ReferenceType: result

ReferenceCitation: Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. Erratum in: Lancet. 2015 Aug 8;386(9993):532. Lancet. 2015 Aug 8;386(9993):532.

family: Moskowitz

full_name: Craig H Moskowitz

given: Craig H

family: Nademanee

full_name: Auayporn Nademanee

given: Auayporn

family: Masszi

full_name: Tamas Masszi

given: Tamas

family: Agura

full_name: Edward Agura

given: Edward

family: Holowiecki

full_name: Jerzy Holowiecki

given: Jerzy

family: Abidi

full_name: Muneer H Abidi

given: Muneer H

full_name: Andy I Chen

given: Andy I

family: Stiff

full_name: Patrick Stiff

given: Patrick

family: Gianni

full_name: Alessandro M Gianni

given: Alessandro M

family: Carella

full_name: Angelo Carella

given: Angelo

family: Osmanov

full_name: Dzhelil Osmanov

given: Dzhelil

family: Bachanova

full_name: Veronika Bachanova

given: Veronika

family: Sweetenham

full_name: John Sweetenham

given: John

family: Sureda

full_name: Anna Sureda

given: Anna

family: Huebner

full_name: Dirk Huebner

given: Dirk

family: Sievers

full_name: Eric L Sievers

given: Eric L

family: Chi

full_name: Andy Chi

given: Andy

family: Larsen

full_name: Emily K Larsen

given: Emily K

family: Hunder

full_name: Naomi N Hunder

given: Naomi N

family: Walewski

full_name: Jan Walewski

given: Jan

journal_name: The Lancet

ReferenceCitation: Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.

name: Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL;

full_name: Craig H. Moskowitz

given: Craig H.

name: Department of Lymphoid Malignancies, Maria Sklodowska-Curie Memorial Institute and Oncology Centre, Warsaw, Poland;

name: Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA;

name: 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary;

name: Blood and Marrow Transplantation, Baylor University Medical Center, Dallas, TX;

name: Department of Bone Marrow Transplantation & Oncohematology, Maria Sklodowska-Curie Institute of Oncology, Gliwice, Poland;

name: Bone Marrow Transplant Program, Spectrum Health Cancer Center, Michigan State University, Grand Rapids, MI;

name: Center for Hematologic Malignancies, Oregon Health & Science University, Portland, OR;

name: Cardinal Bernardain Cancer Center, Loyola University Medical Center, Maywood, IL;

name: Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;

name: Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN;

name: Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d’Oncologia Hospitalet, Barcelona, Spain;

name: Department of Hematology and Blood and Marrow Transplant, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT

location_country:
Italy
United States
Serbia
France
Czechia
Bulgaria
Poland
Romania
Hungary
Russian Federation
Spain
Germany
United Kingdom

location_facility: Klinicki centar Srbije, Klinika za hematologiju

location_facility: Guy's Hospital Haematology Department, 4th Floor Southwark Wing

location_facility: Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: James Cancer Hospital / Ohio State University

location_facility: Virginia Commonwealth University Medical Center

location_facility: Vojnomedicinska akademija, Klinika za hematologiju

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

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: Sverdlovskaja oblastnaja klinicheskaja bol'nica #1

location_facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Vseobecni fakultni nemocnice v Prahe-I. interni klinika

location_facility: Leningradskaja oblastnaja klinicheskaja bol'nica

location_facility: Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach

location_facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center

location_facility: Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Respublikanskaja bol'nica im. V.A. Baranova

location_facility: Hospital Clinic i Provincial Servicio Hematologia

location_facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

location_facility: University of Chicago Section of Hematology/Oncology Lymphoma Program

