summary: The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

ReferenceCitation: Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.

publisher_dissemination: SAGE Publications

title: A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Malaysia
Peru
Estonia
Egypt
Italy
Guatemala
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Panama
South Africa
Jordan
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

acronym: ORATORIO

lead_sponsor: Hoffmann-La Roche

summary: This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

ReferenceType: derived

ReferenceCitation: Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

ReferenceCitation: Butzkueven H, Spelman T, Horakova D, Hughes S, Solaro C, Izquierdo G, Kubala Havrdova E, Grand'Maison F, Prat A, Girard M, Hupperts R, Onofrj M, Lugaresi A, Taylor B; MSBase Study Group; Giovannoni G, Kappos L, Hauser SL, Montalban X, Craveiro L, Freitas R, Model F, Overell J, Muros-Le Rouzic E, Sauter A, Wang Q, Wormser D, Wolinsky JS. Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry. Eur J Neurol. 2022 Apr;29(4):1082-1090. doi: 10.1111/ene.14824. Epub 2021 May 6.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: University of Melbourne - Minerva Access

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

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

repository_institution: University of California - eScholarship University of California

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;cris.unibo.it;ddd.uab.cat;escholarship.org

publisher_dissemination: Wiley

ReferenceCitation: Wolinsky JS, Arnold DL, Brochet B, Hartung HP, Montalban X, Naismith RT, Manfrini M, Overell J, Koendgen H, Sauter A, Bennett I, Hubeaux S, Kappos L, Hauser SL. Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):998-1009. doi: 10.1016/S1474-4422(20)30342-2. Epub 2020 Oct 29. Erratum In: Lancet Neurol. 2020 Nov 17;:

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Fox EJ, Markowitz C, Applebee A, Montalban X, Wolinsky JS, Belachew S, Fiore D, Pei J, Musch B, Giovannoni G. Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial. Mult Scler. 2018 Dec;24(14):1862-1870. doi: 10.1177/1352458518808189. Epub 2018 Nov 12.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Wolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C, Deol-Bhullar G, Garren H, Chin P, Belachew S, Kappos L. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018 Oct;84(4):527-536. doi: 10.1002/ana.25313.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: Tampere University - Tampere University Institutional Repository

repositories_institution: Queen Mary University of London - Queen Mary Research Online

location_facility: Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie

location_facility: Medical Center Ziv Safed; Neurology Department

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: Michigan Institute for Neurological Disorders

location_facility: Wayne State University; Department of Neurology

location_facility: Fakultni nemocnice Brno; Interni kardiologicka klinika

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: University of Colorado; Anschutz Medical Campus Department of Neurology

location_facility: Uni Hospital Queens Medical Centre; Neurology

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Timisoara Emergency County Clinical Hospital

location_facility: Swedish Neuroscience Institute; Multiple Sclerosis Center

location_facility: Weill Medical College of Cornell University; Judith Jaffe MS Ctr

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

location_facility: Centro de Estudios Clinicos y Espec. Med. SC

location_facility: Mount Sinai School of Medicine; Neurology

location_facility: Comprehensive MS Care Center at South Shore Neurologic Assoc.

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Groupe Hospitalo-Universitaire Caremeau; Service Neurologie

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Universitätsklinikum Gießen und Marburg GmbH; Neurologie

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie

location_facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

location_facility: Hopital Purpan; Fédération de neurologie

location_facility: Montreal Neurological Institute and Hospital

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Rabin Medical Center; Multiple Sclerosis Clinic

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center

location_facility: Hospital de Basurto Servicio de Neurologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research

location_facility: Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: The Ohio State University Wexner Medical Center; Department of Neurology

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Hopital Roger Salengro Service de Neurologie

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro

location_facility: DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)

location_facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

location_facility: Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology

location_facility: Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

location_facility: Research Medical Complex "Vashe Zdorovie"; Neurology Department

location_facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: University of New Mexico; MS Specialty Clinic

