisklinik Altötting-Burghausen, Sektion Hämatologie/Onkologie und Palliativmedizin

location_facility: Klinikum Schwäbisch Gmünd, Zentrum Innere Medizin

location_facility: Klinikum Magdeburg gemeinnützige GmbH, Klinik f. Hämatologie/Onkologie

location_facility: Klinikum der Universität zu Köln, Klinik I f. Innere Medizin

location_facility: Diakonie Klinikum Jung Stilling Krankenhaus

location_facility: Krankenhaus der Barmherzigen Brüder, 1. Medizinische Abteilung

status_simplified: Unknown


type: EudraCT Number

title: Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

summary: The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

status: Enrolling by invitation

design_allocation: Non-Randomized

lead_sponsor: Sierra Oncology, Inc.

location_country:
Denmark
Poland
Taiwan
Romania
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Germany
Bulgaria

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Multiprofile Hospital for Active Treatment Ruse

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

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek

location_facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski

location_facility: Catholic University of Korea Seoul Saint Mary's Hospital

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

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

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Ospedale Policlinico Giambattista Rossi Borgo Roma

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Barzilai Medical Center, Hematology Institute

location_facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Petz Aladár Egyetemi Oktató Kórház - Győr

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Northwest Oncology & Hematology - Rolling Meadows

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Research Institute of the McGill University Health Centre

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă


ipd_sharing: Yes

status: Completed

acronym: iNTEGRATE

title: A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

study_completion_date_type: Actual

lead_sponsor: Pharmacyclics LLC.

source: euctr

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

location_country:
Croatia
Taiwan
Spain
Italy
Austria
Australia
Canada
Hungary
Korea, Republic of
United States
France
China
Singapore
Japan
Germany

location_facility: University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166

location_facility: Osaka City University Hospital /ID# 1140-1157

location_facility: Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918

location_facility: Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121

location_facility: Hospital Clinico Universitario de Valencia /ID# 1140-1145

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 1140-0928

location_facility: Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024

location_facility: Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120

location_facility: Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437

location_facility: Kyungpook National Univ Hosp /ID# 1140-1153

location_facility: Dr. Haunerschen Kinderspital /ID# 1140-1142

location_facility: Yonsei University Health System, Severance Hospital /ID# 1140-0927

location_facility: Boston Childrens Hospital /ID# 1140-1615

location_facility: New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200

location_facility: Krankenhaus der Elisabethinen Linz /ID# 1140-0849

location_facility: Jackson Memorial Hospital, University of Miami /ID# 1140-0647

location_facility: National Taiwan Univ Hosp /ID# 1140-1184

location_facility: University of Rochester Cancer Center /ID# 1140-0127

location_facility: University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133

location_facility: Royal Brisbane and Women's Hospital /ID# 1140-0190

location_facility: Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156

location_facility: Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343

location_facility: The Ottawa Hospital Regional Cancer Center /ID# 1140-0159

location_facility: Universitaetsklinikum Dresden /ID# 1140-1367

location_facility: SoonChunHyang University Seoul /ID# 1140-1163

location_facility: Hokkaido University Hospital /ID# 1140-1436

location_facility: Hyogo College of Medicine College Hospital /Id# 1140-1434

location_facility: Duplicate_Kurashiki Central Hospital /ID# 1140-1442

location_facility: National Center for Child Health and Development /ID# 1140-1443

location_facility: Montefiore Medical Center - Moses Campus /ID# 1140-0120

location_facility: Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373

location_facility: Singapore General Hospital /ID# 1140-1162

location_facility: Universitatsklinikum Munster /ID# 1140-1195

location_facility: Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735

location_facility: University Hospital of Regensburg /ID# 1140-1446

location_facility: Tokai University Hospital /ID# 1140-1444

location_facility: Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750

location_facility: Okayama University Hospital /ID# 1140-1430

location_facility: Hospital Universitario Virgen del Rocio /ID# 1140-0863

location_facility: Barbara Ann Karmanos Cancer In /ID# 1140-0130

location_facility: Stony Brook University Medical Center /ID# 1140-0719

location_facility: National University Cancer Institute - National University Health System /ID# 1140-1155

location_facility: Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010

location_facility: Kobe City Medical Center General Hospital /ID# 1140-1438

location_facility: Chinese PLA General Hospital /ID# 1140-1198

location_facility: The Kinghorn Cancer Centre /ID# 1140-1165

location_facility: The First Affiliated Hospital of Soochow University /ID# 1140-1208

location_facility: University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050

