title: A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

summary: The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

location_country:
Malaysia
Australia
Russian Federation
Taiwan
Ukraine
India
France
Poland
Argentina
Korea, Republic of
South Africa
Hong Kong
Bulgaria
Hungary
United States
Italy
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: Centre for Mental Health Prof.N.Shipkovenski EOOD

location_facility: CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

location_facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

location_facility: Psychoneurological Dispensary of Frunzensky District

location_facility: Mental Health Center Prof. Dr. Ivan Temkov

location_facility: Psychiatric Clinical hospital 1 named after N.A. Alekseev

location_facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

location_facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

location_facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council

location_facility: California Pharmaceutical Research Institute, Inc.

location_facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

location_facility: Psychiatricka ambulance, MUDr. Marta Holanova

location_facility: Sverdlovsk Regional Clinical Psychiatric Hospital

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Centro de Estudios Clinicos y Especialidades Medicas, S.C.

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: Kyiv Territorial Medical Incorporation 'Psychiatry'

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

location_facility: Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

location_facility: Nizny Novgorod clinical psychiatric hospital 1

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales

location_facility: Jehangir Clinical Development Center Pvt Ltd

location_facility: Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'

location_facility: Deva Institute of Health Care and Research Pvt Ltd

location_facility: Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

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

location_facility: Sakarya University Medical Faculty Psychiatry Department

location_facility: Józsefvarosi Szent Kozma Egészségügyi Központ

location_facility: Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

location_facility: Saratov Regional Psychiatric hospital named after St. Sofia

location_facility: Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea

location_facility: Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

location_facility: CHA Bundang Medical center, CHA University

location_facility: MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

location_facility: Juan Schrönen - Western Cape South Africa

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

location_facility: Clinica Psichiatrica - Università di Cagliari

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

location_facility: University of Pennsylvania Medical Center

location_facility: Psychiatricka ambulance MUDr. Simona Papezova

location_facility: Selcuk University, Medical School, Department of Psychiatry

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

location_facility: Abdurrah Yurtarslan Training and Research Hospital

location_facility: C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

location_facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: St-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

location_facility: Ankara Numune Research and Training Hospital

location_facility: State Psychiatric HospitalDr.Georgi Kissiov

location_facility: CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

location_facility: Centro de Psiquiatria e Pesquisas Sandra Ruschel

location_facility: Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie


title: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

acronym: MiMe-A

summary:
Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.

Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage:

Platinum-refractory esophageal adenocarcinoma (ADC)
Platinum-refractory esophageal squamous cell carcinoma (SCC)
Platinum-refractory cholangiocarcinoma
Platinum-refractory and progressive after immunotherapy urothelial cancer
Platinum-refractory endometrial cancer

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Jules Bordet Institute

location_country: Belgium France

location_facility: Hôpital universitaire de Strasbourg - ICANS

location_facility: IUCT Oncopole - Institut Claudius Regaud

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD

acronym: AIM-CD

summary:
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 165 sites worldwide.

The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period.

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.

status: Recruiting

design_allocation: Randomized

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: AbbVie

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

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 233722

location_facility: Azienda Ospedaliera di Padova /ID# 233389

location_facility: Aichi Medical University Hospital /ID# 238528

location_facility: Hoag Memorial Hosp Presbyterian /ID# 233555

location_facility: St. Marianna University School of Medicine Hospital /ID# 239167

