ReferenceCitation: Heinen F, Kaňovský P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, Hanschmann A, Martinez-Torres FJ, Pulte I, Banach M, Gaebler-Spira D. IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study. J Pediatr Rehabil Med. 2021;14(2):183-197. doi: 10.3233/PRM-210040.

name: Dr. von Hauner Children’s Hospital, LMU – University Hospital, Ludwig Maximilians Universitat, Munich, Germany

family: Heinen

full_name: Florian Heinen

given: Florian

name: Palacký University Olomouc and University Hospital, Olomouc, Czech Republic

family: Kaňovský

full_name: Petr Kaňovský

given: Petr

family: Schroeder

full_name: A. Sebastian Schroeder

given: A. Sebastian

name: Rady Children’s Hospital, San Diego, CA, USA

family: Chambers

full_name: Henry G. Chambers

given: Henry G.

name: Beaumont Health, Oakland University School of Medicine, Grosse Pointe, MI, USA

family: Dabrowski

full_name: Edward Dabrowski

given: Edward

name: Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany

family: Geister

full_name: Thorin L. Geister

given: Thorin L.

family: Hanschmann

full_name: Angelika Hanschmann

given: Angelika

name: Formerly of Merz North America, Raleigh, NC, USA

family: Martinez-Torres

full_name: Francisco J. Martinez-Torres

given: Francisco J.

family: Pulte

full_name: Irena Pulte

given: Irena

family: Banach

full_name: Marta Banach

given: Marta

name: Shirley Ryan AbilityLab, Chicago, IL, USA

family: Gaebler-Spira

full_name: Deborah Gaebler-Spira

given: Deborah

journal_name: Journal of Pediatric Rehabilitation Medicine

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Austria
France
Czechia
Poland
Israel
Slovakia
Romania
Russian Federation
Turkey
Spain
Estonia
Germany
Korea, Republic of
Ukraine

location_facility:
Merz Investigational Site #043036
Merz Investigational Site #972002
Merz Investigational Site #049329
Merz Investigational Site #048061
Merz Investigational Site #090005
Merz Investigational Site #007018
Merz Investigational Site #048072
Merz Investigational Site #380005
Merz Investigational Site #033055
Merz Investigational Site #049326
Merz Investigational Site #421003
Merz Investigational Site #034026
Merz Investigational Site #033052
Merz Investigational Site #049327
Merz Investigational Site #082021
Merz Investigational Site #048084
Merz Investigational Site #033054
Merz Investigational Site #040002
Merz Investigational Site #082019
Merz Investigational Site #972001
Merz Investigational Site #034031
Merz Investigational Site #043037
Merz Investigational Site #034030
Merz Investigational Site #082018
Merz Investigational Site #049328
Merz Investigational Site #007019
Merz Investigational Site #420029
Merz Investigational Site #048089
Merz Investigational Site #048059
Merz Investigational Site #090002
Merz Investigational Site #972003
Merz Investigational Site #421004
Merz Investigational Site #421008
Merz Investigational Site #040001
Merz Investigational Site #421006
Merz Investigational Site #049330
Merz Investigational Site #033056
Merz Investigational Site #007015
Merz Investigational Site #090003
Merz Investigational Site #372001
Merz Investigational Site #040003
Merz Investigational Site #048063
Merz Investigational Site #380003
Merz Investigational Site #048075
Merz Investigational Site #034032
Merz Investigational Site #082020
Merz Investigational Site #007017
Merz Investigational Site #380001
Merz Investigational Site #372002
Merz Investigational Site #380002
Merz Investigational Site #007014
Merz Investigational Site #007013
Merz Investigational Site #420028

title: Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin® (incobotulinumtoxinA, NT 201) for the Treatment of Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

summary: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.


ReferenceType: derived

ReferenceCitation: Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.

family: Smolen

full_name: Josef S Smolen

given: Josef S

sequence: first

family: Cohen

full_name: Stanley B Cohen

given: Stanley B

sequence: additional

family: Tony

full_name: Hans-Peter Tony

given: Hans-Peter

family: Scheinberg

full_name: Morton Scheinberg

given: Morton

family: Kivitz

full_name: Alan Kivitz

given: Alan

family: Balanescu

full_name: Andra Balanescu

given: Andra

family: Gomez-Reino

full_name: Juan Gomez-Reino

given: Juan

family: Cen

full_name: Liyi Cen

given: Liyi

family: Zhu

full_name: Peijuan Zhu

given: Peijuan

family: Shisha

full_name: Tamas Shisha

given: Tamas

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

design_allocation: Randomized

intervention_type: Biological

status: Completed

study_type: Interventional

lead_sponsor: Sandoz

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
Austria
Brazil
India
Germany
France
Romania
Hungary
Argentina
Belgium
Spain
Estonia
United States
Turkey

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Megyei Csolnoky Ferenc Kórház Nonprofit Zrt.

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.

summary: The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.

lead_sponsor_type: industriel

status_simplified: Completed


title: A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

summary: The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

ReferenceCitation: Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study. Chest. 2016 Oct;150(4):789-798. doi: 10.1016/j.chest.2016.03.032. Epub 2016 Apr 4.

family: Bjermer

full_name: Leif Bjermer

given: Leif

family: Lemiere

full_name: Catherine Lemiere

given: Catherine

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Weiss

full_name: Sivan Weiss

given: Sivan

family: Zangrilli

full_name: James Zangrilli

given: James

family: Germinaro

full_name: Matthew Germinaro

given: Matthew

journal_name: Chest

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
United States
Brazil
Sweden
Mexico
Netherlands
France
Poland
Israel
Hungary
Belgium
Argentina
Canada
Colombia

location_facility:
Teva Investigational Site 120
Teva Investigational Site 184
Teva Investigational Site 404
Teva Investigational Site 422
Teva Investigational Site 128
Teva Investigational Site 103
Teva Investigational Site 205
Teva Investigational Site 17
Teva Investigational Site 203
Teva Investigational Site 1
Teva Investigational Site 21
Teva Investigational Site 406
Teva Investigational Site 142
Teva Investigational Site 505
Teva Investigational Site 341
Teva Investigational Site 144
Teva Investigational Site 20
Teva Investigational Site 264
Teva Investigational Site 502
Teva Investigational Site 150
Teva Investigational Site 421
Teva Investigational Site 7
Teva Investigational Site 402
Teva Investigational Site 400
Teva Investigational Site 127
Teva Investigational Site 143
Teva Investigational Site 601
Teva Investigational Site 73
Teva Investigational Site 260
Teva Investigational Site 182
Teva Investigational Site 181
Teva Investigational Site 125
Teva Investigational Site 104
Teva Investigational Site 602
Teva Investigational Site 18
Teva Investigational Site 45
Teva Investigational Site 141
Teva Investigational Site 15
Teva Investigational Site 9
Teva Investigational Site 12
Teva Investigational Site 512
Teva Investigational Site 2
Teva Investigational Site 126
Teva Investigational Site 185
Teva Investigational Site 121
Teva Investigational Site 513
Teva Investigational Site 147
Teva Investigational Site 123
Teva Investigational Site 14
Teva Investigational Site 180
Teva Investigational Site 344
Teva Investigational Site 10
Teva Investigational Site 504
Teva Investigational Site 27
Teva Investigational Site 183
Teva Investigational Site 204
Teva Investigational Site 261
Teva Investigational Site 43
Teva Investigational Site 24
Teva Investigational Site 6
Teva Investigational Site 420
Teva Investigational Site 342
Teva Investigational Site 140
Teva Investigational Site 340
Teva Investigational Site 11
Teva Investigational Site 507
Teva Investigational Site 19
Teva Investigational Site 600
Teva Investigational Site 8
Teva Investigational Site 401
Teva Investigational Site 122
Teva Investigational Site 105
Teva Investigational Site 403
Teva Investigational Site 5
Teva Investigational Site 200
Teva Investigational Site 26
Teva Investigational Site 145
Teva Investigational Site 202
Teva Investigational Site 407
Teva Investigational Site 263
Teva Investigational Site 124
Teva Investigational Site 3
Teva Investigational Site 460
Teva Investigational Site 4
Teva Investigational Site 146
Teva Investigational Site 16
Teva Investigational Site 101
Teva Investigational Site 500
Teva Investigational Site 343

intervention_type: Drug


title: A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma

summary:
The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib.

Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

ReferenceCitation: Rini BI, Stenzl A, Zdrojowy R, Kogan M, Shkolnik M, Oudard S, Weikert S, Bracarda S, Crabb SJ, Bedke J, Ludwig J, Maurer D, Mendrzyk R, Wagner C, Mahr A, Fritsche J, Weinschenk T, Walter S, Kirner A, Singh-Jasuja H, Reinhardt C, Eisen T. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Nov;17(11):1599-1611. doi: 10.1016/S1470-2045(16)30408-9. Epub 2016 Oct 3.

family: Rini

full_name: Brian I Rini

given: Brian I

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Zdrojowy

full_name: Romauld Zdrojowy

given: Romauld

family: Kogan

full_name: Mikhail Kogan

given: Mikhail

family: Shkolnik

full_name: Mikhail Shkolnik

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Weikert

full_name: Steffen Weikert

given: Steffen

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

family: Crabb

full_name: Simon J Crabb

given: Simon J

family: Bedke

full_name: Jens Bedke

given: Jens

family: Ludwig

full_name: Joerg Ludwig

given: Joerg

family: Maurer

full_name: Dominik Maurer

given: Dominik

family: Mendrzyk

full_name: Regina Mendrzyk

given: Regina

family: Wagner

full_name: Claudia Wagner

given: Claudia

family: Mahr

full_name: Andrea Mahr

given: Andrea

family: Fritsche

full_name: Jens Fritsche

family: Weinschenk

full_name: Toni Weinschenk

given: Toni

family: Walter

full_name: Steffen Walter

family: Kirner

full_name: Alexandra Kirner

given: Alexandra

family: Singh-Jasuja

full_name: Harpreet Singh-Jasuja

given: Harpreet

family: Reinhardt

full_name: Carsten Reinhardt

given: Carsten

family: Eisen

full_name: Tim Eisen

given: Tim

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Southampton - ePrints Soton

location_country:
Italy
United States
Netherlands
France
Poland
Norway
Hungary
Romania
Russian Federation
Germany
United Kingdom

location_facility: Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

location_facility: Oncology Therapy Clinic, University of Szeged

location_facility: State Institution "City Clinical Hospital NO20"

location_facility: Oncology Department, Zala County Hospital

location_facility: State Budget Institution of Ryazan Region "Regional Clinical Oncological Diespensary"

location_facility: Institution of Russian Academy of Medical Science, "Russian Oncological Scientific Center named after N.N. Blokhin of Russian Academy of Medical Science"

location_facility: Hospital Européen Georges Pompidou, Service d'oncologie medicale

location_facility: Klinik und Poliklinik für Urologie, Abteilung für Operative Medizin, Universitätsklinikum Leipzig

location_facility: University of Arkansas for Medical Sciences

location_facility: IRCC-Istituto di Ricerca e Cura del Cancro

location_facility: State Institution of Healthcare "Leningrad Regional Oncological Dispensary"

location_facility: Department of Oncology and Haematology, Division of Medical Oncology, University of Modena and Reggio Emilia

location_facility: University of Debrecen, Faculty of Medicine, Urology Clinic

location_facility: South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care

location_facility: Presidio Ospedaliero Ospedale San Donato, U.O. Oncologia Medica

location_facility: Nonstate Institution of Healthcare "Railway clinical Hospital at Station Saratov-2 of "RZGD" PC"

location_facility: CHU Estaing, Service d'hematologie clinique adulte et de therapie cellulaire

location_facility: Prof. Franciszek Łukaszczyk Oncology Center

location_facility: Medical Oncology Unit, Policlinico Sant'Orsola Malpighi

location_facility: Federal State Institution "Scientific Research Institute of Oncology named after N.N. Petrov of Ministry of Healthcare of Russian Federation"

location_facility: Kaiser Permanente Oncology Hematology Clinic

location_facility: County Oncology Centre, Hetényi Géza Hospital

location_facility: Orenburg Regional Clinical Oncological Dispensary

location_facility: Urology Department, Bajcsy-Zsilinszky Hospital

location_facility: South West Wales Cancer Institute, Singleton Hospital, School of Medicine

location_facility: Emergency Clinical County Hospital Oradea

location_facility: Wojewódzki Szpital Zespolony, Oncology Department

location_facility: Republican Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan

location_facility: CRUK Research Unit, Somers Cancer Research Building, Southampton General Hospital

location_facility: "Prof. Dr. Ioan Chiricuta" Oncology Institute

location_facility: State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncological Hospital"

location_facility: Saint-Petersburg State Institution of Healthcare "City Universal Hospital N02"

location_facility: Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover

location_facility: Klinik für Urologie, Universitätsklinikum Tübingen

location_facility: University Hospital, UOS - Radiumhospital

location_facility: Klinik für Innere Medizin III, Hämatologie - Onkologie - Rheumatologie - Infektionskrankheiten, Universitätsklinikum Ulm

location_facility: Péterfy Utcai Hospital, Urology department

location_facility: Moscow Hertsen Scientific Research Oncological Institute

location_facility: Weinberg Cancer Institute at Franklin Hospital

location_facility: Universitätsklinikum Essen, Klinik für Innere Medizin (Tumorforschung)

location_facility: Addenbrooke's Hospital & Peterborough District Hospital, Cambridge University Hospitals NHS Foundation Trust, Oncology Center

location_facility: Targu-Mures Clinical County Hospital, Oncology and Radiotherapy Department

location_facility: Oxford Cancer and Haematology Centre, University of Oxford, The Churchill Hospital, Oxford Radcliffe Hospital NHS Trust, Dept.of Medical Oncology

location_facility: Przemienienia Pańskiego Clinical Hospital no. 1, Oncology Clinic

location_facility: Pándy Kálmán County Hospital, Oncology and Radiotherapy Center

location_facility: Federal State Institution "Russian Scientific Center of Radiology and Surgery Technologies" of Ministry of Healthcare of Russian Federation"

location_facility: UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen, Abteilung Hämatologie und Onkologie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Chemotherapy Department Center of Oncology of the Lublin Region

location_facility: North Central Cancer Treatment Group, Illinois Cancer Care

location_facility: Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Dzieciątka Jezus Clinical Hospital of Medical University, General Urology and Oncology Clinic

location_facility: Uzsoki Utcai Hospital, Oncoradiology Center

location_facility: Urology and Urological Oncology Department and Clinic

location_facility: Nationales Centrum für Tumorerkrankungen (NCT), Medizinische Onkologie

location_facility: University of Debrecen, Faculty of Medicine, Institute of Oncology

location_facility: Paterson Institute for Cancer Research, Christie Hospital NHS Foundation Trust, Medical Oncology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Urologii

location_facility: Klinik für Hämatologie und internistische Onkologie, Augusta-Krankenanstalt gGmbH

location_facility: State Educational Institution of High Professional Education "Rostov State Medical University of Roszdrav"

location_facility: Saint-Petersburg Clinical Scientific and Practical Centre of Special Methods of Medical Aid (Oncology)

