title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis

acronym: JIGSAW 117

summary: This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

ReferenceCitation: Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Pérez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.

name: IRCCS Istituto Giannina Gaslini, Clinica Pediatrica e Reumatologia—PRINTO, Genoa, Italy

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

name: Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

family: Brunner

full_name: Hermine I Brunner

given: Hermine I

name: University Hospitals Bristol NHS Foundation Trust & Bristol Medical School, University of Bristol, Bristol, UK

family: Ramanan

full_name: Athimalaipet V Ramanan

given: Athimalaipet V

name: Department of General Pediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany

name: Department of Pediatric and Adolescents Medicine, University Hospital of Cologne, Cologne, Germany

family: Horneff

full_name: Gerd Horneff

given: Gerd

name: Rheumatology Section, Hospital Pedro de Elizalde, Buenos Aires, Argentina

family: Cuttica

full_name: Rubén Cuttica

given: Rubén

family: Henrickson

full_name: Michael Henrickson

given: Michael

name: Hospital Sant Joan de Déu, Universitat de Barcelona, Unidad de Reumatología Pediátrica, Esplugues de Llobregat (Barcelona), Spain

family: Anton

full_name: Jordi Anton

given: Jordi

name: Pediatric Rheumatology Unit, University Hospital Ramón y Cajal, Madrid, Spain

family: Boteanu

full_name: Alina Lucica Boteanu

given: Alina Lucica

name: Pediatric Rheumatology Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain

family: Penades

full_name: Inmaculada Calvo Penades

given: Inmaculada Calvo

name: German Rheumatism Research Centre Berlin, Berlin, Germany

name: Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany

family: Minden

full_name: Kirsten Minden

given: Kirsten

name: Department of Pediatrics, Alberta Children’s Hospital and Cumming School of Medicine/University of Calgary, Alberta, Canada

family: Schmeling

full_name: Heinrike Schmeling

given: Heinrike

name: University Medical Center Freiburg, Department of Pediatrics and Adolescent Medicine, Division of Pediatric Infectious Diseases and Rheumatology, Medical Faculty, University of Freiburg, Freiburg, Germany

family: Hufnagel

full_name: Markus Hufnagel

given: Markus

name: Hackensack University Medical Center, Pediatric Rheumatology, Hackensack, NJ, USA

family: Weiss

full_name: Jennifer E Weiss

given: Jennifer E

name: Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy

family: Pardeo

full_name: Manuela Pardeo

given: Manuela

name: Seattle Children’s Hospital, Seattle, WA, USA

family: Nanda

full_name: Kabita Nanda

given: Kabita

name: University of Ottawa and Division of Pediatric Dermatology & Rheumatology, Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada

family: Roth

full_name: Johannes Roth

given: Johannes

name: Universidad Autónoma de Nuevo León, Facultad de Medicina, Departamento de Pediatria, Hospital Universitario ‘Dr. J. E. González’, Monterrey, NL, Mexico

family: Rubio-Pérez

full_name: Nadina Rubio-Pérez

given: Nadina

name: Roche Innovation Center, New York, NY, USA

family: Hsu

full_name: Joy C Hsu

given: Joy C

name: Roche Products Ltd, Welwyn Garden City, UK

family: Wimalasundera

full_name: Sunethra Wimalasundera

given: Sunethra

family: Wells

full_name: Chris Wells

given: Chris

family: Bharucha

full_name: Kamal Bharucha

given: Kamal

family: Douglass

full_name: Wendy Douglass

given: Wendy

family: Bao

full_name: Min Bao

given: Min

name: Università degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili, Genoa, Italy

name: for the Pediatric Rheumatology INternational Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

location_country:
Italy
Brazil
United States
Mexico
Germany
France
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom


intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Janssen Research & Development, LLC

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Austria
United States
Netherlands
Germany
France
Poland
Israel
Belgium
Denmark
Canada

acronym: PURSUIT PEDS PK

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

source: euctr

title: A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Halton J, Brandão LR, Luciani M, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Sharathkumar A, Svirin P, Gorbatikov K, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Reilly P, Brueckmann M, Albisetti M; DIVERSITY Trial Investigators. Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial. Lancet Haematol. 2021 Jan;8(1):e22-e33. doi: 10.1016/S2352-3026(20)30368-9. Epub 2020 Dec 5.

family: Halton

full_name: Jacqueline Halton

given: Jacqueline

sequence: first

family: Brandão

full_name: Leonardo R Brandão

given: Leonardo R

sequence: additional

family: Luciani

full_name: Matteo Luciani

given: Matteo

family: Bomgaars

full_name: Lisa Bomgaars

given: Lisa

family: Chalmers

full_name: Elizabeth Chalmers

given: Elizabeth

family: Mitchell

full_name: Lesley G Mitchell

given: Lesley G

family: Nurmeev

full_name: Ildar Nurmeev

given: Ildar

family: Sharathkumar

full_name: Anjali Sharathkumar

given: Anjali

family: Svirin

full_name: Pavel Svirin

given: Pavel

family: Gorbatikov

full_name: Kirill Gorbatikov

given: Kirill

family: Tartakovsky

full_name: Igor Tartakovsky

given: Igor

family: Simetzberger

full_name: Monika Simetzberger

given: Monika

family: Huang

full_name: Fenglei Huang

given: Fenglei

family: Sun

full_name: Zhichao Sun

given: Zhichao

family: Kreuzer

full_name: Jörg Kreuzer

given: Jörg

family: Gropper

full_name: Savion Gropper

given: Savion

family: Reilly

full_name: Paul Reilly

given: Paul

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Albisetti

full_name: Manuela Albisetti

family: Safina

full_name: Asiya Safina

given: Asiya

family: Zapletal

full_name: Ondrej Zapletal

given: Ondrej

family: Kuhn

full_name: Tomas Kuhn

given: Tomas

family: Votava

full_name: Tomas Votava

ReferenceCitation: Albisetti M, Biss B, Bomgaars L, Brandão LR, Brueckmann M, Chalmers E, Gropper S, Harper R, Huang F, Luciani M, Manastirski I, Mitchell LG, Tartakovsky I, Wang B, Halton JML. Design and rationale for the DIVERSITY study: An open-label, randomized study of dabigatran etexilate for pediatric venous thromboembolism. Res Pract Thromb Haemost. 2018 Mar 25;2(2):347-356. doi: 10.1002/rth2.12086. eCollection 2018 Apr.

