title: A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

summary: This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

ReferenceCitation: O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. doi: 10.1200/JCO.18.00899. Epub 2019 Feb 1.

name: Columbia University Medical Center, New York, NY

family: O’Connor

full_name: Owen A. O’Connor

given: Owen A.

name: Ankara University Medical School, Ankara, Turkey

family: Özcan

full_name: Muhit Özcan

given: Muhit

name: Dana-Farber Cancer Institute, Boston, MA

family: Jacobsen

full_name: Eric D. Jacobsen

given: Eric D.

name: Institut Català d’Oncologia de Girona, Girona, Spain

family: Roncero

full_name: Josep M. Roncero

given: Josep M.

name: Concord Repatriation General Hospital, Concord, New South Wales, Australia

name: University of Sydney, New South Wales, Australia

family: Trotman

full_name: Judith Trotman

given: Judith

name: Semmelweis Egyetem Általános Orvostudományi Kar, Budapest, Hungary

family: Demeter

full_name: Judit Demeter

given: Judit

name: St. István and St. László Hospital, Budapest, Hungary

name: Semmelweis University, Budapest, Hungary

family: Masszi

full_name: Tamás Masszi

given: Tamás

name: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

family: Pereira

full_name: Juliana Pereira

given: Juliana

family: Ramchandren

full_name: Radhakrishnan Ramchandren

given: Radhakrishnan

name: Duke University Health System, Durham, NC

family: Beaven

full_name: Anne Beaven

given: Anne

name: Hospital Universitario de Salamanca, Salamanca, Spain

family: Caballero

full_name: Dolores Caballero

given: Dolores

name: Memorial Sloan Kettering Cancer Center, New York, NY

family: Horwitz

full_name: Steven M. Horwitz

given: Steven M.

name: Northern Centre for Cancer Care, Newcastle upon Tyne, United Kingdom

family: Lennard

full_name: Anne Lennard

name: Ondokuz Mayis University, Samsun, Turkey

family: Turgut

full_name: Mehmet Turgut

given: Mehmet

name: Hospital Israelita Albert Einstein, Sao Paulo, Brazil

family: Hamerschlak

full_name: Nelson Hamerschlak

given: Nelson

name: Aarhus Universitetshospital, Aarhus, Denmark

family: d’Amore

full_name: Francesco A. d’Amore

given: Francesco A.

name: Smilow Cancer Hospital at Yale New Haven, New Haven, CT

family: Foss

full_name: Francine Foss

given: Francine

name: Sungkyunkwan University School of Medicine, Seoul, South Korea

family: Kim

full_name: Won-Seog Kim

given: Won-Seog

name: Weill Cornell Medical College, New York, NY

family: Leonard

full_name: John P. Leonard

given: John P.

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

name: Santa Casa Medical School, São Paulo, Brazil

family: Chiattone

full_name: Carlos S. Chiattone

given: Carlos S.

family: Hsi

full_name: Eric D. Hsi

name: University Medical Center Göttingen, Göttingen, Germany

name: Millennium Pharmaceuticals, Cambridge, MA

name: University of Washington, Seattle Cancer Care Alliance, Seattle, WA

name: on behalf of the Lumiere Study Investigators

repositories_institution:
Elsevier - Scopus
PubMed Central - Europe PMC

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Denmark
Spain
France
Poland
Slovakia
Canada
Turkey
Chile
Sweden
Netherlands
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Egypt
Belarus
New Zealand


title: Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis

summary:
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.

Disease activity will be monitored systematically every 3 months by the Disease Activity Score.

Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies.

Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum.

Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).

Patients will be followed for 2 years.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Sepriano A, Ramiro S, FitzGerald O, Østergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larché MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewé R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.

family: Sepriano

full_name: Alexandre Sepriano

given: Alexandre

sequence: first

family: Ramiro

full_name: Sofia Ramiro

given: Sofia

sequence: additional

family: FitzGerald

full_name: Oliver FitzGerald

given: Oliver

family: Østergaard

full_name: Mikkel Østergaard

given: Mikkel

family: Homik

full_name: Joanne Homik

given: Joanne

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Elkayam

full_name: Ori Elkayam

given: Ori

family: Thorne

full_name: J. Carter Thorne

given: J. Carter

family: Larché

full_name: Maggie J. Larché

given: Maggie J.

family: Ferraccioli

full_name: Gianfranco Ferraccioli

given: Gianfranco

family: Backhaus

full_name: Marina Backhaus

given: Marina

family: Burmester

full_name: Gerd R. Burmester

given: Gerd R.