location_facility: Children's National Medical Center /ID# 1140-1122

location_facility: Medical University of South Carolina, MUSC /ID# 1140-0738

location_facility: Dana-Farber Cancer Institute /ID# 1140-0349

location_facility: A.O. Univ. Ospedali Riuniti /ID# 1140-0932

location_facility: Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400

location_facility: Emory University, Winship Cancer Institute /ID# 1140-0033

location_facility: Rutgers Cancer Institute of NJ /ID# 1140-0803

location_facility: Hospital Santa Creu i Sant Pau /ID# 1140-0535

location_facility: Columbia University Medical Center, MS-CHONY /ID# 1140-1124

location_facility: Massachusetts General Hospital Cancer Center /ID# 1140-0020

location_facility: UCHSC Anschultz Cancer Pavilion /ID# 1140-0068

location_facility: University of Louisville Hospital /ID# 1140-1131

location_facility: Mayo Clinic, Rochester, MN /ID# 1140-0240

location_facility: Fred Hutchinson Cancer Research Center /ID# 1140-0404

location_facility: Ospedale San Raffaele IRCCS /ID# 1140-0523

location_facility: Princess Margaret Cancer Centre /ID# 1140-0043

location_facility: Osaka Women's and Children's Hospital /ID# 1140-1440

location_facility: Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439

location_facility: China Medical University Hosp /ID# 1140-1199

location_facility: CHU Amiens Groupe hospitalier Sud /ID# 1140-1205

location_facility: Emory University/Winship Cancer Institute /ID# 1140-1179

location_facility: Duplicate_University of Tsukuba Hospital /ID# 1140-1445

location_facility: Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019

location_facility: Royal Melbourne Hospital (RMH) /ID# 1140-0633

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150

summary: To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

status_simplified: Completed


title: A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

summary: Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

ReferenceType: derived

ReferenceCitation: Noy A, de Vos S, Coleman M, Martin P, Flowers CR, Thieblemont C, Morschhauser F, Collins GP, Ma S, Peles S, Smith SD, Barrientos JC, Chong E, Wu S, Cheung LW, Kwei K, Hauns B, Arango-Hisijara I, Chen R. Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis. Blood Adv. 2020 Nov 24;4(22):5773-5784. doi: 10.1182/bloodadvances.2020003121.

ReferenceCitation: Noy A, de Vos S, Thieblemont C, Martin P, Flowers CR, Morschhauser F, Collins GP, Ma S, Coleman M, Peles S, Smith S, Barrientos JC, Smith A, Munneke B, Dimery I, Beaupre DM, Chen R. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017 Apr 20;129(16):2224-2232. doi: 10.1182/blood-2016-10-747345. Epub 2017 Feb 6.

location_country:
United Kingdom
United States
France
Belgium
Germany

location_facility:
Site Reference ID/Investigator# 837
Site Reference ID/Investigator# 033
Site Reference ID/Investigator# 814
Site Reference ID/Investigator# 350
Site Reference ID/Investigator# 368
Site Reference ID/Investigator# 750
Site Reference ID/Investigator# 742
Site Reference ID/Investigator# 370
Site Reference ID/Investigator # 200
Site Reference ID/Investigator# 737
Site Reference ID/Investigator# 377
Site Reference ID/Investigator# 735
Site Reference ID/Investigator# 669
Site Reference ID/Investigator# 749
Site Reference ID/Investigator# 348
Site Reference ID/Investigator # 407
Site Reference ID/Investigator# 220
Site Reference ID/Investigator# 142
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Site Reference ID/Investigator# 736
Site Reference ID/Investigator# 560
Site Reference ID/Investigator# 763
Site Reference ID/Investigator# 047
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Site Reference ID/Investigator# 745


status: Terminated

primary_purpose: Prevention

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence

lead_sponsor: Takeda

type: Registry Identifier

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

location_country:
United Kingdom
Austria
United States
France
Germany

location_facility: University of North Carolina School of Medicine

location_facility: The University of Chicago Medical Center

location_facility: Les Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Colorado Hospital Anschutz Cancer Pavilion

location_facility: University of Kentucky Chandler Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Nice Hopital l'Archet

location_facility: NYU Langone Inflammatory Bowel Disease Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Columbia University Irving Medical Center

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: Saint Helens and Knowsley Teaching Hospitals NHS Trust

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

summary:
The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease.

Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it.

Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be conducted at the study clinic. The others can be in the clinic or at the participant's home. Follow-up will occur 4 weeks after final treatment.


title: Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method

acronym: OPTIMA

summary: The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

lead_sponsor: Ipsen

location_country:
Denmark
Romania
Spain
Greece
Italy
Russian Federation
United Kingdom
Finland
Ukraine
France
Belgium
Germany
Slovakia
Czechia

location_facility: Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology

location_facility: Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age

location_facility: Clinica Pediatrica, Universita Federico II di Napoli

location_facility: Azienda Policlinico - Università di Catania

location_facility: Centre Pédiatrique Gatien de Clocheville

location_facility: Institutul de Endocrinologie C.I. Parhon

location_facility: Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation

location_facility: Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine


title: TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

ReferenceCitation: Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.

lead_sponsor: AVEO Pharmaceuticals, Inc.

location_country:
Poland
Brazil
Portugal
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
United States
Chile
France
Belgium
Germany
Czechia

location_facility: ACEREY Centro de Investigación Clínica Oncológica

location_facility: Fairview Ridges Specialty Center - Burnsville

location_facility: Memorial Sloan Kettering Cancer Center - Basking Ridge - Oncology

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

location_facility: Stony Brook University Cancer Clinical Trials

location_facility: Specjalistyczny Szpital Onkologiczny NU-MED

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Beatson West of Scotland Cancer Centre - Oncology

location_facility: Centro Hospitalar Universitário de São João (CHUSJ)

location_facility: Instituto Brasileiro de Controle do Cancer - ibcc

location_facility: Institut Paoli Calmettes - HÃ´pital de jour

location_facility: University of Maryland Medical Center-Greenebaum Cancer Ctr

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia

location_facility: Institut de cancérologie de Strasbourg Europe - ICANS

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: Liverpool Hospital Cancer Therapy Centre

location_facility: Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica - Pharmacy

location_facility: Memorial Sloan Kettering Cancer Center - Nassau

location_facility: Florida Cancer Specialists - Hematology/Oncology

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Inova Schar Cancer Institute - Medical Oncology