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High

location_facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie

location_facility: Washington University School of Medicine

location_facility: Oregon Health and Science University / Center for Hematologic Malignancies

location_facility: Service des Maladies du Sang / Hospital Saint Louis

location_facility: Burdenko Central Military Clinical Hospital

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

location_facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

location_facility: Complejo Hospitalano de Navarra Servicio Hematologia

location_facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie

location_facility: CHU Nantes - Hopital Hotel Dieu Service Hematologie

location_facility: Federal Medical Biophysical Center n.a. A.I. Burnazyan

location_facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

location_facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne

location_facility: University of California at San Francisco

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego

location_facility: Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

acronym: ATLAS

summary: This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Calabrese JR, Jin N, Johnson B, Such P, Baker RA, Madera J, Hertel P, Ottinger J, Amatniek J, Kawasaki H. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018 Jun 10;6(1):14. doi: 10.1186/s40345-018-0122-z.

family: Calabrese

full_name: Joseph R. Calabrese

given: Joseph R.

sequence: first

family: Jin

full_name: Na Jin

sequence: additional

family: Johnson

full_name: Brian Johnson

given: Brian

family: Such

full_name: Pedro Such

given: Pedro

family: Baker

full_name: Ross A. Baker

given: Ross A.

family: Madera

full_name: Jessica Madera

given: Jessica

family: Hertel

full_name: Peter Hertel

given: Peter

family: Ottinger

full_name: Jocelyn Ottinger

given: Jocelyn

family: Amatniek

full_name: Joan Amatniek

given: Joan

family: Kawasaki

full_name: Hiroaki Kawasaki

given: Hiroaki

bso_classification: Social sciences

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Bipolar Disorders

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
France
Japan
Korea, Republic of
Malaysia
Poland
Romania
Hungary
United States
Canada
Taiwan

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride

summary: The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

design_allocation: Randomized

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

family: Boustani

full_name: M. A. Boustani

given: M. A.

name: Providence Medical Group  Terre Haute IN USA

family: Pittman

full_name: I. Pittman

given: I.

suffix: IV

name: Eli Lilly and Company  Toronto ON Canada

family: Yu

full_name: M. Yu

given: M.

name: Eli Lilly and Company  Indianapolis IN USA

family: Thieu

full_name: V. T. Thieu

given: V. T.

family: Varnado

full_name: O. J. Varnado

given: O. J.

family: Juneja

full_name: R. Juneja

given: R.

bso_classification: Medical research

journal_name: Diabetes, Obesity and Metabolism

oa_colors: green hybrid

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

title: Similar efficacy and safety of once‐weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

family: Van Brunt

full_name: K. Van Brunt

given: K.

name: Lilly Diabetes; Eli Lilly and Company; Indianapolis IN USA

family: Boye

full_name: K. S. Boye

given: K. S.

ReferenceCitation: Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.

family: Giorgino

full_name: Francesco Giorgino

given: Francesco

family: Benroubi

full_name: Marian Benroubi

given: Marian

family: Sun

full_name: Jui-Hung Sun

given: Jui-Hung

location_country:
Italy
Brazil
Sweden
India
Mexico
Croatia
France
Greece
Poland
Slovakia
Romania
Hungary
Belgium
Argentina
Australia
Spain
Canada
Czech Republic
Korea, Republic of
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.


status: Terminated

lead_sponsor: Bayer

location_country:
Italy
South Africa
United Kingdom
Germany
Finland
France
Japan
Korea, Republic of
Israel
Poland
Hungary
Ireland
Spain
United States
Czech Republic
Canada

acronym: COMPOSE EARLY

type: EudraCT Number

source: euctr

title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)

summary: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

status_simplified: Unknown


title: A European, Prospective, Non-Interventional Study to Assess Health Related Quality of Life and to Identify Key Transitional Life Events in Patients With Moderate or Severe Haemophilia A Using Helixate NexGen

summary: The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.