name: Hematology Department; University Children's Hospital; Zürich Switzerland

name: Department of Clinical Development; Boehringer Ingelheim RCV GmbH & Co. KG; Vienna Austria

name: Department for Pediatrics; Baylor College of Medicine; Houston TX USA

name: Department of Pediatrics; Division of Hematology/Oncology; University of Toronto; The Hospital for Sick Children; Toronto ON Canada

name: Clinical Development and Medical Affairs; Boehringer Ingelheim Pharma GmbH& Co. KG; Ingelheim Germany

name: Faculty of Medicine Mannheim; University of Heidelberg; Mannheim Germany

name: Royal Hospital for Children; Glasgow Scotland

name: Boehringer Ingelheim Ltd; Bracknell Berkshire UK

name: Translational Medicine and Clinical Pharmacology; Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield CT USA

name: OncoHematology Department; Bambino Gesù Children's Hospital; Rome Italy

name: University of Alberta; Edmonton AB Canada

name: Biostatistics and Data Sciences; Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield CT USA

name: Children's Hospital of Eastern Ontario; University of Ottawa; Ottawa ON Canada

journal_name: Research and Practice in Thrombosis and Haemostasis

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Thailand
Lithuania
Norway
Argentina
Canada
Sweden
Switzerland
Hungary
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: St.Petersburg State Pediatric Univ.Ministry of Healthcare RF

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

location_facility: Cukurova Universitesi Tip Fakultesi Cocuk Sagligi

location_facility: Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Izmilovskaya Child City ClinHosp,Haematological Dept, Moscow

location_facility: Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol

location_facility: Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan

location_facility: Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius

location_facility: PenSI - Pesquisa e Ensino em Saude Infantil

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo

location_facility: University of Iowa Hospitals and Clinics

location_facility: Faculdade de Ciencias Medicas da UNICAMP

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Hospital General de Niños Pedro de Elizalde

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Instituto de Crianca / Hospital das Clínicas-FMUSP

location_facility: Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH

title: Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age

summary: The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.


acronym: PROBESE

summary:
Postoperative respiratory failure, particularly after surgery under general anesthesia, adds to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (PPCs), especially in obese patients. While anesthesiologists tend to use PEEP higher than in non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of PEEP with recruitment maneuvers could compromise intra-operative hemodynamics.

The investigators aim to compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.

We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for PPC.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology, Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group, Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505. Erratum in: JAMA. 2019 Nov 12;322(18):1829-1830.

name: Department of Anesthesiology and Critical Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany

family: Bluth

full_name: Thomas Bluth

given: Thomas

name: Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil

family: Serpa Neto

full_name: Ary Serpa Neto

given: Ary

name: Department of Intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands

family: Schultz

full_name: Marcus J. Schultz

given: Marcus J.

name: Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Policlinico San Martino, Genoa, Italy

family: Pelosi

full_name: Paolo Pelosi

given: Paolo

family: Gama de Abreu

full_name: Marcelo Gama de Abreu

given: Marcelo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

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

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Müller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0. Erratum in: Trials. 2017 Jun 1;18(1):247.

full_name: T. Bluth

given: T.

family: Teichmann

full_name: R. Teichmann

given: R.

family: Kiss

full_name: T. Kiss

family: Bobek

full_name: I. Bobek

given: I.

family: Canet

full_name: J. Canet

given: J.

family: Cinnella

full_name: G. Cinnella

given: G.

family: De Baerdemaeker

full_name: L. De Baerdemaeker

given: L.

family: Gregoretti

full_name: C. Gregoretti

given: C.

family: Hedenstierna

full_name: G. Hedenstierna

name: and the PROtective VEntilation Network (PROVEnet)

name: on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Ghent University - Ghent University Academic Bibliography

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

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

location_country:
Italy
Austria
United States
Brazil
Sweden
Switzerland
Netherlands
Germany
France
Israel
Hungary
Belgium
Spain
Turkey
Canada
United Kingdom

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Saint Michael's Hospital, University of Toronto

location_facility: Massachusetts General Hospital, Harvard University

location_facility: Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus


ReferenceCitation: Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2021 Apr 7. pii: S1542-3565(21)00393-1. doi: 10.1016/j.cgh.2021.04.005. [Epub ahead of print]

family: Benninga

full_name: Marc A. Benninga

given: Marc A.

family: Hussain

full_name: Sunny Z. Hussain

given: Sunny Z.

family: Sood

full_name: Manu R. Sood

given: Manu R.

family: Nurko

full_name: Samuel Nurko

given: Samuel

family: Hyman

full_name: Paul Hyman

given: Paul

family: Clifford

full_name: Robert A. Clifford

given: Robert A.

family: O’Gorman

full_name: Molly O’Gorman

given: Molly

family: Losch-Beridon

full_name: Taryn Losch-Beridon

given: Taryn

family: Mareya

full_name: Shadreck Mareya

given: Shadreck

family: Lichtlen

full_name: Peter Lichtlen

given: Peter

family: Di Lorenzo

full_name: Carlo Di Lorenzo

given: Carlo

journal_name: Clinical Gastroenterology and Hepatology

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Sucampo Pharma Americas, LLC

location_country:
United States
Netherlands
France
Poland
Belgium
Canada
United Kingdom

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: Arizona Children's Center at Maricopa Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: University of South Alabama Women's and Children's Hospital

location_facility: St. Christopher's Hospital for Children Drexel University

location_facility: University of Oklahoma Health Sciences Center

location_facility: Children's Center for Digestive Health Care/GI Care for Kids

location_facility: Coastal Pediatrics Associates - Mount Pleasant

location_facility: University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit

location_facility: Morgan Stanley Children's Hospital of New York Presbyterian

location_facility: Pediatric Gastroenterology Carilion Medical Center

location_facility: Arkansas Childrens Hospital Research Institute

location_facility: UnityPoint Health Des Moines/ Blank Children's Clinic

location_facility: INOVA Pediatric Digestive Diseases Center

location_facility: Pediatric Research of Charlottesville, LLC

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Coastal Pediatric Associates - James Island

ipd_sharing: No

title: A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

summary:
This study is for children with constipation.

Children who completed 3 months of treatment in the earlier study (NCT02042183):

were invited to participate
will receive lubiprostone for 9 more months
will see if lubiprostone safely relieves their constipation if taken for a whole year

status_simplified: Completed


title: A Natural History Study to Observe Disease Progression, Standard of Care and Investigate Biomarkers in Alport Syndrome Patients

summary:
There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients.

Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as GFR and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. The identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (ESRD) is a key goal of the natural history study.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
Germany
France
Australia
Canada
United Kingdom


title: A Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination With Tremelimumab With or Without Azacitidine in Subjects With Myelodysplastic Syndrome After Treatment With Hypomethylating Agents

summary: This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents

design_allocation: Non-Randomized

lead_sponsor: MedImmune LLC

location_country:
Germany
United States
United Kingdom
France


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

acronym: OPAL BROADEN

summary: This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

ReferenceCitation: Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2021 Sep 12. doi: 10.1007/s10067-021-05894-2. [Epub ahead of print]

family: Kivitz

full_name: Alan J. Kivitz

given: Alan J.

family: FitzGerald

full_name: Oliver FitzGerald

given: Oliver

family: Nash

full_name: Peter Nash

family: Pang

full_name: Shirley Pang

given: Shirley

family: Azevedo

full_name: Valderilio F. Azevedo

given: Valderilio F.

family: Wang

full_name: Cunshan Wang

given: Cunshan

family: Takiya

full_name: Liza Takiya

given: Liza

journal_name: Clinical Rheumatology

oa_colors: green hybrid

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2). pii: e001609. doi: 10.1136/rmdopen-2021-001609.

family: de Vlam

full_name: Kurt de Vlam

given: Kurt

family: Ogdie

full_name: Alexis Ogdie

given: Alexis

family: Bushmakin

full_name: Andrew G Bushmakin

given: Andrew G

family: Cappelleri

full_name: Joseph C Cappelleri

given: Joseph C

family: Fleischmann

full_name: Roy Fleischmann

given: Roy

family: Taylor

full_name: Peter C Taylor

given: Peter C

full_name: Valderilio Azevedo

given: Valderilio

family: Fallon

full_name: Lara Fallon

given: Lara

family: Woolcott

full_name: John Woolcott

given: John

family: Mease

full_name: Philip J Mease

given: Philip J

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

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

ReferenceCitation: Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.

