title: A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

acronym: ENDEAVOR

summary: The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

ReferenceCitation: Moreau P, Joshua D, Chng WJ, Palumbo A, Goldschmidt H, Hajek R, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Dimopoulos MA. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017 Jan;31(1):115-122. doi: 10.1038/leu.2016.186. Epub 2016 Jul 4.

ReferenceCitation: Chng WJ, Goldschmidt H, Dimopoulos MA, Moreau P, Joshua D, Palumbo A, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Feng S, Aggarwal S, Hajek R. Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. Leukemia. 2017 Jun;31(6):1368-1374. doi: 10.1038/leu.2016.390. Epub 2016 Dec 27.

ReferenceCitation: Dimopoulos MA, Goldschmidt H, Niesvizky R, Joshua D, Chng WJ, Oriol A, Orlowski RZ, Ludwig H, Facon T, Hajek R, Weisel K, Hungria V, Minuk L, Feng S, Zahlten-Kumeli A, Kimball AS, Moreau P. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1327-1337. doi: 10.1016/S1470-2045(17)30578-8. Epub 2017 Aug 23. Erratum In: Lancet Oncol. 2017 Oct;18(10):e562.

ReferenceCitation: Ludwig H, Dimopoulos MA, Moreau P, Chng WJ, Goldschmidt H, Hajek R, Facon T, Pour L, Niesvizky R, Oriol A, Rosinol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Palumbo A, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Joshua D. Carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma: results of the phase 3 study ENDEAVOR (NCT01568866) according to age subgroup. Leuk Lymphoma. 2017 Oct;58(10):2501-2504. doi: 10.1080/10428194.2017.1298755. Epub 2017 Mar 17. No abstract available.

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.

ReferenceCitation: Dimopoulos M, Siegel D, White DJ, Boccia R, Iskander KS, Yang Z, Kimball AS, Mezzi K, Ludwig H, Niesvizky R. Carfilzomib vs bortezomib in patients with multiple myeloma and renal failure: a subgroup analysis of ENDEAVOR. Blood. 2019 Jan 10;133(2):147-155. doi: 10.1182/blood-2018-06-860015. Epub 2018 Nov 26.

ReferenceCitation: Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

ReferenceCitation: Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

ReferenceCitation: Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.

ReferenceCitation: Ludwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, Feng S, Cocks K, Buchanan J, Weisel K. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019 Feb 22;9(3):23. doi: 10.1038/s41408-019-0181-0.

ReferenceCitation: Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

ReferenceCitation: Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.

ReferenceCitation: Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.

oa_host_type: closed

ReferenceCitation: Goldschmidt H, Moreau P, Ludwig H, Niesvizky R, Chng WJ, Joshua D, Weisel K, Spencer A, Orlowski RZ, Feng S, Iskander KS, Dimopoulos MA. Carfilzomib-dexamethasone versus subcutaneous or intravenous bortezomib in relapsed or refractory multiple myeloma: secondary analysis of the phase 3 ENDEAVOR study. Leuk Lymphoma. 2018 Jun;59(6):1364-1374. doi: 10.1080/10428194.2017.1376743. Epub 2017 Sep 22.

ReferenceCitation: Jakubowiak AJ, Houisse I, Majer I, Benedict A, Campioni M, Panjabi S, Ailawadhi S. Cost-effectiveness of carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone for patients with relapsed or refractory multiple myeloma in the United States. Expert Rev Hematol. 2017 Dec;10(12):1107-1119. doi: 10.1080/17474086.2017.1391088.

ReferenceCitation: Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.

ReferenceCitation: Weisel K, Majer I, DeCosta L, Oriol A, Goldschmidt H, Ludwig H, Campioni M, Szabo Z, Dimopoulos M. Carfilzomib and dexamethasone versus eight cycles of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma: an indirect comparison using data from the phase 3 ENDEAVOR and CASTOR trials. Leuk Lymphoma. 2020 Jan;61(1):37-46. doi: 10.1080/10428194.2019.1648806. Epub 2019 Oct 22.

ReferenceCitation: Orlowski RZ, Moreau P, Niesvizky R, Ludwig H, Oriol A, Chng WJ, Goldschmidt H, Yang Z, Kimball AS, Dimopoulos M. Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups. Clin Lymphoma Myeloma Leuk. 2019 Aug;19(8):522-530.e1. doi: 10.1016/j.clml.2019.04.018. Epub 2019 May 2.

ReferenceCitation: Majer IM, Castaigne JG, Palmer S, DeCosta L, Campioni M. Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology. Pharmacoeconomics. 2019 May;37(5):727-737. doi: 10.1007/s40273-018-0759-6.

ReferenceCitation: Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112.

ReferenceCitation: Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hajek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosinol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5.