location_facility: Taichung Veterans General Hospital /ID# 234131

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299

location_facility: Hospital Santa Creu i Sant Pau /ID# 232301

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 234191

location_facility: Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069

location_facility: Tokyo Women's Medical University Hospital /ID# 239760

location_facility: Tel Aviv Sourasky Medical Center /ID# 238525

location_facility: Hyogo College of Medicine College Hospital /Id# 239049

location_facility: Medical Research Center of CT /ID# 233542

location_facility: University of Utah Hospitals and Clinics /ID# 239264

location_facility: Medizinische Universitaet Wien /ID# 234218

location_facility: Tyler Research Institute, LLC /ID# 233730

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 239012

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 238773

location_facility: Tokyo Medical And Dental University Hospital /ID# 238950

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382

location_facility: NHS Greater Glasgow and Clyde /ID# 234186

location_facility: Universitaetsklinikum Freiburg /ID# 233719

location_facility: Southern California Res. Ctr. /ID# 233512

location_facility: Toronto Immune and Digestive Health Institute Inc /ID# 234142

location_facility: Clinical Research Solutions - Orlando /ID# 234255

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 234166

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 239965

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373

location_facility: Universitatsklinikum Mannheim /ID# 233716

location_facility: Hadassah Medical Center-Hebrew University /ID# 233518

location_facility: Medizinische Universitaet Innsbruck /ID# 234217

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 233759

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 234187

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 234193

location_facility: Digestive Disease Specialists /ID# 233825

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 233831

location_facility: General Hospital of Athens Ippokratio /ID# 231655

location_facility: Toronto Digestive Disease Asso /ID# 234143

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 234194

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 234224

location_facility: Hamamatsu University Hospital /ID# 238527

location_facility: Nemocnice Horovice - NH Hospital a.s /ID# 233915

location_facility: Soroka University Medical Center /ID# 233458

location_facility: The Edith Wolfson Medical Center /ID# 234042

location_facility: East View Medical Research, LLC /ID# 240030

location_facility: Atlantic Medical Research Group /ID# 233506

location_facility: Tokyo Medical University Hospital /ID# 239668

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 239918

location_facility: Agile Clinical Research Trials /ID# 233739

location_facility: Acibadem City Clinic University Hospital EOOD /ID# 240003

location_facility: Universitatsklinik Regensburg /ID# 238702

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 233533

location_facility: National Taiwan University Hospital /ID# 234134

location_facility: Scott Shulman Medicine Professional Corporation /ID# 239567

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 233544

location_facility: The Chaim Sheba Medical Center /ID# 233457

location_facility: The Queen Elizabeth Hospital /ID# 234242

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 234225

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 238953

location_facility: Osaka City University Hospital /ID# 238638

location_facility: Universitaetsklinikum Erlangen /ID# 233529

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 239792

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 234135

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 241136

location_facility: Hospital Universitario La Paz /ID# 232300

location_facility: Fukushima Medical University Hospital /ID# 239314

location_facility: Southern Star Research Institute, LLC /ID# 240132

location_facility: QE II Health Sciences Centre /ID# 233839

location_facility: Concord Repatriation General /ID# 233467

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 238960

location_facility: Gastroenterology Group Naples /ID# 233829

location_facility: Medizinische Hochschule Hannover /ID# 238804

location_facility: University Multiprofile Hospit /ID# 232468

location_facility: Wellington Regional Hospital /ID# 238326

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386

location_facility: China Medical University Hospital /ID# 234132

location_facility: Nagoya City University Hospital /ID# 238368

location_facility: Hiroshima University Hospital /ID# 238947

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 231657

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 231659

location_facility: Hospital Clinico Universitario de Valencia /ID# 234103

location_facility: London Health Sciences Center /ID# 234058

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763

location_facility: Sapporo Medical University Hospital /ID# 239201

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765

location_facility: Gastroenterology Consultants PC - Roswell /ID# 233552

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700

location_facility: Kanazawa University Hospital /ID# 239670

location_facility: Immanuel Kant Baltic Federal University /ID# 234165

location_facility: Yamagata University Hospital /ID# 239572

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 238653

location_facility: Policlinico Agostino Gemelli /ID# 233380


title: A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study

acronym: MEADOWSPRING

summary: This study will evaluate the long-term sequelae of COVID-19 in patients diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study), for approximately 6 months after the end of the parent study.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

lead_sponsor: Atea Pharmaceuticals, Inc.

location_country:
Peru
Greece
Romania
Belgium
Russian Federation
Denmark
Ukraine
India
Costa Rica
Croatia
France
Japan
Poland
Argentina
Colombia
South Africa
Chile
Switzerland
Hungary
Portugal
Germany
Italy
Brazil
Serbia
Mexico
Spain
Turkey

location_facility: Bangalore Medical College and Research Institute

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Asociacion Civil Impacta Salud y Educacion

location_facility: Health Centre 'Dr. Dragisa Misovic' Cacak

location_facility: Hospital Alberto Sabogal Sologuren ESSALUD

location_facility: Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases

location_facility: Clinica Providencia (Inverconsult Sociedad Anonima)

location_facility: PanAmerican Clinical Research, Querétaro

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Centro de Atencion y Diagnostico de Enfermedades Infecciosas CDI S.A.

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: CNE Kyiv City Clinical Hospital#1 of Exec. Body

location_facility: Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

location_facility: Hospital Clinico de la Pontificia universidad Catolica de Chile

location_facility: St Petersburg City Outpatient Clinic #109

location_facility: Hospital Chancay y Servicios Basicos de Salud

location_facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council

location_facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: L2IP -Instituto de Pesquisas Clínicas Ltda.

location_facility: National Hospital Organization Kasumigaura Medical Center

location_facility: Sanatorio Medico de Diagnostico Y Tratamiento

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Moscow Scientific Research Institute of Epidemiology

location_facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

location_facility: Fundacion Hospitalaria San Vicente de Paul

location_facility: Institute of Infectious Diseases Emilio Ribas

location_facility: AES - AS - Grant Medical Foundation Ruby Hall Clinic

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council

location_facility: Fundacion Hospital Universidad del Norte

location_facility: Dorozhnaya Clinical Hospital n.a. Semashko at Lublino Station OAO Rzhd

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Instituto de Pesquisa Grupo NotreDame Intermedica

location_facility: Fundacion Oftalmologica de Santander Foscal

location_facility: University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: AES - AS - Yashwantrao Chavan Memorial Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: Fujita Health University Banbuntane Hotokukai Hospital

location_facility: AES - AE - Grant Medical College and Sir JJ Group of Hospitals

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Asociación IPS Médicos Internistas de Caldas

location_facility: Hospital Universitario Cruces; Servicio de Farmacia. Ensayos Clinicos

location_facility: Centro de Estudios Clinicos E Investigaciones Medicas

location_facility: Hospital Interzonal General de Agudos Eva Perón

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC

location_facility: Ospedali Riuniti Azienda Ospedaliero Universitaria

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Russian Medical Military Academy n.a. S.M. Kirov

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology Clinic

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Clinical Hospital For Infectious Diseases; Infectious Diseases

location_facility: Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: Hospital E Maternidade Celso Pierro PUCCAMP


design_allocation: Non-Randomized

intervention_type: Other

status: Completed

lead_sponsor: Bayer

location_country:
Italy
Austria
Sweden
Switzerland
Spain
Germany
Finland
France
Czechia
Poland
Israel
Norway
Hungary
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem

location_facility: Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Universitätsklinik Gießen und Marburg GmbH

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Universitätsmedizin der Georg-August-Universität Göttingen

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Helse Bergen HF Haukeland universitetssjukehus

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Klinikum der Universität München Grosshadern

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Peterfy Sandor utcai Korhaz - Rendelointezet

location_facility: IRCCS Ist Neurologico Nazionale C.Mondino

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

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

location_facility: Instituto Português de Oncologia Francisco Gentil - Coimbra

study_completion_date_type: Actual

source: euctr

title: BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

summary:
The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.