study_type: Observational

time_perspective: Prospective

lead_sponsor: CSL Behring

location_country: Italy Austria Switzerland France Belgium Spain Germany

location_facility:
CSLB Study Site 71
CSLB Study Site 23
CSLB Study Site 72
CSLB Study Site 52
CSLB Study Site 21
CSLB Study Site 74
CSLB Study Site 27
CSLB Study Site 25
CSLB Study Site 6
CSLB Study Site 60
CSLB Study Site 26
CSLB Study Site 24
CSLB Study Site 20
CSLB Study Site 51
CSLB Study Site 22
CSLB Study Site 29
CSLB Study Site 1
CSLB Study Site 68
CSLB Study Site 98
CSLB Study Site 7
CSLB Study Site 73
CSLB Study Site 64
CSLB Study Site 4
CSLB Study Site 2
CSLB Study Site 91
CSLB Study Site 66
CSLB Study Site 36
CSLB Study Site 35
CSLB Study Site 95
CSLB Study Site 65
CSLB Study Site 3


ReferenceCitation: Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Bergeron

full_name: Christophe Bergeron

given: Christophe

family: Gore

full_name: Lia Gore

given: Lia

family: Sender

full_name: Leonard Sender

given: Leonard

family: Dunkel

full_name: Ira J. Dunkel

given: Ira J.

family: Herzog

full_name: Cynthia Herzog

given: Cynthia

family: Brochez

full_name: Lieve Brochez

given: Lieve

family: Cruz

full_name: Ofelia Cruz

given: Ofelia

family: Nysom

full_name: Karsten Nysom

given: Karsten

family: Berghorn

full_name: Elmer Berghorn

given: Elmer

family: Simsek

full_name: Burcin Simsek

given: Burcin

family: Shen

full_name: Jun Shen

given: Jun

family: Pappo

full_name: Alberto Pappo

given: Alberto

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Biological

study_start_date_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Mexico
Germany
France
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: University Of Pittsburgh Medical Center Cancer Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: James Whitcomb Riley Hospital For Children

title: Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma

summary: The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab


title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

ReferenceCitation: Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

family: Combe

full_name: Bernard Combe

given: Bernard

family: Tsai

full_name: Tsen-Fang Tsai

given: Tsen-Fang

family: Huffstutter

full_name: J. Eugene Huffstutter

given: J. Eugene

family: Sprabery

full_name: Aubrey Trevelin Sprabery

given: Aubrey Trevelin

family: Lin

full_name: Chen-Yen Lin

given: Chen-Yen

family: Park

full_name: So Young Park

given: So Young

family: Kronbergs

full_name: Andris Kronbergs

given: Andris

family: Hufford

full_name: Matthew M. Hufford

given: Matthew M.

family: Nash

full_name: Peter Nash

given: Peter

journal_name: Arthritis Research & Therapy

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

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square
research-repository.griffith.edu.au

ReferenceCitation: Schweikert B, Malmberg C, Núñez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

family: Schweikert

full_name: Bernd Schweikert

given: Bernd

family: Malmberg

full_name: Chiara Malmberg

given: Chiara

family: Núñez

full_name: Mercedes Núñez

given: Mercedes

family: Dilla

full_name: Tatiana Dilla

given: Tatiana

family: Sapin

full_name: Christophe Sapin

family: Hartz

full_name: Susanne Hartz

ReferenceCitation: Chandran V, van der Heijde D, Fleischmann RM, Lespessailles E, Helliwell PS, Kameda H, Burgos-Vargas R, Erickson JS, Rathmann SS, Sprabery AT, Birt JA, Shuler CL, Gallo G. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020 Oct 1;59(10):2774-2784. doi: 10.1093/rheumatology/kez684.

name: Division of Rheumatology, Department of Medicine, University of Toronto, ON, Canada

name: Institute of Medical Science, University of Toronto, ON, Canada

name: Krembil Research Institute, University Health Network, Toronto, ON, Canada

name: Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands

name: Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA

name: Department of Rheumatology CHR Orléans, University of Orléans, Orléans, France

name: Department of Internal Medicine, Toho University, Tokyo, Japan

name: Department of Rheumatology, Hospital General de Mexico, Mexico City, Mexico

name: Eli Lilly and Company, Indianapolis, IN, USA

ReferenceCitation: Combe B, Rahman P, Kameda H, Cañete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

ReferenceCitation: Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

ReferenceCitation: Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

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

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

title: Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients’ health-related quality of life and productivity