family: Boire

full_name: Gilles Boire

given: Gilles

family: Combe

full_name: Bernard Combe

given: Bernard

family: Schaeverbeke

full_name: Thierry Schaeverbeke

given: Thierry

family: Saraux

full_name: Alain Saraux

given: Alain

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Rossini

full_name: Maurizio Rossini

given: Maurizio

family: Govoni

full_name: Marcello Govoni

given: Marcello

family: Sinigaglia

full_name: Luigi Sinigaglia

given: Luigi

family: Cantagrel

full_name: Alain Cantagrel

family: Barnabe

full_name: Cheryl Barnabe

given: Cheryl

family: Bingham

full_name: Clifton O. Bingham

given: Clifton O.

suffix: III

ReferenceCitation: Maksymowych WP, FitzGerald O, Østergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larché MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewé R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.

lead_sponsor: Canadian Research & Education in Arthritis

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

location_facility: Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology

location_facility: Division of Allergy, Immunology and Rheumatology, University of Rochester

location_facility: Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie

location_facility: Department of Rheumatology, Copenhagen University Hospital at Glostrup

location_facility: Johns Hopkins Arthritis Center, Johns Hopkins University

location_facility: Departement de rheumatologie, Hopital Lapeyronie

location_facility: Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie

location_facility: Division of Rheumatology, University of Alberta Hospital

location_facility: Le Roux Liana, Centre d'Investigation Clinique

location_facility: Department of Rheumatology, University of Verona

location_facility: Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan

location_facility: Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie

location_facility: Department of Rheumatology, St. Vincents University Hospital

location_facility: Department of Rheumatology, Diakonhjemmet Hospital

location_facility: Afdeling Reumatologie, Leids Universitair Medisch Centrum

location_facility: Service de Rheumatologie-CHU Bordeaux Pellegrin

location_facility: Arthritis Center, University of Manitoba

location_facility: Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen

location_facility: Division of Rheumatology, Columbia University, College of Physicians and Surgeons

location_facility: Rheumatologist Hospital for Special Surgery


type: EudraCT Number

title: A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

summary: The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-γ-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Colombel

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

family: Petryka

full_name: Robert Petryka

given: Robert

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Mitra

full_name: Pranab Mitra

given: Pranab

family: Luo

full_name: Allison Luo

given: Allison

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Crohn's and Colitis

oa_colors: green hybrid

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: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Eldelumab [anti-interferon-γ-inducible protein-10 antibody] Induction Therapy for Active Crohn’s Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study

ReferenceCitation: Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.

family: Khanna

full_name: Reena Khanna

given: Reena

family: Zou

full_name: Guangyong Zou

given: Guangyong

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: McDonald

full_name: J W D McDonald

given: J W D

family: Daperno

full_name: Marco Daperno

given: Marco

family: Feagan

full_name: Brian G Feagan

given: Brian G

full_name: William J Sandborn

given: William J

family: Dubcenco

full_name: Elena Dubcenco

location_country:
South Africa
France
Poland
Israel
Hungary
Belgium
Puerto Rico
United States

location_facility: Nyu Langone Long Island Clinical Research Associates

location_facility: Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

location_facility: Gastroenterology Research Of San Antonio

location_facility: University Of North Carolina At Chapel Hill

location_facility: Gastroenterology Research Of New Orleans

location_facility: Southern California Medical Gastroenterology Group

location_facility: University Of Puerto Rico School Of Medicine


type: Other Identifier

title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

acronym: OCTAVE

summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

name: Robarts Research Institute Western University London Ontario Canada

full_name: Brian G. Feagan

given: Brian G.

name: Department of Medicine Division of Gastroenterology Western University London Ontario Canada

name: Division of Gastroenterology University of California San Diego La Jolla CA USA

name: Department of Gastroenterology University Hospitals Leuven Leuven Belgium

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

name: Department of Internal Medicine III Medical University of Vienna Vienna Austria

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Su

full_name: Chinyu Su

given: Chinyu

family: Salese

full_name: Leonardo Salese

given: Leonardo

family: Fan

full_name: Haiyun Fan

given: Haiyun

family: Paulissen

full_name: Jerome Paulissen

given: Jerome

family: Woodworth

full_name: Deborah A. Woodworth

given: Deborah A.

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

name: Dr. Henry D. Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sinai New York NY USA

journal_name: Alimentary Pharmacology & Therapeutics

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

name: Inflammatory Bowel Disease Center Department of Gastroenterology and Hepatology Mayo Clinic Jacksonville FL USA

family: Farraye

full_name: Francis A. Farraye

given: Francis A.

name: Digestive Disease and Surgery Institute Cleveland Clinic Cleveland OH USA

family: Qazi

full_name: Taha Qazi

given: Taha

name: IBD Outpatient Clinics Colorectal Surgery Unit Cajuru University HospitalPontifical Catholic University of Paraná (PUCPR) Curitiba Brazil

family: Kotze

full_name: Paulo G. Kotze

given: Paulo G.