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repository_institution: University of Turin - Institutional Research Information System University of Turin

version: submittedVersion

lead_sponsor: Amgen

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Thailand
Czechia
Canada
France
Slovakia
Hungary
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie

location_facility: MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Universitari i Politecnic La Fé de Valencia

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

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

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carità

location_facility: Haematology and Oncology Clinics of Australia at Wesley

location_facility: The Chaim Sheba Medical Center at Tel Hashomer

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

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

location_facility: Hopital Hotel-Dieu - Service d'Hematologie

location_facility: National Hospital Organization Nishigunma National Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

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

location_facility: Instituto Centros Oncológicos Integrados de Educação e Pesquisa

location_facility: Wake Forest University Health Sciences, Section on Hematology and Oncology

location_facility: National Hospital Organization Kyushu Cancer Center

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

location_facility: Azienda Ospedaliera Pisana Ospedale Santa Chiara

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: National Institute of Cancer, Oncohematology Department

location_facility: Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Municipal Institution of Health Protection "Clinical Hospital #8"

location_facility: Zamojski Szpital Niepubliczny Sp. z o.o.

location_facility: Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: National Hospital Organization Okayama Medical Center

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin

location_facility: Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations

location_facility: Seoul National University Bundang Hospital

location_facility: Military Medical Academy Hospital for Active Treatment

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Università Tor Vergata Ospedale Sant Eugenio

location_facility: Medizinische Klinik der Universität Würzburg

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

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

location_facility: Haematology & Oncology Clinics of Australia

location_facility: Haematology and Oncology Clinics of Australia at Chermside

location_facility: Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)

location_facility: Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences

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

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: The Cancer Institute Hospital Of Japanese Foundation For Cancer Research

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Egyesített Szent István és Szent László Kórház-Rendelointézet

location_facility: Khmelnytsky Regional Hospital, Department of Hematology

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Specjalistyczny Szpital Miejski im. Mikolaja Kopernika

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


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Takeda

summary:
The main aims of this 3-part study are as follows:

Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.

Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.

Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.

Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

location_facility: Northwestern Medicine - Northwestern Medical Group

location_facility: USOR - Comprehensive Cancer Centers of Nevada - Central Valley

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Sir Mortimer B. Davis Jewish General Hospital

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Genesis Care Windsor - Genesis Care UK Ltd.

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Toulouse Hopital Purpan

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: Los Angeles Cancer Network - Glendale Adventist Medical Center

location_facility: University Regional General Hospital of Patras

location_facility: Winship Cancer Institute of Emory University

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: National Hospital Organization Okayama Medical Center

location_facility: British Columbia Cancer Agency Vancouver Centre

location_facility: Chonnam National University Hwasun Hospital

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Baptist Cancer Center - Memphis - Walnut Grove

location_facility: The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital

location_facility: Hospital Universitario Virgen de la Arrixaca

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

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers

status: Active, not recruiting

title: A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

primary_purpose: Treatment

type: Other Identifier

type: Registry Identifier

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

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.

design_allocation: Non-Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Israel
Norway
United Kingdom
Japan
United States
China
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Canada
Puerto Rico
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

acronym: SEQUENCE

summary:
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

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

design_allocation: Randomized

enrollment_type: Actual

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

lead_sponsor: AbbVie

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Slovakia
Hungary
Switzerland
United States
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420

location_facility: Digestive Disease Specialists /ID# 223528

location_facility: The Sixth Affiliated Hosp Sun /ID# 224416

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 223586

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482

location_facility: Nottingham University Hospitals NHS Trust /ID# 224179

location_facility: The Chaim Sheba Medical Center /ID# 223557

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 223525

location_facility: The Third Xiangya Hospital of Central South University /ID# 224754

location_facility: Plains Clinical Research Center, LLC /ID# 223522

location_facility: Hospital Clinico Universitario San Carlos /ID# 223367

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395

location_facility: Hospital Universitario Virgen Macarena /ID# 223315

location_facility: Hospital Privado Univesitario /ID# 223433

location_facility: Advanced Research Institute, Inc /ID# 223470

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 241098

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 223656

location_facility: University General Hospital of Ioannina /ID# 223339

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 223887

location_facility: Ospedale Policlinico San Martino /ID# 223329

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 223319

location_facility: Scott Shulman Medicine Professional Corporation /ID# 223754

location_facility: Karolinska University Hospital Solna /ID# 223423

location_facility: Medical Research Center of CT /ID# 223540

location_facility: Belfast Health and Social Care Trust /ID# 224023

location_facility: Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048

location_facility: Universitaetsklinikum St. Poelten /ID# 223437

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 223325

location_facility: Universitatsklinikum Mannheim /ID# 223410

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 223336

location_facility: Hospital Universitario Virgen del Rocio /ID# 223476

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 223860

location_facility: Royal Devon and Exeter NHS Foundation Trust /ID# 223644

location_facility: CHU Reims - Hôpital Robert Debre /ID# 224530

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 223497

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 223233

location_facility: Hospital Universitario Central de Asturias /ID# 223368

location_facility: Universitaetsklinikum Frankfurt /ID# 223396

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 223229

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302

location_facility: Univ Emergency Hosp Bucharest /ID# 223579

location_facility: Renmin Hospital of Wuhan University /ID# 224525

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 226554

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 223668

location_facility: Southern Star Research Institute, LLC /ID# 223598

location_facility: NorthShore University HealthSystem /ID# 223538

location_facility: AA Medical Research Center - Flint /ID# 224384

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 224662

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 223645

location_facility: Calderdale and Huddersfield NHS Foundation Trust /ID# 223654

location_facility: London Health Sciences Center- University Hospital /ID# 223741