location_facility: Universitätsmedizin Berlin, Charité Campus Benjamin Franklin, Urologische Klinik und Hochschulambulanz

location_facility: Urologische Klinik Dr. Castringius, München-Planegg

location_facility: Federal State Institution "Russian Scientific Center of Radiology and Nuclear Medicine of Healthcare of Russian Federation"

location_facility: Medical Oncology, Hospital Santa Maria Nuova of Reggio Emilia

location_facility: Leeds Institute of Molecular Medicine, Section of Oncology and Clinical Research, St. James's University Hospital

location_facility: State Budget Institution of Healthcare "Chelyabinsk regional clinical oncological Dispensary"

location_facility: Saint Petersburg State Institution of Healthcare "City Clinical Oncological Dispensary"

location_facility: ROSEMERE CANCER CENTRE, Royal Preston Hospital, Lancashire Teaching Hospital

location_facility: University Medical Center St. Radboud Centraal, Department of Urology

location_facility: Centre Rene Gauducheau, Service d'oncologie medicale

location_facility: Postgraduate Medical School, University of Surrey

location_facility: Centre Francois Baclesse, Comite Urologie-Gynecologie

location_facility: Klinikum rechts der Isar, Urologischen Klinik und Poliklinik, Technische Universität München

location_facility: Dipartimento di Oncologia, IRCCS Fondazione

location_facility: Pomeranian Medical University Hospital, NZOZ Innowacyjna Medycyna

location_facility: Centro di riferimento Oncologico di Aviano

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Oncology Centre, Markhot Ferenc Training Hospital and Clinic

location_facility: Medizinische Klinik III für Hämatologie und Onkologie, Universitätsklinikum Bonn


title: A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer

acronym: DISRUPT

summary:
Primary Objective:

To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Secondary Objective:

To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.

lead_sponsor: Sanofi

location_country:
Italy
Chile
Serbia
Germany
France
Croatia
Poland
Romania
Australia
Russian Federation
United States
Korea, Republic of
Ukraine

location_facility:
Investigational Site Number 191001
Investigational Site Number 152002
Investigational Site Number 276001
Investigational Site Number 250005
Investigational Site Number 250004
Investigational Site Number 380001
Investigational Site Number 642004
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 642003
Investigational Site Number 840009
Investigational Site Number 250001
Investigational Site Number 036001
Investigational Site Number 804003
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 616003
Investigational Site Number 191002
Investigational Site Number 804001
Investigational Site Number 804002
Investigational Site Number 643002
Investigational Site Number 152005
Investigational Site Number 250003
Investigational Site Number 191003
Investigational Site Number 840001
Investigational Site Number 410002
Investigational Site Number 616001
Investigational Site Number 410003
Investigational Site Number 840002
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 152003
Investigational Site Number 152004
Investigational Site Number 688003
Investigational Site Number 643004
Investigational Site Number 642001
Investigational Site Number 642002
Investigational Site Number 036002
Investigational Site Number 380002
Investigational Site Number 688001
Investigational Site Number 276003
Investigational Site Number 276002
Investigational Site Number 616004


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

summary: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

ReferenceCitation: Gottenberg JE, Dörner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.

name: Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares; CNRS; Institut de Biologie Moléculaire et Cellulaire; Immunopathologie et Chimie Thérapeutique; Laboratory of Excellence MEDALIS; Strasbourg University Hospital; Strasbourg France

family: Gottenberg

full_name: Jacques-Eric Gottenberg

given: Jacques-Eric

name: Charité University Hospital Berlin; Berlin Germany

family: Dörner

full_name: Thomas Dörner

given: Thomas

name: University of Groningen; Groningen The Netherlands

family: Bootsma

full_name: Hendrika Bootsma

given: Hendrika

name: INSERM 1227; Brest University Medical School; Brest France

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

family: Bowman

full_name: Simon J. Bowman

given: Simon J.

name: Université Paris-Sud, AP-HP; Hôpitaux Universitaires Paris-Sud; INSERM U1184; Le Kremlin-Bicêtre France

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Bartz

full_name: Holger Bartz

given: Holger

family: Oortgiesen

full_name: Marga Oortgiesen

given: Marga

family: Shock

full_name: Anthony Shock

given: Anthony

family: Koetse

full_name: Willem Koetse

given: Willem

family: Galateanu

full_name: Catrinel Galateanu

given: Catrinel

family: Bongardt

full_name: Sabine Bongardt

given: Sabine

family: Wegener

full_name: William A. Wegener

given: William A.

family: Goldenberg

full_name: David M. Goldenberg

given: David M.

family: Meno-Tetang

full_name: Guy Meno-Tetang

given: Guy

family: Kosutic

full_name: Gordana Kosutic

given: Gordana

name: University of Birmingham and NIHR/Wellcome Trust Clinical Research Facility; University Hospitals Birmingham NHS Foundation Trust; Birmingham UK

family: Gordon

full_name: Caroline Gordon

given: Caroline

journal_name: Arthritis & Rheumatology

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories:
PubMed Central
Pure (Denmark)
pure.rug.nl

ReferenceCitation: Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczyński P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

name: Duke University Medical Center; Durham North Carolina

name: Cedars-Sinai Medical Center; Los Angeles California

name: Johns Hopkins University School of Medicine; Baltimore Maryland

name: MedPharm Consulting; Cambridge Massachusetts

name: Poznan University of Medical Sciences; Poznan Poland

name: Alameda County Health System; Oakland California

name: Denver Arthritis Clinic; Denver Colorado

name: Pontifical Catholic University; Porto Alegre Brazil

name: University of California San Diego School of Medicine; La Jolla

name: University of Birmingham and University Hospital Birmingham NHS Foundation Trust; Birmingham UK

name: on behalf of the EMBODY Investigator Group

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

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

location_country:
Italy
Brazil
South Africa
India
Mexico
Germany
France
Poland
Romania
Hungary
Russian Federation
Spain
United States
United Kingdom
Canada
Ukraine


ReferenceCitation: Goemans N, Mercuri E, Belousova E, Komaki H, Dubrovsky A, McDonald CM, Kraus JE, Lourbakos A, Lin Z, Campion G, Wang SX, Campbell C; DEMAND III study group. A randomized placebo-controlled phase 3 trial of an antisense oligonucleotide, drisapersen, in Duchenne muscular dystrophy. Neuromuscul Disord. 2018 Jan;28(1):4-15. doi: 10.1016/j.nmd.2017.10.004. Epub 2017 Dec 6.

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: Mercuri

full_name: Eugenio Mercuri

given: Eugenio

family: Belousova

full_name: Elena Belousova

given: Elena

family: Komaki

full_name: Hirofumi Komaki

given: Hirofumi

family: Dubrovsky

full_name: Alberto Dubrovsky

given: Alberto

family: McDonald

full_name: Craig M. McDonald

given: Craig M.

family: Kraus

full_name: John E. Kraus

given: John E.

family: Lourbakos

full_name: Afrodite Lourbakos

given: Afrodite

family: Lin

full_name: Zhengning Lin

given: Zhengning

family: Campion

full_name: Giles Campion

given: Giles

family: Wang

full_name: Susanne X. Wang

given: Susanne X.

family: Campbell

full_name: Craig Campbell

given: Craig

family: Araujo

full_name: A. Araujo

given: A.

family: Bertini

full_name: E. Bertini

given: E.

family: Born

full_name: P. Born

given: P.

family: Cances

full_name: C. Cances

given: C.

family: Chabrol

full_name: B. Chabrol

given: B.

family: Chae

full_name: J.-H. Chae

family: Colomer Oferil

full_name: J. Colomer Oferil

given: J.

family: Comi

full_name: G.P. Comi

family: Cuisset

full_name: J.-M. Cuisset

family: D'Anjou

full_name: G. D'Anjou

given: G.

family: Desguerre

full_name: I. Desguerre

given: I.

family: Erazo Torricelli

full_name: R. Erazo Torricelli

given: R.

family: Escobar

full_name: R. Escobar

family: Feder

full_name: D. Feder

repositories_institution: University of Ferrara - Institutional Research Information System University of Ferrara

location_country:
Italy
Brazil
Chile
Netherlands
Germany
France
Czechia
Japan
Poland
Norway
Hungary
Belgium
Argentina
Russian Federation
Spain
Turkey
Denmark
Canada
Korea, Republic of
Taiwan

title: A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

summary: The purpose of this study is to determine whether GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.


intervention_type: Other

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Israel
Slovakia
Singapore
Hungary
Belgium
Australia
Latvia
Russian Federation
Turkey
Canada
Czech Republic
Korea, Republic of

title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

summary: To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).


