title: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)

acronym: CENTER-TBI

summary:
The research aims of the CENTER-TBI study are to:

better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and
identify the most effective clinical interventions for managing TBI.

Specific aims

To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI.
To refine and improve outcome assessment and develop health utility indices for TBI.
To develop multidimensional approaches to characterisation and prediction of TBI.
To define patient profiles which predict efficacy of specific interventions ("Precision Medicine").
To develop performance indicators for quality assurance and quality improvement in TBI care.
To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder.
To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR).
To intensify networking activities and international collaborations in TBI.
To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels.
To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

ReferenceCitation: Rezoagli E, Petrosino M, Rebora P, Menon DK, Mondello S, Cooper DJ, Maas AIR, Wiegers EJA, Galimberti S, Citerio G; CENTER-TBI, OzENTER-TBI Participants and Investigators. High arterial oxygen levels and supplemental oxygen administration in traumatic brain injury: insights from CENTER-TBI and OzENTER-TBI. Intensive Care Med. 2022 Dec;48(12):1709-1725. doi: 10.1007/s00134-022-06884-x. Epub 2022 Oct 20. Erratum In: Intensive Care Med. 2023 Feb;49(2):269-272.

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repository_institution: University of Oslo - Duo Research Archive

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: University of Cambridge - Apollo

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

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Akerlund CAI, Holst A, Stocchetti N, Steyerberg EW, Menon DK, Ercole A, Nelson DW; CENTER-TBI Participants and Investigators. Clustering identifies endotypes of traumatic brain injury in an intensive care cohort: a CENTER-TBI study. Crit Care. 2022 Jul 27;26(1):228. doi: 10.1186/s13054-022-04079-w.

repository_institution: Monash University - Monash University Research Portal

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

repositories_institution: Monash University - Monash University Research Portal

ReferenceCitation: Volovici V, Pisica D, Gravesteijn BY, Dirven CMF, Steyerberg EW, Ercole A, Stocchetti N, Nelson D, Menon DK, Citerio G, van der Jagt M, Maas AIR, Haitsma IK, Lingsma HF; CENTER-TBI investigators, participants for the ICU stratum. Comparative effectiveness of intracranial hypertension management guided by ventricular versus intraparenchymal pressure monitoring: a CENTER-TBI study. Acta Neurochir (Wien). 2022 Jul;164(7):1693-1705. doi: 10.1007/s00701-022-05257-z. Epub 2022 Jun 1.

ReferenceCitation: van Essen TA, Lingsma HF, Pisica D, Singh RD, Volovici V, den Boogert HF, Younsi A, Peppel LD, Heijenbrok-Kal MH, Ribbers GM, Walchenbach R, Menon DK, Hutchinson P, Depreitere B, Steyerberg EW, Maas AIR, de Ruiter GCW, Peul WC; CENTER-TBI Collaboration Group. Surgery versus conservative treatment for traumatic acute subdural haematoma: a prospective, multicentre, observational, comparative effectiveness study. Lancet Neurol. 2022 Jul;21(7):620-631. doi: 10.1016/S1474-4422(22)00166-1. Epub 2022 May 5. Erratum In: Lancet Neurol. 2022 Jul;21(7):e7.

ReferenceCitation: Holthe IL, Dahl HM, Rohrer-Baumgartner N, Eichler S, Elseth MF, Holthe O, Berntsen T, Yeates KO, Andelic N, Lovstad M. Neuropsychological Impairment, Brain Injury Symptoms, and Health-Related Quality of Life After Pediatric TBI in Oslo. Front Neurol. 2022 Jan 28;12:719915. doi: 10.3389/fneur.2021.719915. eCollection 2021.

ReferenceCitation: Huijben JA, Pisica D, Ceyisakar I, Stocchetti N, Citerio G, Maas AIR, Steyerberg EW, Menon DK, van der Jagt M, Lingsma HF. Pharmaceutical Venous Thrombosis Prophylaxis in Critically Ill Traumatic Brain Injury Patients. Neurotrauma Rep. 2022 Jan 7;2(1):4-14. doi: 10.1089/neur.2021.0037. eCollection 2022.

ReferenceCitation: Galimberti S, Graziano F, Maas AIR, Isernia G, Lecky F, Jain S, Sun X, Gardner RC, Taylor SR, Markowitz AJ, Manley GT, Valsecchi MG, Bellelli G, Citerio G; CENTER-TBI and TRACK-TBI participants and investigators. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation. Lancet Neurol. 2022 Feb;21(2):153-162. doi: 10.1016/S1474-4422(21)00374-4.

ReferenceCitation: Puybasset L, Perlbarg V, Unrug J, Cassereau D, Galanaud D, Torkomian G, Battisti V, Lefort M, Velly L, Degos V, Citerio G, Bayen E, Pelegrini-Issac M; MRI-COMA Investigators CENTER-TBI MRI Participants and MRI Only Investigators. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Feb;48(2):201-212. doi: 10.1007/s00134-021-06583-z. Epub 2022 Dec 14. Erratum In: Intensive Care Med. 2022 Jan 20;:

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Citerio G, Robba C, Rebora P, Petrosino M, Rossi E, Malgeri L, Stocchetti N, Galimberti S, Menon DK; Center-TBI participants and investigators. Management of arterial partial pressure of carbon dioxide in the first week after traumatic brain injury: results from the CENTER-TBI study. Intensive Care Med. 2021 Sep;47(9):961-973. doi: 10.1007/s00134-021-06470-7. Epub 2021 Jul 24.