name: Department of Gastroenterology Monash Health Melbourne Vic. Australia

name: School of Clinical Sciences at Monash Health Monash University Melbourne Vic. Australia

family: Moore

full_name: Gregory T. Moore

given: Gregory T.

family: Mundayat

full_name: Rajiv Mundayat

given: Rajiv

family: Lawendy

full_name: Nervin Lawendy

given: Nervin

family: Sharma

full_name: Puza P. Sharma

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

name: University of Chicago Medicine, Inflammatory Bowel Disease Center, 5841 S. Maryland Avenue, MC4076, Chicago, IL 60637, USA

name: Medical University of Vienna, Vienna, Austria

name: Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland

name: IBD Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil

name: Pfizer Switzerland AG, Zürich, Switzerland

name: Zentrum für Gastroenterologie und Hepatologie AG, Zürich, Switzerland

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA

journal_name: Therapeutic Advances in Gastroenterology

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2021 Mar 6. pii: S1542-3565(21)00222-6. doi: 10.1016/j.cgh.2021.02.043. [Epub ahead of print]

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

name: Beijing Linking Truth Technology Co. Ltd  Shanghai China

name: Pfizer Inc  Collegeville Pennsylvania USA

name: Division of Gastroenterology University of California, San Diego  La Jolla California USA

journal_name: Clinical Pharmacology in Drug Development

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

name: Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA

name: Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA

name: Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct 27. pii: S1542-3565(20)31496-8. doi: 10.1016/j.cgh.2020.10.038. [Epub ahead of print]

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

name: Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA

name: Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, California, USA

name: PEC2, EA 7460, University of Bourgogne—Franche Comté and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France

name: IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

name: Inflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA

name: Inflammation & Immunology, Pfizer Inc, New York, New York, USA

name: Division of Cardiovascular Medicine, University of California, San Diego, California, USA

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

title: Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management

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: Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panés J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.

name: Icahn School of Medicine at Mount Sinai, New York, New York, USA

name: Pfizer Inc., Collegeville, Pennsylvania, USA

name: Inflammatory Bowel Diseases Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA

name: Department of Gastroenterology and Hepatology, University of Zürich, Zürich, Switzerland

name: Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA

name: Pfizer Inc, Collegeville, Pennsylvania, USA

name: Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

name: Division of Gastroenterology; University of California, San Diego; La Jolla California

name: Hospital Clínic de Barcelona; IDIBAPS, CIBERehd; Barcelona Spain

name: Dr. Henry D. Janowitz Division of Gastroenterology; Icahn School of Medicine at Mount Sinai; New York New York

name: Medical University of Vienna; Vienna Austria

name: Division of Gastroenterology; IBD Center; Humanitas University; Rozzano Milan Italy

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

name: Oregon Health & Science University, Portland, Oregon

name: Cedars-Sinai Medical Center, Los Angeles, California

name: Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium

name: Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum in: Intest Res. 2018 Jul;16(3):499-501.

name: IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.

name: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.

name: Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.

name: Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

name: Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.

name: Inflammation & Immunology, Pfizer Japan Inc, Tokyo, Japan.

name: Center for Advanced IBD Research and Treatment, Kitasato University, Tokyo, Japan.

publisher: Korean Association for the Study of Intestinal Diseases

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

publisher_group: Korean Association for the Study of Intestinal Diseases

publisher_normalized: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Panés J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum in: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

name: Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK

name: Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

name: The University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panés J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

name: From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I,...

title: Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
Croatia
France
Poland
Slovakia
Canada
Korea, Republic of
Colombia
South Africa
Netherlands
Hungary
Germany
United States
United Kingdom
Austria
Brazil
Serbia
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: Vanderbilt University Medical Center - Drug Shipment

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and

location_facility: East Tallinn Central Hospital Internal Medicine Clinic

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: Vanderbilt University Medical Center - GCRC

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: X-Ray Unit, East Tallinn Central Hospital

location_facility: Virginia Commonwealth University, Clinical Research Services (CRSU)

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Krankenhaus Barmherzige Brueder St. Veit/Glan

location_facility: OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"

location_facility: The Gastroenterology Group of South Jersey

location_facility: University Hospital Center Zagreb,Department of Gastroenterology

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: Carolina Research - Carolina Digestive Diseases

location_facility: Universitäetsklinik Schleswig-Holstein, Campus Kiel

location_facility: VCU Health System Digestive Health Center

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

location_facility: Federal state budget institution "State scientific centre of coloproctology"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie

location_facility: H-T Centrum Medyczne sp. z o.o. sp. komandytowa

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: The Edith Wolfson Medical Center/Gastroenterology Institute

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital

location_facility: Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Concord Hospital -Concord Repatriation Hospital

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: Austin Gastroenterology PA/Professional Quality Research, Inc.