ReferenceCitation: Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

ReferenceCitation: Gottlieb AB, Strand V, Kishimoto M, Mease P, Thaçi D, Birt J, Lee CH, Shuler CL, Lin CY, Gladman DD. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1). Rheumatology (Oxford). 2018 Oct 1;57(10):1777-1788. doi: 10.1093/rheumatology/key161.

name: Department of Dermatology, New York Medical College, Metropolitan Hospital, New York, NY

name: Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA

name: St Luke’s International Hospital, Immuno-Rheumatology Centre, Tokyo, Japan

name: Department of Rheumatology, Swedish Medical Centre, Seattle, WA, USA

name: Division of Rheumatology, University of Washington, Seattle, WA, USA

name: Comprehensive Centre for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany

name: Division of Rheumatology, Department of Medicine, University of Toronto, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada

ReferenceCitation: Coates LC, Kishimoto M, Gottlieb A, Shuler CL, Lin CY, Lee CH, Mease PJ. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017 Dec 22;3(2):e000567. doi: 10.1136/rmdopen-2017-000567. eCollection 2017.

ReferenceCitation: van der Heijde D, Gladman DD, Kishimoto M, Okada M, Rathmann SS, Moriarty SR, Shuler CL, Carlier H, Benichou O, Mease PJ. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1). J Rheumatol. 2018 Mar;45(3):367-377. doi: 10.3899/jrheum.170429. Epub 2017 Dec 15. Erratum in: J Rheumatol. 2018 Nov;45(11):1608.

ReferenceCitation: Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017 Jan;76(1):79-87. doi: 10.1136/annrheumdis-2016-209709. Epub 2016 Aug 23.

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

location_country:
United States
Mexico
Netherlands
France
Czechia
Bulgaria
Japan
Poland
Belgium
Russian Federation
Spain
Estonia
Canada
United Kingdom
Ukraine


title: MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial

summary: This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

family: Ortega

full_name: Hector G. Ortega

given: Hector G.

family: Meyer

full_name: Erik Meyer

given: Erik

family: Brusselle

full_name: Guy Brusselle

given: Guy

family: Asano

full_name: Koichiro Asano

given: Koichiro

family: Prazma

full_name: Charlene M. Prazma

given: Charlene M.

family: Albers

full_name: Frank C. Albers

given: Frank C.

family: Mallett

full_name: Stephen A. Mallett

given: Stephen A.

family: Yancey

full_name: Steve W. Yancey

given: Steve W.

family: Gleich

full_name: Gerald J. Gleich

given: Gerald J.

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

oa_host_type: publisher

ReferenceCitation: Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019 May;143(5):1742-1751.e7. doi: 10.1016/j.jaci.2018.09.033. Epub 2018 Oct 23.

family: Khatri

full_name: Sumita Khatri

given: Sumita

family: Moore

full_name: Wendy Moore

given: Wendy

family: Gibson

full_name: Peter G. Gibson

given: Peter G.

family: Leigh

full_name: Richard Leigh

given: Richard

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Barros

full_name: Manuel Barros

given: Manuel

family: Buhl

full_name: Roland Buhl

given: Roland

family: Howarth

full_name: Peter Howarth

family: Bradford

full_name: Eric S. Bradford

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

location_country:
United States
Chile
Germany
France
Poland
Romania
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
Ukraine


title: A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma

acronym: TAURUS

summary: Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

ipd_sharing: No

lead_sponsor: AVEO Pharmaceuticals, Inc.

location_country:
Italy
United States
France
Belgium
Spain
Germany
United Kingdom


ReferenceCitation: Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Józwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.

name: The Center for Neurological and Neurodevelopmental Health (CNNH) and the Clinical Research Center of New Jersey (CRCNJ), Voorhees, NJ, USA

family: Mintz

full_name: Mark Mintz

given: Mark

name: Centennial Children’s Hospital, Nashville, TN, USA

family: Pina-Garza

full_name: Jesus E. Pina-Garza

given: Jesus E.

name: Department of Neurology, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA

family: Wolf

full_name: Steven M. Wolf

given: Steven M.