ReferenceCitation: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Patterson B, Samis J, Aimone P, Allepuz A, Titorenko K, Sosothikul D. A phase 2 study of nilotinib in pediatric patients with CML: long-term update on growth retardation and safety. Blood Adv. 2021 Jul 27;5(14):2925-2934. doi: 10.1182/bloodadvances.2020003759.

name: Division of Pediatric Hematology/Oncology/Stem Cell Transplantation, Columbia University Irving Medical Center, New York, NY;

family: Hijiya

full_name: Nobuko Hijiya

given: Nobuko

name: Dmitrii Rogachev Federal Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation;

family: Maschan

full_name: Alexey Maschan

given: Alexey

name: Department of Pediatrics, Pediatric Hematology Oncology Unit, University of Milano Bicocca, Monza Brianza per il Bambino e la sua Mamma (MBBM) Foundation, Azienda Socio Sanitaria Territoriale (ASST), Monza, Italy;

family: Rizzari

full_name: Carmelo Rizzari

given: Carmelo

name: Keio University School of Medicine, Shinjuku-ku, Japan;

family: Shimada

full_name: Hiroyuki Shimada

given: Hiroyuki

name: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Giannina Gaslini, Genoa, Italy;

family: Dufour

full_name: Carlo Dufour

given: Carlo

family: Goto

full_name: Hiroaki Goto

given: Hiroaki

name: Wide River Institute of Immunology, Hongcheon-gun, South Korea;

name: Department of Pediatrics, Seoul National University College of Medicine, Seoul, South Korea;

family: Kang

full_name: Hyoung Jin Kang

given: Hyoung Jin

name: Nationwide Children's Hospital, The Ohio State University, Columbus, OH;

family: Guinipero

full_name: Terri Guinipero

given: Terri

name: Department of Pediatric Hematology/Oncology, Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey;

family: Karakas

full_name: Zeynep Karakas

given: Zeynep

family: Bautista

full_name: Francisco Bautista

given: Francisco

name: Groupe Hospitalier Pellegrin-Hôpital des Enfants, Bordeaux, France;

family: Ducassou

full_name: Stéphane Ducassou

given: Stéphane

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea;

family: Yoo

full_name: Keon Hee Yoo

given: Keon Hee

name: Department of Pediatric Oncology/Hematology, Erasmus Medical Center (MC)-Sophia Children’s Hospital, Rotterdam, The Netherlands;

name: Innovative Therapies for Children with Cancer (ITCC) Consortium, The Netherlands;

family: Zwaan

full_name: Christian Michel Zwaan

given: Christian Michel

name: Unité d'Onco-Hématologie Pédiatrique, Centre d'Investigation Clinique (CIC) 1402 INSERM, Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, France;

family: Millot

full_name: Frédéric Millot

given: Frédéric

name: Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta and Emory University School of Medicine, Atlanta, GA;

family: Patterson

full_name: Briana Patterson

given: Briana

name: Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL;

family: Samis

full_name: Jill Samis

given: Jill

family: Aimone

full_name: Paola Aimone

given: Paola

family: Allepuz

full_name: Alex Allepuz

given: Alex

name: Novartis Pharmaceuticals Corporation, Moscow, Russian Federation; and

family: Titorenko

full_name: Ksenia Titorenko

given: Ksenia

name: Clinical Research for Holistic Management in Pediatric Hematology and Oncology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

family: Sosothikul

full_name: Darintr Sosothikul

given: Darintr

journal_name: Blood Advances

oa_colors: green gold

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

ReferenceCitation: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Aimone P, Allepuz A, Quenet S, Hourcade-Potelleret F, Hertle S, Sosothikul D. Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. Blood. 2019 Dec 5;134(23):2036-2045. doi: 10.1182/blood.2019000069.

name: Department of Pediatrics, Columbia University Medical Center, New York, NY;

name: Dmitrii Rogachev Federal Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia;

name: Department of Pediatrics, Pediatric Hematology Oncology Unit, University of Milano Bicocca, Monza e Brianza per il Bambino e la sua Mamma Foundation, Azienda Socio Sanitaria Territoriale Monza, Monza, Italy;

name: Department of Pediatrics, Keio University School of Medicine, Tokyo, Japan;

name: IRCCS Hematology Unit, Istituto Giannina Gaslini, Genoa, Italy;

name: Division of Hematology/Oncology, Kanagawa Children’s Medical Center, Yokohama, Japan;

name: Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Cancer Research Institute, Seoul National University Children’s Hospital, Seoul, South Korea;

name: Department of Pediatrics, Division of Pediatric Hematology/Oncology/Bone Marrow Transplantation, Nationwide Children’s Hospital, The Ohio State University, Columbus, OH;

name: Department of Pediatrics, Hematology/Oncology Unit, Istanbul University, Istanbul School of Medicine, Istanbul, Turkey;

name: Department of Pediatric Oncology, Hospital Niño Jesus, Madrid, Spain;

name: Centre Hospitalier Universitaire (CHU) Bordeaux, Oncologie Hématologie Pédiatrique, Université de Bordeaux, Unité INSERM U1218, Bordeaux, France;

name: Department of Pediatric Oncology/Hematology, Erasmus Medical Center-Sophia Children’s Hospital, Rotterdam, The Netherlands;

name: Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands;

name: Innovative Therapies for Children with Cancer Consortium, Utrecht, The Netherlands;

name: Unité d’Onco-Hématologie Pédiatrique, Clinical Investigation Center 1402 INSERM, CHU de Poitiers, Poitiers, France;

name: Trial Management, Novartis Pharma AG, Basel, Switzerland; and

name: Department of Pediatrics, Hematology and Oncology Division, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

title: Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
Netherlands
France
Japan
Malaysia
Thailand
Hungary
Russian Federation
Spain
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Lucile Salter Packard Children's Hospital at Stanford

location_facility: University of Texas Southwestern Medical Center Oncology

title: A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

summary: To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).


title: An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

summary: The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (sc) CEP 33457 for injection every 4 weeks over 72 weeks (18 doses) in patients with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP 33457, and completed at least visit 8 (week 24 of that study).

status: Terminated

lead_sponsor: Cephalon

location_country:
United States
Spain
France
Czechia
Poland
Hungary
Belgium
Portugal
Germany
United Kingdom
Ukraine

location_facility: Akademicki Szpital Kliniczny we Wroclawiu im. Jana Mikulicza

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Scott - White Clinic/Texas A and M University