ReferenceCitation: Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.

name: University of Rochester Medical Center Rochester New York

name: Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania

name: Hospital Clínico Universitario Santiago de Compostela Spain

name: Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds Leeds UK

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

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

ReferenceCitation: Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.

name: University of Toronto and Toronto Western Hospital Toronto Ontario Canada

name: St. Vincent's University Hospital and University College Dublin Dublin Ireland

name: Medical University of South Carolina Charleston

name: Amsterdam Rheumatology and Immunology CenterVU University Medical Center, and Reade Amsterdam The Netherlands

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

title: Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long‐Term Extension Studies

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

ReferenceCitation: van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.

ReferenceCitation: Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5. Corrected and republished in: J Patient Rep Outcomes. 2019 May 20;3(1):30. Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32.

RetractionSource: J Patient Rep Outcomes. 2019 May 28;3(1):32

title: RETRACTED ARTICLE: Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis

ReferenceCitation: Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.

ReferenceCitation: Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.

ReferenceCitation: Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieślak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

location_country:
United States
Mexico
Germany
France
Bulgaria
Czechia
Poland
Slovakia
Hungary
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom
Taiwan

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A

location_facility: State Budgetary Institution of Healthcare of Moscow City Clinical Hospital

location_facility: Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only

location_facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.

location_facility: University Hospital Leuven, Department of Rheumatology

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: OOO City Neurological Centre "Sibneiromed"

location_facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

location_facility: Medical Plus s.r.o. Lekarna Hradebni s. r.o

location_facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)

location_facility: Csolnoky Ferenc Korhaz, Reumatologiai Osztaly

location_facility: Regional State Budgetary Healthcare Institution of Karelia Republic

location_facility: Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)

location_facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: Unidad Reumatologica Las Americas, S.C.P.

location_facility: Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"

location_facility: Dynacare Laboratories (Specimen processing for shipment)

location_facility: Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"

location_facility: Wirral University Teaching Hospital NHS Foundation Trust

location_facility: MEDMAN s.r.o. - reumatologicka ambulancia

location_facility: State Institution of Healthcare "Regional Clinical Hospital"

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,

location_facility: Revmatologicky Ustav - Lekarna (pharmacy only)

location_facility: ROMJAN s.r.o., Reumatologicka ambulancia

location_facility: Hospital General de Culiacán Dr. Bernardo J. Gastélum

location_facility: Investigacion y Biomedicina de Chihuahua SC

location_facility: Complexo Hospitalario Universitario A Coruna

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

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)

location_facility: West Island Rheumatology Research Associates

location_facility: Hopital Erasme - Clinique Universitaire de Bruxelles

location_facility: State Budget Educational Institution of Highest Professional Education

location_facility: ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik

location_facility: Synexus Polska Sp. z o.o. Oddz. we Wroclawiu

location_facility: Investigational Drug Service Pharmacy, Swedish Medical Center.

location_facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

location_facility: Centro de Investigacion Clinica Pensiones

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: MC "New rehabilitation center" EOOD, Rheumatology Cabinet

location_facility: Hospital Star Medica Merida (For Emergencies Only)

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: ClinicMed Badurski i wspolnicy Spolka Jawna

location_facility: Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital

location_facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

location_facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa

location_facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

location_facility: State Institution of Healthcare of Yaroslavl Region

location_facility: Rheumatology Associates of North Alabama, PC


lead_sponsor: Novartis Pharmaceuticals

location_country:
Hong Kong
France
Belgium
Spain
United States

location_facility: Oregon Health and Science University SC-5

location_facility: University of Texas MD Anderson Cancer Center Onc Dept

location_facility: Sylvester Comprehensive Cancer Center Main Center

title: A Phase Ib Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

summary:
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer

Dose Expansion part of the study: To characterize the safety and tolerability of the triplet combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6 inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients treated with prior LEE011 are not allowed in Group 3).


title: An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer

summary: This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.

primary_purpose: Basic Science

ReferenceCitation: Plummer R, Verheul HM, De Vos FYFL, Leunen K, Molife LR, Rolfo C, Grundtvig-Sørensen P, De Grève J, Rottey S, Jerusalem G, Italiano A, Spicer J, Dirix L, Goessl C, Birkett J, Spencer S, Learoyd M, Bailey C, Dean E. Pharmacokinetic Effects and Safety of Olaparib Administered with Endocrine Therapy: A Phase I Study in Patients with Advanced Solid Tumours. Adv Ther. 2018 Nov;35(11):1945-1964. doi: 10.1007/s12325-018-0804-z. Epub 2018 Oct 15.

family: Plummer

full_name: Ruth Plummer

given: Ruth

family: Verheul

full_name: Henk M. Verheul

given: Henk M.

family: De Vos

full_name: Filip Y. F. L. De Vos

given: Filip Y. F. L.

family: Leunen

full_name: Karin Leunen

given: Karin

family: Molife

full_name: L. Rhoda Molife

given: L. Rhoda

family: Rolfo

full_name: Christian Rolfo

given: Christian

family: Grundtvig-Sørensen

full_name: Peter Grundtvig-Sørensen

given: Peter

family: De Grève

full_name: Jacques De Grève

given: Jacques

family: Rottey

full_name: Sylvie Rottey

given: Sylvie

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Spicer

full_name: James Spicer

given: James

family: Dirix

full_name: Luc Dirix

given: Luc

family: Goessl

full_name: Carsten Goessl

given: Carsten

family: Birkett

full_name: Joseph Birkett

given: Joseph

family: Spencer

full_name: Stuart Spencer

given: Stuart

family: Learoyd

full_name: Maria Learoyd

given: Maria

family: Bailey

full_name: Christopher Bailey

given: Christopher

family: Dean

full_name: Emma Dean

given: Emma

journal_name: Advances in Therapy

lead_sponsor: AstraZeneca

location_country:
Netherlands
France
Belgium
Denmark
United Kingdom

intervention_type: Procedure


title: EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

acronym: EXPERT

summary: In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

lead_sponsor: Bayer

location_country:
Luxembourg
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Slovakia
Norway
Argentina
Canada
Turkey
Colombia
Sweden
Saudi Arabia
Switzerland
Netherlands
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Spain
Estonia


title: An Open-Label, Single-Group Clinical Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Mepesuccinate Given Subcutaneously as a Fixed Dose inPatients With Chronic Phase or Accelerated Phase Chronic Myeloid Leukemia Who Have Failed 2 or More Tyrosine Kinase Inhibitor Therapies

summary: To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase 1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP or AP CML who have failed 2 or more tyrosine kinase inhibitor (TKI) therapies.