location_facility: CHU Grenoble - Hopital Michallon /ID# 224091

location_facility: Assaf Harofeh Medical Center /ID# 224686

location_facility: Tel Aviv Sourasky Medical Center /ID# 223551

location_facility: Sociedad de Servicios Medicos Walsen Galmez /ID# 224032

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545

location_facility: Gazi Universitesi Tip Fakultes /ID# 223386

location_facility: Hospital Clinico Universitario de Valencia /ID# 223321

location_facility: Azienda Ospedaliera G. Brotzu /ID# 241165

location_facility: NHS Greater Glasgow and Clyde /ID# 223653

location_facility: Targu Mures Emergency Clinical County Hospital /ID# 223613

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340

location_facility: Intercity Advanced Gastroentertology Center /ID# 224313

location_facility: Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179

location_facility: Omega Research Maitland, LLC /ID# 223463

location_facility: University of California, San Francisco /ID# 223621

location_facility: Medizinische Universitaet Wien /ID# 223438

location_facility: Agaplesion Markus Krankenhaus /ID# 223673

location_facility: General Hospital of Athens Ippokratio /ID# 223344

location_facility: King's College Hospital NHS Foundation Trust /ID# 223649

location_facility: Tyler Research Institute, LLC /ID# 223469

location_facility: University of Vermont Medical Center /ID# 224047

location_facility: Montreal General Hospital- McGill University Health Center /ID# 223743

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 224428

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333

location_facility: The Second Xiangya Hospital of Central South University /ID# 224684

location_facility: Hospital Clinic de Barcelona /ID# 223355

location_facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 223765

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location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327

location_facility: Centro Medico Zambrano Hellion /ID# 224025

location_facility: City Clinical Hospital No. 31 /ID# 224223

location_facility: Kaiser Clinica e Hospital Dia /ID# 223232

location_facility: Medical Care & Research SA de CV /ID# 223974

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387

location_facility: Northern Care Alliance NHS Group /ID# 223650

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 223768

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411

location_facility: Percuro Clinical Research, Ltd /ID# 223747

location_facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744

location_facility: Malopolskie Centrum Kliniczne /ID# 223708

location_facility: Hospital Universitario de Bellvitge /ID# 225719

location_facility: Policlinico Agostino Gemelli /ID# 223323

location_facility: Universitair Ziekenhuis Leuven /ID# 223901

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 223256

location_facility: Wake Forest Baptist Medical Center /ID# 224406

location_facility: Zhongshan Hospital Xiamen University /ID# 224663

location_facility: Faculdade de Medicina do ABC /ID# 223231

location_facility: Massachusetts General Hospital /Id# 224335

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 223822

location_facility: Radboud Universitair Medisch Centrum /ID# 233750

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 224351

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 223763

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 223277

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597

location_facility: Hoag Memorial Hosp Presbyterian /ID# 224373

location_facility: Medizinische Hochschule Hannover /ID# 223402

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 223409

location_facility: Beth Israel Deaconess Medical Center /ID# 228094

location_facility: Yale Univ Digestive Diseases /ID# 224463

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324

location_facility: Immanuel Kant Baltic Federal University /ID# 224224

location_facility: Universitaetsklinikum Freiburg /ID# 223406

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 223755

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465

location_facility: Digestive Disease Associates, LTD /ID# 223462

location_facility: Penn State Milton S. Hershey Medical Center /ID# 224216

location_facility: Hospital Britanico de Buenos Aires /ID# 223432

location_facility: The Edith Wolfson Medical Center /ID# 227652

location_facility: Universitatsklinik Regensburg /ID# 223407

location_facility: Columbia Univ Medical Center /ID# 224215

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580

location_facility: Hospital Universitario La Paz /ID# 223318

location_facility: Medical University of South Carolina /ID# 223485

location_facility: Hospital General Universitario Gregorio Maranon /ID# 223317

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405

location_facility: Consultants in Gastroenterology - Columbia NE /ID# 224263

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 224552

location_facility: Hopital Universitaire Purpan Hopital Rangueil /ID# 224732

location_facility: Hospital Universitario y Politecnico La Fe /ID# 223314

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 223767

location_facility: Shengjing Hospital of China Medical University /ID# 224478

location_facility: The First Affiliated Hospital of Nanchang University /ID# 224507

location_facility: The Second Affiliated Hospital of Zhengzhou University /ID# 224528

location_facility: Changzhou No.2 People's Hospital /ID# 238965

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456

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location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655

location_facility: North Shore University Hospital /ID# 224356

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335

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location_facility: Southern California Res. Ctr. /ID# 223484

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location_facility: West China Hospital, Sichuan University /ID# 224786

location_facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 223552

location_facility: West Virginia University Hospitals /ID# 223501

location_facility: Peking University Third Hospital /ID# 224479

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 223898

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 223902

location_facility: Gastroenterology Group Naples /ID# 223516

location_facility: Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249859

location_facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474

location_facility: Vanderbilt University Medical Center /ID# 224610

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 224264


summary:
The study consists of 4 sub-studies, as follows:

Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

ReferenceType: derived

ReferenceCitation: Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.

repositories_concat: closed

publisher_dissemination: Elsevier

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location_facility: King's College Hospital NHS Foundation Trust /ID# 158760