This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.

status_simplified: Completed


title: A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)

acronym: SAMETA

summary: A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma)

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Romania
Australia
Russian Federation
Taiwan
Ukraine
India
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey


type: Other Identifier

title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Colombia
Sweden
China
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Spain
Turkey

location_facility: Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Tianjin Medical University General Hospital

location_facility: Pusan National University Yangsan Hospital

location_facility: FM Clinical Research, LLC South Florida Neurology Associates, P. A.

location_facility: The Second Affiliated Hospital of Air Force Medical University - Tangdu Hospital

location_facility: Selçuk Üniversitesi Tıp Fakültesi Hastanesi

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego Uniwersytetu Medycznego w Łodzi

location_facility: The First Bethune Hospital of Jilin University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Neuromuscular Research Center and Clinic

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: Qianfoshan hospital of Shandong Province

location_facility: IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: DKD HELIOS Klinik Wiesbaden, Fachbereich Neurologie

location_facility: Xuanwu Hospital, Capital Medical University

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Washington University School of Medicine

location_facility: Regional State Budgetary Healthcare Organization 'Regional Clinical Hospital'

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Korea University Medical Center (KUMC) - Korea University Anam Hospital

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

location_facility: Istanbul Universitesi Istanbul Tip Fakültesi

location_facility: Chang Gung Memorial Hospital Kaohsiung Branch

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Seconda Università degli Studi di Napoli, Neurologica

location_facility: Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College

location_facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

location_facility: West China Hospital of Sichuan University

location_facility: Fujian Medical University Union Hospital


lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Switzerland
Mexico
Germany
France
Czechia
Japan
Poland
Argentina
Australia
Spain
United States
United Kingdom
Taiwan

location_facility:
Klein And Associates, M.D., Pa
Klein & Associates, M.D., P.A.
West Tennessee Research Institute
Altoona Center For Clinical Research
Revmatologie s.r.o.
Local Institution

type: Registry Identifier

title: A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

summary: The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.


location_country:
Italy
Austria
United States
Germany
France
Australia
Spain
Canada

location_facility: Midway Immunology and Research /ID# 229194

location_facility: Angels Clinical Research Institute /ID# 234090

location_facility: Hospital General Universitario de Valencia /ID# 226709

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 227126

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 230814

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 227183

location_facility: University of Kentucky Chandler Medical Center /ID# 231588

location_facility: Hospital Parc de Salut del Mar /ID# 226696

location_facility: Velocity Clinical Research Chula Vista /ID# 238352

location_facility: Universitaetsklinikum St. Poelten /ID# 227098

location_facility: Medizinische Universitaet Wien /ID# 226938

location_facility: Vancouver Infectious Diseases Centre /ID# 227125

location_facility: Cherokee Nation Outpatient Health Center /ID# 232618

location_facility: Winship Cancer Institute of Emory University /ID# 229927

location_facility: Digestive and Liver Disease Sp /ID# 232633

location_facility: Medical College of Wisconsin - Plank Rd /ID# 230116

location_facility: HCL - Hopital de la Croix-Rousse /ID# 229077

location_facility: ICH Study Center GmbH & Co KG /ID# 228162

location_facility: Weill Cornell Medical College /ID# 230815

location_facility: zibp-Zentrum fuer Infektiologie /ID# 226765

location_facility: The Institute for Liver Health /ID# 228427

location_facility: University of Louisville Research Foundation Inc /ID# 232139

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 227080

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985

location_facility: University of Iowa Hospitals and Clinics /ID# 226934

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783

location_facility: AP-HP - Hopital Saint-Antoine /ID# 229070

location_facility: Liver Associates of Texas, P.A /ID# 229775

location_facility: South Riverdale Community Health Centre /ID# 228098

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 229083

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 226698

location_facility: Hospital Clinic de Barcelona /ID# 226695

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 227078

location_facility: Atrium Health - Huntersville /ID# 238365

location_facility: University of Mississippi Medical Center /ID# 232620

title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

summary:
Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

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, monitoring for side effects and completing questionnaires.


title: A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

summary:
Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.

Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide.

In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles.