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Institute of Cardiology named after Strazhesko

location_facility: Feinstein Institute for Medical Research

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Centre for Rheumatology, Immunology and Arthritis Research

location_facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Unica

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Országos Reumatológiai és Fizioterápiás Intézet

location_facility: Box Arthritis and Rheumatology of the Carolinas PLLC

location_facility: Regional Clinical Hospital for Professional Diseases

status_simplified: Unknown


title: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

summary: This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated. The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.

status: Approved for marketing

study_completion_date_type: Anticipated

study_type: Expanded Access

lead_sponsor: Eisai Inc.

location_country: Canada Belgium France


title: A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

summary: The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Baselga J, Costa F, Gomez H, Hudis CA, Rapoport B, Roche H, Schwartzberg LS, Petrenciuc O, Shan M, Gradishar WJ. A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial. Trials. 2013 Jul 22;14:228. doi: 10.1186/1745-6215-14-228.

family: Baselga

full_name: José Baselga

given: José

family: Costa

full_name: Frederico Costa

given: Frederico

family: Gomez

full_name: Henry Gomez

given: Henry

family: Hudis

full_name: Clifford A Hudis

given: Clifford A

family: Rapoport

full_name: Bernardo Rapoport

given: Bernardo

family: Roche

full_name: Henri Roche

given: Henri

family: Schwartzberg

full_name: Lee S Schwartzberg

given: Lee S

family: Petrenciuc

full_name: Oana Petrenciuc

given: Oana

family: Shan

full_name: Minghua Shan

given: Minghua

family: Gradishar

full_name: William J Gradishar

given: William J

currency_apc_doaj: GBP

journal_name: Trials

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Baselga J, Zamagni C, Gómez P, Bermejo B, Nagai SE, Melichar B, Chan A, Mángel L, Bergh J, Costa F, Gómez HL, Gradishar WJ, Hudis CA, Rapoport BL, Roché H, Maeda P, Huang L, Meinhardt G, Zhang J, Schwartzberg LS. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer. Clin Breast Cancer. 2017 Dec;17(8):585-594.e4. doi: 10.1016/j.clbc.2017.05.006. Epub 2017 May 22.

family: Zamagni

full_name: Claudio Zamagni

given: Claudio

family: Gómez

full_name: Patricia Gómez

given: Patricia

family: Bermejo

full_name: Begoña Bermejo

given: Begoña

family: Nagai

location_country:
Greece
Australia
Belgium
Russian Federation
France
Japan
Poland
Argentina
Canada
South Africa
Sweden
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain


title: BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

summary: The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

primary_purpose: Prevention

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
South Africa
Sweden
Netherlands
Finland
France
Norway
Hungary
Belgium
Denmark
Czech Republic

location_facility: 1160.19.46006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal

location_facility: 1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center

location_facility: 1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum

location_facility: 1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad

location_facility: 1160.19.31006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.45042 Orthopedic Surgical Clinic

location_facility: 1160.19.31003 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.39004 Ospedale di Circolo di Varese

location_facility: 1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.

location_facility: 1160.19.39001 IRCCS Policlinico San Matteo

location_facility: 1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus

location_facility: 1160.19.36004 Bács-Kiskun County Hospital

location_facility: 1160.19.36001 Kálmán Pándy County Hospital

location_facility: 1160.19.47002 Sykehuset Telemark HF, Avd. Skien

location_facility: 1160.19.32006 Boehringer Ingelheim Investigational Site

location_facility: 1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping

location_facility: 1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia

location_facility: 1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt

location_facility: 1160.19.43002 Orthopädisches Spital Speising

location_facility: 1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz

location_facility: 1160.19.42009 University Hospital Na Bulovce

location_facility: 1160.19.39003 U. O. Ortopedia e Traumatologia

location_facility: 1160.19.39002 Fondazione Centro S. Raffaele

location_facility: 1160.19.47001 Nordlandssykehuset HF, Bodø

location_facility: 1160.19.42003 University Hospital Ostrava

location_facility: 1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

ReferenceType: background

ReferenceCitation: Cutolo M, Myerson GE, Fleischmann RM, Lioté F, Díaz-González F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.

ReferenceCitation: Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.

ReferenceCitation: Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

name: Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine Seattle

family: Mease

full_name: Philip J. Mease

given: Philip J.

name: Toronto Western Hospital Toronto Ontario Canada

family: Gladman

full_name: Dafna D. Gladman

given: Dafna D.

family: Ogdie

full_name: Alexis Ogdie

given: Alexis

family: Coates

full_name: Laura C. Coates

given: Laura C.

family: Behrens

full_name: Frank Behrens

given: Frank

name: University of California San Diego La Jolla

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

family: McInnes

full_name: Iain McInnes

given: Iain

name: Hospital Universitario Central de Asturias Oviedo Spain

family: Queiro

full_name: Rubén Queiro

given: Rubén

family: Guerette

full_name: Benoit Guerette

given: Benoit

family: Brunori

full_name: Michele Brunori

given: Michele

family: Teng

full_name: Lichen Teng

given: Lichen

name: Medical University of Vienna Vienna Austria

family: Smolen

full_name: Josef S. Smolen

given: Josef S.

journal_name: Arthritis Care & Research

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Treatment‐to‐Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

family: Edwards

full_name: Christopher J. Edwards

given: Christopher J.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

title: Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis

ReferenceCitation: Gladman DD, Kavanaugh A, Gómez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

title: Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1–3 studies

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Italy
United States
South Africa
Germany
France
Czechia
Bulgaria
Poland
Hungary
Belgium
Russian Federation
Spain
Estonia
Canada
United Kingdom
Taiwan

location_facility: Associated Internal Medical Specialist, PC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: Unifour Medical Research Associatets LLC

location_facility: Basingstoke and North Hampshire Hospital

location_facility: Tacoma Center for Arthritis Research, PS

location_facility: St.Petersburg State Medical Academy n. a. I.I.Mechnikov

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: City Clinical Hospital #1 n.a. N.I.Pirogov

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: NZOZ Osteo-Medic sc A. Racewicz J. Supronik

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Seconda Universita degli Studi di Napoli

location_facility: Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: 17 Diagnostic and Consulting Centre Sofia EOOD


title: A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases The Proportion Of Subjects Achieving Insulin Independence After First Transplantation

summary: This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.

lead_sponsor: Novo Nordisk A/S

location_country:
United States
Switzerland
France
Germany
United Kingdom
Canada


title: A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

summary: The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.

ReferenceCitation: Léger JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Shebl A, Bauhofer A, Zenker O, Merkies IS; PRIMA study investigators. Efficacy and safety of Privigen(®) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013 Jun;18(2):130-40. doi: 10.1111/jns5.12017.

name: Reference Center for Rare Neuromuscular Diseases Hôpital Pitié‐Salpêtrière and University Paris VI Paris France

family: Léger

full_name: Jean‐Marc Léger

given: Jean‐Marc

family: De Bleecker

full_name: Jan L. De Bleecker

given: Jan L.

name: Department of Neurology Universitätsklinikum Würzburg Würzburg Germany

family: Sommer

full_name: Claudia Sommer

given: Claudia

family: Robberecht

full_name: Wim Robberecht

given: Wim

name: Department of Neurology Helsinki University Central Hospital Helsinki Finland

family: Saarela

full_name: Mika Saarela

given: Mika

name: Dolnośląski Szpital Specjalistyczny Wrocław Poland

family: Kamienowski

full_name: Jerzy Kamienowski

given: Jerzy

name: Samodzielny Publiczny Szpital Kliniczny Lublin Poland

family: Stelmasiak

full_name: Zbigniew Stelmasiak

given: Zbigniew

family: Mielke

full_name: Orell Mielke

given: Orell

name: Department of Neurology Philipps University Marburg Germany

family: Tackenberg

full_name: Björn Tackenberg

given: Björn

family: Shebl

full_name: Amgad Shebl

given: Amgad

family: Bauhofer

full_name: Artur Bauhofer

given: Artur

family: Zenker

full_name: Othmar Zenker

given: Othmar

name: Spaarne Hospital Hoofddorp and Maastricht University Medical Centre Maastricht The Netherlands

family: Merkies

full_name: Ingemar S. J. Merkies

given: Ingemar S. J.