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: The University of Manchester - Research Explorer

repositories_institution: The University of Manchester - Research Explorer

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: Robba C, Rebora P, Meyfroidt G, Citerio G. The authors reply. Crit Care Med. 2021 May 1;49(5):e554-e555. doi: 10.1097/CCM.0000000000004961. No abstract available.

ReferenceCitation: Huijben JA, Dixit A, Stocchetti N, Maas AIR, Lingsma HF, van der Jagt M, Nelson D, Citerio G, Wilson L, Menon DK, Ercole A; CENTER-TBI investigators and participants. Use and impact of high intensity treatments in patients with traumatic brain injury across Europe: a CENTER-TBI analysis. Crit Care. 2021 Feb 23;25(1):78. doi: 10.1186/s13054-020-03370-y.

repository_institution: University of Stirling - Stirling Online Research Repository

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_institution: Umeå University - DiVA at Umeå University

repositories_institution: Umeå University - DiVA at Umeå University

ReferenceCitation: Borgen IMH, Roe C, Brunborg C, Tenovuo O, Azouvi P, Dawes H, Majdan M, Ranta J, Rusnak M, Wiegers EJA, Tverdal C, Jacob L, Cogne M, von Steinbuechel N, Andelic N; CENTER-TBI participants investigators. Care transitions in the first 6months following traumatic brain injury: Lessons from the CENTER-TBI study. Ann Phys Rehabil Med. 2021 Nov;64(6):101458. doi: 10.1016/j.rehab.2020.10.009. Epub 2021 Jul 23.

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

ReferenceCitation: Robba C, Banzato E, Rebora P, Iaquaniello C, Huang CY, Wiegers EJA, Meyfroidt G, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) ICU Participants and Investigators. Acute Kidney Injury in Traumatic Brain Injury Patients: Results From the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study. Crit Care Med. 2021 Jan 1;49(1):112-126. doi: 10.1097/CCM.0000000000004673.

ReferenceCitation: Gravesteijn BY, Sewalt CA, Nieboer D, Menon DK, Maas A, Lecky F, Klimek M, Lingsma HF; CENTER-TBI collaborators. Tracheal intubation in traumatic brain injury: a multicentre prospective observational study. Br J Anaesth. 2020 Oct;125(4):505-517. doi: 10.1016/j.bja.2020.05.067. Epub 2020 Jul 31.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Gao G, Wu X, Feng J, Hui J, Mao Q, Lecky F, Lingsma H, Maas AIR, Jiang J; China CENTER-TBI Registry Participants. Clinical characteristics and outcomes in patients with traumatic brain injury in China: a prospective, multicentre, longitudinal, observational study. Lancet Neurol. 2020 Aug;19(8):670-677. doi: 10.1016/S1474-4422(20)30182-4.

ReferenceCitation: Robba C, Rebora P, Banzato E, Wiegers EJA, Stocchetti N, Menon DK, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Participants and Investigators. Incidence, Risk Factors, and Effects on Outcome of Ventilator-Associated Pneumonia in Patients With Traumatic Brain Injury: Analysis of a Large, Multicenter, Prospective, Observational Longitudinal Study. Chest. 2020 Dec;158(6):2292-2303. doi: 10.1016/j.chest.2020.06.064. Epub 2020 Jul 4.

ReferenceCitation: Riemann L, Beqiri E, Smielewski P, Czosnyka M, Stocchetti N, Sakowitz O, Zweckberger K, Unterberg A, Younsi A; CENTER-TBI High Resolution ICU (HR ICU) Sub-Study Participants and Investigators. Low-resolution pressure reactivity index and its derived optimal cerebral perfusion pressure in adult traumatic brain injury: a CENTER-TBI study. Crit Care. 2020 May 26;24(1):266. doi: 10.1186/s13054-020-02974-8.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Gravesteijn BY, Nieboer D, Ercole A, Lingsma HF, Nelson D, van Calster B, Steyerberg EW; CENTER-TBI collaborators. Machine learning algorithms performed no better than regression models for prognostication in traumatic brain injury. J Clin Epidemiol. 2020 Jun;122:95-107. doi: 10.1016/j.jclinepi.2020.03.005. Epub 2020 Mar 20.

ReferenceCitation: Huijben JA, Wiegers EJA, Ercole A, de Keizer NF, Maas AIR, Steyerberg EW, Citerio G, Wilson L, Polinder S, Nieboer D, Menon D, Lingsma HF, van der Jagt M; CENTER-TBI investigators and participants for the ICU stratum. Quality indicators for patients with traumatic brain injury in European intensive care units: a CENTER-TBI study. Crit Care. 2020 Mar 4;24(1):78. doi: 10.1186/s13054-020-2791-0.

ReferenceCitation: Van Essen TA, Volovici V, Cnossen MC, Kolias A, Ceyisakar I, Nieboer D, Peppel LD, Heijenbrok-Kal M, Ribbers G, Menon D, Hutchinson P, Depreitere B, de Ruiter GCW, Lingsma HF, Steyerberg EW, Maas AI, Peul WC. Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe. BMJ Open. 2019 Oct 16;9(10):e033513. doi: 10.1136/bmjopen-2019-033513.

repositories_concat: LIRIAS (KU Leuven);PubMed Central;irua;pure.eur.nl;repub.eur.nl

ReferenceCitation: Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbuchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK; CENTER-TBI Participants and Investigators. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. Lancet Neurol. 2019 Oct;18(10):923-934. doi: 10.1016/S1474-4422(19)30232-7.