status: Terminated

primary_purpose: Other

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

location_country:
United States
Belgium
France
Korea, Republic of

location_facility:
Teva Investigational Site 35157
Teva Investigational Site 12544
Teva Investigational Site 12543
Teva Investigational Site 37048
Teva Investigational Site 87026
Teva Investigational Site 12550
Teva Investigational Site 12545
Teva Investigational Site 12547
Teva Investigational Site 12546
Teva Investigational Site 37047

status_simplified: Unknown


title: An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

summary: This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
France
Poland
Greece
Australia
Puerto Rico
Spain
United States
United Kingdom
Taiwan


ReferenceCitation: Soulières D, Faivre S, Mesía R, Remenár É, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamás L, Kim SB, Erfán J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.

family: Soulières

full_name: Denis Soulières

given: Denis

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

family: Mesía

full_name: Ricard Mesía

given: Ricard

family: Remenár

full_name: Éva Remenár

given: Éva

family: Li

full_name: Shau-Hsuan Li

given: Shau-Hsuan

family: Karpenko

full_name: Andrey Karpenko

given: Andrey

family: Dechaphunkul

full_name: Arunee Dechaphunkul

given: Arunee

family: Ochsenreither

full_name: Sebastian Ochsenreither

given: Sebastian

family: Kiss

full_name: Laura Anna Kiss

given: Laura Anna

family: Lin

full_name: Jin-Ching Lin

given: Jin-Ching

family: Nagarkar

full_name: Raj Nagarkar

given: Raj

family: Tamás

full_name: László Tamás

given: László

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Erfán

full_name: Jozsef Erfán

given: Jozsef

family: Alyasova

full_name: Anna Alyasova

given: Anna

family: Kasper

full_name: Stefan Kasper

given: Stefan

family: Barone

full_name: Carlo Barone

given: Carlo

family: Turri

full_name: Sabine Turri

given: Sabine

family: Chakravartty

full_name: Arunava Chakravartty

given: Arunava

family: Chol

full_name: Marie Chol

given: Marie

family: Aimone

full_name: Paola Aimone

given: Paola

family: Hirawat

full_name: Samit Hirawat

given: Samit

family: Licitra

full_name: Lisa Licitra

given: Lisa

journal_name: The Lancet Oncology

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

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

location_country:
Italy
United States
India
Switzerland
Germany
France
Japan
Poland
Thailand
Hungary
Australia
Ireland
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr.

location_facility: The Mount Sinai Hospital Dept of Oncology

location_facility: Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201

location_facility: University Hospitals Case Medical Center Univ. Hospitals of Cleveland

title: Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

summary: Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.


ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

name: Biometrics Genentech Inc. South San Francisco CA USA

family: He

full_name: Xian He

given: Xian

family: Zhang

full_name: Wei Zhang

given: Wei

name: Clinical Pharmacology Genentech‐Roche Marseille France

family: Bruno

full_name: René Bruno

given: René

currency_apc_doaj: USD

journal_name: Pharmacology Research & Perspectives

oa_colors: green gold

evidence: oa journal (via doaj)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

lead_sponsor: Genentech, Inc.

location_country:
Netherlands
France
Belgium
United States
United Kingdom

location_facility: Penn Presbyterian Medical Center; Abramson Cancer Center

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: The University of Chicago Medical Center

location_facility: The Angeles Clinic and Research Institute, Santa Monica Office

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology

location_facility: Stanford University/Lucile Packard Children's Hospital

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Carolina BioOncology Institute; Can Therapy & Res Ctr

location_facility: Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr

location_facility: University of Washington Seattle Cancer Care Alliance

title: A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

summary:
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

Eligible participants will be categorized in to three groups as follows:

Participants with no prior chemotherapy for advanced disease;
Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
Participants who are 2L+ and previously treated for brain metastases.


title: Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

summary: Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.

enrollment_type: Anticipated

ReferenceCitation: Shi SM, Sung M, Afilalo J, Lipsitz LA, Kim CA, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Lee J, Marcantonio ER, Kim DH. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement. J Am Geriatr Soc. 2019 Jul;67(7):1393-1401. doi: 10.1111/jgs.15867. Epub 2019 Mar 18.

name: Division of Gerontology, Department of MedicineBeth Israel Deaconess Medical Center, Harvard Medical School Boston Massachusetts

full_name: Sandra M. Shi

given: Sandra M.

name: Department of MedicineBoston University Medical Center Boston Massachusetts

family: Sung

full_name: Minhee Sung

given: Minhee

name: Division of Cardiology and Centre for Clinical EpidemiologyJewish General Hospital, McGill University Montreal Quebec Canada

family: Afilalo

full_name: Jonathan Afilalo

given: Jonathan

name: Hinda and Arthur Marcus Institute for Aging ResearchHebrew SeniorLife, Harvard Medical School Boston Massachusetts

family: Lipsitz

full_name: Lewis A. Lipsitz

given: Lewis A.

name: Division of Hospital MedicineSouth Shore Hospital Weymouth Massachusetts

family: Kim

full_name: Caroline A. Kim

given: Caroline A.

name: Division of Cardiology, Department of MedicineBeth Israel Deaconess Medical Center, Harvard Medical School Boston Massachusetts

family: Popma

full_name: Jeffrey J. Popma

given: Jeffrey J.

name: Division of Cardiac Surgery, Department of SurgeryBeth Israel Deaconess Medical Center, Harvard Medical School Boston Massachusetts

family: Khabbaz

full_name: Kamal R. Khabbaz

given: Kamal R.

family: Laham

full_name: Roger J. Laham

given: Roger J.

family: Guibone

full_name: Kimberly Guibone

given: Kimberly

family: Lee

full_name: Jung Lee

given: Jung

name: Division of General Medicine and Primary Care, Department of MedicineBeth Israel Deaconess Medical Center, Harvard Medical School Boston Massachusetts

family: Marcantonio

full_name: Edward R. Marcantonio

given: Edward R.

name: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women's Hospital, Harvard Medical School Boston Massachusetts

full_name: Dae Hyun Kim

given: Dae Hyun

journal_name: Journal of the American Geriatrics Society

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

ReferenceCitation: Afilalo J, Lauck S, Kim DH, Lefèvre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Généreux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.

family: Lauck

full_name: Sandra Lauck

given: Sandra

full_name: Dae H. Kim

given: Dae H.

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Piazza

full_name: Nicolo Piazza

given: Nicolo

family: Lachapelle

full_name: Kevin Lachapelle

given: Kevin

family: Martucci

journal_name: Journal of the American College of Cardiology

location_facility: Centre Hospitalier Universite de Montreal


title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures

summary: This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.