family: McGoldrick

full_name: Patricia E. McGoldrick

given: Patricia E.

name: Department of Pediatric Neurology, Medical University Warsaw, Warsaw, Poland

name: Department of Neurology and Epileptology, The Children’s Memorial Health Institute, Warsaw, Poland

family: Józwiak

full_name: Sergiusz Józwiak

given: Sergiusz

name: Sunovion Pharmaceuticals Inc, Marlborough, MA, USA

family: Grinnell

full_name: Todd Grinnell

given: Todd

family: Cantu

full_name: David Cantu

given: David

name: BIAL–Portela & Cª, SA, Coronado (São Romão e São Mamede), Portugal

family: Costa

full_name: Raquel Costa

given: Raquel

family: Moreira

full_name: Joana Moreira

given: Joana

family: Li

full_name: Yan Li

given: Yan

family: Blum

full_name: David Blum

journal_name: Journal of Child Neurology

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Bial - Portela C S.A.

location_country:
Malaysia
Romania
Russian Federation
Taiwan
Ukraine
Croatia
France
Poland
Slovakia
Moldova, Republic of
Philippines
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Czechia
Spain

location_facility: Clinical Centre Nis, Clinic of Children Internal Diseases, Child Neurology Department

location_facility: Clinical Centre Banja Luka Pediatric Clinic Department of Neurology

location_facility: University Putra Malaysia/Hospital Serdang - Department of Paediatrics, Faculty of Medicine and Health Sciences

location_facility: Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: AKADEMIA MEDYCZNA im. Karola Marcinkowskiego w Poznaniu Katedra I Klinika Neurologii Wieku Rozwojowego

location_facility: Epilepsiezentrum Kehl-Kork Kinderklinik Anfallsambulanz für Kinder und jugendliche

location_facility: Institute of Neurology, Psychiatry and Narcology, AMS of Ukraine Acad.

location_facility: Research Center of Children Health of RAMS

location_facility: Tempus, s.r.o.Child Epileptology Ambulance

location_facility: Krakowski Szpital, Specjalistyczny Im. Jana Pawła Ii W Krakowie

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde, Klinische Abteilung für allg. Pädiatrie, AKH Wien

location_facility: Child Neurology Clinic of the DNsP Ostrava

location_facility: A.O.U. di Cagliari Clinica di neurologia infantile

location_facility: Budai Gyermekkórház, Buda Children's Hospital and Outpatient Clinic

location_facility: Department of Paediatric, Clarendon Wing, Leeds General Infirmary

location_facility: Hospital Materno Infantil Virgen de las Nieves

location_facility: IMAS Hospital del Mar - Servicio de Pediatria

location_facility: Pediatric Clinical Hospital No. 5, Department of Pediatric Neurology

location_facility: Moscow Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology

location_facility: Clinical Hospital for children, Paediatric Neurology clinic

location_facility: Hospital Clínico San Carlos, Servicio de Neurología Pediátrica

location_facility: National Taiwan University Hospital - Department of Paediatrics

location_facility: Pécsi Tudományegyetem AOK Gyermekklinika

location_facility: Instytut "Centrum Zdrowia Matki Polki" Klinika Neurologii

location_facility: Children Neurology Dept., Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Manila Doctors Hospital - Child Nueroscience Center

location_facility: Child Neurology Service, Institute of Mother and Child Healthcare of Serbia "Dr. Vukan Cupic"

location_facility: Hospital Raja Perempuan Zainab II - Jabatan Paediatrik

location_facility: SAMODZIELNY PUBLICZNY SZPITAL KLINICZNY NR 6 ŚLĄSKIEJ AKADEMII MEDYCZNEJ W KATOWICACH GÓRNOŚLĄSKIE CENTRUM ZDROWIA DZIECKA I MATKI IM. JANA PAWŁA II Klinika Pediatrii i Neurologii Wieku Rozwojowego

location_facility: Nizhny Novgorod State Medical Academy Pediatric City Clinical Hospital No. 1

location_facility: Department of Neurolog, Regional Pediatric Clinical Hospital No. 1 Ekaterinburg

location_facility: Neurological Department, Voronezh Regional Pediatric Clinical Hospital No. 1

location_facility: Taipei Veterans General Hospital - Department of Paediatrics

location_facility: Ukrainian Medical Rehabilitation Centre for Children with Organic Disorders of Nervous System

location_facility: IMSP Centrul National Stiintifico-Practic Medicina de Urgenta

location_facility: Servizio di Neuropsichiatria Infantile Policlinico "G.B. Rossi" Borgo Roma