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210724

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 157050

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 158693

location_facility: Renmin Hospital of Wuhan University /ID# 214874

location_facility: CHU Grenoble - Hopital Michallon /ID# 212834

location_facility: The Edith Wolfson Medical Center /ID# 217331

location_facility: Gastroenterology Associates LLC - Jefferson Hwy /ID# 161963

location_facility: The Jikei University Kashiwa Hospital /ID# 200030

location_facility: Digestive Disease Associates, LTD /ID# 208297

location_facility: West China Hospital, Sichuan University /ID# 210890

location_facility: Aichi Medical University Hospital /ID# 160097

location_facility: East Tallinn Central Hospital /ID# 157074

location_facility: Yamanashi Prefectural Central Hospital /ID# 160094

location_facility: Health Pharma Professional Research S.A de C.V /ID# 170730

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 159988

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 162562

location_facility: Percuro Clinical Research, Ltd /ID# 161631

location_facility: North Estonia Medical Centre /ID# 164326

location_facility: Medical University of South Carolina /ID# 212858

location_facility: Nishinomiya Municipal Central Hospital /ID# 210103

location_facility: Hospital Privado Univesitario /ID# 168076

location_facility: Clinical Neuroscience Solutions - Memphis /ID# 164180

location_facility: Hospital Universitario Basurto /ID# 205190

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029

location_facility: Southern California Res. Ctr. /ID# 211991

location_facility: Texas Digestive Disease Consultants /ID# 209797

location_facility: Revival Research Institute, Inc /ID# 210985

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 158203

location_facility: Hospital Universitario de Bellvitge /ID# 208207

location_facility: Kanazawa University Hospital /ID# 202258

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 158036

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126

location_facility: Scott Shulman Medicine Professional Corporation /ID# 165906

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 161323

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 157422

location_facility: Clinical Center University of Sarajevo /ID# 165139

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 162557

location_facility: Hospital Britanico de Buenos Aires /ID# 168077

location_facility: Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799

location_facility: Rapid City Medical Center - GI Research /ID# 163838

location_facility: Kyiv Railway Clinical Hosp No.2 /ID# 217366

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 211242

location_facility: Centex Studies, Inc. - Houston /ID# 201219

location_facility: Kuzbass Regional Clinical Hospital /ID# 200962

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 160672

location_facility: Calderdale and Huddersfield NHS Foundation Trust /ID# 209570

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 162531

location_facility: Omega Research Maitland, LLC /ID# 171082

location_facility: Western Connecticut Medical Group /ID# 165879

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912

location_facility: Virginia Mason Medical Center /ID# 155556

location_facility: Second Multiprofile Hospital f /ID# 165702

location_facility: Hometown Urgent Care and Resea /ID# 170464

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 210858

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 157728

location_facility: Clinical Research of West Florida, Inc /ID# 205865

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 157099

location_facility: Tokyo Medical And Dental University Hospital /ID# 160095

location_facility: University Clinical Center Kragujevac /ID# 157049

location_facility: Inselspital, Universitätsspital Bern /ID# 163535

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237

location_facility: Toho University Sakura Medical Center /ID# 160099

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 158034

location_facility: University of Kentucky Chandler Medical Center /ID# 157120

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212601

location_facility: Universitaetsklinikum St. Poelten /ID# 166424

location_facility: Cabinet Particular Policlinic Algomed /ID# 170900

location_facility: Clin Res Inst of Michigan, LLC /ID# 169179

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306

location_facility: Hyogo Medical University Hospital /ID# 160107

location_facility: Duplicate_Centrul Medical Tuculanu SRL /ID# 170903

location_facility: The Sixth Affiliated Hosp Sun /ID# 210784

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 154850

location_facility: Guangdong Provincial People's Hospital /ID# 212949

location_facility: Southern Star Research Institute, LLC /ID# 168773

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169384

location_facility: Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262

location_facility: Fakultni Thomayerova nemocnice /ID# 162941

location_facility: St Vincent's University Hospital /ID# 157540

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894

location_facility: University of Nebraska Medical Center /ID# 210058

location_facility: West Tallinn Central Hospital /ID# 157075

location_facility: Clinical Hosp Center Zvezdara /ID# 157052

location_facility: Northwell Health Division of Gastroenterology at Great Neck /ID# 168738

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 215147

location_facility: Instituto de Coloproctologia /ID# 158743

location_facility: Houma Digestive Health Special /ID# 158264

location_facility: CHA University Bundang Medical Center /ID# 158698

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 163226

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713

location_facility: Children's Hospital of Pittsburgh of UPMC /ID# 212544

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 157560

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884

location_facility: Adult Gastroenterology Associates - Gen 1 Research /ID# 208864