ReferenceCitation: Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18.

name: Pfizer Global Research and Development Groton Connecticut

family: Mann

full_name: Donald Mann

given: Donald

family: Antinew

full_name: Jeremias Antinew

given: Jeremias

family: Knapp

full_name: Lloyd Knapp

given: Lloyd

family: Almas

full_name: Mary Almas

given: Mary

family: Liu

full_name: Jing Liu

given: Jing

family: Scavone

full_name: Joseph Scavone

given: Joseph

family: Yang

full_name: Ruoyong Yang

given: Ruoyong

name: Department of Pediatrics Perpetual Succour Hospital Cebu City Philippines

family: Modequillo

full_name: Margaret Modequillo

given: Margaret

name: Dnipro City Children’s Clinical Hospital #5 of Dnipro City Council Dnipro Ukraine

family: Makedonska

full_name: Iryna Makedonska

given: Iryna

name: Child Neuroscience Division Philippine Children's Medical Center Quezon City Philippines

family: Ortiz

full_name: Marilyn Ortiz

given: Marilyn

name: Department of Internal Medicine Dnipro Medical Institute of Conventional and Alternative Medicine Dnipro Ukraine

family: Kyrychenko

full_name: Alla Kyrychenko

given: Alla

name: Pediatric Neurology University of Chicago Medicine Chicago Illinois

family: Nordli

full_name: Douglas Nordli

given: Douglas

name: First Department of Pediatrics Semmelweis University Budapest Hungary

family: Farkas

full_name: Viktor Farkas

given: Viktor

full_name: Mark Kristof Farkas

given: Mark Kristof

family: Shalkevich

full_name: Leanid Shalkevich

given: Leanid

family: Jansen

full_name: Anna Jansen

given: Anna

family: Ivanov

full_name: Ivan Ivanov

given: Ivan

family: Nedkova

full_name: Vania Nedkova

given: Vania

family: Fang

full_name: Fang Fang

given: Fang

family: Wang

full_name: Yi Wang

given: Yi

family: Pinard

full_name: Jean‐Marc Pinard

given: Jean‐Marc

family: Brandl

full_name: Ulrich Brandl

given: Ulrich

family: Zafeiriou

full_name: Dimitrios Zafeiriou

given: Dimitrios

title: Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double‐blind, placebo‐controlled, video‐electroencephalographic trial

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Malaysia
Greece
Romania
Belgium
Russian Federation
Taiwan
Ukraine
France
Thailand
Korea, Republic of
Philippines
Bulgaria
Hungary
China
Germany
United States
Bosnia and Herzegovina
Serbia
Lebanon
Israel
Belarus
Spain
Turkey

location_facility: The University of Texas Health Science Center at Houston

location_facility: Szent János Kórház es Észak Budai Egyesitett Kórházak

location_facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

location_facility: SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev

location_facility: Institute for Child and Youth Healthcare of Vojvodina

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"

location_facility: The First Bethune Hospital of Jilin University

location_facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

location_facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria"

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Chang Gung Memorial Hospital- Kaohsiung branch

location_facility: GU Republican Scientific and Practical Center Mother and Child

location_facility: American University of Beirut Medical Center

location_facility: Dr. Kenessey Albert Korhaz es Rendelointezet

location_facility: Mother and Child Healthcare Institute Dr Vukan Cupic

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: Pharmacy of Tel Aviv Sourasky Medical Center

location_facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

location_facility: RSBHI Smolensk Regional Clinical Hospital

location_facility: Pediatric Epilepsy & Neurology Specialists, PA

location_facility: Pediatric Epilepsy Center of Central Florida

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

location_facility: Siriraj Hospital, Faculty of Medicine, Mahidol University

location_facility: Saint George Hospital - University Medical Center

location_facility: St. Petersburg State Pediatric Medical University

location_facility: DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam

location_facility: Perm State Medical University n. a. acad. E.A. Vagner

location_facility: Pharmacy of The E. Wolfson Medical Center


title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

summary: Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

lead_sponsor: Actelion

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Czechia
Israel
Belgium
Spain
Canada

location_facility: Hospital Vall d´Hebron Servicio de Cardiologia

location_facility: Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie

location_facility: FN Olomouc, 1. Interní klinika - kardiologická

location_facility: University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program

location_facility: Washington University School of Medicine - Center for Advanced Med

location_facility: University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie

location_facility: Centre Hospitalier Universitaire Vaudois Service de Cardiologie

location_facility: FN Brno-Bohunice, I. interní kardiologická klinika

location_facility: Houston Methodist Hospital - Heart Failure/Pulm Hypertension

location_facility: Medical University of Vienna and AKH Cardiology

location_facility: The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise

location_facility: Institute of Pulmonology Hadassah Medical Centre : Ein Karem

location_facility: DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie

location_facility: Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie

location_facility: Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie

location_facility: Hospital Reina Sofia Servicio de Cardiologia

location_facility: Hospital Universitario 12 Octubre Servicio de Cardiología

location_facility: Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung

location_facility: Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)

location_facility: Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern

location_facility: Kaplan Medical Centre / Pulmonary Institute and Department of Medicine

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia

location_facility: Hôpital Charles Nicolle Service de Cardiologie

location_facility: Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie

location_facility: IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)


title: An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome

acronym: SONICS

summary: The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.

ReferenceType: result

ReferenceCitation: Fleseriu M, Pivonello R, Elenkova A, Salvatori R, Auchus RJ, Feelders RA, Geer EB, Greenman Y, Witek P, Cohen F, Biller BMK. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):855-865. doi: 10.1016/S2213-8587(19)30313-4. Epub 2019 Sep 18. Erratum in: Lancet Diabetes Endocrinol. 2019 Nov;7(11):e22.

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

family: Pivonello

full_name: Rosario Pivonello

given: Rosario

family: Elenkova

full_name: Atanaska Elenkova

given: Atanaska

family: Salvatori

full_name: Roberto Salvatori

given: Roberto

family: Auchus

full_name: Richard J Auchus

given: Richard J

family: Feelders

full_name: Richard A Feelders

given: Richard A

family: Geer

full_name: Eliza B Geer

given: Eliza B

family: Greenman

full_name: Yona Greenman

given: Yona

family: Witek

full_name: Przemyslaw Witek

given: Przemyslaw

family: Cohen

full_name: Fredric Cohen

given: Fredric

family: Biller

full_name: Beverly M K Biller

given: Beverly M K

journal_name: The Lancet Diabetes & Endocrinology

ReferenceCitation: Geer EB, Salvatori R, Elenkova A, Fleseriu M, Pivonello R, Witek P, Feelders RA, Bex M, Borresen SW, Puglisi S, Biller BMK, Cohen F, Pecori Giraldi F. Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome. Pituitary. 2021 Feb;24(1):104-115. doi: 10.1007/s11102-020-01103-6. Epub 2020 Nov 20. Erratum in: Pituitary. 2020 Dec 14;:.