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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.

location_country:
United States
France
Israel
Australia
Spain
Germany
United Kingdom

location_facility: Columbia University Medical Center /ID# 229971

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 228333

location_facility: Hospital Universitario 12 de Octubre /ID# 229355

location_facility: Universitaetsklinik Heidelberg /ID# 229145

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 229473

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 228323

location_facility: University of Texas Southwestern Medical Center /ID# 228830

location_facility: Rutgers Cancer Institute of New Jersey /ID# 230174

location_facility: Hospital Santa Creu i Sant Pau /ID# 229369

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 228559

location_facility: The Chaim Sheba Medical Center /ID# 229483

location_facility: University of Arizona Cancer Center - Tucson /ID# 229696

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 228332

location_facility: University of Kentucky Markey Cancer Center /ID# 229506

location_facility: Norton Cancer Institute - St Matthews /ID# 229319

location_facility: Massachusetts General Hospital /ID# 229326

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309

location_facility: Perelman Center for Advanced Medicine - /ID# 228693

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 229356

location_facility: Hospital Parc de Salut del Mar /ID# 229371

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 229141

location_facility: Sylvester Comprehensive Cancer Center /ID# 228817

location_facility: Hadassah Medical Center-Hebrew University /ID# 229477

location_facility: The Queen Elizabeth Hospital /ID# 229345

location_facility: Tel Aviv Sourasky Medical Center /ID# 229478

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 230291

location_facility: Hospital Universitario Reina Sofia /ID# 229388

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 228328

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 229354

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 230007


location_country:
Peru
Greece
Romania
Belgium
Russian Federation
Denmark
Ukraine
India
Costa Rica
Croatia
France
Japan
Poland
Argentina
Colombia
South Africa
Chile
Switzerland
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Brazil
Serbia
Mexico
Spain
Turkey

acronym: MORNINGSKY

location_facility: Bangalore Medical College and Research Institute

location_facility: AES - AS - Smt. Kashibai Navale Medical College and General Hospital

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Asociacion Civil Impacta Salud y Educacion

location_facility: Health Centre 'Dr. Dragisa Misovic' Cacak

location_facility: Hospital Alberto Sabogal Sologuren ESSALUD

location_facility: Radiodiagnostic CETIR - Clinica del Pilar

location_facility: Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases

location_facility: Clinica Providencia (Inverconsult Sociedad Anonima)

location_facility: PanAmerican Clinical Research, Querétaro

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: AES - AS - Shree Giriraj Multispeciality Hospital - Rajkot

location_facility: Multiprofile Hospital for Active Treatment - Samokov EOOD

location_facility: GMERS Medical College and General Hospital

location_facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

location_facility: Central Clinical Hospital of the General Management

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Centro de Atencion y Diagnostico de Enfermedades Infecciosas CDI S.A.

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy

location_facility: Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

location_facility: CNE Kyiv City Clinical Hospital#1 of Exec. Body

location_facility: AES - AS - Atharva Multispeciality Hospital & Research Centre

location_facility: Hospital Clinico de la Pontificia universidad Catolica de Chile

location_facility: St Petersburg City Outpatient Clinic #109

location_facility: Hospital Chancay y Servicios Basicos de Salud

location_facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council

location_facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

location_facility: Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: National Hospital Organization Kasumigaura Medical Center

location_facility: Sanatorio Medico de Diagnostico Y Tratamiento

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Moscow Scientific Research Institute of Epidemiology

location_facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

location_facility: AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli

location_facility: Fundacion Hospitalaria San Vicente de Paul

location_facility: Institute of Infectious Diseases Emilio Ribas

location_facility: AES - AS - Grant Medical Foundation Ruby Hall Clinic

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council

location_facility: Fundacion Hospital Universidad del Norte

location_facility: Dorozhnaya Clinical Hospital n.a. Semashko at Lublino Station OAO Rzhd

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Fundacion Oftalmologica de Santander Foscal

location_facility: University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS

location_facility: Multiprofile Hospital for Active Treatment Puls AD PPDS

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse

location_facility: AES - AS - Government Medical College - Nagpur

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: AES - AS - Yashwantrao Chavan Memorial Hospital

location_facility: AES - AS - Aakash Healthcare Private Limited

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: IDIAPJGol_Fundacion Instituto Universitario Investigacion AP Salud Jordi Gol i Gurina

location_facility: Fujita Health University Banbuntane Hotokukai Hospital

location_facility: AES - AE - Grant Medical College and Sir JJ Group of Hospitals

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi

location_facility: Asociación IPS Médicos Internistas de Caldas

location_facility: Multiprofile Hospital for Active Treatment - Dobrich AD

location_facility: Centro de Estudios Clinicos E Investigaciones Medicas

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Hospital Interzonal General de Agudos Eva Perón

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC

location_facility: Ospedali Riuniti Azienda Ospedaliero Universitaria

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Clinical Hospital For Infectious Diseases; Infectious Diseases

location_facility: Panamerican Clinical Research S.A de C.V.

location_facility: Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: Multiprofile Hospital for Active Treatment Plovdiv

location_facility: Hospital E Maternidade Celso Pierro PUCCAMP

location_facility: Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases

title: A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19

summary: This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.


location_country:
United States
Finland
France
Bulgaria
Japan
Russian Federation
Germany
Ukraine

location_facility: State Psychiatric Hospital - Tzarev Brod

location_facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

location_facility: Mental Health Center Prof. Dr. Ivan Temkov

location_facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

location_facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

location_facility: Poltava O.F. Maltsev RC Psychiatric Hospital Dept #9 (Ad-P Dept) HSEIU Ukrainian MSA

location_facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council

location_facility: Neurologische Praxis Dr. Schoell & Kollegen

location_facility: California Pharmaceutical Research Institute, Inc.

location_facility: Clinical Psychiatry Hospital n.a. N.N. Solodovnikov

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

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: City Psychiatric Hospital of St. Nikolay Chudotvorets

location_facility: Closed corporation 'Scientific Center of Personalized Psychiatry'