name: on behalf of the PRIMA study investigators

journal_name: Journal of the Peripheral Nervous System

repository_institution: Ghent University - Ghent University Academic Bibliography

title: Efficacy and safety of Privigen ® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)

ReferenceCitation: Merkies ISJ, Lawo JP, Edelman JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Léger JM; PRIMA trial investigators. Minimum clinically important difference analysis confirms the efficacy of IgPro10 in CIDP: the PRIMA trial. J Peripher Nerv Syst. 2017 Jun;22(2):149-152. doi: 10.1111/jns.12204.

name: Spaarne Hospital; Hoofddorp, and Maastricht University Medical Centre; Maastricht The Netherlands

name: Department of Neurology; Universitätsklinikum Würzburg; Würzburg Germany

name: Department of Neurology; Helsinki University Central Hospital; Helsinki Finland

name: Dolnośląski Szpital Specjalistyczny; Wroclaw Poland

name: Samodzielny Publiczny Szpital Kliniczny; Lublin Poland

name: Department of Neurology; Philipps University; Marburg Germany

name: Reference Center for Rare Neuromuscular Diseases; Hôpital Pitié-Salpêtrière, and University Paris VI; Paris France

name: on behalf of the PRIMA trial investigators


ReferenceCitation: Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DH. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol. 2014 Jan;2(1):30-7. doi: 10.1016/S2213-8587(13)70090-1. Epub 2013 Sep 25. Erratum in: Lancet Diabetes Endocrinol. 2014 Jan;2(1):e3.

family: Rodbard

full_name: Helena W Rodbard

given: Helena W

family: Visco

full_name: Virginia E Visco

given: Virginia E

family: Andersen

full_name: Henning Andersen

given: Henning

family: Hiort

full_name: Line C Hiort

given: Line C

family: Shu

full_name: David HW Shu

given: David HW

journal_name: The Lancet Diabetes & Endocrinology

location_country: Macedonia, The Former Yugoslav Republic of

acronym: Full STEP™

title: A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin With or Without Oral Anti-diabetic Drugs: Step-wise Addition Versus Complete Basal-bolus Therapy

summary: This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.


title: TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

acronym: TOTAL

summary: This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

ReferenceCitation: Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemelä K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Džavík V. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J. 2014 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemelä K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Džavík V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

family: Jolly

full_name: Sanjit S. Jolly

given: Sanjit S.

family: Cairns

full_name: John A. Cairns

given: John A.

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Meeks

full_name: Brandi Meeks

given: Brandi

family: Pogue

full_name: Janice Pogue

given: Janice

family: Rokoss

full_name: Michael J. Rokoss

given: Michael J.

family: Kedev

full_name: Sasko Kedev

given: Sasko

family: Thabane

full_name: Lehana Thabane

given: Lehana

family: Stankovic

full_name: Goran Stankovic

given: Goran

family: Moreno

full_name: Raul Moreno

given: Raul

family: Gershlick

full_name: Anthony Gershlick

given: Anthony

family: Chowdhary

full_name: Saqib Chowdhary

given: Saqib

family: Lavi

full_name: Shahar Lavi

given: Shahar

family: Niemelä

full_name: Kari Niemelä

given: Kari

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Bernat

full_name: Ivo Bernat

given: Ivo

family: Xu

full_name: Yawei Xu

given: Yawei

family: Cantor

full_name: Warren J. Cantor

given: Warren J.

family: Overgaard

full_name: Christopher B. Overgaard

given: Christopher B.

family: Naber

full_name: Christoph K. Naber

given: Christoph K.

family: Cheema

full_name: Asim N. Cheema

given: Asim N.

family: Welsh

full_name: Robert C. Welsh

given: Robert C.

family: Bertrand

full_name: Olivier F. Bertrand

given: Olivier F.

title: Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy

ReferenceCitation: Moxham R, Džavík V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505.

name: McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada

name: Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada

name: Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada

name: Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada

name: McGill University Health Centre, Montreal, Quebec, Canada

name: London Health Sciences Centre, Western University, London, Ontario, Canada

name: Southlake Regional Health Center, University of Toronto, Toronto, Ontario, Canada

name: Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

ReferenceCitation: Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Džavík V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemelä K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414.

name: From the Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, Canada (T.N.S., M.K.N., O.S., R.T., B.M., S.S.J.); Heart Hospital, Tampere University Hospital and School of Medicine, University of Tampere, Tampere, Finland (O.A.K., K.N.); London Health Sciences Centre, London, Canada (S.L.); Royal North Shore Hospital, Sydney, Australia (R.B.), Southlake Regional Health Centre, University of Toronto, Newmarket, Canada (W.J.C.); St. Michael’s Hospital,...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Optical Coherence Tomography–Guided Percutaneous Coronary Intervention in ST-Segment–Elevation Myocardial Infarction

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Džavík V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Džavík V; TOTAL Investigators. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29.

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14.

title: A Coronary Artery Cast

location_facility: Barts and The London Heart and Chest Centre

location_facility: Fundação Faculdade de Medicina de São José do Rio Preto

location_facility: Queen Elizabeth the Queen Mother Hospital

location_facility: Soonchunhyang University Cheonan Hospital

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: The First People's Hospital, Jiatong University

location_facility: Frimley Park Hospital, NHS Foundation Trust

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Yueyang Hospital Shanghai University of TCM

location_facility: University of New Mexico Health Sciences Center

location_facility: Lindner Research Center at Christ Hospital

location_facility: Hampshire Hospitals NHS Fuondation Trust

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Semmelweis University Heart and Vascular Center

location_facility: The Tenth People's Hospital Tongji University

location_facility: Heart Center, Tampere University Hospital


ReferenceCitation: Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.

ReferenceCitation: Newland A, Godeau B, Priego V, Viallard JF, López Fernández MF, Orejudos A, Eisen M. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016 Jan;172(2):262-73. doi: 10.1111/bjh.13827. Epub 2015 Nov 5.

ReferenceCitation: Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21.

lead_sponsor: Amgen

location_country:
Italy
United States
France
Czechia
Poland
Australia
Spain
Germany
United Kingdom

title: A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

summary: The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.