location_facility: H. Santo Antonio. Centro Hospitalar do Porto

location_facility: City of Hope Comprehensive Cancer Center

location_facility: University Of Washington - Medical Center

location_facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie

location_facility: AOU Policlinico di Modena - Attività Integrata di Oncologi

location_facility: Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi

location_facility: Townsville Hospital and Health Service (THHS) HREC/RGO

location_facility: COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii

location_facility: US Oncology - Comprehensive Cancer Centers of Nevada (CCCN)

location_facility: CHU Michallon - Hopital Nord - Cancérologie Et Hématologie

location_facility: Roswell - Roswell Park Cancer Institute - Medical Oncology

location_facility: CHD Vendee La Roche sur Yon - Gastro-Entérologie

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital

location_facility: John Hopkins Medicine - Hematology/oncology

location_facility: Ospedale Cannizzaro, AO per l'Emergenza Cannizzaro

location_facility: Instituto Portugues de Oncologia Francisco Gentil

location_facility: Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie

location_facility: Sunnybrook Research Institute, sunnybrook Health Sciences Ct

location_facility: Johns Hopkins Medicine - Sibley Memorial Hospital

location_facility: Memorial Sloan Kettering Cancer Center - Oncology - Bergen

location_facility: Hopital Saint-Andre - Service d'Oncologie Medicale

location_facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: Universitätsmedizin Mainz - III. Medizinische Klinik und Poliklinik

location_facility: Centre Leon Berard - departement d'oncologie medicale

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hospital Particular do Algarve - Gambelas-Faro

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych

location_facility: ICO - Site Rene Gauducheau - Oncologie Medicale

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

location_facility: Centro para la Atención Integral del paciente Oncológico

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: University of Kentucky UK Markey Cancer Center

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Baylor Scott and White Research Institute - Hematology/Oncology

location_facility: Memorial Sloan Kettering Cancer Center - Monmouth - Oncology

location_facility: Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location

location_facility: Hospital Universitario Y Politécnico La Fe

location_facility: Banner MD Anderson Cancer Center - Laboratory

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: The Christie NHS Foundation Trust - Medical Oncology

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Clínica Universitaria Reina Fabiola - Oncology

location_facility: Fox Chase Cancer Center - Medical Oncology

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: University of New Mexico - Comprehensive Cancer Center

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Chattanooga Oncology and Hematology Associates

location_facility: Universitätsklinikum Erlangen - Urologische und Kinderurologische Universitätsklinik (Erlangen)

location_facility: PO di Cremona, ASST di Cremona - Oncologia medica

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Memorial Sloan Kettering Cancer Center - Westchester


title: SYMPHONY-1: A Phase 1b/3 Double-blind, Randomized, Active-controlled, 3-stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination With Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

summary: This is a multicenter, double-blind, active-controlled, randomized, 3-stage, biomarker enrichment design featuring early futility stopping and sample-size re-estimation with safety run-in designed to evaluate the efficacy and safety of tazemetostat in combination with lenalidomide and rituximab (R2) in subjects with relapsed or refractory (R/R) follicular lymphoma (FL), who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.

lead_sponsor: Epizyme, Inc.

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Hungary
Korea, Republic of
United States
France
China
Belgium
Germany

location_facility: Regional Cancer Care Associates-Freehold

location_facility: Regional Cancer Care Associates LLC - Howell

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Hopital Henri Mondor - Hemopathies Lymphoides

location_facility: Texas Oncology - Medical City Dallas Pediatric Hematology

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

location_facility: CHU Jean Minjoz - Service d'Hematologie Clinique

location_facility: Cancer Specialists of Tidewater - Chesapeake Office

location_facility: The office of Frederick P. Smith, MD, P.C.

location_facility: Oncology and Hematology Associates of Southwest Virginia

location_facility: AO Spedali Civili di Brescia, PO Spedali Civili

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

location_facility: St. Mary's Hospital and Regional Medical Center - St. Mary's

location_facility: Barwon Health, University Hospital Geelong

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Seoul National University Hospital - Department of Internal

location_facility: Severance Hospital, Yonsei University Health System - Haematology and Oncology

location_facility: Oncology Hematology Care (OHC), Inc. - Kenwood Office

location_facility: Fairfax Northern Virginia Hematology Oncology PC

location_facility: GHR Mulhouse Sud Alsace - Hopital Emile Muller - Departement d'Hematologic

location_facility: Service d'Hématologie Clinique Place Alexis Ricordeau

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Columbia U - Herbert Irving Comprehensive Cancer Center

location_facility: Tianjin Medical University Cancer Institute & Hospital

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

location_facility: Mass General Cancer Center at Newton-Wellesley

location_facility: St. Joseph Mercy Hospital- Inpatient Pharmacy

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Rocky Mountain Cancer Centers (RMCC) - Boulder

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Cancer Specialists, LLC Department of Clinical Research

location_facility: University of Tennessee Medical Center - Cancer Institute

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet

location_facility: The First Bethune Hospital of Jilin University

location_facility: Willamette Valley Cancer Institute and Research Center - Oncology

location_facility: Hackensack University Medical John Theurer Cancer Center

location_facility: Western Pennsylvania Hospital Hematology & Cellular Therapy

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

location_facility: Yakima Valley Memorial Hospital - North Star Lodge Cancer Center

location_facility: Hematology Oncology Associates of Rockland, P.C.