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: National Center for Global Health and Medicine, Kohnodai hospital

location_facility: Mental Health Center - Veliko Tarnovo EOOD

location_facility: Synergy Clinical Research Center Of Escondido

location_facility: FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia

location_facility: Sverdlov Regional Psychiatric Clinical Hospital

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez

location_facility: Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: St-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

location_facility: CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'

location_facility: Medical and Rehabilitation Research Center Phoenix

location_facility: CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

location_facility: SHI Arkhangelsk Regional Clinical Psychiatric Hospital

title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Adaptive Dose-Finding Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

summary: The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.


title: A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

summary: CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.

lead_sponsor: Checkpoint Therapeutics, Inc.

location_country:
South Africa
France
Poland
Thailand
Russian Federation
Australia
New Zealand
Spain
Ukraine


ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Brazil
Chile
Netherlands
France
Japan
Poland
Hungary
Argentina
United States
Korea, Republic of
Ukraine

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council

location_facility: ASCLEPES Research Centers, P.C. dba Alliance Research

title: A Phase III Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-2)

summary:
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called BI 425809 improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes BI 425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809 tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.

During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.

Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.


title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma

summary:
Primary Objectives:

To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.
To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria.

Secondary Objectives:

To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS).
To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination.
To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country:
Italy
Brazil
United States
France
Czechia
Greece
Hungary
Australia
Spain
Canada

location_facility:
Investigational Site Number 3800001
Investigational Site Number 3800005
Investigational Site Number 8400003
Investigational Site Number 3800003
Investigational Site Number 1240001
Investigational Site Number 2030002
Investigational Site Number 0760003
Investigational Site Number 2500002
Investigational Site Number 8400004
Investigational Site Number 8400001
Investigational Site Number 0360003
Investigational Site Number 7240003
Investigational Site Number 2030003
Investigational Site Number 7240002
Investigational Site Number 2500003
Investigational Site Number 2030001
Investigational Site Number 3800002
Investigational Site Number 0760001
Investigational Site Number 2500001
Investigational Site Number 0360001
Investigational Site Number 2500004
Investigational Site Number 7240004
Investigational Site Number 7240005
Investigational Site Number 0760004
Investigational Site Number 8400002
Investigational Site Number 7240006
Investigational Site Number 1240003
Investigational Site Number 3480002
Investigational Site Number 1240005
Investigational Site Number 3000001
Investigational Site Number 0360002
Investigational Site Number 2500005


title: Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.

summary:
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine.

Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

location_country:
Malaysia
Greece
Australia
Belgium
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Hong Kong
Netherlands
Singapore
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
New Zealand
Spain

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: University of Iowa Hospitals and Clinics

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Southern California Gastrointestinal and Liver Centers

location_facility: Digestive Health Research of Southern CA

location_facility: CHTAD, EPE - Hospital São Pedro de Vila Real

location_facility: National Diabetes and Obesity Research Institute

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital General Universitario de Valencia

location_facility: General Oncology Hospital "Agioi Anargyri"

location_facility: Private health care facility "Your Health EL" LLC

location_facility: National Chen Kung University, Dept of Neurology

location_facility: General Hospital of Thessaloniki "Hippokrateio"

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Niigata University Medical and Dental Hospital

location_facility: University Clinical Center Professor Gibinskiego

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: IRCCS Ospedale "Casa Sollievo della Sofferenza"


title: A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

acronym: SERENADE

summary:
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.

The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

lead_sponsor: Actelion

location_country:
Austria
Brazil
Sweden
Germany
France
Bulgaria
Czechia
Israel
Poland
Romania
Hungary
Argentina
Russian Federation
Spain
Denmark
United States
United Kingdom

location_facility: State Healthcare Institution, Regional Clinical Cardiology Dispensary

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: Maestri E Kormann Consultoria Médico- Científica Ltda

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Herzzentrum Uniklinik Köln Klinik III für Innere Medizin

location_facility: Multiprofile Hospital for Active Treatment - National Heart Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: University of North Carolina (UNC) - School of Medicine

location_facility: Vascular Medicine Institute University Of Pittsburgh

location_facility: Hospital Clinico Universitario de Valencia

location_facility: State Autonomous Healthcare Institution Of Yaroslavl Region

location_facility: Instituto de Moléstias Cardiovasculares Tatuí

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: Federal State Budget Scientific Institution

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Washington University School of Medicine

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Specialized Hospital for Active Treatment in Cardiology - Pleven

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD


title: A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

summary: This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.

lead_sponsor: Adaptimmune

location_country:
France
Spain
United States
United Kingdom
Canada

location_facility: University of Kansas Clinical Research Center

location_facility: Cedars Cancer Centre, McGill University Health Centre

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

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Hospital Clinico Universitario de Valencia, INCLIVA Biomedical Research Institute

location_facility: Providence Health & Services - Providence Cancer Center Oncology And Hematology Care Clinic

location_facility: Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

location_facility: Stephenson Cancer Center - University of Oklahoma Health Sciences Center

location_facility: The Christie - The Christie NHS Foundation Trust

location_facility: University Of Wisconsin Carbone Cancer Center

location_facility: University Of Texas, Md Anderson Cancer Center

location_facility: Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro

intervention_type: Genetic


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

summary: This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
France
Japan
Belgium
Spain
United States
United Kingdom
Korea, Republic of
Taiwan


title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis

acronym: FILLMORE

summary: Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

lead_sponsor: Applied Molecular Transport

location_country:
United States
Switzerland
Netherlands
Germany
France
Hungary
Belgium
Spain
Canada
United Kingdom

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Praxis fur Gastroenterologie am Bayerischen Platz

location_facility: Gastrointestinal Asssociates- GIA Clinical Trials, LLC

location_facility: Groupe santé CHC / Clinique du MontLégia, Liege

location_facility: Semmelweis Egyetem I. sz Belgyogyaszati Klinika

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: University of Utah Health Sciences Center


title: Defining Cut-off Values for Widely-used Composite Scores and Patient-reported Outcome Measures in Psoriatic Arthritis Corresponding to Remission and Flare Assessed by the Physician and the Patient

acronym: ReFlaP

summary: The purpose of this study is to define cut-off values of the most widely used composite scores and patient-reported outcomes, for levels corresponding to remission/low disease activity and for changes in levels corresponding to flares, in PsA, when remission/low disease activity and flare are defined from the patient and physician perspective. The ReFlaP (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal, observational study.