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny

location_facility: Medizinische Universitat Wien Medical University of Vienna

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: University of Minnesota; Clin. Neuro Research Unit

location_facility: University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver

location_facility: Dnipropetrovsk State Medical Academy; Dept of Neurology

location_facility: Indiana University Medical Center; Department of Neurology

location_facility: Klinikum Bayreuth GmbH; Neurologische Klinik

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Heinrich Heine Universität Düsseldorf; Neurologische Klinik

location_facility: Washington University School of Medicine; Department of Neurology

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: Klaipeda University Hospital Public Institution

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Royal Victoria Infirmary; Neurology Dept.

location_facility: Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Trustees of the University of Pennsylvania; Neurology

location_facility: Wellington Hospital; Department of Neurology

location_facility: Barzilai Medical Center; Neurology Department

location_facility: SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii

location_facility: CNPE City Clinical Hospital #3 of Chernivtsi City Council

location_facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Hadassah University Hospital Ein Kerem; Neurology Department

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Univ of CA San Francisco; Department of Neurology

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika

location_facility: Oklahoma Medical Research Foundation; MS Center of Excellence

location_facility: Elias Emergency University Hospital Neurology Dept; Neurology Department

location_facility: Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Vero Beach Neurology and Research Institute

location_facility: Lviv Regional Clinical Hospital; Department of Neurology

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling

location_facility: Turku University Central Hospital; Pharmacy

location_facility: Fövárosi Önkormányzat uzsoki utcai Kórház

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Instituto Nacional de Neurologia y Neurocirugia

location_facility: Henry Ford Health System; Neurology & Neurosurgery

title: A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

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/members/ourmembers/). 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:
Finland
Germany
Poland
New Zealand
Australia
Brazil
Czechia
Canada
France
Lithuania
Portugal
Hungary
Switzerland
United States
Ukraine
Romania
Belgium
Peru
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Uruguay
Spain
Greece
Bulgaria
Russian Federation
Israel


title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

acronym: EMERALD

summary: The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: MicroPort CRM

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

location_facility: Baerenfaenger Dr. Petra Private Practice

location_facility: Complete Cardiology Care Live Oak Street

location_facility: Kardiologische - angiologische Praxis Dr. med. Jörg Walter

location_facility: FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung

location_facility: Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme

location_facility: Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt

location_facility: Clinique & Maternité Sainte-Elisabeth Namur

location_facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

location_facility: Med. Martina Trummel Praxis Innere Medizin / Kardiologie

location_facility: Hospital General Universitario de Alicante

location_facility: Ospedale OO.OO.San Giovanni e Ruggi d'Aragona

location_facility: Staedt. Linikum Medizinische Klinik Lueneburg

location_facility: Sohien und Hufeland Klinikum Weimar Gmbh

location_facility: National Hospital Organization Oita Medical Center

location_facility: Centre hospitalier de la Région d'Annecy

location_facility: Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel

lead_sponsor_type: industriel

status_simplified: Completed


title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

acronym: EPICOR

summary: The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

ReferenceCitation: Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven);PubMed Central;docusalut.com;researchonline.lshtm.ac.uk

publisher_dissemination: Springer-Nature

ReferenceCitation: Martin-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.

ReferenceCitation: Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.

oa_host_type: repository

version: acceptedVersion

repositories_concat: LIRIAS (KU Leuven)

unpaywall_oa_status: green

publisher_dissemination: Bentham Science Publishers Ltd.

ReferenceCitation: Bardaji A, Leal M, Arrarte V, Garcia-Moll X, Perez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.

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

repository_normalized: dnet

repositories_concat: dnet

ReferenceCitation: Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_concat: LIRIAS (KU Leuven);PubMed Central;dnet;open-archive.highwire.org;researchonline.lshtm.ac.uk

ReferenceCitation: Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.

ReferenceCitation: Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.