location_facility: Univ. of Pittsburgh Med Center - Oncology

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

location_facility: Huntsman Cancer Institute; The University of Utah

location_facility: Samsung Medical Center - Hematology-Oncology

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia

location_facility: Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

location_facility: Regional Cancer Care Associates LLC - Little Silver

intervention_type: Combination Product


status: Active, not recruiting

acronym: RA-BRIDGE

title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

lead_sponsor: Eli Lilly and Company

type: Other Identifier

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
South Africa
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Slovakia
Switzerland
Hungary
Germany
Denmark
Greece
France
Netherlands

location_facility: Ankara University Ibni Sina Hospital - Rheumatology

location_facility: Università degli studi della Campania Luigi Vanvitelli

location_facility: DM Clinical Research/Rheumatology Clinic of Houston

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: East Bay Rheumatology Medical Group, Inc

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Rheumatology Associates of South Florida

location_facility: Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí

location_facility: The Center for Rheumatology and Bone Research

location_facility: Aintree University Hospital NHS Foundation Trust

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim

location_facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Nizhny Novgorod City Clinical Hospital Number 5

location_facility: Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka

location_facility: City Rheumatology Center (City Hospital #25)

location_facility: Arthritis & Osteoporosis Clinic of Brazos Valley

location_facility: Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Rheuma Medicus- Zak��ad Opieki Zdrowotnej

location_facility: Institut für Präventive Medizin & Klinische Forschung GbR

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

location_facility: University Hospital Basel - Rheumatology

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: North-Western State Med. Univ. n.a. I.I. Mechnikov of MoH of

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: M. F. Vladimirskiy Moscow Regional Research Clinical Institute

location_facility: St Luke's Clinic - Intermountain Orthopaedics

location_facility: Hôpital Saint Joseph (Grand hôpital de Charleroi)

location_facility: Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi

location_facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Private Practice - Dr. Christine J. Leehealey

summary: This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.


intervention_type: Other

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

lead_sponsor: Halozyme Therapeutics

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Czechia
Poland
Australia
Israel
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Latvia
Estonia
Korea, Republic of
France
Netherlands

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: Memorial Healthcare System - Memorial Cancer Institute

location_facility: Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center

location_facility: Kaiser Permanente Franklin Medical Offices - Denver

location_facility: Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Fort Wayne Medical Oncology/Hematology, INC.

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Fundação Amaral Cravalho / Hospital Amaral Carvalho

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Universitätsklinikum Halle-Universitätsklinik und Poliklinik

location_facility: NYU Langone Medical Center - NYU Langone Arena Oncology

location_facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital de Clinicas de Porto Alegre - UFRGS

location_facility: Klinikum der Universität München - Campus Grosshadern

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: CENANTRON - Centro Avançado de Tratamento Oncologico

location_facility: East Tallinn Central Hospital Oncology Center

location_facility: Klinicki bolnički centar Sestre milosrdnice

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Samuel Oschin Comprehensive Cancer Institute

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: Mount Sinai School of Medicine - The Tisch Cancer Institute

location_facility: AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro

location_facility: Faculdade de Medicina da Universidade de Sao Paulo

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: AZ Maria Middelares - Campus Maria Middelares

location_facility: North Estonian Medical Centre Foundation Clinic of Oncology

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: SIA "Rigas Austrumu Kliniska Universitates Slimnica"

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: University of Washington (UW) - Seattle Cancer Care Alliance

location_facility: The Royal Marsden NHS Foundation Trust - Chelsea

location_facility: University of Wisconsin Health - UW Carbone Cancer Center

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: David Geffen School of Medicine (DGSOM) at UCLA

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: Sarah Cannon Research Institute UK (SCRI UK)

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Semmelweis Egyetem - Onkohaematológiai Osztály

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: The Royal Marsden NHS Foundation - Sutton

location_facility: Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Innovative Clinical Research Institution

location_facility: Nemocnice Na Bulovce (Hospital Na Bulovce)

location_facility: Fundacao Pio XII Hospital De Câncer de Barretos

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health

location_facility: ICM Val d'Aurelle Saint Eloi - Departement Oncologie

location_facility: The Chaim Sheba Medical Center [Oncology]

summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).


title: A Phase III Double-blind, Randomised, Parallel-Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human IFN Beta-1a) and Placebo in the Treatment of Patients With Moderate or Severe Acute Respiratory Distress Syndrome

acronym: INTEREST

summary: In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.

ReferenceCitation: Ranieri VM, Pettilä V, Karvonen MK, Jalkanen J, Nightingale P, Brealey D, Mancebo J, Ferrer R, Mercat A, Patroniti N, Quintel M, Vincent JL, Okkonen M, Meziani F, Bellani G, MacCallum N, Creteur J, Kluge S, Artigas-Raventos A, Maksimow M, Piippo I, Elima K, Jalkanen S, Jalkanen M, Bellingan G; INTEREST Study Group. Effect of Intravenous Interferon β-1a on Death and Days Free From Mechanical Ventilation Among Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2020 Feb 25;323(8):725-733. doi: 10.1001/jama.2019.22525.

lead_sponsor: Faron Pharmaceuticals Ltd

location_country:
Spain
Italy
United Kingdom
Finland
France
Belgium
Germany
Czechia

location_facility: Bristol Royal Infirmary University Hospitals, Bristol Foundation Trust

location_facility: Charing Cross Hospital St Mary's Hospital, Imperial College Healthcare NHS Trust

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitätsklinikum Carl Gustav Carus Klinik für Anästhesiologie und Intensivmedizin

location_facility: Lancashire Treaching Hospitals NHS Foundation Trust

location_facility: AOU Città della Salute e della Scienza di Torino

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Universita degli Studi di Roma "La Sapienza"

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hôpital Cochin, Réanimation Médicale Hospitalisation

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Klinikum Augsburg Klinik für Anästhesiologie