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék

location_facility: Department of Gastroenterology, Old Building

location_facility: Vanderbilt University Medical Center - GI Research Office

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

location_facility: The University of Texas Health Science Center at Houston

location_facility: Vanderbilt University Medical Center - Heart Station

location_facility: Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat

location_facility: Chevy Chase Endoscopy Center (Endoscopies Only)

location_facility: Vanderbilt University Medical Center - Radiology

location_facility: State budget Healthcare Institution Moscow regional scientific research clinical institute

location_facility: Center for Digestive & Liver Disease, Inc.

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital

location_facility: Connecticut Clinical Research Foundation

location_facility: Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie

location_facility: Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Municipal institution of healthcare "City clinical hospital 12"

location_facility: Municipal institution of healthcare "Clinical Hospital # 2"

location_facility: Oddzial Chorob Wewnetrznych i Gastroenterologii,

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

location_facility: University Medical Center Groningen (UMCG)

location_facility: VCU Medical Center Investigational Drug Service (IDS)

location_facility: Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.

location_facility: Citrus Surgery & Endoscopy Center (Colonoscopy)

location_facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Hanyang University Guri Hospital, Clinical Laboratory

location_facility: Medical Clinical Research Center "Health Clinic" on the base of

location_facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Minicipal Institution "City Hospital #7" Therapeutic Department,

location_facility: State Institution Institute of Gastroenterology of the National Academy of Medical Sciences

location_facility: State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"

location_facility: University Hospital Center Osijek, Clinic of Internal Medicine,

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: Clinical Research Institute of Michigan, LLC


type: Registry Identifier

title: A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy

summary: The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.

lead_sponsor: Takeda

location_country:
Italy
Sweden
Serbia
Netherlands
France
Bulgaria
Lithuania
Poland
Slovakia
Hungary
Spain
Estonia
Germany
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.

summary: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157.

ReferenceCitation: Woodcock A, Lötvall J, Busse WW, Bateman ED, Stone S, Ellsworth A, Jacques L. Efficacy and safety of fluticasone furoate 100 μg and 200 μg once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study. BMC Pulm Med. 2014 Jul 9;14:113. doi: 10.1186/1471-2466-14-113.

family: Woodcock

full_name: Ashley Woodcock

given: Ashley

family: Lötvall

full_name: Jan Lötvall

given: Jan

family: Busse

full_name: William W Busse

given: William W

family: Bateman

full_name: Eric D Bateman

given: Eric D

family: Stone

full_name: Sally Stone

given: Sally

family: Ellsworth

full_name: Anna Ellsworth

given: Anna

family: Jacques

full_name: Loretta Jacques

given: Loretta

currency_apc_doaj: GBP

journal_name: BMC Pulmonary Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Cape Town - Open University of Cape Town

repository_normalized: localhost

evidence: oa repository (via pmcid lookup)

repositories:
PubMed Central
localhost

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19.

family: Svedsater

full_name: Henrik Svedsater

given: Henrik

family: Goldfrad

full_name: Caroline Goldfrad

given: Caroline

family: Bleecker

full_name: Eugene R Bleecker

given: Eugene R

currency_apc_doaj: USD

journal_name: npj Primary Care Respiratory Medicine

ReferenceCitation: Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

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

location_country:
Chile
Mexico
France
Argentina
Russian Federation
United States


ReferenceCitation: Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2021 Mar 16. doi: 10.1111/ene.14823. [Epub ahead of print]

name: Queen Mary University of London London UK

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

name: Research Center for Clinical Neuroimmunology and Neuroscience and MS Center University Hospital Basel and University of Basel Basel Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: University Hospital of Strasbourg Strasbourg France

family: Seze

full_name: Jerome Seze

given: Jerome

name: University of California San Francisco CA USA

family: Hauser

full_name: Stephen L. Hauser

given: Stephen L.

name: F. Hoffmann‐La Roche Ltd Basel Switzerland

family: Overell

full_name: James Overell

given: James

family: Koendgen

full_name: Harold Koendgen

given: Harold

family: Manfrini

full_name: Marianna Manfrini

given: Marianna

family: Wang

full_name: Qing Wang

given: Qing

name: McGovern Medical School The University of Texas Health Science Center at Houston (UTHealth) Houston TX USA

family: Wolinsky

full_name: Jerry S. Wolinsky

given: Jerry S.

journal_name: European Journal of Neurology

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Brochet

full_name: Bruno Brochet

given: Bruno

family: Naismith

full_name: Robert T. Naismith

given: Robert T.

family: Traboulsee

full_name: Anthony Traboulsee

given: Anthony

family: Belachew

full_name: Shibeshih Belachew

given: Shibeshih

family: Levesque

full_name: Victoria Levesque

given: Victoria

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

name: University Hospital Basel, University of Basel, Basel, Switzerland

name: McGovern Medical School, The University of Texas Health Science Center at Houston, Houston

name: Queen Mary University of London, London, United Kingdom

name: McGill University, Montreal, Quebec, Canada

name: NeuroRx Research, Montreal, Quebec, Canada

name: F. Hoffmann–La Roche Ltd, Basel, Switzerland

name: Now with Biogen, Cambridge, Massachusetts

name: Weill Institute for Neurosciences, University of California, San Francisco, San Francisco