full_name: Eliza B. Geer

given: Eliza B.

full_name: Richard A. Feelders

given: Richard A.

family: Bex

full_name: Marie Bex

given: Marie

family: Borresen

full_name: Stina W. Borresen

given: Stina W.

family: Puglisi

full_name: Soraya Puglisi

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

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

title: Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing’s syndrome

ReferenceCitation: Pivonello R, Elenkova A, Fleseriu M, Feelders RA, Witek P, Greenman Y, Geer EB, Perotti P, Saiegh L, Cohen F, Arnaldi G. Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study. Front Endocrinol (Lausanne). 2021 Apr 7;12:595894. doi: 10.3389/fendo.2021.595894. eCollection 2021.

title: Levoketoconazole in the Treatment of Patients With Cushing’s Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study

location_country:
Italy
United States
Serbia
Netherlands
Germany
France
Czechia
Bulgaria
Israel
Poland
Belgium
Spain
Turkey
Denmark
Canada

location_facility: St. Pauls Hospital/Vancouver General Hospital

location_facility: Hôpital de la CONCEPTION, Service d'Endocrinologie, Diabète et Maladies Métaboliques

location_facility: UOC di Endocrinologia, Dipartimento di Medicina Clinica e Sperimentale

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego

location_facility: Bezmi Alem Vakıf Üniversitesi Endokrinoloji Bölümü Adnan

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Leiden University, Leiden University Medical Center, Dept. of Endocrinology

location_facility: University Specialized Hospital for Active Treatment in Endocrinology (USHATE)

location_facility: Sourasky Medical Center, Endocrinology & Metabolism

location_facility: Vseobecna fakultni nemocnice v Praze - III. Interni klinika VFN a 1. LF UK

location_facility: Endocrinologia, Hospital Sant Pau,Universitat Autònoma de Barcelona

location_facility: Erasmus MC, Dpt. Of Internal Medicine, Division of Endocrinology

location_facility: Institute of Endocrinology & Metabolism, Rabin Medical Center

location_facility: University Hospitals Leuven Department of Endocrinology

location_facility: Bnail Zion Medical Center Institute of Endocrinology & Metabolism

location_facility: Azienda Ospedaliero - Universitaria Città della Salute e della Scienza di Torino

location_facility: SCDU Medicina Interna I Università di Torino Dipartimento di Scienze Cliniche e Biologiche


title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

ReferenceCitation: Kollmeier AP, Barnathan ES, O'Brien C, Chen B, Xia YK, Zhou B, Loza MJ, Silkoff PE, Ge M, Thurmond RL. A phase 2a study of toreforant, a histamine H(4) receptor antagonist, in eosinophilic asthma. Ann Allergy Asthma Immunol. 2018 Nov;121(5):568-574. doi: 10.1016/j.anai.2018.08.001. Epub 2018 Aug 11.

family: Kollmeier

full_name: Alexa P. Kollmeier

given: Alexa P.

family: Barnathan

full_name: Elliot S. Barnathan

given: Elliot S.

family: O'Brien

full_name: Christopher O'Brien

given: Christopher

family: Chen

full_name: Bin Chen

given: Bin

family: Xia

full_name: Yichuan (Karen) Xia

given: Yichuan (Karen)

family: Zhou

full_name: Bei Zhou

given: Bei

family: Loza

full_name: Matthew J. Loza

given: Matthew J.

family: Silkoff

full_name: Philip E. Silkoff

given: Philip E.

family: Ge

full_name: Michelle Ge

given: Michelle

family: Thurmond

full_name: Robin L. Thurmond

given: Robin L.

journal_name: Annals of Allergy, Asthma & Immunology

title: A phase 2a study of toreforant, a histamine H4 receptor antagonist, in eosinophilic asthma

location_country:
United States
France
Israel
Germany
United Kingdom
Canada


lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country: Belgium France

title: An Open-Label, Single and Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-17299425 in Patients With Traumatic Brain Injury

summary: The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores what the body does to the drug) and pharmacodynamics (the study of the action or effects a drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain stem).


title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

summary: The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

lead_sponsor: Charite University, Berlin, Germany

location_country:
Italy
Austria
Switzerland
Netherlands
Finland
France
Czechia
Japan
Israel
Poland
Norway
Australia
Belgium
Portugal
Denmark
Germany
United Kingdom

location_facility: Dpt. SCT and Hematology/Oncology University Wroclaw

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: Hòpital Universitaire des Enfants Reine Fabiola

location_facility: Australian & New Zealand Childhood Hematology & Oncology Group

location_facility: Instituto Português de Oncologia de Lisboa

lead_sponsor_type: academique


title: A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

lead_sponsor: Eli Lilly and Company

location_country:
Netherlands
Mexico
France
Spain
United States
Canada
Taiwan

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


ReferenceCitation: Gupta V, Wolleschak D, Hasselbalch H, Vannucchi AM, Koschmieder S, Cervantes F, Li Y, Dong T, Wroclawska M, Bharathy S, Harrison C. Safety and efficacy of the combination of sonidegib and ruxolitinib in myelofibrosis: a phase 1b/2 dose-finding study. Blood Adv. 2020 Jul 14;4(13):3063-3071. doi: 10.1182/bloodadvances.2019001212.

name: Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada;

family: Gupta

full_name: Vikas Gupta

given: Vikas

name: Department of Hematology and Oncology, University Medical Center Magdeburg, Magdeburg, Germany;

family: Wolleschak

full_name: Denise Wolleschak

given: Denise

name: Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;

family: Hasselbalch

full_name: Hans Hasselbalch

given: Hans

name: Center for Research and Innovation of Myeloproliferative Neoplasms, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy;

family: Vannucchi

full_name: Alessandro Maria Vannucchi

given: Alessandro Maria

name: Faculty of Medicine, Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany;

family: Koschmieder

full_name: Steffen Koschmieder

given: Steffen

name: Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain;

family: Cervantes

full_name: Francisco Cervantes

given: Francisco

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ;

family: Li

full_name: Yang Li

given: Yang

family: Dong

full_name: Tuochuan Dong

given: Tuochuan

family: Wroclawska

full_name: Monika Wroclawska

given: Monika

family: Bharathy

full_name: Savita Bharathy

given: Savita

name: Guy’s and St Thomas’ National Health Service Foundation Trust, Guy’s Hospital, London, United Kingdom

family: Harrison

full_name: Claire Harrison

given: Claire

journal_name: Blood Advances

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

ipd_sharing: Yes

title: A Phase Ib/II, Open-label, Multi-center, Dose-finding Study to Assess the Safety and Efficacy of the Oral Combination of LDE225 and INC424 (Ruxolitinib) in Patients With Myelofibrosis

summary: The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.