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Azienda Ospedaliera Universitaria Senese Ospedale Santa Maria alle Scotte Dipartimento materno infantile Struttura Complessa di Pediatria

location_facility: Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. Univ. Graz

location_facility: Children Neurology Clinic, University Hospital Motol

location_facility: Clinica de Neurologie Peciatrica, Spitalul "Alexandru Obregia"

location_facility: Clinical hospital Osjek Pediatric clinic, neuropediatric department

location_facility: Spitalul Clinic de Urgenta pentru copii Luis Turcanu, Clinica de Psihiatrie si Neurologie pentru copii si adolescenti

location_facility: WOJEWÓDZKI SPECJALISTYCZNY SZPITAL DZIECIĘCY im. ŚW. LUDWIKA W KRAKOWIE

location_facility: Jose R. Reyes Memorial Medical Center - 5th Floor, Training and Research Office, Jose Reyes Memorial Hospital

location_facility: Children Neurology Dept., Institute of Child- and Adolescent Health Care of Vojvodina

location_facility: Pediatric Scientific-practical Center of cranio-facial surgery and neurology

location_facility: Clinic of Neurology and Psychiatry for Children and Youth

location_facility: Hospital Sant Joan de Déu, Dep. Neuropediatría

location_facility: Hospital Son Dureta, Dep. Neuropediatría

location_facility: Université Paris Descartes, Hopital Necker-Enfants Malades, Département de Neuropédiatrie

location_facility: Hospital pediatrics of Odessa State Medical University Odessa

location_facility: Dipartimento di Neuroscienze, Unità Operativa di Neurologia Ospedale Bambin Gesù

location_facility: Clinical Center University of Sarajevo Pediatric Clinic Neuropediatrics Department

location_facility: Perpetual Succour Hospital - Neuroscience Center, 7/F SPC Medical Specialty Center

title: Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

summary: The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.


title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

summary:
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH.

It will consist of 2 phases:

Randomized Double-Blind Phase
Open-Label Phase (optional)

ReferenceCitation: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.

ReferenceCitation: Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.

ReferenceCitation: Ratziu V, Sanyal A, Torres D, Hinrichsen H, Serfaty L, Bambha K, et al. Impact of weight reduction on serum markers and liver histology including progression to cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and bridging fibrosis. J Hepatol 2017; 66 (1): S594.

ReferenceCitation: Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.

ReferenceCitation: Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.

ReferenceCitation: Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.

ReferenceCitation: Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.

ReferenceCitation: Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

family: Wai-Sun Wong

full_name: Vincent Wai-Sun Wong

given: Vincent

family: Trauner

full_name: Michael Trauner

given: Michael

family: Lawitz

full_name: Eric J. Lawitz

given: Eric J.

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

family: Camargo

full_name: Marianne Camargo

given: Marianne

family: Kersey

full_name: Kathryn Kersey

given: Kathryn

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: Myers

full_name: Robert P. Myers

given: Robert P.

family: Stepanova

full_name: Maria Stepanova

given: Maria

journal_name: Gastroenterology

ReferenceCitation: Harrison SA, Abdelmalek MF, Caldwell S, Shiffman ML, Diehl AM, Ghalib R, Lawitz EJ, Rockey DC, Schall RA, Jia C, McColgan BJ, McHutchison JG, Subramanian GM, Myers RP, Younossi Z, Ratziu V, Muir AJ, Afdhal NH, Goodman Z, Bosch J, Sanyal AJ; GS-US-321-0105 and GS-US-321-0106 Investigators. Simtuzumab Is Ineffective for Patients With Bridging Fibrosis or Compensated Cirrhosis Caused by Nonalcoholic Steatohepatitis. Gastroenterology. 2018 Oct;155(4):1140-1153. doi: 10.1053/j.gastro.2018.07.006. Epub 2018 Jul 7.