ReferenceCitation: Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

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

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

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

repository_institution: Tampere University - Tampere University Institutional Repository

location_country:
Belgium
Russian Federation
Ukraine
Croatia
France
Poland
Slovakia
Norway
Argentina
Canada
Sweden
Bulgaria
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Mexico
Czechia
Belarus
Spain
Turkey

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii

location_facility: City General Hospital; Department of Neurology

location_facility: MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: ALPI-Inst. de Rehabilitacion Marcelo Fitte

location_facility: Pardubicka Krajska Nemocnice; Department of Neurology

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hospital Mexico Americano SC; Departamento de Electroencefalografía

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

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: University of Miami; Dept. of Neurology MS Center

location_facility: Kings College Hospital; Neurosciences Clinical Trials Office

location_facility: MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie

location_facility: Road Clinical Hospital of Donetsk Station; Neurology Department

location_facility: Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie

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

location_facility: Vseobecna nemocnica s poliklinikou Levoca a.s.

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Universitätsklinikum Düsseldorf; Neurologische Klinik

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department

location_facility: Hospital Angeles Culiacan; Neurociencias

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Kirov City Clinical Hospital #1; Neurology Department

location_facility: Wayne State University; Department of Neurology

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Montreal Neurological Institute and Hospital

location_facility: Mun.Med.Proph.Inst."Chernihiv Reg.Hosp."; Neurology Department

location_facility: Karolinska Universitetssjukhuset Solna; Neurology

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: MHAT National Cardiology Hospital, EAD; Neurology

location_facility: Saratov State Medical University of RosZdrav; Neurology

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Territory Neurology and Research Institute

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a

location_facility: Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Associated Neurologists of Southern CT PC

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: University of Alberta; Northern Alberta Trials & Research Centre

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit

location_facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: University of Texas Southwestern Medical Center

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


title: A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

summary: The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

lead_sponsor: UCB Pharma

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Poland
Lithuania
Canada
Korea, Republic of
South Africa
Hong Kong
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Estonia


title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.

summary: the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

ReferenceCitation: Dieterich D, Nelson M, Soriano V, Arastéh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon α-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

family: Dieterich

full_name: Douglas Dieterich

given: Douglas

family: Nelson

full_name: Mark Nelson

given: Mark

family: Soriano

full_name: Vicente Soriano

given: Vicente

family: Arastéh

full_name: Keikawus Arastéh

given: Keikawus

family: Guardiola

full_name: Josep M. Guardiola

given: Josep M.

family: Rockstroh

full_name: Jürgen K. Rockstroh

given: Jürgen K.

family: Bhagani

full_name: Sanjay Bhagani

given: Sanjay

family: Laguno

full_name: Montserrat Laguno

given: Montserrat

family: Tural

full_name: Cristina Tural

given: Cristina

family: Ingiliz

full_name: Patrick Ingiliz

given: Patrick

family: Jain

full_name: Mamta K. Jain

given: Mamta K.

family: Stern

full_name: Jerry O. Stern

given: Jerry O.

family: Manero

full_name: Montserrat Manero

family: Vinisko

full_name: Richard Vinisko

given: Richard

family: Kort

full_name: Jens Kort

given: Jens

journal_name: AIDS

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Brazil
Switzerland
Germany
France
Spain
United States
United Kingdom

location_facility: 1220.19.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3904 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3906 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5503 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3902 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5505 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5508 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4102 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0006 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5506 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0007 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3306 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0079 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4919 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4921 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0045 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3905 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0060 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3408 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4402 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0044 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0014 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0026 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4920 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3407 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3901 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0008 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4924 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3903 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4922 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0021 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4104 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0086 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4923 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0005 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5501 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3907 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0011 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0084 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0031 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3307 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5502 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0016 Boehringer Ingelheim Investigational Site


title: A 12 Week Study to Evaluate the Effect of Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) on Arterial Stiffness Compared With Tiotropium Bromide 18 mcg Delivered Once Daily Via a HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

summary: This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.

ReferenceCitation: Pepin JL, Cockcroft JR, Midwinter D, Sharma S, Rubin DB, Andreas S. Long-acting bronchodilators and arterial stiffness in patients with COPD: a comparison of fluticasone furoate/vilanterol with tiotropium. Chest. 2014 Dec;146(6):1521-1530. doi: 10.1378/chest.13-2859.