repository_institution: Maastricht University - Research Publications

repositories_institution: Maastricht University - Research Publications

ReferenceCitation: Maas AI, Menon DK, Steyerberg EW, Citerio G, Lecky F, Manley GT, Hill S, Legrand V, Sorgner A; CENTER-TBI Participants and Investigators. Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study. Neurosurgery. 2015 Jan;76(1):67-80. doi: 10.1227/NEU.0000000000000575.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

repositories_institution: The University of Glasgow - Enlighten: Publications

sponsor_collaborators:
University Hospital, Antwerp
University of Cambridge
Erasmus Medical Center
San Gerardo Hospital
University of Sheffield
University of California, San Francisco
Karolinska Institutet
ICON plc
GABO:mi
icoMetrix NV, Leuven, Belgium

location_country:
Finland
Germany
Serbia
France
Lithuania
Hungary
Denmark
Switzerland
Latvia
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Israel

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: St Olavs Hospital/Norwegian University of science and technology

location_facility: Riga Eastern Clinical University Hospital

location_facility: Center of neurovascular surgery, Clinic of neurology and neurosurgery, Vilnius University

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliera Università di Padova

location_facility: University Hospitals Southampton NHS Trust

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hadassah-hebrew University Medical Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Poloclinico

location_facility: Kaunas University of technology and Vilnius University


title: A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary:
This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7.

HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Shah D, Driessen M, Risebrough N, Baker T, Naya I, Briggs A, Ismaila AS. Cost-effectiveness of umeclidinium compared with tiotropium and glycopyrronium as monotherapy for chronic obstructive pulmonary disease: a UK perspective. Cost Eff Resour Alloc. 2018 May 10;16:17. doi: 10.1186/s12962-018-0101-3. eCollection 2018.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

version: acceptedVersion

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Feldman G, Maltais F, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA, Trivedi R. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 mug compared with tiotropium 18 mug in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Apr 7;11:719-30. doi: 10.2147/COPD.S102494. eCollection 2016.

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Informa

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Argentina
Denmark
Romania
United States
Korea, Republic of
South Africa
Chile
Canada
Ukraine
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

type: Registry Identifier

title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant

summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Kaiser M, Beksac M, Gulbrandsen N, Schjesvold F, Hajek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1. Erratum In: Ann Hematol. 2021 Jan;100(1):297-302.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;www.duo.uio.no

unpaywall_oa_status: hybrid

ReferenceCitation: Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22.

repositories_institution: University of Southern Denmark - University of Southern Denmark Research Portal

publisher_dissemination: Wiley

ReferenceCitation: Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

unpaywall_oa_status: green

publisher_dissemination: Elsevier

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.

lead_sponsor: Takeda

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel

location_facility: Hospital Universitario HM Sanchinarro CIOCC

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

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

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

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: University College London Hospitals (UCLH)

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Chang Gung Medical Foundation-Kaoshiung Branch

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: IRCCS Az. Osp. Universitaria San Martino- IST

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Kobe City Medical Center General Hospital

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Universidade Federal do Rio de Janeiro - UFRJ

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Gachon University Gil Medical Center Pharmacy

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

location_facility: Hospital Das Clinicas Da Universidade Federal de Minas Gerais

location_facility: Evangelisches Krankenhaus Essen Werden gGmbH

location_facility: Centre Hospitalier Universitaire Ambroise Pare

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Pamukkale Universitesi Tip Fakultesi Hastanesi

location_facility: Instituto Nacional de Cancerologia Colombia

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

location_facility: Mae de Deus Center Hospital Giovanni Battista

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Vestre Viken HF Sykehuset Asker Og Barum

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital

location_facility: IRCCS Centro Di Riferimento Oncologico Della Basilicata

location_facility: National Hospital Organaization Shibukawa Medical Center

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Aarhus Universitetshospital Arhus Sygehus

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Klinik Ottakring (fruher: Wilhelminenspital)

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

location_facility: Klinikum Mannheim Universitatsklinikum gGmbH

status_simplified: Ongoing


lead_sponsor: Novartis Pharmaceuticals

summary:
The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU.

This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.

ReferenceCitation: Fontaine-Sylvestre C, Letourneau-Guillon L, Moumdjian RA, Berthelet F, Lacroix A. Corticotroph tumor progression during long-term therapy with osilodrostat in a patient with persistent Cushing's disease. Pituitary. 2021 Apr;24(2):207-215. doi: 10.1007/s11102-020-01097-1. Epub 2020 Oct 19.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Pivonello R, Fleseriu M, Newell-Price J, Bertagna X, Findling J, Shimatsu A, Gu F, Auchus R, Leelawattana R, Lee EJ, Kim JH, Lacroix A, Laplanche A, O'Connell P, Tauchmanova L, Pedroncelli AM, Biller BMK; LINC 3 investigators. Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase. Lancet Diabetes Endocrinol. 2020 Sep;8(9):748-761. doi: 10.1016/S2213-8587(20)30240-0. Epub 2020 Jul 27. Erratum In: Lancet Diabetes Endocrinol. 2020 Aug 5;:

location_facility: The Johns Hopkins University School of Medicine Johns Hopkins University

location_facility: Oregon Health and Science University SC LCI699C2301

location_facility: Columbia University Medical Center New York Presbyterian SC - LCI699C2301

location_facility: Northwestern University SC - LCI699C2301

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: Mount Sinai School of Medicine SC - LCI699C2301