ReferenceType: derived

ReferenceCitation: Coates LC, Robinson DE, Orbai AM, Kiltz U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Meisalu S, Ruyssen-Witrand A, Eder L, de Wit M, Smolen JS, Lubrano E, Gossec L. What influences patients' opinion of remission and low disease activity in psoriatic arthritis? Principal component analysis of an international study. Rheumatology (Oxford). 2021 Nov 3;60(11):5292-5299. doi: 10.1093/rheumatology/keab220.

name: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

family: Coates

full_name: Laura C Coates

given: Laura C

sequence: first

family: Robinson

full_name: Danielle E Robinson

given: Danielle E

sequence: additional

name: Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

family: Orbai

full_name: Ana-Maria Orbai

given: Ana-Maria

name: Rheumazentrum Ruhrgebiet, Herne and Ruhr-Universität, Bochum, Germany

family: Kiltz

full_name: Uta Kiltz

given: Uta

name: Rheumatology Department, Singapore General Hospital, Singapore, Singapore

family: Leung

full_name: Ying-Ying Leung

given: Ying-Ying

name: Serviço de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

family: Palominos

full_name: Penelope Palominos

given: Penelope

name: Rheumatology Department, Hospital Clinic and Institut D'Investigacions Biomediques August Pi Sunyer, Barcelona, Spain

family: Cañete

full_name: Juan D Cañete

given: Juan D

name: Rheumatology Unit, Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza Università di Roma, Rome, Italy

family: Scrivo

full_name: Rossana Scrivo

given: Rossana

name: Sf Maria Hospital, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania

family: Balanescu

full_name: Andra Balanescu

given: Andra

name: Rheumatology Department, Le Mans Central Hospital, Le Mans, France

family: Dernis

full_name: Emmanuelle Dernis

given: Emmanuelle

name: Rheumatology Department, East-Tallinn Central Hospital, Tallinn, Estonia

family: Meisalu

full_name: Sandra Meisalu

given: Sandra

name: Rheumatology Unit, Toulouse University Hospital, UMR 1027, INSERM, Université Paul Sabatier Toulouse III, Toulouse, France

family: Ruyssen-Witrand

full_name: Adeline Ruyssen-Witrand

given: Adeline

name: Women’s College Hospital, University of Toronto, Toronto, Ontario, Canada

family: Eder

full_name: Lihi Eder

given: Lihi

name: Patient Research Partner, Amsterdam, The Netherlands

family: de Wit

full_name: Maarten de Wit

given: Maarten

name: Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria

family: Smolen

full_name: Josef S Smolen

given: Josef S

name: Academic Rheumatology Unit, Dipartimento di Medicina e Scienze della Salute ‘Vincenzo Tiberio’, University of Molise, Campobasso, Italy

family: Lubrano

full_name: Ennio Lubrano

given: Ennio

name: Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Sorbonne Université

name: Rheumatology Department, Pitié Salpêtrière Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Gossec

full_name: Laure Gossec

given: Laure

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: What influences patients’ opinion of remission and low disease activity in psoriatic arthritis? Principal component analysis of an international study

ReferenceCitation: Orbai AM, Perin J, Gorlier C, Coates LC, Kiltz U, Leung YY, Palominos PE, Cañete JD, Scrivo R, Balanescu A, Dernis E, Tälli S, Ruyssen-Witrand A, Soubrier M, Aydin S, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, Smolen JS, de Wit M, Gossec L. Determinants of Patient-Reported Psoriatic Arthritis Impact of Disease: An Analysis of the Association With Sex in 458 Patients From Fourteen Countries. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1772-1779. doi: 10.1002/acr.24090.

name: Johns Hopkins University  Baltimore Maryland

full_name: Ana‐Maria Orbai

given: Ana‐Maria

family: Perin

full_name: Jamie Perin

given: Jamie

name: Sorbonne Université INSERM Institut Pierre Louis d'Epidémiologie et de Santé Publique and Pitié Salpêtrière Hospital AP‐HP  Paris France

family: Gorlier

full_name: Clémence Gorlier

given: Clémence

full_name: Laura C. Coates

name: Rheumazentrum Ruhrgebiet, Herne and Ruhr‐University  Bochum Germany

name: Singapore General Hospital Duke‐NUS Medical School  Singapore

name: Hospital de Clinicas de Porto Alegre  Porto Alegre Brazil

name: Hospital Clínic and IDIBAPS  Barcelona Spain

name: Sf Maria Hospital University of Medicine and Pharmacy Carol Davila  Bucharest Romania