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario de Gran Canaria Dr Negrin

location_facility: Charing Cross Hospital Imperial College Healthcare NHS Trust

location_facility: Universitätsmedizin Göttingen Klinik für Anästhesiologie

location_facility: CHU Charleroi Site Hôpital Civil Marie Curie

location_facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University College London Hospitals, NHS Foundation Trust

location_facility: Kliniken der Stadt Köln Klinikum Merheim

location_facility: Universitätsklinik Leipzig Klinik und Poliklinik für Anäesthesiologie und Intensivtherapie

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Intesivmedizin

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Universitätsklinikum Bonn Klinik und Poliklinik für Anästhesiologie

location_facility: St George's University Hospitals, NHS Foundation Trust

location_facility: Hammersmith Hospital Imperial College Healthcre NHS Trust

location_facility: Azienda Ospedaliera Universitaria Sant' Anna

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

lead_sponsor: Geron Corporation

ReferenceCitation: Steensma DP, Fenaux P, Van Eygen K, Raza A, Santini V, Germing U, Font P, Diez-Campelo M, Thepot S, Vellenga E, Patnaik MM, Jang JH, Varsos H, Bussolari J, Rose E, Sherman L, Sun L, Wan Y, Dougherty S, Huang F, Feller F, Rizo A, Platzbecker U. Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study. J Clin Oncol. 2021 Jan 1;39(1):48-56. doi: 10.1200/JCO.20.01895. Epub 2020 Oct 27.

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
Switzerland
Ukraine
Korea, Republic of
France
United States
Israel
Turkey
Belgium
Germany
Czechia

location_facility: Wojewódzki Szpital Specjalistyczny sp.z o.o.

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital

location_facility: Washington University School of Medicine

location_facility: Pusan National University Hospital - Hematology and Oncology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Ankara University Medical Faculty - Hematology

location_facility: SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

location_facility: Kantonsspital St. Gallen - Onkologie/Hämatologie

location_facility: Ege Universitesi Tip Fakultesi - Hematology

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr

location_facility: Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su

location_facility: A.O. Universitaria Policlinico Tor Vergata

location_facility: Fred Hutchinson Cancer Research Center (FHCRC)

location_facility: A.O. Ospedali Riuniti Marche Nord Presidio Ospedaliero S. Salvatore di Pesaro-Stabilim. di Muraglia

location_facility: Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz

location_facility: Fachärztliche Gemeinschaftspraxis mit Schwerpunkt

location_facility: The Ohio State Comprehensive Cancer Center

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi di Firenze

location_facility: Gachon University Gil Medical Center - oncology

location_facility: Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: Texas Oncology/Methodist Charlton Cancer Center

location_facility: University of Alberta Hospital - Hematology Research

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Tennessee Oncology at Centennial Medical Center

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

location_facility: AO S. Andrea, Università degli Studi di Roma La Sapienza

location_facility: CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

location_facility: Nottingham City Hospital - Clinical Haematology

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi

location_facility: Vanderbilt University Medical - Hematology-Oncology

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

summary: The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study.


title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

summary: The purpose of this study is to compare the efficacy and safety of CC-92480, bortezomib and dexamethasone (480Vd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Ireland
Austria
Australia
Italy
Argentina
Canada
Finland
United Kingdom
Korea, Republic of
United States
France
China
Turkey
Belgium
Germany

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: WellSpan York Hospital Community Health Center

location_facility: The University of Mississippi Medical Center

location_facility: The West Clinic, PLLC dba West Cancer Center


title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Relapsed / Refractory (R/R) to Janus Kinase (JAK) Inhibitor

summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment.

ReferenceCitation: Mascarenhas J, Harrison CN, Kiladjian JJ, Komrokji RS, Koschmieder S, Vannucchi AM, Berry T, Redding D, Sherman L, Dougherty S, Peng L, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Verstovsek S. Imetelstat in intermediate-2 or high-risk myelofibrosis refractory to JAK inhibitor: IMpactMF phase III study design. Future Oncol. 2022 Jul;18(22):2393-2402. doi: 10.2217/fon-2022-0235. Epub 2022 May 5.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Malaysia
Singapore
Brazil
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Georgia
Korea, Republic of
France
Colombia

location_facility: GOU VPO Saratov State Medical University n.a. V.I. Razumovsk

location_facility: Pusan National University Hospital - Hematology and Oncology

location_facility: Deenanath Mangeshkar Hospital & Research Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hopital Avicenne - HÃ©matologie Clinique

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA

location_facility: Hospital A.C.Camargo Cancer Center - Clinical Oncology

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl

location_facility: Hospital de Clinicas de Porto Alegre - UFRGS

location_facility: CEPON Centro de Pesquisas Oncologicas SC

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

location_facility: Seoul National University Hospital - Department of Internal

location_facility: CCA-Braga. Centro Clínico Académico - Hospital Braga

location_facility: CHU - HÃ´pital Saint Louis - Centre D'Investigations Cliniq

location_facility: Institut de cancérologie du Gard - Hematologie clinique

location_facility: Centre Hospitalier Du Mans - Cancérologie Médicale

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: National University Cancer Institute (NCIS)

location_facility: Marmara university pendik training and research hospital

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András

location_facility: Specialized Hospital for Active Therapy of Hematological dis

location_facility: Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre

location_facility: Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)

location_facility: All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)

location_facility: University of California-San Diego/Moores UCSD Cancer Center

location_facility: Instituto Português de Oncologia de Lisboa

location_facility: Arcispedale S Maria Nuova, AO di Reggio Emilia


acronym: REVERBREZ

title: Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Burgel PR, Le Gros V, Decuypère L, Bourdeix I, Perez T, Deslée G. Immediate salbutamol responsiveness does not predict long-term benefits of indacaterol in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2017 Jan 31;17(1):25. doi: 10.1186/s12890-017-0372-z.