location_facility: Emory University School of Medicine G2304 - C2301

location_facility: University of Colorado Hospital SC - LCI699C2301

location_facility: University of Pennsylvania Clinical Studies Unit Unniv SC

location_facility: University of Michigan Comprehensive Cancer Center

title: Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

source: euctr

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:
Germany
Argentina
Japan
Thailand
Turkey
Canada
France
Colombia
United States
India
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Bulgaria
Russian Federation


title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

summary: This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

design_allocation: Non-Randomized

lead_sponsor: CSL Behring

location_country:
Germany
Ireland
Poland
Australia
Japan
Thailand
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
Ukraine
Romania
Lebanon
Malaysia
Philippines
Italy
United Kingdom
Netherlands
Austria
Spain
South Africa
Georgia

location_facility:
Study Site 8400184
Study Site 7240008
Study Site 6200001
Study Site 2760034
Study Site 4580001
Study Site 1240022
Study Site 0400003
Study Site 7560010
Study Site 2500017
Study Site 6080002
Study Site 2680001
Study Site 8400041
Study Site 0400002
Study Site 2760091
Study Site 6160013
Study Site 6160035
Study Site 3920029
Study Site 7100001
Study Site 7640005
Study Site 8260008
Study Site 2760087
Study Site 2500002
Study Site 3920064
Study Site 7640004
Study Site 8400213
Study Site 3920033
Study Site 8400240
Study Site 8040005
Study Site 8040007
Study Site 2760066
Study Site 3920025
Study Site 8400116
Study Site 6080001
Study Site 5280007
Study Site 7240021
Study Site 0400012
Study Site 8400204
Study Site 2500028
Study Site 8400154
Study Site 6420030
Study Site 6420037
Study Site 0400001
Study Site 7640003
Study Site 3720002
Study Site 8400241
Study Site 6160038
Study Site 8400118
Study Site 7640001
Study Site 6160014
Study Site 7240007
Study Site 2500015
Study Site 7640002
Study Site 5280008
Study Site 7240023
Study Site 3480007
Study Site 3800023
Study Site 2500018
Study Site 0360028
Study Site 2030017
Study Site 0360014
Study Site 0360031
Study Site 3920031
Study Site 4220007
Study Site 5280006

intervention_type: Biological


acronym: LOTUS

lead_sponsor: Genentech, Inc.

summary: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.

ReferenceCitation: Kim SB, Dent R, Im SA, Espie M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. doi: 10.1016/S1470-2045(17)30450-3. Epub 2017 Aug 8. Erratum In: Lancet Oncol. 2018 Dec;19(12):e667.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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

repository_institution: California Digital Library - eScholarship

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Farmacia

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Seoul National University Bundang Hospital

location_facility: Chi Mei Medical Center, Yong kang; Endocrinology

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

title: A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

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

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


title: A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis

summary: This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

ReferenceCitation: VanDevanter DR, Hamblett NM, Simon N, McIntosh J, Konstan MW. Evaluating assumptions of definition-based pulmonary exacerbation endpoints in cystic fibrosis clinical trials. J Cyst Fibros. 2021 Jan;20(1):39-45. doi: 10.1016/j.jcf.2020.07.008. Epub 2020 Jul 15.

license: publisher-specific-oa

license_normalized: publisher-specific

license: unspecified-oa

license_normalized: unspecified-oa

repositories_concat: PubMed Central

ReferenceCitation: Konstan MW, VanDevanter DR, Rowe SM, Wilschanski M, Kerem E, Sermet-Gaudelus I, DiMango E, Melotti P, McIntosh J, De Boeck K; ACT CF Study Group. Efficacy and safety of ataluren in patients with nonsense-mutation cystic fibrosis not receiving chronic inhaled aminoglycosides: The international, randomized, double-blind, placebo-controlled Ataluren Confirmatory Trial in Cystic Fibrosis (ACT CF). J Cyst Fibros. 2020 Jul;19(4):595-601. doi: 10.1016/j.jcf.2020.01.007. Epub 2020 Jan 23.

evidence: open (via free article)

ipd_sharing: No

lead_sponsor: PTC Therapeutics

sponsor_collaborators:
PTC Therapeutics
Cystic Fibrosis Foundation
ECFS-Clinical Trial Network (ECFS-CTN)

location_country:
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Australia
Brazil
Netherlands
Belgium
United States
Spain
Greece
Bulgaria
Canada
France

location_facility: Hospital de Niños Superiora Sor Maria Ludovica

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Instituto da Criança - Hospital das Clínicas

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Southampton University Hospitals NHS Trust

location_facility: General Hospital of Thessaloniki Ippokration

location_facility: New York University Langone Medical Center

location_facility: University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

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

location_facility: Hospital Regional Universitario de Malaga

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul

location_facility: NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii

location_facility: Hospital de Sabadell, Consorci Sanitari Parc Tauli

location_facility: University of Toronto Hospital for Sick Children

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Szpital Dzieciecy Polanki im Macieja Plazynskiego w Gdansku

location_facility: University of Texas Health Science Center


title: A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF

summary:
This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF.