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

family: Cockcroft

full_name: John R. Cockcroft

given: John R.

family: Midwinter

full_name: Dawn Midwinter

given: Dawn

family: Sharma

full_name: Sanjay Sharma

family: Rubin

full_name: David B. Rubin

given: David B.

family: Andreas

full_name: Stefan Andreas

given: Stefan

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Long-Acting Bronchodilators and Arterial Stiffness in Patients With COPD

ipd_sharing: Yes

lead_sponsor: GlaxoSmithKline

location_country:
Italy
France
Norway
Argentina
Russian Federation
Germany
Ukraine


title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

summary: This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

ReferenceCitation: Lacroix A, Bronstein MD, Schopohl J, Delibasi T, Salvatori R, Li Y, Barkan A, Suzaki N, Tauchmanova L, Ortmann CE, Ravichandran S, Petersenn S, Pivonello R. Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study. J Endocrinol Invest. 2020 Nov;43(11):1613-1622. doi: 10.1007/s40618-020-01246-0. Epub 2020 May 8.

family: Lacroix

full_name: A. Lacroix

given: A.

family: Bronstein

full_name: M. D. Bronstein

given: M. D.

family: Schopohl

full_name: J. Schopohl

given: J.

family: Delibasi

full_name: T. Delibasi

given: T.

family: Salvatori

full_name: R. Salvatori

given: R.

family: Li

full_name: Y. Li

given: Y.

family: Barkan

full_name: A. Barkan

family: Suzaki

full_name: N. Suzaki

given: N.

family: Tauchmanova

full_name: L. Tauchmanova

given: L.

family: Ortmann

full_name: C.-E. Ortmann

family: Ravichandran

full_name: S. Ravichandran

given: S.

family: Petersenn

full_name: S. Petersenn

family: Pivonello

full_name: R. Pivonello

journal_name: Journal of Endocrinological Investigation

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

title: Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study

ReferenceCitation: Newell-Price J, Pivonello R, Tabarin A, Fleseriu M, Witek P, Gadelha MR, Petersenn S, Tauchmanova L, Ravichandran S, Gupta P, Lacroix A, Biller BMK. Use of late-night salivary cortisol to monitor response to medical treatment in Cushing's disease. Eur J Endocrinol. 2020 Feb;182(2):207-217. doi: 10.1530/EJE-19-0695.

name: 1The Medical School, University of Sheffield, Sheffield, UK

family: Newell-Price

full_name: John Newell-Price

given: John

name: 2Università Federico II di Napoli, Naples, Italy

full_name: Rosario Pivonello

given: Rosario

name: 3Department of Endocrinology, CHU of Bordeaux, Bordeaux, France

family: Tabarin

full_name: Antoine Tabarin

given: Antoine

name: 4Northwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

name: 5Department of Endocrinology, Military Institute of Medicine and Department of Internal Medicine, Endocrinology and Diabetes, Medical University of Warsaw, Warsaw, Poland

family: Witek

full_name: Przemysław Witek

given: Przemysław

name: 6Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil

family: Gadelha

full_name: Mônica R Gadelha

given: Mônica R

name: 7ENDOC Center for Endocrine Tumors, Hamburg, Germany

full_name: Stephan Petersenn

given: Stephan

full_name: Libuse Tauchmanova

given: Libuse

name: 9Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

name: 10Novartis Healthcare Private Limited, Hyderabad, India

name: 11Centre Hospitalier de l’Université de Montréal, Montreal, Canada

name: 12Neuroendocrine Clinical Center, Massachusetts General Hospital, Boston, Massachusetts, USA

title: Use of late-night salivary cortisol to monitor response to medical treatment in Cushing’s disease

ReferenceCitation: Fleseriu M, Petersenn S, Biller BMK, Kadioglu P, De Block C, T'Sjoen G, Vantyghem MC, Tauchmanova L, Wojna J, Roughton M, Lacroix A, Newell-Price J. Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study. Clin Endocrinol (Oxf). 2019 Dec;91(6):776-785. doi: 10.1111/cen.14081. Epub 2019 Oct 1.

name: Northwest Pituitary Center Oregon Health & Science University Portland OR USA

name: ENDOC Center for Endocrine Tumors Hamburg Germany

name: Massachussetts General Hospital Boston MA USA

name: Pituitary Center Istanbul University Istanbul Turkey

name: Department of Endocrinology, Diabetology and Metabolism Antwerp University Hospital Antwerp Belgium

name: Department of Endocrinology and Center for Sexology and Gender Ghent University Hospital Ghent Belgium

name: Endocrinology, Diabetology and Metabolism CHU Lille Lille France

name: Novartis Pharmaceuticals Corporation East Hanover NJ USA

name: Centre hospitalier de l'Université de Montréal Montreal QC Canada

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

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

title: Long‐term efficacy and safety of once‐monthly pasireotide in Cushing's disease: A Phase III extension study

ReferenceCitation: Lacroix A, Gu F, Gallardo W, Pivonello R, Yu Y, Witek P, Boscaro M, Salvatori R, Yamada M, Tauchmanova L, Roughton M, Ravichandran S, Petersenn S, Biller BMK, Newell-Price J; Pasireotide G2304 Study Group. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):17-26. doi: 10.1016/S2213-8587(17)30326-1. Epub 2017 Oct 12. Erratum in: Lancet Diabetes Endocrinol. 2018 Jan;6(1):e1.