ReferenceCitation: Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.

repositories:
PubMed Central
dnet
researchonline.lshtm.ac.uk

ReferenceCitation: Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.

location_country:
Finland
Germany
Poland
Argentina
Brazil
Luxembourg
Turkey
France
Slovenia
Denmark
Romania
Belgium
Italy
Norway
United Kingdom
Venezuela
Netherlands
Mexico
Spain
Greece


title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

summary: This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: LivaNova

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
Monaco
France

location_facility: CHRU du Morvan Hôpital la Cavale Blanche

location_facility: Passaic Beth Israel Regional Medical Center

location_facility: Complejo Hospitalario Universitario de Vigo (CHUVI)

location_facility: University of Mississippi Medical Center

location_facility: Johannes Gutenberg-Universität - Mainz Klinikum

intervention_type: Device


lead_sponsor: Boehringer Ingelheim

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: submittedVersion

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

oa_host_type: publisher

ReferenceCitation: Haring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

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location_facility: 1245.23.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33013 Boehringer Ingelheim Investigational Site

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location_facility: 1245.23.86058 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86037 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33018 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10145 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20023 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86038 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86036 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33015 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86041 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10046 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20029 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86033 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86053 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20024 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10149 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33045 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10148 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20028 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10117 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86042 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20033 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33019 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33020 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91103 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10153 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86040 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82011 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10156 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20036 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10042 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86048 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20039 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10095 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91105 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10143 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20032 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86051 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91102 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86054 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88011 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86013 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86056 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86032 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86049 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10133 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88021 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88013 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10074 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10127 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20037 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91104 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86045 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20030 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49011 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10123 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20035 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20027 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86055 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10109 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20025 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10080 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20040 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91101 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33016 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10106 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10159 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86039 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86052 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20022 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20038 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86043 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20026 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10120 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86002 Boehringer Ingelheim Investigational Site

title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

primary_purpose: Treatment

type: EudraCT Number

source: euctr

location_country:
Germany
Slovenia
India
Slovakia
Mexico
United States
China
Korea, Republic of
Turkey
Taiwan
Canada
France


title: A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

summary:
The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults.

Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ipd_sharing: No

ipd_sharing_description: Takeda does not provide access to Individual Participant Data when a study is in a very limited (small) study population due to participant privacy concerns such as potential reidentification of study participants.

lead_sponsor: Baxalta now part of Shire

collaborators: Baxalta Innovations GmbH, now part of Shire

collaborators: Takeda Development Center Americas, Inc.

location_country:
Germany
Italy
Hungary
Austria
United States
Spain
France

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Regional Universitario de Malaga

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

status_simplified: Ongoing


lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.

ReferenceCitation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

ReferenceCitation: Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Thyssen JP, Buhl T, Fernandez-Penas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Stander S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

ReferenceCitation: Reich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2022 May;33(3):1521-1530. doi: 10.1080/09546634.2020.1839008. Epub 2020 Nov 22.

publisher_dissemination: Informa

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Aarhus Universitehospital Marselisborg Centret

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Dr. D. Y. Patil Medical College & Hospital

location_facility: Russian state medical-stomatological university n.a. Evdokimov

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Kyoto Prefectural University of Medicine

location_facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Hospital Univ. Dr. Jose Eleuterio Gonzalez

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Chennai Meenakshi Multispeciality Hospital

location_facility: Queen's Square Dermatology and Allergology

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: All India Institue of Medical Sciences (AIIMS)

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

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

location_country:
Germany
Italy
India
Denmark
Japan
Mexico
Taiwan
Czechia
Russian Federation
France


title: A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed

summary: This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.

ReferenceType: background

ReferenceCitation: Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, Garcia Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/S0140-6736(20)32666-0. Epub 2020 Dec 9.

ReferenceCitation: Chounta V, Snedecor SJ, Wu S, Van de Velde N. Indirect comparison of 48-week efficacy and safety of long-acting cabotegravir and rilpivirine maintenance every 8 weeks with daily oral standard of care antiretroviral therapy in participants with virologically suppressed HIV-1-infection. BMC Infect Dis. 2022 May 4;22(1):428. doi: 10.1186/s12879-022-07243-3.

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ReferenceCitation: Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.