ReferenceCitation: Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.

family: Staurenghi

full_name: Giovanni Staurenghi

given: Giovanni

family: Garweg

full_name: Justus G. Garweg

given: Justus G.

family: Gerendas

full_name: Bianca S. Gerendas

given: Bianca S.

family: Macfadden

full_name: Wayne Macfadden

given: Wayne

family: Gekkiev

full_name: Boris Gekkiev

given: Boris

family: Margaron

full_name: Philippe Margaron

given: Philippe

family: Dunger-Baldauf

full_name: Cornelia Dunger-Baldauf

given: Cornelia

family: Kolar

full_name: Petr Kolar

given: Petr

currency_apc_doaj: GBP

journal_name: BMC Ophthalmology

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repository_institution: Research Square - Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

title: Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

location_country:
Guatemala
Finland
Greece
France
Panama
Lithuania
Slovakia
Argentina
Canada
Colombia
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Spain
Turkey

title: A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

summary:
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.

The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.


title: A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects With Metastatic or Unresectable Melanoma in Combination With Dabrafenib and Trametinib or With Trametinib Alone

summary: The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (WT) BRAF, respectively.

ReferenceType: background

ReferenceCitation: Gordon MS, Lutzky J, Lawrence D, Butler M, Ascierto PA, Hug B, et al. Phase 1 study evaluating safety and tolerability of MEDI4736, an anti-programmed cell death ligand-1 (PD-L1) antibody, in combination with dabrafenib and trametinib or trametinib alone in patients with unresectable or metastatic melanoma. Ann Oncol 2014; 25(suppl_4): iv374-iv393 (abstract 8004).

ReferenceCitation: Ribas A, Butler M, Lutzky J, Lawrence DP, Robert C, Miller W, et al. Phase 1 study combining anti-PD-L1 (MEDI4736) and BRAF (dabrafenib) and/or MEK (trametinib) inhibitors in advanced melanoma. J Clin Oncol 2015; 33 (15_suppl): (abstract 3003).

ReferenceCitation: Ribas A, Algazi A, Ascierto PA, Butler MO, Chandra S, Gordon M, Hernandez-Aya L, Lawrence D, Lutzky J, Miller WH Jr, Campbell KM, Delafont B, Marshall S, Mueller N, Robert C. PD-L1 blockade in combination with inhibition of MAPK oncogenic signaling in patients with advanced melanoma. Nat Commun. 2020 Dec 7;11(1):6262. doi: 10.1038/s41467-020-19810-w. Erratum in: Nat Commun. 2021 Aug 12;12(1):5022.

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Algazi

full_name: Alain Algazi

given: Alain

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Butler

full_name: Marcus O. Butler

given: Marcus O.

family: Chandra

full_name: Sunandana Chandra

given: Sunandana

family: Gordon

full_name: Michael Gordon

given: Michael

family: Hernandez-Aya

full_name: Leonel Hernandez-Aya

given: Leonel

family: Lawrence

full_name: Donald Lawrence

given: Donald

family: Lutzky

full_name: Jose Lutzky

given: Jose

family: Miller

full_name: Wilson H. Miller

given: Wilson H.

suffix: Jr

family: Campbell

full_name: Katie M. Campbell

given: Katie M.

family: Delafont

full_name: Bruno Delafont

given: Bruno

family: Marshall

full_name: Shannon Marshall

given: Shannon

family: Mueller

full_name: Nancy Mueller

given: Nancy

family: Robert

full_name: Caroline Robert

given: Caroline

bso_classification: Biology (fond.)

journal_name: Nature Communications

repository_institution: California Digital Library - eScholarship


title: Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003

summary:
This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.

Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.

The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).

lead_sponsor: CSL Behring

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Japan
Australia
Spain
Canada
United Kingdom

location_facility:
Site Reference 1240007
Site Reference 7240010
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Site Reference 3920037
Site Reference 2030009
Site Reference 3920061
Site Reference 0360017
Site Reference 2760055
Site Reference 8400181
Site Reference 2760069
Site Reference 7240011
Site Reference 2500022
Site Reference 0360011
Site Reference 2760049
Site Reference 3920038
Site Reference 3800031
Site Reference 2760054
Site Reference 2760094
Site Reference 5280001
Site Reference 2760039
Site Reference 2760052
Site Reference 1240009
Site Reference 3920035
Site Reference 8400166
Site Reference 3920065
Site Reference 8400182
Site Reference 8400169
Site Reference 2760072
Site Reference 8260032
Site Reference 2760047
Site Reference 8400167
Site Reference 2030002
Site Reference 3920040

intervention_type: Biological


title: A Prospective Natural History Study of Progression of Physical Impairment, Activity Limitation and Quality of Life in Duchenne Muscular Dystrophy.

summary: To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to help inform the design of future studies, to capture biomarkers of safety and disease progression and to provide comparative data for the development of rare exons for which formal controlled trials are not feasible.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Italy
Brazil
Sweden
Netherlands
Germany
France
Belgium
Argentina
Turkey
United States

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Policlinico Univsersitario Agostino Gemelli

location_facility: Hospital de Pediatria Prof Dr Juan P Garrahan

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Drottning Silvias Barn- ochungdomssjukhus

intervention_type: Other


title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

summary: The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.

lead_sponsor: Vascutek Ltd.

location_country:
Italy
France
Australia
New Zealand
Spain
Germany
United Kingdom

location_facility: Hospital Universitario Madrid Monteprincipe

intervention_type: Device


title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy Phase 3b

summary: N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

family: Markham

full_name: Anthony Markham

given: Anthony

journal_name: Drugs

title: Brivaracetam: First Global Approval

lead_sponsor: UCB Pharma SA

location_country:
Germany
United States
France
Spain


title: Micra Transcatheter Pacing Study

summary: The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

ReferenceCitation: El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.

name: Division of Cardiology, Section of Electrophysiology Emory University Atlanta Georgia USA

family: El‐Chami

full_name: Mikhael F. El‐Chami

given: Mikhael F.

family: Shinn

full_name: Timothy Shinn

given: Timothy

name: Lancaster General Health  Lancaster Pennsylvania USA

family: Bansal

full_name: Sundeep Bansal

given: Sundeep

name: Unidad de Arritmias, Servicio de Cardiología, University Clinical Hospital of Santiago de Compostela Santiago de Compostela Spain

family: Martinez‐Sande

full_name: Jose L. Martinez‐Sande

given: Jose L.

name: Department of Cardiologic Medicine Centre Hospitalier Régional Universitaire de Tours ‐ Hôpital Trousseau Tours France

family: Clementy

full_name: Nicolas Clementy

given: Nicolas

name: Division of Cardiovascular Medicine, Department of Internal Medicine, Electrophysiology Section The Ohio State University Wexner Medical Center  Columbus Ohio USA

family: Augostini

full_name: Ralph Augostini

given: Ralph

family: Ravindran

full_name: Bipin Ravindran

given: Bipin

name: Baptist Heart Specialists, Baptist Medical Center  Jacksonville Florida USA

family: Sagi

full_name: Venkata Sagi

given: Venkata

name: Department of Cardiology Haga Teaching Hospital  The Hauge The Netherlands

family: Ramanna

full_name: Hemanth Ramanna

given: Hemanth

name: Department of Cardiovascular Sciences, Department of Cardiology University Hospitals Leuven Leuven Belgium

family: Garweg

full_name: Christophe Garweg

given: Christophe

name: University Hospital Southampton NHS Foundation Trust  Southampton UK

family: Roberts

full_name: Paul R. Roberts

given: Paul R.