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 211966

location_facility: Universitaetsklinikum Regensburg /ID# 163813

location_facility: Universitair Ziekenhuis Leuven /ID# 157407

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 213848

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154832

location_facility: Royal Devon University Healthcare NHS Foundation Trust /ID# 157544

location_facility: Gomel Regional Clinical Hospital /ID# 205112

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 157546

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530

location_facility: 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940

location_facility: The Second Xiangya Hospital of Central South University /ID# 211700

location_facility: Theageneio Anticancer Hospital /ID# 163897

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 163839

location_facility: Odense Universitets Hospital /ID# 155531

location_facility: Agaplesion Markus Krankenhaus /ID# 159345

location_facility: Tel Aviv Sourasky Medical Center /ID# 157792

location_facility: Hospital Garcia de Orta, EPE /ID# 160745

location_facility: Vanderbilt University Medical Center /ID# 157121

location_facility: Yamagata University Hospital /ID# 200159

location_facility: Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202773

location_facility: Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169763

location_facility: Medizinische Universitaet Wien /ID# 158141

location_facility: Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212478

location_facility: Velocity Clinical Research - Salt Lake City /ID# 161778

location_facility: Hospital Universitario Miguel Servet /ID# 157557

location_facility: Fujita Health University Hospital /ID# 163234

location_facility: Hadassah Medical Center-Hebrew University /ID# 165914

location_facility: South Lake Pain Institute, Inc /ID# 162808

location_facility: Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751

location_facility: Advanced Research Institute, Inc /ID# 161966

location_facility: Stadtisches Klinikum Braunschweig /ID# 163680

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 157085

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468

location_facility: CHU Amiens-Picardie Site Sud /ID# 165058

location_facility: Universitatsklinikum Mannheim /ID# 162031

location_facility: Hospital General Universitario Gregorio Maranon /ID# 161145

location_facility: Sapporo Medical University Hospital /ID# 163056

location_facility: University of California, San Francisco /ID# 157127

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 212474

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363

location_facility: Hospital Universitario La Paz /ID# 159235

location_facility: Hospital Universitario San Vic /ID# 171486

location_facility: Medizinisches Versorgunszentrum Dachau /ID# 211555

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 155643

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220

location_facility: Hospital Clinic de Barcelona /ID# 157552

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873

location_facility: NorthShore University HealthSystem /ID# 158265

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164540

location_facility: Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349

title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

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


lead_sponsor: pharmaand GmbH

summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.

ReferenceCitation: Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.

publisher_dissemination: Springer-Nature

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Swisher EM, Kwan TT, Oza AM, Tinker AV, Ray-Coquard I, Oaknin A, Coleman RL, Aghajanian C, Konecny GE, O'Malley DM, Leary A, Provencher D, Welch S, Chen LM, Wahner Hendrickson AE, Ma L, Ghatage P, Kristeleit RS, Dorigo O, Musafer A, Kaufmann SH, Elvin JA, Lin DI, Chambers SK, Dominy E, Vo LT, Goble S, Maloney L, Giordano H, Harding T, Dobrovic A, Scott CL, Lin KK, McNeish IA. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun. 2021 May 3;12(1):2487. doi: 10.1038/s41467-021-22582-6.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

repository_institution: Imperial College London - Spiral

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org;spiral.imperial.ac.uk

unpaywall_oa_status: gold

ReferenceCitation: Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmana J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. doi: 10.1136/ijgc-2019-000623.

oa_colors: green hybrid

evidence: open (via page says license)

repositories_concat: UCL Discovery;spiral.imperial.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ReferenceCitation: Swisher EM, Lin KK, Oza AM, Scott CL, Giordano H, Sun J, Konecny GE, Coleman RL, Tinker AV, O'Malley DM, Kristeleit RS, Ma L, Bell-McGuinn KM, Brenton JD, Cragun JM, Oaknin A, Ray-Coquard I, Harrell MI, Mann E, Kaufmann SH, Floquet A, Leary A, Harding TC, Goble S, Maloney L, Isaacson J, Allen AR, Rolfe L, Yelensky R, Raponi M, McNeish IA. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017 Jan;18(1):75-87. doi: 10.1016/S1470-2045(16)30559-9. Epub 2016 Nov 29.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repository_institution: The University of Glasgow - Enlighten: Publications

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

sponsor_collaborators:
pharmaand GmbH
Foundation Medicine
Myriad Genetics, Inc.

location_facility: University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: New York University Langone Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA)

location_facility: Washington University School of Medicine

location_facility: Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Flinders Cancer Clinic - Flinders Medical Centre (FMC)

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Cincinnati Physicians Company

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Crown Princess Mary Cancer Centre (Westmead Hospital)

location_facility: Hospital Clinico Universitario de Valencia

title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

location_country:
United Kingdom
Australia
United States
Spain
Canada
France


summary:
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

ReferenceCitation: Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;pure.eur.nl

repositories_institution: University of Melbourne - Minerva Access

publisher_dissemination: Oxford University Press

ReferenceCitation: Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

ReferenceCitation: Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.