summary: In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.


title: Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

acronym: GRECCAR 5

summary: After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy

location_facility: Service de Chirurgie Viscérale - CHU Pontchaillou

location_facility: Service de Chirurgie Digestive - CHU Charles Nicolle

location_facility: Service de Chirurgie Digestive - Hôpital A. Michallon

location_facility: Service de Chirurgie Digestive et Viscérale - CHU Timone

location_facility: Service de Chirurgie Digestive et Générale - Brabois

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Beaujon

location_facility: Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux

location_facility: Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon

location_facility: Département de Chirurgie Oncologique - Institut Paoli Calmette

location_facility: Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine

location_facility: Département de Chirurgie Oncologique - Centre Oscar Lambret

location_facility: Département de Chirurgie Oncologique - CRLC Val d'Aurelle

intervention_type: Procedure

lead_sponsor_type: academique


title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

ReferenceCitation: Motzer RJ, McDermott DF, Escudier B, Burotto M, Choueiri TK, Hammers HJ, Barthélémy P, Plimack ER, Porta C, George S, Powles T, Donskov F, Gurney H, Kollmannsberger CK, Grimm MO, Barrios C, Tomita Y, Castellano D, Grünwald V, Rini BI, McHenry MB, Lee CW, McCarthy J, Ejzykowicz F, Tannir NM. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022 Jun 1;128(11):2085-2097. doi: 10.1002/cncr.34180. Epub 2022 Apr 5.

ReferenceCitation: Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5.

ReferenceCitation: Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Leung D, Saggi SS, Lee CW, McHenry MB, Motzer RJ. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial. Eur Urol. 2022 Mar;81(3):266-271. doi: 10.1016/j.eururo.2021.10.001. Epub 2021 Nov 5.

ReferenceCitation: Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, Arén Frontera O, Melichar B, Powles T, Donskov F, Plimack ER, Barthélémy P, Hammers HJ, George S, Grünwald V, Porta C, Neiman V, Ravaud A, Choueiri TK, Rini BI, Salman P, Kollmannsberger CK, Tykodi SS, Grimm MO, Gurney H, Leibowitz-Amit R, Geertsen PF, Amin A, Tomita Y, McHenry MB, Saggi SS, Tannir NM. Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial. J Immunother Cancer. 2020 Jul;8(2). pii: e000891. doi: 10.1136/jitc-2020-000891. Erratum in: J Immunother Cancer. 2021 May;9(5):.

ReferenceCitation: Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

ReferenceCitation: Tomita Y, Kondo T, Kimura G, Inoue T, Wakumoto Y, Yao M, Sugiyama T, Oya M, Fujii Y, Obara W, Motzer RJ, Uemura H. Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: analysis of Japanese patients in CheckMate 214 with extended follow-up. Jpn J Clin Oncol. 2020 Jan 24;50(1):12-19. doi: 10.1093/jjco/hyz132.

ReferenceCitation: Motzer RJ, Rini BI, McDermott DF, Arén Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthélémy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grünwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum in: Lancet Oncol. 2019 Aug 21;:. Erratum in: Lancet Oncol. 2020 Jun;21(6):e304. Lancet Oncol. 2020 Nov;21(11):e518.

ReferenceCitation: Cella D, Grünwald V, Escudier B, Hammers HJ, George S, Nathan P, Grimm MO, Rini BI, Doan J, Ivanescu C, Paty J, Mekan S, Motzer RJ. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):297-310. doi: 10.1016/S1470-2045(18)30778-2. Epub 2019 Jan 15. Erratum in: Lancet Oncol. 2019 Jun;20(6):e293.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthélémy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Ireland
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Local Institution - 0068
Local Institution - 0148
Local Institution - 0155
Local Institution - 0036
Local Institution - 0197
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Local Institution - 0019
Local Institution - 0149
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Local Institution - 0164
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Local Institution - 0124
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Local Institution - 0077
Local Institution - 0117
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Local Institution - 0189
Local Institution - 0006
Local Institution - 0195
Local Institution - 0206
Local Institution - 0147
Local Institution - 0192
Local Institution - 0107
Local Institution - 0022
Local Institution - 0106
Local Institution - 0175
Local Institution - 0119
Local Institution - 0139
Local Institution - 0162
Local Institution - 0040
Local Institution - 0062
Local Institution - 0010
Local Institution - 0185
Local Institution - 0131
Local Institution - 0112
Local Institution - 0137
Local Institution - 0170
Local Institution - 0122
Local Institution - 0071
Local Institution - 0102
Local Institution - 0144
Local Institution - 0141
Local Institution - 0176
Local Institution - 0034
Local Institution - 0188
Local Institution - 0199
Local Institution - 0023
Local Institution - 0173
Local Institution - 0161
Local Institution - 0115
Local Institution - 0060
Local Institution - 0163
Local Institution - 0182
Local Institution - 0084
Local Institution - 0168
Local Institution - 0109
Local Institution - 0035
Local Institution - 0039
Local Institution - 0064
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Local Institution - 0046
Local Institution - 0121
Local Institution - 0045
Local Institution - 0055
Local Institution - 0058
Local Institution - 0004
Local Institution - 0204
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Local Institution - 0104
Local Institution - 0177
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Local Institution - 0135
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Local Institution - 0156
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Local Institution - 0041
Local Institution - 0065
Local Institution - 0193
Local Institution - 0129
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Local Institution - 0133
Local Institution - 0007
Local Institution - 0083
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Local Institution - 0079
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Local Institution - 0067

intervention_type: Biological


acronym: SELF

title: A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses

lead_sponsor: UCB Pharma

ReferenceType: result

ReferenceCitation: Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907.

summary:
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.

Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility


time_perspective: Prospective

acronym: ISALP

title: Evaluating the Performance of Isotopic Brain Imaging of Glucose Metabolism Via PET (18F-FDG) and Perfusion SPECT (99mTc-ECD) for the Diagnosis of Prodromal Stage Alzheimer's Disease

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

study_type: Observational

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

summary: The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.


title: An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

summary:
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).

The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Optional Sub-Study:

The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.

The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

ReferenceCitation: Blauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2022 Nov 1. doi: 10.1007/s12325-022-02322-y. [Epub ahead of print]

ReferenceCitation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

ReferenceCitation: Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.

ReferenceCitation: Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.

ReferenceCitation: Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaçi D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.

ReferenceCitation: Beck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.

ReferenceCitation: Beck LA, Thaçi D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Singapore
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Denmark
Ireland
Estonia
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility:
Regeneron Study Site
Regeneron Study Site 2
Regeneron Study Site 8
Regeneron Study Site 6
Regeneron Study Site 3
Regeneron Study Site 4
Regeneron Study Site 5
Regeneron Study Site 1
Regeneron Study Site 7


title: Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock

acronym: ABDO-MIX

summary: The purpose of this randomized, comparative, open and multi-centre study is to show that two sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from septic shock.

ReferenceCitation: Payen DM, Guilhot J, Launey Y, Lukaszewicz AC, Kaaki M, Veber B, Pottecher J, Joannes-Boyau O, Martin-Lefevre L, Jabaudon M, Mimoz O, Coudroy R, Ferrandière M, Kipnis E, Vela C, Chevallier S, Mallat J, Robert R; ABDOMIX Group. Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med. 2015 Jun;41(6):975-84. doi: 10.1007/s00134-015-3751-z. Epub 2015 Apr 11.

lead_sponsor: Meditor SAS

location_facility:
Lille University Hospital
Saint Louis Hospital
Poitiers University Hospital
Vendée Hospital
Strasbourg University Hospital
Lariboisière University Hospital
Pontchaillou University Hospital
Saint-Malo Hospital
Tours University Hospital
Dr Schaffner Hospital
Limoges University Hospital
Roanne Hospital
La Source Hospital
Dieppe Hospital
Bordeaux University Hospital
Clermont-Ferrand University Hospital
Rouen University Hospital
Saint Jean Hospital

intervention_type: Device


title: An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with relapsed or refractory small cell lung cancer.

This study will be conducted in 2 parts. Part 1 will evaluate two treatment arms, each with a different KRT-232 dose. Part 2 will continue the evaluation of the selected treatment arms from Part 1.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Spain
Korea, Republic of
United States
France
Germany

location_facility: Hospital Regional Universitario de Malaga - Hospital Civil

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Florida Cancer Specialists - 3840 Broadway

location_facility: University Hospitals Cleveland Medical Center

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

location_facility: Florida Cancer Specialists - 560 Jackson St, Suite 220

location_facility: Mark H Zangmeister Center - 3100 Plaza Properties Boulevard


title: Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer

acronym: CARACO

summary: It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.

status: Suspended

primary_purpose: Other

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Hôpital Bretonneau
Centre Paul Strauss
Centre Jean Perrin
Institut Paoli Calmette
Centre René Huguenin
Hôpital Européen Georges Pompidou
Hopital
Centre Val d'Aurelle
Clinique Sainte Thérèse
Institut Cancerologie de l'Ouest
Centre Paul Papin
Hôpital des Diaconesses
Clinique Mutualiste
Institut Claudius Regaud
Hospital
Hôpital Lariboisière
Centre G F Leclerc


title: Prevention of Venous Thromboembolism Disease for Acutelly Ill Medical Patients Admitted to Hospital : Systematic Analysis of Thrombosis Risk Factors and Remember of Prevention Treatment Indications in Emergency Departments.

acronym: PREVENU

summary:
The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected.

We aim to analyse the incidence of symptomatic thromboembolic disease following hospitalisation in medical setting and the efficacy of a multicomponent prevention approach in emergency department including systematic evaluation of thrombosis risk factors and remembers of thrombophylaxis indications and modalities for acutely ill medical patients.

Design: cluster randomized interventional study - Observational study at patient level

Setting: 30 French emergency departments

Patients: Patients over 40 years old admitted in participating emergency departments and hospitalized for acute medical reasons.

Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.

ReferenceCitation: Roy PM, Rachas A, Meyer G, Le Gal G, Durieux P, El Kouri D, Honnart D, Schmidt J, Legall C, Hausfater P, Chrétien JM, Mottier D; PREVENU study group. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial. PLoS One. 2016 May 26;11(5):e0154832. doi: 10.1371/journal.pone.0154832. eCollection 2016.

lead_sponsor: University Hospital, Angers

location_facility:
UH Rennes
UH Grenoble
H Bobigny
UH Brest
H Bethune
UH Poitiers
UH la pitié salpetriere
UH Marseille
UH Besançon
UH Nimes
H Compiegne
UH Dijon
UH Nantes
H Clermont Ferrand
UH Hotel Dieu
UH Ambroise Pare
UH Bichat
H Argenteuil
H Chateauroux
UH Agen
H Cochin
UH La Reunion
UH Metz Thionville

intervention_type: Behavioral


title: A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

summary: The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 (BMS-986415) alone and in combination with Nivolumab in participants with advanced solid tumors.