name: Le Mans Central Hospital  Le Mans France

name: East‐Tallinn Central Hospital  Tallinn Estonia

name: Toulouse University Hospital UMR 1027 INSERM Université Paul Sabatier Toulouse III  Toulouse France

name: Gabriel Montpied Hospital  Clermont Ferrand France

name: University of Ottawa the Ottawa Hospital Research Institute  Ottawa Canada

name: Women’s College Hospital University of Toronto  Toronto Ontario Canada

name: North‐western State Medical University  St. Petersburg Russia

name: Hopital Lariboisiere Centre Viggo Petersen service de Rhumatologie and Universite Paris Diderot UFR de Medecine INSERM UMR1132 Bioscar  Paris France

name: Medical University of Vienna  Vienna Austria

name: Amsterdam University Medical Centre  Amsterdam Netherlands

title: Determinants of Patient‐Reported Psoriatic Arthritis Impact of Disease: An Analysis of the Association WithSex in 458 Patients From Fourteen Countries

ReferenceCitation: Gorlier C, Orbai AM, Puyraimond-Zemmour D, Coates LC, Kiltz U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Tälli S, Ruyssen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, de Wit M, Smolen JS, Gossec L. Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries. Ann Rheum Dis. 2019 Feb;78(2):201-208. doi: 10.1136/annrheumdis-2018-214140. Epub 2018 Nov 15.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

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

repository_institution: Université de Lille (University Of Lille) - LillOA

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories:
HAL
LillOA (Lille Open Archive)
ora.ox.ac.uk

location_country:
Italy
Austria
Brazil
Germany
France
Romania
Singapore
Russian Federation
Turkey
Spain
Estonia
United States
United Kingdom
Canada

location_facility:
Soubrier
Balanescu
Juan Canete
Smolen
Rossana Scrivo
Eder
Husni
Ruyssen-Witrand
Laura Coates
Dernis
Ana- Maria Orbai
Uta Kiltz
Palominos
Katy Leung
Kalyoncu
Lubrano
Talli
Laure Gossec
Inna Gaydukova
Sibel Aydin
Aydin
Richette


title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension

summary:
This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH).

The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo; the treatment dose with the best efficacy and safety profile will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose group is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12.

The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12.

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Germany
France
Poland
Israel
Argentina
Australia
New Zealand
Russian Federation
Turkey
United States
Colombia

location_facility: Cardiovascular Institute of North Colorado - Banner Health ( Site 0013)

location_facility: Methodist Hospital [Indianapolis, IN] ( Site 0045)

location_facility: Medizinische Hochschule Hannover ( Site 0284)

location_facility: University of Colorado - Denver ( Site 0003)

location_facility: Hospital Universitario Austral ( Site 0138)

location_facility: Instituto Cardiovascular de Rosario ( Site 0128)

location_facility: Shaare Zedek Medical Center ( Site 0331)

location_facility: University of Nebraska Medical Center ( Site 0041)

location_facility: Clinical Trials Unit at Eastowne Medical Office Building ( Site 0019)

location_facility: Sentara Norfolk General Hospital ( Site 0014)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0276)

location_facility: Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502)

location_facility: Centro Cardiologico Monzino IRCCS ( Site 0306)

location_facility: Georgetown University Hospital ( Site 0025)

location_facility: Hospital Universitario San Ignacio ( Site 0152)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 0504)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509)

location_facility: Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María ( Site 0154)

location_facility: Houston Methodist Research Institute ( Site 0036)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0137)

location_facility: Universitaetsklinikum Leipzig ( Site 0285)

location_facility: Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506)

location_facility: Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351)

location_facility: University of Naples Federico II ( Site 0308)

location_facility: CHRU Brest - Hopital Cavale Blanche ( Site 0254)

location_facility: Dokuz Eylul University Faculty of Medicine ( Site 0505)

location_facility: Institut Coeur Poumon - CHRU de Lille ( Site 0252)

location_facility: Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403)

location_facility: Almazov National Medical Research Centre of the Ministry of Health ( Site 0402)

location_facility: University of Kansas Medical Center ( Site 0038)

location_facility: Norton Pulmonary Associates ( Site 0048)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0279)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0258)


intervention_type: Biological

status: Not yet recruiting

study_start_date_type: Anticipated

location_country:
United States
France
Australia
Spain
Germany

acronym: PIVOT IO 020

title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

summary: The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.


title: Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

summary: This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
France
Japan
Korea, Republic of
Spain
United States
Canada
Taiwan

location_facility: Memorial Sloan-Kettering Cancer Center at Memorial Hospital

location_facility: University Hospital - Kyoto Prefectural University of Medicine

location_facility: National Cheng Kung University Hospital - Internal Medicine

location_facility: Seoul National University Hospital - Department of Internal

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Washington University School of Medicine

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

location_facility: Hokkaido University Hospital - Medical Oncology Center

location_facility: National Hospital Organization Nagoya Medical Center - Hematology

location_facility: Centre Hospitalier Lyon Sud - Hématologie

location_facility: University of Pennsylvania Perelman Center for Advanced Medicine

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: Emory University Hospital - Winship Cancer Institute