ReferenceCitation: De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1). pii: 1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.

family: De Soyza

full_name: Anthony De Soyza

family: Aksamit

full_name: Timothy Aksamit

given: Timothy

family: Bandel

full_name: Tiemo-Joerg Bandel

given: Tiemo-Joerg

family: Criollo

full_name: Margarita Criollo

given: Margarita

family: Elborn

full_name: J. Stuart Elborn

given: J. Stuart

family: Operschall

full_name: Elisabeth Operschall

given: Elisabeth

family: Polverino

full_name: Eva Polverino

given: Eva

family: Roth

full_name: Katrin Roth

given: Katrin

family: Winthrop

full_name: Kevin L. Winthrop

given: Kevin L.

family: Wilson

full_name: Robert Wilson

given: Robert

journal_name: European Respiratory Journal

evidence: open (via free pdf)

repository_institution: Newcastle Univesity - Newcastle University ePrints

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.

location_country:
Italy
United Kingdom
Germany
France
Japan
Israel
Slovakia
Argentina
Australia
New Zealand
Spain
Denmark
United States
Latvia

title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.

summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.


title: BEL114674: A 2 Year Study of Efficacy and Safety of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

summary: The main clinical study will be a randomized, double-blind, placebo-controlled, long term study involving a 100 week treatment period. The purpose of this study is to test for superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study is also to investigate the effect of initiating earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens. The study will also determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of action of Belimumab as well as effects on quality of life. All subjects (on either active treatment or placebo) will receive background supportive therapy throughout the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study treatment at any time during the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to week 104. A subject will be regarded as having completed the main clinical study if they complete all phases of the main clinical study (screening, treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects who complete the main clinical study will therefore participate in the main clinical study for approximately 28 months. After the main clinical study, there will be a 5 year (long term) follow-up phase to assess long term outcomes.

status: Withdrawn

ReferenceCitation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11:CD004293. doi: 10.1002/14651858.CD004293.pub4. Review.

name: Department of Anaesthesiology, Intensive Care and Pain Medicine; University Hosptial Münster; Münster Germany

family: von Groote

full_name: Thilo C von Groote

given: Thilo C

name: Analytics Assist; NSW Ministry of Health; North Sydney Australia

family: Williams

full_name: Gabrielle Williams

given: Gabrielle

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Renal Medicine; Westmead Hospital; Westmead Australia

family: Au

full_name: Eric H Au

given: Eric H

name: Department of Nephrology, Hainan Hospital of Chinese PLA General Hospital; Hainan Provincial Academician Team Innovation Center; Sanya China

name: Senior Department of Nephrology, the First Medical Center of Chinese PLA General Hospital; Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research; Beijing China

family: Chen

full_name: Yizhi Chen

given: Yizhi

name: Department of Nephrology; McMaster University; Hamilton Canada

family: Mathew

full_name: Anna T Mathew

given: Anna T

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

family: Hodson

full_name: Elisabeth M Hodson

given: Elisabeth M

family: Tunnicliffe

full_name: David J Tunnicliffe

given: David J

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
United Kingdom
Netherlands
Germany
France
Australia
Spain
Canada
Czech Republic


title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

acronym: MAESTRO

summary: Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

ReferenceCitation: Gatzoulis MA, Landzberg M, Beghetti M, Berger RM, Efficace M, Gesang S, He J, Papadakis K, Pulido T, Galiè N; MAESTRO Study Investigators. Evaluation of Macitentan in Patients With Eisenmenger Syndrome. Circulation. 2019 Jan 2;139(1):51-63. doi: 10.1161/CIRCULATIONAHA.118.033575.

name: The Royal Brompton Hospital and National Heart & Lung Institute, Imperial College, London, United Kingdom (M.A.G.).

family: Gatzoulis

full_name: Michael A. Gatzoulis

given: Michael A.

family: Landzberg

full_name: Michael Landzberg

given: Michael

name: Centre Universitaire de Cardiologie et Chirurgie Cardiaque Pédiatrique, Congenital Heart Center (CHUV et HUG) Hôpital des Enfants, University of Geneva and Lausanne, Geneva, Switzerland (M.B.).

family: Beghetti

full_name: Maurice Beghetti

given: Maurice

name: Center for Congenital Heart Diseases, Department of Paediatric and Congenital Cardiology, University of Groningen, University Medical Center Groningen, The Netherlands (R.M.B.).

family: Berger

full_name: Rolf M. Berger

given: Rolf M.

name: Actelion Pharmaceuticals Italia, Imperia, Italy (M.E.).

family: Efficace

full_name: Michela Efficace

given: Michela

name: Actelion Pharmaceuticals, Allschwil, Switzerland (S.G.).

family: Gesang

full_name: Sophie Gesang

given: Sophie

name: Pulmonary Vascular Diseases Department, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (J.H.).

family: He

full_name: Jian’guo He

given: Jian’guo

name: Actelion Clinical Research Inc, Cherry Hill, NJ (K.P.).

family: Papadakis

full_name: Kelly Papadakis

given: Kelly

name: Cardiopulmonary Department, Ignacio Chávez National Heart Institute, Mexico City, Mexico (T.P.).

family: Pulido

full_name: Tomás Pulido

given: Tomás

name: Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, Italy (N.G.).

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

name: On behalf of the MAESTRO Study Investigators

journal_name: Circulation

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Actelion

location_country:
Malaysia
Greece
Romania
Russian Federation
France
Poland
Chile
Vietnam
Philippines
Bulgaria
China
Portugal
Germany
United States
United Kingdom
Austria
Serbia
Mexico
Israel
Spain
Turkey

location_facility: Texas Children'S Hosp - Dept of Cardiology

location_facility: Unidad de Investigacion Clin En Med, Sc (Udicem)

location_facility: Hosp Univ Virgen Macarena - Dpt Cardiology

location_facility: Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept

location_facility: Inst Nat Torax, Unidad Cardiopatia Congenitas Del Adulto

location_facility: Barnes-Jewish Hosp/Wash Univ School of Med

location_facility: Guangdong General Hospital, Cardiology Dpt

location_facility: Mother and Child Health Care Inst "Dr Vukan Cupic"

location_facility: The General Hosp of Shenyang Military Region

location_facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

location_facility: Instituto Nacional de Cardiologia (Inc) Ignacio Chavez

location_facility: Hosp Pompidou - Dept Congenital Cardiac Diseases

location_facility: Dedinje Cardiovasc Inst - Cardiovasc Research Ctr

location_facility: Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult

location_facility: Hosp Cardiology Haut Leveque - Dept Congenital Diseases

location_facility: Bristol Univ Hosp Congenital Heart Centre

location_facility: Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm

location_facility: Emory University Hospital/the Emory Clinic

location_facility: Sci Institute Systemic Problems Cardio Diseases Kemerovo

location_facility: Hosp La Timone - Dept Pediatric Cardiology

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Er Inst For Cardvasc Dis "Prof Dr Cc Iliescu" - Card Ii

location_facility: Universitätsklinikum Giessen - Pediatric Heart Center


title: Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

acronym: MAESTRO-OL

summary: Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

location_country:
Austria
Chile
Serbia
Mexico
Philippines
Germany
Spain
Vietnam
France
Bulgaria
Greece
Malaysia
Poland
Romania
Russian Federation
China
United States
United Kingdom
Portugal

location_facility: Texas Children'S Hosp - Dept of Cardiology

location_facility: Unidad de Investigacion Clin En Med, Sc (Udicem)

location_facility: Sci Institute Systemic Poriblems Cardio Diseases Kemerovo

location_facility: Hosp Univ Virgen Macarena - Dpt Cardiology

location_facility: Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept

location_facility: Barnes-Jewish Hosp/Wash Univ School of Med

location_facility: Guangdong General Hospital, Cardiology Dpt

location_facility: Mother and Child Health Care Institute Dr. Vukan Cupic


title: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)

acronym: SABLE

summary: The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

location_country:
Italy
Austria
United States
Sweden
Spain
Germany
France
Israel
Slovakia
Argentina
Belgium
Portugal
Canada

status_simplified: Ongoing


title: Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

summary: The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

ReferenceCitation: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. doi: 10.1016/S1470-2045(18)30379-6. Epub 2018 Aug 9. Erratum in: Lancet Oncol. 2018 Nov;19(11):e581.