This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

ReferenceCitation: Gallant JE, Daar ES, Raffi F, Brinson C, Ruane P, DeJesus E, Johnson M, Clumeck N, Osiyemi O, Ward D, Morales-Ramirez J, Yan M, Abram ME, Plummer A, Cheng AK, Rhee MS. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016 Apr;3(4):e158-65. doi: 10.1016/S2352-3018(16)00024-2. Epub 2016 Mar 14.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

lead_sponsor: Gilead Sciences

location_country:
Italy
United Kingdom
Belgium
United States
Canada
Puerto Rico
France

location_facility: University Health Network/Toronto General Hospital

location_facility: Maple Leaf Medical Clinic/Maple Leaf Research

location_facility: North Texas Infectious Diseases Consulants

location_facility: Tarrant County Infectious Disease Associates

location_facility: University of Puerto Rico School of Medicine

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: Highland Hospital - Alameda Health System (formerly Alameda County medical Center)

location_facility: AIDS Research & Treatment Center of the Treasure Coast

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: IRCCS Ospedale San Raffaele, Centro San Luigi

location_facility: Community Research Initiative of New England

location_facility: La Playa Medical Group and Clinical Research

location_facility: Kaiser Permanente Medical Group San Francisco

location_facility: Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: Brighton and Sussex University Hospitals

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: University Hospital of Montpellier (CHU-Gui de Chauliac)


acronym: The JANUS 2 Study

lead_sponsor: Incyte Corporation

summary: This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.

ReferenceCitation: Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.

status: Terminated

title: A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)

location_country:
Ireland
Colombia
Portugal
Israel
Denmark
Sweden
Netherlands
Austria
Mexico
Switzerland
United States
Chile
Puerto Rico
France

status_simplified: Unknown


title: A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies

summary: To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

ReferenceCitation: Voss MH, Azad AA, Hansen AR, Gray JE, Welsh SJ, Song X, Kuziora M, Meinecke L, Blando J, Achour I, Wang Y, Walcott FL, Oosting SF. A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Clin Cancer Res. 2022 Jul 15;28(14):3032-3041. doi: 10.1158/1078-0432.CCR-21-4115.

evidence: oa repository (via page says license)

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

publisher_dissemination: American Association for Cancer Research

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

lead_sponsor: MedImmune LLC

location_country:
United Kingdom
Australia
Netherlands
United States
Canada
France


title: A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate

summary:
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.

Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.

Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

lead_sponsor: Coherus Biosciences, Inc.

sponsor_collaborators:
Coherus Biosciences, Inc.
Daiichi Sankyo Co., Ltd.

location_country:
Germany
Belarus
Poland
Hungary
Israel
United Kingdom
Japan
United States
Spain
South Africa
Russian Federation
France

location_facility: Medical Corporation Kojyokai Hirose Clinic

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet

location_facility: Kawasaki Rheumatism and Internal Medicine Clinic

location_facility: Otsuka Clinica of Rheumatism and Medicine

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: University of Szeged, Faculty of Medicine

location_facility: St. Petersburg State Healthcare Institution "Consultative diagnostic center #85

location_facility: Yoshida Orthopaedic and Rheumatology Clinic

location_facility: Tokito Clinic Rheumatology and Orthopaedics, Surgery

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj

location_facility: Wirral University Teaching Hospital NHS Foundation Trust

location_facility: State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov

location_facility: Smolensk State Medical University (SSMU)

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Rheumatoid Arthritis Investigational Network

location_facility: Hospital Regional Universitario de Málaga

location_facility: The Center for Rheumatology and Bone Research

location_facility: Mazowieckie Centrum Badan Klinicznych (MCBK) SC

location_facility: University of Occupational and Environmental Health Hospital

location_facility: Rinku Hashimoto Rheumatology Orthopedics

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Kondo Clinic for Rheumatism and Orthopaedics

location_facility: SMO.MD GmbH - Zentrum fuer klinische Studien

location_facility: Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev

location_facility: Hokkaido Medical Center for Rheumatic Diseases


title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

ReferenceCitation: Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Biogen

location_country:
Germany
Ireland
Italy
Israel
Norway
United Kingdom
Netherlands
Belgium
United States
Canada
France


lead_sponsor: Debiopharm International SA

summary: The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

location_country:
United States
France


title: A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Versus Specified Physician's Choice in Patients ≥ 60 Years Old With Relapsed or Refractory Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy and/or Transplantation

acronym: SOPRA

summary: This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

ReferenceCitation: Sweet K, Bhatnagar B, Dohner H, Donnellan W, Frankfurt O, Heuser M, Kota V, Liu H, Raffoux E, Roboz GJ, Rollig C, Showel MM, Strickland SA Jr, Vives S, Tang S, Unger TJ, Joshi A, Shen Y, Alvarez MJ, Califano A, Crochiere M, Landesman Y, Kauffman M, Shah J, Shacham S, Savona MR, Montesinos P. A 2:1 randomized, open-label, phase II study of selinexor vs. physician's choice in older patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2021 Dec;62(13):3192-3203. doi: 10.1080/10428194.2021.1950706. Epub 2021 Jul 29.

oa_host_type: publisher

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Netherlands
United States
Spain
Canada
France

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii

location_facility: Institut Universitaire du Cancer Toulouse

location_facility: UNIVERSITÄTSKLINIKUM TU DRESDEN Medizinische Klinik und Poliklinik I,

location_facility: Stellvertretende Klinikleiterin Charité, Campus Benjamin Franklin

location_facility: Ev. Diakonie-Krankenhaus Gemeinnutzige GMBH Medizinische Klinik 2

location_facility: Vanderbilt-Ingram Cancer Center / Vanderbilt University

location_facility: Hospital Universitario de Salamanca Servicio de Hematologia

location_facility: Milton S. Hershey Medical Center / Penn State

location_facility: Medizinische Hochschule Hannover (Hannover Medical School) Dept. of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

location_facility: UNIVERSITY HOSPITAL OF MÜNSTER Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Colorado Blood Cancer Institute/Sarah Cannon Research Institute

location_facility: Universitair Medisch Centrum Groningen Department of Haematology

location_facility: Stanford Cancer Institute / Stanford University

location_facility: University of Massachusetts Medical School

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Abteilung Hämatologie, internistische Onkologie und Hämostaseologie