ReferenceCitation: Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1. Review.

title: Hyperglycemia induced by pasireotide in patients with Cushing’s disease or acromegaly

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
Brazil
Peru
India
Netherlands
Spain
Germany
France
Japan
Poland
Israel
Thailand
Belgium
Argentina
Russian Federation
China
Turkey
Canada
United Kingdom

location_facility: University of Michigan Comprehensive Cancer Center SC-2

location_facility: Mount Sinai School of Medicine Mt. Sinai Medical Center

location_facility: Vanderbilt University Medical Center CSOM230G2304

location_facility: Oregon Health & Sciences University DeptofOregonHealth&Sciences(2)

location_facility: Pituitary Center, Division of Endocrinology SC

location_facility: University of Pennsylvania - Clinical Studies Unit Unniv SC

location_facility: University of California at Los Angeles UCLA Tiverton

location_facility: Emory University School of Medicine/Winship Cancer Institute G2304 - C2301


title: A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

summary: The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Zoulim F, Moreno C, Lee SS, Buggisch P, Horban A, Lawitz E, Corbett C, Lenz O, Fevery B, Verbinnen T, Shukla U, Jessner W. A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection. Virol J. 2018 Jan 30;15(1):26. doi: 10.1186/s12985-018-0936-4.

family: Zoulim

full_name: Fabien Zoulim

given: Fabien

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Lee

full_name: Samuel S. Lee

given: Samuel S.

family: Buggisch

full_name: Peter Buggisch

given: Peter

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Corbett

full_name: Chris Corbett

given: Chris

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Fevery

full_name: Bart Fevery

given: Bart

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Shukla

full_name: Umesh Shukla

given: Umesh

family: Jessner

full_name: Wolfgang Jessner

given: Wolfgang

journal_name: Virology Journal

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Calgary - PRISM

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

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

location_country:
United States
Germany
France
Poland
Belgium
Russian Federation
Canada


title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

acronym: GRAMS

summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

primary_purpose: Diagnostic

lead_sponsor: Bayer

location_country:
Austria
Brazil
Switzerland
Germany
France
Poland
Argentina
Turkey
United States
Czech Republic
Korea, Republic of
Taiwan
Colombia


title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

family: Glaspole

full_name: Ian Glaspole

given: Ian

family: Bonella

full_name: Francesco Bonella

given: Francesco

family: Bargagli

full_name: Elena Bargagli

given: Elena

family: Glassberg

full_name: Marilyn K. Glassberg

given: Marilyn K.

family: Caro

full_name: Fabian Caro

given: Fabian

family: Stansen

full_name: Wibke Stansen

given: Wibke

family: Quaresma

full_name: Manuel Quaresma

given: Manuel

family: Orsatti

full_name: Leticia Orsatti

given: Leticia

family: Bendstrup

full_name: Elisabeth Bendstrup

given: Elisabeth

journal_name: Respiratory Research

ReferenceCitation: Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

family: Jouneau

full_name: Stéphane Jouneau

given: Stéphane

family: Crestani

full_name: Bruno Crestani

given: Bruno

family: Thibault

full_name: Ronan Thibault

given: Ronan

family: Lederlin

full_name: Mathieu Lederlin

given: Mathieu

family: Vernhet

full_name: Laurent Vernhet

given: Laurent

family: Valenzuela

full_name: Claudia Valenzuela

given: Claudia

family: Wijsenbeek

full_name: Marlies Wijsenbeek

given: Marlies

family: Kreuter

full_name: Michael Kreuter

given: Michael

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

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6). pii: 2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

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

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
publicatt.unicatt.it

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: Università Cattolica del Sacro Cuore - PubliCatt

ReferenceCitation: Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS® trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

ReferenceCitation: Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(®) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

title: Subgroup Analysis for Chinese Patients Included in the INPULSIS® Trials on Nintedanib in Idiopathic Pulmonary Fibrosis

ReferenceCitation: Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS® trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

ReferenceCitation: Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5). pii: 1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

ReferenceCitation: Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

name: Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland; and

name: Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland

ReferenceCitation: Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
spiral.imperial.ac.uk

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Southampton - ePrints Soton

ReferenceCitation: Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

ReferenceCitation: Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum in: N Engl J Med. 2015 Aug 20;373(8):782.