location_country:
Australia
United States
Spain
France

location_facility: University of Iowa Hospitals and Clinics

location_facility: HealthPartners Cancer Center at Regions Hospital

location_facility: Augusta University Georgia Cancer Center

location_facility: USOR - Virginia Cancer Specialists - Fairfax Office

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: SCRI - Tennessee Oncology - Saint Thomas West Clinic


primary_purpose: Diagnostic

acronym: FUO-TEP

title: Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients

lead_sponsor: University Hospital, Limoges

location_facility: Médecine Interne - AP-HP - Hôpital Cochin

location_facility: Médecine Interne - AP-HP - Hôpital Bichat

location_facility: Médecine Nucléaire - AP-HP - La Pitié Salpétrière

location_facility: Médecine Interne - AP-HP - La Pitié Salpétrière

location_facility: Médecine Interne - AP-HP - Hôpital Hôtel Dieu

location_facility: Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu

location_facility: Médecine Nucléaire et Imagerie Fonctionnelle - CHU

location_facility: Service des Isotopes - CRLCC Centre Eugène Marquis

location_facility: Médecine Nucléaire - AP-HP - Hôpital Bichat

location_facility: Département de Médecine pour adulte - CHU

summary: Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many affections. The diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. For this reason, the diagnosis involves many additional and expensive tests such as computed tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO and chronic inflammatory syndrome.


acronym: DETERMINED 1

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

lead_sponsor: AbbVie

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

location_country:
Spain
Australia
Netherlands
Canada
United States
France
Japan
Germany

location_facility: Penn State Hershey Medical Ctr /ID# 211659

location_facility: Modern Research Associates, PL /ID# 215202

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912

location_facility: University of the Ryukyus Hospital /ID# 211373

location_facility: Burke Pharmaceutical Research /ID# 211671

location_facility: Integrative Skin Science and Research /ID# 212550

location_facility: Virginia Clinical Research, Inc. /ID# 215959

location_facility: California Dermatology Institute /ID# 211786

location_facility: The Royal Melbourne Hospital /ID# 212436

location_facility: CHU Toulouse - Hopital Larrey /ID# 213581

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 212563

location_facility: Nagoya City University Hospital /ID# 211155

location_facility: HCL - Hopital Edouard Herriot /ID# 218408

location_facility: Beth Israel Deaconess Medical Center /ID# 211794

location_facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043

location_facility: Hospital Universitario Virgen de la Victoria /ID# 212013

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 212564

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015

location_facility: Wiseman Dermatology Research /ID# 212243

location_facility: Staedtisches Klinikum Dessau /ID# 211914

location_facility: Oregon Medical Res Center PC /ID# 211796

location_facility: Bakersfield Derma & Skin Cance /ID# 211684

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 212249

location_facility: Universitaetsklinikum Frankfurt /ID# 211913

location_facility: Minnesota Clinical Study Center /ID# 211979

location_facility: Hospital General Universitario Alicante /ID# 212010

location_facility: Montefiore Medical Center - Moses Campus /ID# 211800

location_facility: Hospital Santa Creu i Sant Pau /ID# 212009

location_facility: Hospital Universitario Virgen de las Nieves /ID# 212014

location_facility: Hospital General Universitario Gregorio Maranon /ID# 212011

summary: The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.


title: A Phase 4, Observational Study to Explore How Different Treatment Regimens Affect Continuation With Treatment in the First 6 Months Following Initiation of XAGRID Into Adult Patients' Essential Thrombocythemia Therapy

acronym: FOX

summary: This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.

ReferenceCitation: Rey J, Viallard JF, Keddad K, Smith J, Wilde P, Kiladjian JJ; FOX study investigators. Characterization of different regimens for initiating anagrelide in patients with essential thrombocythemia who are intolerant or refractory to their current cytoreductive therapy: results from the multicenter FOX study of 177 patients in France. Eur J Haematol. 2014 Feb;92(2):127-36. doi: 10.1111/ejh.12210. Epub 2013 Nov 25.

lead_sponsor: Shire

location_facility:
CH Departemental Des Oudairies
CHRU Lille - Hopital Huriez
Hopital Robert Ballanger
CHI Poissy Saint German en Laye
Ch De Fleyriat
Ch D Arras
Hotel Dieu
CHU Nord - Chemin Des Bourrely
Hopital Robert Boulin
Institut de Cancerologie de la Loire
CHRA
Hopitaux de Brabois
Hopital De Haut Leveque
Polyclinique Bordeaux Nord Aquitaine
Hopital Augustin Morvan
Hopital N D Bon Secours
Hopital Font Pre
CH DU Pays D Aix
Hopital Saint Philibert
Clinique Du Parc
CH De Blois
Chi De Cornouaille
Hopital Tenon
Clinique Pont de Chaume
Hopital de La Maison Blanche
Ch De Brive La Gaillarde
Hopital Pontchaillou
Hopital De L Archet
Hopital Edouard Herriot
Cabinet D'Hematologie
Hopital Henri Mondor
Institut J Paoli Calmettes
Hopital Saint Jean
Hopital Hotel Dieu Et Hme
Hopital Saint Antoine
CME
Nouvelles Cliniques Nantaises
Hia Sainte Anne
GH Pitie Salpetriere
Hopital Dupuytren
CH De Bicetre
Ch De Vendome
Centre De Radiotherapie
Hopital Emile Muller
Hopital Hautepierre