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: AMC, Academisch Medisch Centrum Afdeling Klinische Hematologie

location_facility: Radboud University Medical Center Department of Haematology (476)

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa Spraw Wewnętrznych

location_facility: Jonsson Comprehensive Cancer Center / University of California, Los Angeles

location_facility: AORN Cardarelli / UOSC di Ematologia con TMO

location_facility: Texas Transplant Institute/Sarah Cannon Research Institute

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Winship Cancer Institute / Emory University

location_facility: New York Presbyterian Hospital / Weill Cornell Medical College

location_facility: Plymouth Hospitals NHS Trust/Derriford Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Sir Mortimer B. Davis Jewish General Hospital / McGill University

location_facility: Westchester Medical Center / New York Medical College

location_facility: Ninewells Hospital and Medical School NHS Tayside

location_facility: Hull and East Yorkshire Hospitals NHS Trust Queens Centre for Oncology and Haematology

location_facility: Tennessee Oncology/Sarah Cannon Research Institute

location_facility: Department of Haematology, National University Hospital, Rigshospitalet

location_facility: Sidney Kimmel Comprehensive Cancer Center / John Hopkins University

location_facility: Royal Liverpool University Hospital, Dept of Cellular and Molecular Physiology, Molecular and Clinical Cancer Medicine

location_facility: Odense University Hospital, Department of Hematology


acronym: ALEX

summary: This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.

ReferenceCitation: Dziadziuszko R, Peters S, Mok T, Camidge DR, Gadgeel SM, Ou SI, Konopa K, Noe J, Nowicka M, Bordogna W, Morcos PN, Smoljanovic V, Shaw AT. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. Clin Cancer Res. 2022 May 2;28(9):1800-1808. doi: 10.1158/1078-0432.CCR-21-2840.

ReferenceCitation: Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Perol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanovic V, Hilton M, Ruf T, Noe J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11.

ReferenceCitation: Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Perol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nuesch E, Balas B, Camidge DR. Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study. Ann Oncol. 2018 Nov 1;29(11):2214-2222. doi: 10.1093/annonc/mdy405.

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

ReferenceCitation: Burudpakdee C, Wong W, Seetasith A, Corvino FA, Yeh W, Gubens M. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9.

ReferenceCitation: Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University Clinical Center Sarajevo;Institute of oncology

location_facility: Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

location_facility: Monash Health Translational Precinct; Clinical Trials Centre, Level 3

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

location_facility: Birmingham Heartlands Hospital; Dept of Oncology

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Dnipropetrovsk State Medical Academy; Chemotherapy Department

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: Klinik Löwenstein gGmbH Medizinische Klinik II

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis

location_facility: Massachusetts General Hospital Cancer Center

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Seoul National University Bundang Hospital

location_facility: University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: University Clinical Center Sarajevo;Clinic for Pulmonary disease

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Institute for pulmonary diseases of Vojvodina

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Queen Elizabeth Hospital; Medical Oncology

title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Costa Rica
Bosnia and Herzegovina
Thailand
Turkey
Chile
Canada
Serbia
France
Portugal
Hong Kong
Switzerland
United States
Ukraine
China
Egypt
Italy
Guatemala
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)

summary: This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis

ReferenceCitation: Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.

ReferenceCitation: Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.

publisher_dissemination: Oxford University Press

ReferenceCitation: Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, Ziv M, Pinter A, Hugot S, You R, Milutinovic M. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

ipd_sharing: Undecided

location_country:
Germany
Australia
Turkey
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel


title: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

summary:
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Austria
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Texas Institute for Neurological Disorders

location_facility: Azienda Ospedaliero-Universitaria di Ferrara

location_facility: University of Texas Health Medical Arts and Research Center

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hadassah Hebrew University Medical Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

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

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Wake Forest University School of Medicine

intervention_type: Device


title: A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Darbepoetin Alfa Comparator in the Long Term Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease in Europe and Asia Pacific

acronym: DIALOGUE 3

summary:
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this extension study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.

lead_sponsor: Bayer

location_country:
Germany
Italy
Poland
Hungary
Israel
Romania
Australia
Japan
United Kingdom
Korea, Republic of
Spain
Turkey
Bulgaria
France

location_facility:
Baskent University Medical Faculty
Ankara Univ. Medical Faculty
Sifa University Medical Faculty


title: A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)

acronym: guardian™ 5

summary: This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Italy
Poland
Slovenia
Slovakia
Hungary
Sweden
Netherlands
Austria
Switzerland
United States
Spain
Greece
Czechia
France


title: A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard of Care Therapy

summary: The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of <=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.