name: Department of Cardiovascular Medicine Kyorin University School of Medicine  Tokyo Japan

family: Soejima

full_name: Kyoko Soejima

given: Kyoko

name: Medtronic, Inc.  Mounds View Minnesota USA

family: Stromberg

full_name: Kurt Stromberg

given: Kurt

family: Fagan

full_name: Dedra H. Fagan

given: Dedra H.

family: Zuniga

full_name: Nicky Zuniga

given: Nicky

name: Duke University Medical Center and Duke Clinical Research Institute  Durham North Carolina USA

family: Piccini

full_name: Jonathan P. Piccini

given: Jonathan P.

journal_name: Journal of Cardiovascular Electrophysiology

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

family: Garg

full_name: Aatish Garg

given: Aatish

family: Koneru

full_name: Jayanthi N. Koneru

given: Jayanthi N.

ReferenceCitation: Tjong FVY, Beurskens NEG, de Groot JR, Waweru C, Liu S, Ritter P, Reynolds D, Wilde AAM, Knops RE; Micra Investigators. Health-related quality of life impact of a transcatheter pacing system. J Cardiovasc Electrophysiol. 2018 Dec;29(12):1697-1704. doi: 10.1111/jce.13726. Epub 2018 Oct 15.

name: Department of CardiologyAmsterdam UMC, University of Amsterdam, Meibergdreef 9Amsterdam The Netherlands

name: Department of Cardiac Pacing and ElectrophysiologyCHU/Universitéde BordeauxPessac France

name: INSERM U1045, L’Institut de Rythmologie et de Modélisation Cardiaque LIRYC, CHU/Universitéde BordeauxPessac France

name: The Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical CenterOklahoma Oklahoma

title: Health‐related quality of life impact of a transcatheter pacing system

ReferenceCitation: El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Viñolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.

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

repository_institution: University of Copenhagen - Research at the University of Copenhagen

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

ReferenceCitation: Okabe T, El-Chami MF, Lloyd MS, Buck B, Gornick CC, Moore JC, Augostini RS, Hummel JD. Leadless pacemaker implantation and concurrent atrioventricular junction ablation in patients with atrial fibrillation. Pacing Clin Electrophysiol. 2018 May;41(5):504-510. doi: 10.1111/pace.13312. Epub 2018 Apr 16.

name: Division of Cardiovascular Medicine, Department of Internal Medicine; The Ohio State University Wexner Medical Center; Columbus OH USA

name: Department of Medicine-Cardiology; Emory University Hospital; Atlanta GA USA

name: Department of Cardiac Electrophysiology; Minneapolis Heart Institute; Minneapolis MN USA

ReferenceCitation: Soejima K, Asano T, Ishikawa T, Kusano K, Sato T, Okamura H, Matsumoto K, Taguchi W, Stromberg K, Lande J, Kobayashi Y; Micra Transcatheter Pacing Study Group. Performance of Leadless Pacemaker in Japanese Patients vs. Rest of the World - Results From a Global Clinical Trial. Circ J. 2017 Oct 25;81(11):1589-1595. doi: 10.1253/circj.CJ-17-0259. Epub 2017 May 30.

name: Department of Cardiology, Kyorin University Hospital

name: Department of Cardiology, Showa University Hospital

name: Department of Cardiology, Yokohama City University Hospital

name: Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center

name: Institute for Medical Regulatory Science, Waseda University

title: Performance of Leadless Pacemaker in Japanese Patients vs. Rest of the World ― Results From a Global Clinical Trial ―

ReferenceCitation: Lloyd M, Reynolds D, Sheldon T, Stromberg K, Hudnall JH, Demmer WM, Omar R, Ritter P, Hummel J, Mont L, Steinwender C, Duray GZ. Rate adaptive pacing in an intracardiac pacemaker. Heart Rhythm. 2017 Feb;14(2):200-205. doi: 10.1016/j.hrthm.2016.11.016. Epub 2016 Nov 15.

ReferenceCitation: Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA, Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. doi: 10.1056/NEJMoa1511643. Epub 2015 Nov 9.

ReferenceCitation: Ritter P, Duray GZ, Steinwender C, Soejima K, Omar R, Mont L, Boersma LV, Knops RE, Chinitz L, Zhang S, Narasimhan C, Hummel J, Lloyd M, Simmers TA, Voigt A, Laager V, Stromberg K, Bonner MD, Sheldon TJ, Reynolds D; Micra Transcatheter Pacing Study Group. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J. 2015 Oct 1;36(37):2510-9. doi: 10.1093/eurheartj/ehv214. Epub 2015 Jun 4.

ReferenceCitation: Ritter P, Duray GZ, Zhang S, Narasimhan C, Soejima K, Omar R, Laager V, Stromberg K, Williams E, Reynolds D; Micra Transcatheter Pacing Study Group. The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker. Europace. 2015 May;17(5):807-13. doi: 10.1093/europace/euv026. Epub 2015 Apr 7.

name: for the Micra Transcatheter Pacing Study Group

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
United States
South Africa
India
Serbia
Netherlands
Spain
France
Czechia
Greece
Japan
Malaysia
Hungary
Australia
China
Denmark
Canada
United Kingdom

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Lancaster Heart & Vascular Research Institute

location_facility: Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

location_facility: Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: St. Antonius Ziekenhuis - Locatie Nieuwegein

location_facility: Hospital Universitari Clínic de Barcelona

location_facility: University General Hospital of Heraklion

location_facility: University of Oklahoma Health Science Center (OUHSC)


title: A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis

summary: This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

ReferenceCitation: Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.

family: Cheng

full_name: Laurence E. Cheng

given: Laurence E.

family: Amoura

full_name: Zahir Amoura

given: Zahir

name: International Medical University; Kuala Lumpur Malaysia

family: Cheah

full_name: Benjamin Cheah

given: Benjamin

name: Charité Universitätsmedizin Berlin; Berlin Germany

family: Hiepe

full_name: Falk Hiepe

given: Falk

family: Sullivan

full_name: Barbara A. Sullivan

given: Barbara A.

family: Zhou

full_name: Lei Zhou

given: Lei

family: Arnold

full_name: Gregory E. Arnold

given: Gregory E.

family: Tsuji

full_name: Wayne H. Tsuji

given: Wayne H.

name: Oklahoma Medical Research Foundation; Oklahoma City

family: Merrill

full_name: Joan T. Merrill

given: Joan T.

family: Chung

full_name: James B. Chung

given: James B.

journal_name: Arthritis & Rheumatology

lead_sponsor: Amgen

location_country:
Germany
France
Malaysia
Australia
Denmark
United States
United Kingdom
Taiwan