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repositories_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

title: Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis

ReferenceCitation: Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

title: Design of the INPULSIS™ trials: Two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis

location_country:
Chile
India
Mexico
Netherlands
Germany
Spain
Finland
France
Japan
Greece
Korea, Republic of
Russian Federation
China
Turkey
United States
Canada
Portugal

location_facility: 1199.34.81062 Boehringer Ingelheim Investigational Site

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location_facility: 1199.34.86058 Boehringer Ingelheim Investigational Site

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location_facility: 1199.34.81056 Boehringer Ingelheim Investigational Site

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location_facility: 1199.34.91054 Boehringer Ingelheim Investigational Site

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location_facility: 1199.34.31002 Boehringer Ingelheim Investigational Site

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location_facility: 1199.34.81057 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33005 Boehringer Ingelheim Investigational Site

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location_facility: 1199.34.91055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34005 Boehringer Ingelheim Investigational Site

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title: An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

acronym: SPARTAN

summary: The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Poland
Spain
Germany
United Kingdom

location_facility:
Aids Care
The Research Institute
Orange County Health Dept.
Health For Life Clinic Pllc
Metropolis Medical Pc
Triple O Medical Services, P.A.
Eisenhower Medical Center
Local Institution
Consultive Medicine


lead_sponsor: Hoffmann-La Roche

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

source: euctr

title: A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer

summary: This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

ReferenceCitation: Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.

family: Barker

full_name: Alan F Barker

given: Alan F

family: O'Donnell

full_name: Anne E O'Donnell

given: Anne E

family: Flume

full_name: Patrick Flume

given: Patrick

family: Thompson

full_name: Philip J Thompson

given: Philip J

family: Ruzi

full_name: Jonathan D Ruzi

given: Jonathan D

family: de Gracia

full_name: Javier de Gracia

given: Javier

family: Boersma

full_name: Wim G Boersma

given: Wim G

family: De Soyza

full_name: Anthony De Soyza

given: Anthony

family: Shao

full_name: Lixin Shao

given: Lixin

family: Zhang

full_name: Jenny Zhang

given: Jenny

family: Haas

full_name: Laura Haas

given: Laura

family: Lewis

full_name: Sandra A Lewis

given: Sandra A

family: Leitzinger

full_name: Sheila Leitzinger

given: Sheila

family: Montgomery

full_name: A Bruce Montgomery

given: A Bruce

family: McKevitt

full_name: Matthew T McKevitt

given: Matthew T

family: Gossage

full_name: David Gossage

given: David

family: Quittner

full_name: Alexandra L Quittner

given: Alexandra L

family: O'Riordan

full_name: Thomas G O'Riordan

given: Thomas G

journal_name: The Lancet Respiratory Medicine

lead_sponsor: Gilead Sciences

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

location_facility: University of Texas Health Science Center at Tyler

location_facility: Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord

location_facility: The Lung Centre at Vancouver General Hospital

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Medical College of Wisconsin Froedtert Hospital

location_facility: UO Broncopneumologia IRCCS Fondazione Cà Granda Milano

location_facility: Columbia University, NY Presbyterian Hospital

location_facility: Royal Devon and Exeter Hospital, NHS Foundation Trust

location_facility: Tampa General Hospital - New Lung Associates

location_facility: Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica

location_facility: Sarasota Memorial Hospital - Clinical Research Center

location_facility: Pulmonary & Critical Care Associates of Baltimore

location_facility: Universitätsklinikum Jena Clinic for Internal Medicine II

location_facility: Kelowna Respiratory Research and Allergy Clinic

location_facility: University of Pennsylvania Medical Center

location_facility: GBS RE Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Sir William Leech Centre for Lung Research, Freeman Hospital

location_facility: CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP

location_facility: Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.

location_facility: University of Miami Miller School of Medicine

location_facility: The Oregon Clinic P.C./ Pulmonary Division

location_facility: Research Center for Medical Studies (RCMS)


title: A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

acronym: D-LITE

summary: The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

location_country:
Italy
United States
France
Japan
Australia
Puerto Rico
New Zealand
Spain
Germany

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: University Of Colorado Denver And Hospital

location_facility: Bristol-Myers Squibb/David E. Bernstein, Md


title: Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

summary: The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

primary_purpose: Prevention

lead_sponsor: BioTech Tools S.A.

location_country: Luxembourg Belgium France

location_facility:
UZ Leuven
CHRU Lille
CHU Ambroise Paré
CH Luxembourg
AZ Sint Lucas
UZ Brussel
CHU Reims
UCL Mont Godinne
Hôpital Saint Vincent de Paul
CHR Citadelle
CHRU Strasbourg
UZ Gent
CHU Sart-Tilman
Private practice
CHR Saint Joseph Warquignies
UCL Saint Luc
Clinique du Parc Léopold
UZ Antwerpen

intervention_type: Biological