ReferenceCitation: Wechsler ME, Akuthota P, Jayne D, Khoury P, Klion A, Langford CA, Merkel PA, Moosig F, Specks U, Cid MC, Luqmani R, Brown J, Mallett S, Philipson R, Yancey SW, Steinfeld J, Weller PF, Gleich GJ; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017 May 18;376(20):1921-1932. doi: 10.1056/NEJMoa1702079.

oa_colors: green other

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

repositories_concat: PubMed Central;ora.ox.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Germany
Italy
United Kingdom
Japan
Belgium
United States
Spain
Canada
France


title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

acronym: OlympiAD

summary: This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

ReferenceCitation: Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4. Erratum In: N Engl J Med. 2017 Oct 26;377(17 ):1700.

endpoint_id: ebkqzhfrceygztdsjokh

repository_institution: University of Padua - Padua Research Archive

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

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Myriad Genetic Laboratories, Inc.
Merck Sharp & Dohme LLC

location_country:
Poland
Japan
Turkey
Czechia
France
Hungary
Switzerland
United States
Romania
China
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation


title: A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

summary: This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

ReferenceCitation: Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int J Hepatol. 2020 Jan 25;2020:5421632. doi: 10.1155/2020/5421632. eCollection 2020.

publisher_dissemination: Hindawi

ReferenceCitation: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.

lead_sponsor: Eisai Inc.

location_country:
Germany
Italy
Israel
Argentina
Romania
Australia
Brazil
Japan
Mexico
Belgium
United States
China
Spain
Czechia
Canada
Russian Federation
France


acronym: SELENE

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
France
United States
Ukraine
Belgium
China
Puerto Rico
United Kingdom
Sweden
Korea, Republic of
Spain
Russian Federation
Israel


title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

acronym: SPIRE-LDL

summary: This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

ReferenceCitation: Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.

ReferenceCitation: Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.

ReferenceCitation: Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.

lead_sponsor: Pfizer

location_country:
Lithuania
Colombia
Hungary
United Kingdom
Romania
Mexico
United States
Spain
Taiwan
Canada
Russian Federation
France

location_facility: Metabolic and Atherosclerosis Research Center

location_facility: Synexus North East Clinical Research Centre

location_facility: Instituto de Diabetes, Obesidad y Nutricion S.C.

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

location_facility: Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna

location_facility: Morton Plant Mease Health Care, Inc. Cardiovascular Research

location_facility: London Road Diagnostic Clinic and Medical Centre

location_facility: Centro de Investigaciones Clinicas S.A.S

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: South Miami Clinical Research Center, LLC

location_facility: KCUMB Center for Community and Clinical Research

location_facility: Detweiler Family Medicine and Associates, PC

location_facility: Municipal Institution of Healthcare "City Clinical Hospital 12

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham

location_facility: Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Fundacion Centro de Investigaciones Biomedicas RIESCARD

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"

location_facility: Fleming Island Center for Clinical Research

location_facility: Clinical Research Institute of Southern Oregon, PC

location_facility: The University of Iowa - College of Public Health - Preventive Intervention Center

location_facility: Arch Health Partners Clinical Research Department

location_facility: Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)

location_facility: LMC Research Inc. d.b.a. Manna Research Inc.

location_facility: National Clinical Research-Richmond, Inc.

location_facility: Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: Centro de Diagnostico Cardiologico LTDA.

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi

location_facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Atlanta Center for Clinical Research / Internal Medicine

location_facility: Southern Health & Social Care Trust, Craigavon Area Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie

location_facility: Sentral Clinical Research Services - Admin Only

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Synexus North East Clinical Research Centre-Hexham General Hospital

location_facility: Centro Hospitalario Mac, S.A. De C.V. (Emergencies)

location_facility: Hospital Clinico Universitario Miguel Servet; Medicina Interna

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: New Orleans Center for Clinical Research

location_facility: East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA

location_facility: Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"

location_facility: Asociacion IPS Medicos InterniStas de Caldas

location_facility: Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.

location_facility: Hospital Universitario Sant Joan de Reus

location_facility: The Bradford on Avon & Melksham Health Partnership

location_facility: Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA

location_facility: East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic

location_facility: Hospital Universitario La Paz; Unidad Metabolico-Vascular

location_facility: FSAEI of Higher Education "People's Friendship University of Russia",

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Metabolic Research Institute Incorporated

location_facility: Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular

location_facility: Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice

location_facility: Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation

location_facility: East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center

location_facility: East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: The Lindner Center for Research and Education at The Christ Hospital

location_facility: Northmed Clinical Research Ltd, Randalstown Health Centre

location_facility: California Medical Research Associates Inc.

location_facility: IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.

location_facility: North Texas Healthcare System, Dallas VAMC

location_facility: Stroke Prevention & Atherosclerosis Research Centre (SPARC)

location_facility: Hospital Angeles Centro Medico del Potosi (Emergencies)

location_facility: Florida Institute For Clinical Research, LLC

location_facility: HealthEast St. Joseph's Hospital Pharmacy

location_facility: Magyar Imre Korhaz, Belgyogyaszati Szakrendeles

location_facility: Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School

location_facility: Synexus Thames Valley Clinical Research Centre


lead_sponsor: Bristol-Myers Squibb

summary:
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

ReferenceCitation: Nielsen M, Presti M, Sztupinszki Z, Jensen AWP, Draghi A, Chamberlain CA, Schina A, Yde CW, Wojcik J, Szallasi Z, Crowther MD, Svane IM, Donia M. Coexisting Alterations of MHC Class I Antigen Presentation and IFNgamma Signaling Mediate Acquired Resistance of Melanoma to Post-PD-1 Immunotherapy. Cancer Immunol Res. 2022 Oct 4;10(10):1254-1262. doi: 10.1158/2326-6066.CIR-22-0326.

evidence: open (via free pdf)

location_facility: Istituto Nazionale Tumori Fondazione Pascale

title: A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Japan
Netherlands
Austria
Switzerland
United States
Spain
Canada
France


title: APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy-FAP)

summary: The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

ReferenceCitation: Quan D, Obici L, Berk JL, Ando Y, Aldinc E, White MT, Adams D. Impact of baseline polyneuropathy severity on patisiran treatment outcomes in the APOLLO trial. Amyloid. 2023 Mar;30(1):49-58. doi: 10.1080/13506129.2022.2118043. Epub 2022 Sep 18.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Zhang X, Goel V, Attarwala H, Sweetser MT, Clausen VA, Robbie GJ. Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis. J Clin Pharmacol. 2020 Jan;60(1):37-49. doi: 10.1002/jcph.1480. Epub 2019 Jul 19.