sponsor_collaborators:
AbbVie
Radiation Therapy Oncology Group

location_facility: QE II Health Sciences Centre /ID# 151600

location_facility: The University of Chicago Medical Center /ID# 144158

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 154592

location_facility: Univ of Colorado Cancer Center /ID# 148194

location_facility: Hospital Santa Creu i Sant Pau /ID# 143900

location_facility: Intermountain Medical Center /ID# 144142

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939

location_facility: Universitair Medisch Centrum Utrecht /ID# 141406

location_facility: Levine Cancer Ins, Carolina Me /ID# 144124

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 144167

location_facility: Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936

location_facility: Krajska nemocnice Liberec, a.s. /ID# 142024

location_facility: Vrije Universiteit Medisch Centrum /ID# 143889

location_facility: Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883

location_facility: Duplicate_Cancer Care Manitoba /ID# 149253

location_facility: Medizinische Universitaet Graz /ID# 141982

location_facility: Seoul National University Hospital /ID# 143886

location_facility: St John Of God Subiaco Hospital /ID# 143869

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877

location_facility: Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961

location_facility: Boca Raton Regional Hospital /ID# 163659

location_facility: University of California, Los Angeles /ID# 149239

location_facility: Liga Norte Riograndense Contra o Câncer /ID# 143878

location_facility: GEMC - European Medical Center /ID# 141703

location_facility: Universitair Medisch Centrum Groningen /ID# 141408

location_facility: Inselspital, Universitätsspital Bern /ID# 141886

location_facility: National Cancer Ctr Singapore /ID# 143932

location_facility: University of Rochester Medical Center /ID# 144166

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 163820

location_facility: Duplicate_St. Joseph Mercy Hospital /ID# 144143

location_facility: Medizinische Universitaet Wien /ID# 141981

location_facility: National University Hospital /ID# 143933

location_facility: Associated Neurologists of Sou /ID# 147701

location_facility: University of Nebraska Medical Center /ID# 145899

location_facility: National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701

location_facility: Taipei Veterans General Hosp /ID# 143955

location_facility: Froedtert Memorial Lutheran Hospital /ID# 144139

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 143915

location_facility: St Vincent's Hospital Melbourne /ID# 143858

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 141653

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983

location_facility: State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706

location_facility: Ottawa Hospital Research Institute /ID# 150120

location_facility: Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890

location_facility: Linkou Chang Gung Memorial Hospital /ID# 143941

location_facility: Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593

location_facility: NorthShore University HealthSystem /ID# 144017

location_facility: St. Josephs Hospital and Med Center /ID# 144149

location_facility: Calvary North Adelaide Hospita /ID# 143866

location_facility: Maine Medical Partners Neurolo /ID# 160864

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707

location_facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064

location_facility: The First Affiliated Hospital of Soochow University /ID# 165596

location_facility: Duplicate_Regina Elena National Cancer I /ID# 141795

location_facility: Duplicate_St. John's Health Center /ID# 148192

location_facility: Centro Medico Zambrano Hellion /ID# 143845

location_facility: Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846

location_facility: Regional Clinical Hospital of Kaliningrad region /ID# 141702

location_facility: Sverdlovsk Regional Oncology Dispensary /ID# 141700

location_facility: Medical University of South Carolina /ID# 144141

location_facility: Netcare Oncology Intervent Ctr /ID# 143951

location_facility: Massachusetts General Hospital /ID# 144145

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 147525

location_facility: Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315

location_facility: Hospital Clinico Universitario San Carlos /ID# 143901

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844

location_facility: Southern Medical Day Care Centre /ID# 143868

location_facility: Administradora del Country_S.A-Clinica Del Country /ID# 143881

location_facility: Univ Kansas Cancer Ctr - Overl /ID# 145895

location_facility: University of Southern California /ID# 147543

location_facility: Duplicate_Shengjing Hospital of China Medical University /ID# 167016

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941

location_facility: Northwestern Medicine Cancer Center - Warrenville /ID# 148476

location_facility: University of Pennsylvania Medical Center - Shadyside /ID# 144159

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914

location_facility: Federal State Treatment and Rehabilitation center /ID# 141704

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830

location_facility: Cleveland Clinic Main Campus /ID# 144023

location_facility: Duplicate_Scott and White Medical Center /ID# 160743

location_facility: Highlands Oncology Group, PA /ID# 142050

location_facility: University of Texas MD Anderson Cancer Center /ID# 144018

location_facility: Beijing Tian Tan Hospital, Capital Medical University /ID# 167160

location_facility: Tel Aviv Sourasky Medical Center /ID# 143956

location_facility: Hospital Universitario 12 de Octubre /ID# 143930

location_facility: Washington University-School of Medicine /ID# 144174

location_facility: Columbia University Medical Center /ID# 144020

location_facility: Dana-Farber Cancer Institute /ID# 148475

location_facility: CHU de Quebec-Universite Laval /ID# 144189

location_facility: Baylor Sammons Cancer Center /ID# 155542

location_facility: Universitaetsklinikum Tuebingen /ID# 143926

location_facility: Hospital General Universitario de Valencia /ID# 143903

location_facility: Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 142652

location_facility: Peking Union Medical College Hospital /ID# 157430

location_facility: Hospital Clinic de Barcelona /ID# 143906

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 148472

location_facility: Duplicate_Huashan Hospital of Fudan University /ID# 159999

location_facility: Northwestern University Feinberg School of Medicine /ID# 147895

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 149014

location_facility: Universitair Ziekenhuis Leuven /ID# 143872

location_facility: The First Affiliated Hospital of Fujian Medical University /ID# 159166

location_facility: Hospital Universitario HM Sanchinarro /ID# 143496

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876

location_facility: CCA Braga - Hospital de Braga /ID# 141940

location_facility: University College London Hospitals NHS Foundation Trust /ID# 142658

location_facility: AP-HM - Hopital de la Timone /ID# 143911

location_facility: Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 144187

location_facility: Sun Yat-Sen University Cancer Center /ID# 143919

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 143923

location_facility: Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999

location_facility: Duplicate_Jewish General Hospital /ID# 144029

location_facility: Velindre University NHS Trust /ID# 141996

location_facility: MD Anderson Cancer Center at Cooper - Camden /ID# 145891

location_facility: The Chaim Sheba Medical Center /ID# 143960

location_facility: The University of Texas Health Science Center at Houston /ID# 144013