family: Kim

full_name: Youn H Kim

given: Youn H

family: Bagot

full_name: Martine Bagot

given: Martine

family: Pinter-Brown

full_name: Lauren Pinter-Brown

given: Lauren

family: Rook

full_name: Alain H Rook

given: Alain H

family: Porcu

full_name: Pierluigi Porcu

given: Pierluigi

family: Horwitz

full_name: Steven M Horwitz

given: Steven M

family: Whittaker

full_name: Sean Whittaker

given: Sean

family: Tokura

full_name: Yoshiki Tokura

given: Yoshiki

family: Vermeer

full_name: Maarten Vermeer

given: Maarten

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Sokol

full_name: Lubomir Sokol

given: Lubomir

family: Morris

full_name: Stephen Morris

given: Stephen

full_name: Ellen J Kim

given: Ellen J

family: Ortiz-Romero

full_name: Pablo L Ortiz-Romero

given: Pablo L

family: Eradat

full_name: Herbert Eradat

given: Herbert

family: Scarisbrick

full_name: Julia Scarisbrick

given: Julia

family: Tsianakas

full_name: Athanasios Tsianakas

given: Athanasios

family: Elmets

full_name: Craig Elmets

given: Craig

family: Dalle

full_name: Stephane Dalle

given: Stephane

family: Fisher

full_name: David C Fisher

given: David C

family: Halwani

full_name: Ahmad Halwani

given: Ahmad

family: Poligone

full_name: Brian Poligone

given: Brian

family: Greer

full_name: John Greer

given: John

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

location_country:
Italy
Switzerland
Netherlands
Germany
France
Japan
Australia
Spain
Denmark
United States
United Kingdom

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: Washington University School of Medicine

location_facility: The Christie Hospital Foundation NHS Trust

location_facility: University of Rochester School of Medicine

location_facility: Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)

location_facility: Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna

location_facility: The Winship Cancer Institute (Emory University)

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Pittsburgh School of Medicine

location_facility: Boston Medical Center, Department of Medicine, Section of Hem/Onc


location_country:
Guatemala
Finland
Romania
Russian Federation
India
France
Panama
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Singapore
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Israel
Turkey

title: A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

summary: This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.


title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

summary: This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

ReferenceCitation: Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4). doi: 10.15326/jcopdf.6.4.2019.0131.

family: Mahler

full_name: Donald Mahler

given: Donald

family: Kerwin

full_name: Edward Kerwin

given: Edward

family: Murray

full_name: Lindsey Murray

given: Lindsey

family: Dembek

full_name: Carole Dembek

given: Carole

journal_name: Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation

oa_colors: green other

repository_institution: PubMed Central - Europe PMC

publisher: COPD Foundation

publisher_dissemination: COPD Foundation

publisher_group: COPD Foundation

publisher_normalized: COPD Foundation

location_country:
Guatemala
France
Panama
Slovakia
Hungary
Egypt
United States
Slovenia
Colombia


ReferenceCitation: Straus DJ, Długosz-Danecka M, Connors JM, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Munoz J, Lee HJ, Kim WS, Advani R, Ansell SM, Younes A, Gallamini A, Liu R, Little M, Fenton K, Fanale M, Radford J. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e410-e421. doi: 10.1016/S2352-3026(21)00102-2.

family: Straus

full_name: David J Straus

given: David J

family: Długosz-Danecka

full_name: Monika Długosz-Danecka

given: Monika

family: Connors

full_name: Joseph M Connors

given: Joseph M

family: Alekseev

full_name: Sergey Alekseev

given: Sergey

family: Illés

full_name: Árpád Illés

given: Árpád

family: Picardi

full_name: Marco Picardi

given: Marco

family: Lech-Maranda

full_name: Ewa Lech-Maranda

given: Ewa

family: Feldman

full_name: Tatyana Feldman

given: Tatyana

family: Smolewski

full_name: Piotr Smolewski

given: Piotr

family: Savage

full_name: Kerry J Savage

given: Kerry J

family: Bartlett

full_name: Nancy L Bartlett

given: Nancy L

family: Walewski

full_name: Jan Walewski

given: Jan

family: Ramchandren

full_name: Radhakrishnan Ramchandren

given: Radhakrishnan

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Hutchings

full_name: Martin Hutchings

given: Martin

family: Munoz

full_name: Javier Munoz

given: Javier

family: Lee

full_name: Hun Ju Lee

given: Hun Ju

family: Kim

full_name: Won Seog Kim

given: Won Seog

family: Advani

full_name: Ranjana Advani

given: Ranjana

family: Ansell

full_name: Stephen M Ansell

given: Stephen M

family: Younes

full_name: Anas Younes

given: Anas

family: Gallamini

full_name: Andrea Gallamini

given: Andrea

family: Liu

full_name: Rachael Liu

given: Rachael

family: Little

full_name: Meredith Little

given: Meredith

family: Fenton

full_name: Keenan Fenton

given: Keenan

ReferenceCitation: Straus DJ, Długosz-Danecka M, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Connors JM, Radford J, Munoz J, Kim WS, Advani R, Ansell SM, Younes A, Miao H, Liu R, Fenton K, Forero-Torres A, Gallamini A. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020 Mar 5;135(10):735-742. doi: 10.1182/blood.2019003127.

name: Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY;

name: Department of Hematology, Jagiellonian University Medical College, Krakow, Poland;

name: N. N. Petrov Scientific Research Institute of Oncology, St. Petersburg, Russian Federation;

name: Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary;

name: Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Italy;

name: Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland;

name: John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ;

name: Department of Experimental Hematology, Medical University of Lodz, Lodz, Poland;

name: Department of Medicine, University of British Columbia, Vancouver, BC, Canada;

name: Department of Medical Oncology, BC Cancer Centre for Lymphoid Cancer, Vancouver, BC, Canada;

name: Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO;

name: Department of Lymphoid Malignancy, The Maria Sklodowska-Curie Memorial Institute and Oncology Center, Warsaw, Poland;

name: Department of Medicine, Graduate School of Medicine, The University of Tennessee, Knoxville, TN;

name: Institute of Hematology Seragnoli, University of Bologna, Bologna, Italy;

name: Department of Hematology, Finsen Centre, National Hospital, Copenhagen University Hospital, Copenhagen, Denmark;

name: Department of Medical Oncology, University of Manchester, Manchester, United Kingdom;

name: Manchester Academic Health Science Centre, The Christie NHS Foundation Trust, Manchester, United Kingdom;

name: Department of Lymphoma/Myeloma, Banner MD Anderson Cancer Center, Gilbert, AZ;

name: Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea;

name: Department of Medicine/Oncology, Stanford Cancer Institute, Stanford, CA;

name: Department of Internal Medicine, Mayo Clinic, Rochester, MN;

name: Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited;

name: Research and Clinical Innovation, Antoine-Lacassagne Cancer Centre, Nice, France

ReferenceCitation: Ramchandren R, Advani RH, Ansell SM, Bartlett NL, Chen R, Connors JM, Feldman T, Forero-Torres A, Friedberg JW, Gopal AK, Gordon LI, Kuruvilla J, Savage KJ, Younes A, Engley G, Manley TJ, Fenton K, Straus DJ. Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma. Clin Cancer Res. 2019 Mar 15;25(6):1718-1726. doi: 10.1158/1078-0432.CCR-18-2435. Epub 2019 Jan 7.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984. Epub 2017 Dec 10. Erratum in: N Engl J Med. 2018 Mar 1;378(9):878.

name: From the University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, Canada (J.M.C., K.J.S.); the Department of Hematology, Jagiellonian University, Krakow (W.J.), the Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw (E.L.-M.), the Department of Hematology and Transfusion Medicine, Center of Postgraduate Medical Education, Warsaw (E.L.-M.), the Department of Experimental Hematology, Medical...

repositories_institution: University of Debrecen - University of Debrecen Electronic Archive

title: Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma

ReferenceCitation: Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

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

location_country:
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Canada
Korea, Republic of
South Africa
Hong Kong
Hungary
United States
United Kingdom
Italy
Brazil
Czechia
Spain
Turkey

title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

summary: This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)