ReferenceCitation: Minamisawa M, Claggett B, Adams D, Kristen AV, Merlini G, Slama MS, Dispenzieri A, Shah AM, Falk RH, Karsten V, Sweetser MT, Chen J, Riese R, Vest J, Solomon SD. Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study. JAMA Cardiol. 2019 May 1;4(5):466-472. doi: 10.1001/jamacardio.2019.0849.

publisher_dissemination: American Medical Association

ReferenceCitation: Solomon SD, Adams D, Kristen A, Grogan M, Gonzalez-Duarte A, Maurer MS, Merlini G, Damy T, Slama MS, Brannagan TH 3rd, Dispenzieri A, Berk JL, Shah AM, Garg P, Vaishnaw A, Karsten V, Chen J, Gollob J, Vest J, Suhr O. Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis. Circulation. 2019 Jan 22;139(4):431-443. doi: 10.1161/CIRCULATIONAHA.118.035831.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Adams D, Gonzalez-Duarte A, O'Riordan WD, Yang CC, Ueda M, Kristen AV, Tournev I, Schmidt HH, Coelho T, Berk JL, Lin KP, Vita G, Attarian S, Plante-Bordeneuve V, Mezei MM, Campistol JM, Buades J, Brannagan TH 3rd, Kim BJ, Oh J, Parman Y, Sekijima Y, Hawkins PN, Solomon SD, Polydefkis M, Dyck PJ, Gandhi PJ, Goyal S, Chen J, Strahs AL, Nochur SV, Sweetser MT, Garg PP, Vaishnaw AK, Gollob JA, Suhr OB. Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):11-21. doi: 10.1056/NEJMoa1716153.

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

ReferenceCitation: Adams D, Suhr OB, Dyck PJ, Litchy WJ, Leahy RG, Chen J, Gollob J, Coelho T. Trial design and rationale for APOLLO, a Phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy. BMC Neurol. 2017 Sep 11;17(1):181. doi: 10.1186/s12883-017-0948-5.

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

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Portugal
United States
Malaysia
Italy
Cyprus
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Sweden


title: A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)

acronym: SALT

summary: The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Portugal Norway Denmark Sweden Netherlands Austria Belgium Switzerland France


acronym: TRANSFORM

summary: This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

ReferenceCitation: Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.

publisher_dissemination: British Medical Journal

ReferenceCitation: Watarai Y, Danguilan R, Casasola C, Chang SS, Ruangkanchanasetr P, Kee T, Wong HS, Kenmochi T, Amante AJ, Shu KH, Ingsathit A, Bernhardt P, Hernandez-Gutierrez MP, Han DJ, Kim MS. Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study. Clin Transplant. 2021 Oct;35(10):e14415. doi: 10.1111/ctr.14415. Epub 2021 Sep 23.

ReferenceCitation: Citterio F, Henry M, Kim DY, Kim MS, Han DJ, Kenmochi T, Mor E, Tisone G, Bernhardt P, Hernandez Gutierrez MP, Watarai Y. Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study. Expert Opin Drug Saf. 2020 Oct;19(10):1339-1348. doi: 10.1080/14740338.2020.1792441. Epub 2020 Jul 20.

ReferenceCitation: Berger SP, Sommerer C, Witzke O, Tedesco H, Chadban S, Mulgaonkar S, Qazi Y, de Fijter JW, Oppenheimer F, Cruzado JM, Watarai Y, Massari P, Legendre C, Citterio F, Henry M, Srinivas TR, Vincenti F, Gutierrez MPH, Marti AM, Bernhardt P, Pascual J; TRANSFORM investigators. Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study. Am J Transplant. 2019 Nov;19(11):3018-3034. doi: 10.1111/ajt.15480. Epub 2019 Jul 1.

ReferenceCitation: Pascual J, Berger SP, Witzke O, Tedesco H, Mulgaonkar S, Qazi Y, Chadban S, Oppenheimer F, Sommerer C, Oberbauer R, Watarai Y, Legendre C, Citterio F, Henry M, Srinivas TR, Luo WL, Marti A, Bernhardt P, Vincenti F; TRANSFORM Investigators. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation. J Am Soc Nephrol. 2018 Jul;29(7):1979-1991. doi: 10.1681/ASN.2018010009. Epub 2018 May 11.

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

repositories_concat: PubMed Central;pure.rug.nl

title: A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

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.clinicalstudydata request.com

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Kuwait
Thailand
Turkey
Croatia
Chile
Czechia
Serbia
France
Slovenia
Colombia
Portugal
Slovakia
Switzerland
United States
India
Lebanon
Belgium
Malaysia
Egypt
Philippines
Italy
Norway
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Randomized, Double-blind, Parallel-arm, Phase I Study to Evaluate the Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab (MabThera) Induction Immunotherapy as a First-line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

summary:
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL).

The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Poland
New Zealand
Hungary
Australia
Austria
Belgium
Spain
Greece
Croatia
Czechia
Russian Federation
France

location_facility: Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: BHI of Omsk region - Clinical Oncology Dispensary

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: St. Petersburg GUZ City Clinical Oncology Dispensary

location_facility: Semmelweis University, 1st Dept. Internal Medicine