location_facility: Univ California, San Francisco /ID# 145889

location_facility: Duplicate_The Prince of Wales Hospital /ID# 144882

location_facility: Maastricht Universitair Medisch Centrum /ID# 143585

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031

location_facility: Duplicate_Canterbury District Health Boa /ID# 143861

location_facility: Universitaetsklinikum Leipzig /ID# 143962

location_facility: Emory Midtown Infectious Disease Clinic /ID# 144015

location_facility: Gastroenterology Institute, Division of Medicine /ID# 143958

location_facility: Universitaetsklinik Heidelberg /ID# 143927

location_facility: Rutgers Cancer Institute of New Jersey /ID# 148190

location_facility: Duplicate_Instituto Med Alex Flem /ID# 142884

location_facility: Centro Medico Imbanaco de Cali /ID# 143882

location_facility: Princess Margaret Cancer Centre /ID# 166277

location_facility: Christiana Care Health Service /ID# 144127

location_facility: Duplicate_Centre Hospitalier Jolimont /ID# 143873

location_facility: Duplicate_Univ Hosp Cleveland /ID# 144153

location_facility: Virginia Mason Medical Center /ID# 144022

location_facility: Duplicate_Xiangya Hospital Central South University /ID# 166791

location_facility: SanboBrain Hospital Capital Medical University /ID# 166422

location_facility: National Taiwan University Hospital /ID# 143940

status: Completed

title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

study_completion_date_type: Actual

location_country:
Germany
Ireland
New Zealand
Argentina
Australia
Brazil
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

status_simplified: Completed


acronym: Venetoclax in children with relapsed AML

lead_sponsor: LLS PedAL Initiative, LLC

summary: A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

sponsor_collaborators: Princess Maxima Center for Pediatric Oncology (European Sponsor)

location_facility: Benioff Children's Hospital - Mission Bay

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Alliance for Childhood Diseases dba Cure 4 The Kids Foundation

location_facility: Washington University School of Medicine in St. Louis

location_facility: SickKids - The Hospital for Sick Children

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Nemours Children's Specialty Care Jacksonville

location_facility: Children's Hospital of Orange County Main Campus - Orange

location_facility: The Children's Mercy Hospital - Adele Hall Campus

location_facility: University of Iowa Stead Family Children's Hospital

location_facility: Nemours Alfred I. Dupont Hospital for Children

location_facility: Monroe Carell Jr. Children's Hospital at Vanderbilt

location_facility: CHU de Nantes - Hôpital Femme-Enfant-Adolescent

location_facility: Harold C. Simmons Comprehensive Cancer Center

location_facility: Instituto Portugues De Oncologia De Lisboa Francisco Gentil

location_facility: Children's Health Queensland Hospital and Health Service

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: University of Mississippi Medical Center

location_facility: Memorial Sloan Kettering Cancer Center - New York

location_facility: Columbia University Irving Medical Center

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: MemorialCare Miller Children's and Women's Hospital Long Beach

location_facility: Golisano Children's Hospital of Southwest Florida

location_facility: The Royal Children's Hospital - Children's Cancer Centre

status: Recruiting

title: A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

location_country:
Italy
Portugal
New Zealand
Norway
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France

ipd_sharing: No


title: Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

acronym: ALLELE

summary: The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

lead_sponsor: Atara Biotherapeutics

location_country:
Italy
United Kingdom
Australia
Austria
Belgium
United States
Spain
Canada
France

location_facility: Nationwide Children's Hospital (Pediatrics only)

location_facility: University of California San Diego Moores Cancer Center (Adults only)

location_facility: Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)

location_facility: University Hospital Virgen del Rocio (Adults and Pediatrics)

location_facility: University Hospitals Birmingham NHS Foundation Trust (Adults only)

location_facility: Alberta Children's Hospital (Adults and Pediatrics)

location_facility: Princess Margaret Cancer Centre (Adults only)

location_facility: Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)

location_facility: Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)

location_facility: University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)

location_facility: Hospital Universitario La Fe (Adults and Pediatrics)

location_facility: Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)

location_facility: Ospedale Pediatrico Bambino Gesu (Pediatrics only)

location_facility: Washington University School of Medicine (Adults only)

location_facility: Winship Cancer Institute of Emory University (Adults only)

location_facility: Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)

location_facility: Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)

location_facility: King's College Hospital NHS Foundation Trust (Adults only)

location_facility: Hôpital Universitaire Pitié Salpêtrière (Adults only)

location_facility: Children's Hospital of Philadelphia (Pediatrics only)

location_facility: Columbia University Medical Center (Adults and Pediatrics)

location_facility: University of Miami/Jackson Memorial Hospital (Adults only)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)

location_facility: Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)

location_facility: Hôpital Necker-Enfants Malades (Pediatrics only)

location_facility: Cleveland Clinic Foundation (Adults and Pediatrics)

location_facility: Loyola University Medical Center (Adults and Pediatrics)

location_facility: Froedtert Hospital & the Medical College of Wisconsin (Adults only)

location_facility: Medical University of South Carolina (Adults and Pediatrics)

location_facility: University of Florida (Adults and Pediatrics)