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hackensack University Medical Center - John Theurer Cancer Center


title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

acronym: CHOICE-MI

summary: This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

time_perspective: Retrospective

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_country:
Italy
United States
Switzerland
Germany
France
Norway
Australia
Denmark
Canada
United Kingdom

location_facility: Cedars-Sinai Medical Center, Los Angeles

location_facility: Heart Center of the University Medical Center Mainz

location_facility: Rikshospitalet, Oslo University Hospital (OUS)

location_facility: Goethe-Universität - University Hospital Frankfurt

location_facility: University Heart and Vascular Center Hamburg

lead_sponsor_type: academique


title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

acronym: ASSERT

summary: Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

lead_sponsor: Albireo

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Belgium
Canada
United Kingdom

location_facility: The Childrens Hospital at Montefiore Albert Einstein School of Medicine

location_facility: Universitätsklinik für Kinder-und Jugendmedizin Tübingen

location_facility: Cliniques Universitaires Saint-Luc Bruxelles

location_facility: Oregon Health Science University School of Medicine

location_facility: Antenne pédiatrique du CIC - Hopital Jeanne De Flandre

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: University of California - San Francisco


location_country:
Italy
United States
Germany
France
Poland
Israel
Belgium
Spain
Canada

acronym: THEIA

location_facility: ASUI Santa Maria della Misericordia di Udine

location_facility: Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

summary: The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Adult Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

acronym: RSVTx

summary: This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

lead_sponsor: Enanta Pharmaceuticals

location_country:
South Africa
Spain
France
Israel
Argentina
Australia
China
United States
Korea, Republic of
Taiwan
Colombia

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Hospital Clinico Universitario de Valencia


location_country:
United States
France
Israel
Australia
New Zealand
Spain
Canada
United Kingdom
Korea, Republic of

acronym: Substudy 03B: Phase 1b/2 Umbrella Study of Combination Therapies in RCC

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 3017)

location_facility: Institut De Cancerologie De Lorraine ( Site 3204)

location_facility: Hospital Universitario Ramon y Cajal ( Site 3301)

location_facility: Hadassah Medical Center-Oncology ( Site 3504)

location_facility: Western Sydney Local Health District ( Site 3601)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 3002)

location_facility: Hospital Universitari Vall d Hebron ( Site 3300)

location_facility: Princess Margaret Cancer Centre ( Site 3101)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 3203)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 3016)

location_facility: Royal Brisbane and Women s Hospital ( Site 3603)

location_facility: Sheba Medical Center - Oncology Division ( Site 3501)

location_facility: Vanderbilt University Medical Center ( Site 3004)

title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03B

summary:
Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.


acronym: Substudy 03A: Phase 1b/2 Umbrella Study of Combination Therapies in RCC

location_facility: Western Sydney Local Health District ( Site 1601)

location_facility: Hadassah Medical Center-Oncology ( Site 1504)

location_facility: Princess Margaret Cancer Centre ( Site 1101)

location_facility: Royal Brisbane and Women s Hospital ( Site 1603)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

location_facility: Hospital Universitari Vall d Hebron ( Site 1300)

location_facility: Institut De Cancerologie De Lorraine ( Site 1204)

location_facility: Sheba Medical Center - Oncology Division ( Site 1501)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1002)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 1016)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 1017)

title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A

summary:
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.


title: RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

summary: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

lead_sponsor: CymaBay Therapeutics, Inc.

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Israel
New Zealand
Spain

location_facility: University of Colorado Denver and Hospital

location_facility: Texas Digestive Disease Consultants dba GI Alliance

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Clinic of High Medical Technologies n.a. N.I. Pirogov

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Centre Hospitalier Universitaire Grenoble-Alpes

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: University of Minnesota Medical Center, Fairview

location_facility: Hospital Universitario German Trias i Pujol

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Southern Therapy and Advanced Research, LLC (STAR)

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Center For Gastrointestinal Health - CAR

location_facility: Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc

location_facility: Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine

location_facility: Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Bon Secours Richmond Community Hospital LLC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Gastroenterologisch Hepatologisches Zentrum Kiel

location_facility: Centro de Investigaciones Clínicas Vina del Mar

location_facility: Universitatsklinik Tubingen, Medizinische Klinik, lnnere Medizin I

location_facility: Hospital Universitario Margues de Valdecilla

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

location_facility: Seoul National University Bundang Hospital

location_facility: CINME (Centro de Investigaciones Metabolicas)

location_facility: Institute for Digestive Tract & Liver Disease

location_facility: Domaine Universitaire du Sart Tilman Batiment B 35

location_facility: General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases

location_facility: Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara

location_facility: Liver Disease Center, Sheba Medical Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of California, Davis Medical Center

location_facility: Gastroenterology Research Unit Dunedin Hospital

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation

location_facility: Universitatsklinikum Leipzig, Klinik und Poliklinik fur Onkologie, Gastroenterologie, Hepatologie, Pneumologie, lnfektiologie - Bereich Hepatologie

location_facility: Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

location_facility: State budget institution of healthcare of Moscow city "Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov" of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology

location_facility: University General Hospital of Heraklion

location_facility: Tulane University Health Sciences Center

location_facility: University of Texas Southwestern Medical Center


title: A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study

summary: The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
Germany
France
Hungary
Australia
Spain
Canada
United Kingdom

location_facility: Hospital Infanta Luisa Quirón Salud Servicio de Reumatología

location_facility: Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia

location_facility: CLINICAL GAIAS SANTIAGO Servicio de Reumatología

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

location_facility: The Queen Elizabeth Hospital Rheumatology Unit

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék

location_facility: Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie

location_facility: Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos

location_facility: Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő

location_facility: Southampton General Hospital, University Hospital Southampton NHS Trust

location_facility: Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie

location_facility: Medizinische Hochschule Hannover Klinik für Rheumatologie und Immunologie