ReferenceCitation: Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

repositories_concat: PubMed Central;digitalcommons.unmc.edu

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Chounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR. Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). Patient. 2021 Nov;14(6):849-862. doi: 10.1007/s40271-021-00524-0. Epub 2021 May 31.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
Janssen Research and Development

location_country:
Germany
Italy
Argentina
Australia
Sweden
Mexico
United States
Korea, Republic of
Spain
South Africa
Canada
Russian Federation
France


title: A Phase 2 Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects With High-risk Diffuse Large B-cell Lymphoma Post-autologous Hematopoietic Stem-cell Transplantation.

summary: The study will estimate the MRD-negative response rate after treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following aHSCT. The clinical hypothesis is that the MRD-negative response rate will be greater than 10%. Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.

status: Terminated

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

lead_sponsor: Amgen

location_country:
Italy
Australia
Switzerland
Belgium
United States
Greece
France

status_simplified: Unknown


type: Other Identifier

title: A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

summary: This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Global Development, Inc.

collaborators:
Merck Sharp & Dohme LLC
Seagen Inc.

location_country:
Italy
United States
Spain
Canada
Puerto Rico
France

location_facility: Case Western Reserve University / University Hospitals Case Medical Center

location_facility: New York University (NYU) Cancer Institute

location_facility: Stanford Cancer Center / Blood & Marrow Transplant Program

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Boca Raton Regional Hospital / Lynn Cancer Institute

location_facility: University of California Irvine - Newport

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Memorial Sloan Kettering Cancer Center - Basking Ridge

location_facility: Northwestern Medicine Cancer Center Delnor

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Tennessee Oncology / Sarah Cannon Research Institute

location_facility: Memorial Sloan Kettering Cancer Center - Bergen

location_facility: Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Memorial Sloan Kettering Cancer Center - Nassau

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University of California, Davis Comprehensive Cancer Center

location_facility: Southcoast Centers for Cancer Care - Fairhaven Site

location_facility: Medical College of Wisconsin (Milwaukee)

location_facility: Memorial Sloan Kettering Cancer Center - Westchester

location_facility: Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: University of California at San Francisco

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center

location_facility: Texas Oncology - Fort Worth Cancer Center

location_facility: Northwell Cancer Center / Monter Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: Memorial Sloan Kettering Cancer Center - Monmouth

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: University of Colorado Hospital / University of Colorado


acronym: Dose Ranging Trial of MK-8591 Given in Combination with Doravirine (DOR) and Lamivudine (3TC)

lead_sponsor: Merck Sharp & Dohme LLC

summary: This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.

ReferenceCitation: Molina JM, Yazdanpanah Y, Afani Saud A, Bettacchi C, Chahin Anania C, Klopfer SO, Grandhi A, Eves K, Hepler D, Robertson MN, Hwang C, Hanna GJ, Correll T. Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):68-72. doi: 10.1097/QAI.0000000000002879. Epub 2021 Dec 8.

ReferenceCitation: Molina JM, Yazdanpanah Y, Afani Saud A, Bettacchi C, Chahin Anania C, DeJesus E, Olsen Klopfer S, Grandhi A, Eves K, Robertson MN, Correll T, Hwang C, Hanna GJ, Sklar P. Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial. Lancet HIV. 2021 Jun;8(6):e324-e333. doi: 10.1016/S2352-3018(21)00021-7. Epub 2021 May 14.

location_facility: Centre Hospitalier de Tourcoing ( Site 2301)

location_facility: Hopital Bichat - Claude Bernard ( Site 2309)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 0203)

location_facility: Orlando Immunology Center (OIC) ( Site 0105)

location_facility: The Royal Free London NHS Foundation Trust ( Site 2102)

location_facility: Tarrant County Infectious Disease Associates ( Site 0112)

location_facility: The Crofoot Research Center, Inc. ( Site 0118)

location_facility: North Manchester General Hospital ( Site 2104)

location_facility: Chelsea and Westminster Hospital ( Site 2101)

location_facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2105)

location_facility: CHU de Nice Hopital Archet 1 ( Site 2303)

location_facility: Saint Hope Foundation, Inc. ( Site 0116)

location_facility: University California / Davis ( Site 0101)

location_facility: North Texas Infectious Diseases Consultants, PA ( Site 0103)

title: A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults

location_country:
United States
United Kingdom
Chile
France