location_facility: MD Anderson Cancer Center (Adults and Pediatrics)

location_facility: Loma Linda University Cancer Center (Adults only)

location_facility: Groupe Hospitalier du Haut Leveque (Adults only)

location_facility: MedStar Georgetown University Hospital (Adults and Pediatrics)

location_facility: Baylor Scott and White Research Institute (Adults only)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli (Adults only)

location_facility: Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)

location_facility: University of Maryland School of Medicine (Adults only)

location_facility: University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)

location_facility: Imperial College Healthcare NHS Trust (Adults only)

location_facility: Montefiore Medical Center (Pediatrics only)

location_facility: The Royal Children's Hospital Melbourne (Pediatrics only)

location_facility: UCLA Medical Center (Adults and Pediatrics)

location_facility: University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)

location_facility: Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)

location_facility: University of Pennsylvania (Adults only)

location_facility: University of Pittsburgh Medical Center (Adults only)

location_facility: The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics)

location_facility: University of California Davis Comprehensive Cancer Center (Adults only)

location_facility: Medizinische Universitat Wien (Adults only)

location_facility: Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)

location_facility: Saint Jude Children's Research Hospital (Pediatrics only)

location_facility: Children's Healthcare of Atlanta at Egleston (Pediatrics)

location_facility: Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)

location_facility: The Prince Charles Hospital (Adults only)

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)

location_facility: Universitair Ziekenhuis Leuven (Adults and Pediatrics)

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)

location_facility: The Children's Hospital at Westmead (Pediatrics only)

location_facility: Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)

intervention_type: Biological


title: Long Term, Double Blind, Randomized, Placebo Controlled Multi-center Study of FRE.M.S.- Frequency Modulated Neural Stimulation Lorenz Therapy™ in Symptomatic Diabetic Neuropathy

summary: Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in patients with diabetes mellitus.

ReferenceType: background

ReferenceCitation: Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10.

ReferenceCitation: Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. doi: 10.1007/s00125-005-1734-2. Epub 2005 Apr 15.

ReferenceCitation: Bosi E, Bax G, Scionti L, Spallone V, Tesfaye S, Valensi P, Ziegler D; FREMS European Trial Study Group. Frequency-modulated electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind, randomised, multicentre, long-term, placebo-controlled clinical trial. Diabetologia. 2013 Mar;56(3):467-75. doi: 10.1007/s00125-012-2795-7. Epub 2012 Dec 13.

lead_sponsor: Lorenz Biotech S.p.A.

location_country: Germany Italy France

location_facility: San Raffaele Hospital & Scientific Institute

intervention_type: Device


title: A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

summary: The proposed 36-month Post Approval Efficacy Study (PAES) is a prospective, interventional, multicentre study to explore the long-term evolution of signs and symptoms, and occurrence of complications in Dry Eye Disease (DED) patients with severe keratitis receiving Ikervis® (1mg/mL ciclosporin) eye drops administered once daily

lead_sponsor: Santen SAS

location_country:
Italy
Poland
Spain
Turkey
Czechia
Russian Federation
France

location_facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Bichat - Claude Bernard

location_facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

location_facility: Ankara Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı Vehbi Koç Göz Hastanesi

location_facility: Hospices Civils de Lyon - Hopital de la Croix-Rousse

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: FSBI The Academician S.N. Fyodorov IRTC Eye Microsurgery of the Minzdrava - Novosibirsk

location_facility: Uniwersytecki Szpital Kiliniczny IM. Jana Milkulicza-Radeckiego we Wroclawiu

location_facility: ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario - Clinica Oculistica III

location_facility: Uniwersyteckie Centrum Kliniczne Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo - Clinica Oculistic

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Diagnostyki i Mikrochirurgii Jaskry Oddział Okulistyki

location_facility: Universita degli Studi di Milano - Ospedale San Giuseppe - Clinica Oculistica (University Eye Clinic)

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica

location_facility: First Saint Petersburg State Medical University named after academician I.P. Pavlov

location_facility: Fakultni Nemocnice Ostrava, Oční Klinika

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Fundación Oftalmológica del Mediterráneo

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Oko-Laser

location_facility: NMRC ISTC Eye Microsurgery n. a. Fyodorov - Moscow

location_facility: Selcuk University School of Medicine Ophthalmology department

location_facility: Universita degli Studi di Milano - Clinica Oculistica I

location_facility: Gabinet Okulistyczny Prof. Edward Wylęgała

location_facility: Hopitaux Universitaires Paris-Sud - Hopital Bicetre

location_facility: Polo Universita degli Studi di Milano - Ospedale Luigi Sacco - Clinica Oculistica (Eye Clinic)

location_facility: Federal State Institution Intersectoral Research and Technology Complex Eye microsurgery n.a. academician S.N. Fyodorov - Cheboksary

location_facility: GBOU VPO Omsk State Medical Academy, Ophthalmology Department

location_facility: Bayındır Kavaklidere Hospital Ophthalmology department

location_facility: Ege Universitesi Tip Fakultesi Hastanesi Goz Hastaliklari Anabilim Dali

location_facility: State Budget Educational Institution of High Professional Education Moscow State Medical Stomatology University named after A.I.Evdokimov of MoH of RF

location_facility: Hospital Universitario Donostia, Oftalmalogia