family: Abdelmalek

full_name: Manal F. Abdelmalek

given: Manal F.

family: Caldwell

full_name: Stephen Caldwell

given: Stephen

family: Shiffman

full_name: Mitchell L. Shiffman

given: Mitchell L.

family: Diehl

full_name: Anna Mae Diehl

given: Anna Mae

family: Ghalib

full_name: Reem Ghalib

given: Reem

family: Rockey

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

location_facility: Miami Veterans Administration Healthcare System

location_facility: Virginia Commonwealth University Health System

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

location_facility: University Hospitals Case Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: King's College Hospital NHS Foundation Trust No. 1 Account

location_facility: University of California, San Diego (UCSD)

location_facility: University of California San Francisco (UCSF)

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Walter Reed National Military Medical Center

location_facility: Nottingham University Hospitals Queens Medica


title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis

acronym: BREVAS

summary: The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.

ReferenceCitation: Jayne D, Blockmans D, Luqmani R, Moiseev S, Ji B, Green Y, Hall L, Roth D, Henderson RB, Merkel PA; BREVAS Study Collaborators. Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study. Arthritis Rheumatol. 2019 Jun;71(6):952-963. doi: 10.1002/art.40802. Epub 2019 Apr 16.

family: Jayne

full_name: David Jayne

given: David

name: University Hospital Gasthuisberg Leuven Belgium

family: Blockmans

full_name: Daniel Blockmans

given: Daniel

family: Luqmani

full_name: Raashid Luqmani

given: Raashid

name: Sechenov First Moscow State Medical University Moscow Russia

family: Moiseev

full_name: Sergey Moiseev

given: Sergey

family: Ji

full_name: Beulah Ji

given: Beulah

family: Green

full_name: Yulia Green

given: Yulia

family: Hall

full_name: Leanne Hall

given: Leanne

family: Roth

full_name: David Roth

family: Henderson

full_name: Robert B. Henderson

given: Robert B.

family: Merkel

full_name: Peter A. Merkel

given: Peter A.

family: Lozano

full_name: Jose Alfaro Lozano

given: Jose Alfaro

family: Becker

full_name: Heidemarie Becker

given: Heidemarie

family: Quiroz

full_name: Armando Calvo Quiroz

given: Armando Calvo

family: Carette

full_name: Simon Carette

given: Simon

family: Carrillo‐Vazquez

full_name: Sandra Carrillo‐Vazquez

given: Sandra

family: Cid

full_name: María C. Cid

given: María C.

family: D'Cruz

full_name: David D'Cruz

family: Deodhar

full_name: Atul Deodhar

given: Atul

family: Flossman

full_name: Oliver Flossman

given: Oliver

family: Garibotto

full_name: Giacomo Garibotto

given: Giacomo

family: Gesualdo

full_name: Loreto Gesualdo

given: Loreto

full_name: Stephen Hall

family: Hauser

full_name: Thomas Hauser

given: Thomas

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

repository_institution: Aberdeen University - Aberdeen University Research Archive

title: Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: A Randomized Controlled Study

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Italy
United States
Peru
Sweden
Switzerland
Mexico
Spain
Germany
France
Czechia
Poland
Norway
Hungary
Belgium
Australia
Ireland
Romania
Russian Federation
Canada
United Kingdom


title: A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee

summary: In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Tetec AG

location_country:
Austria
Switzerland
United Kingdom
France
Czechia
Lithuania
Poland
Hungary
Germany
Latvia

location_facility: B-A-Z Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Fakultni nemocnice Hradec Kralove - Ortopedicka klinika

location_facility: Orthopädische Klinik und Poliklinik der LMU München

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Orthopaedie

location_facility: Urazova nemocnice v Brne - Traumatologie

location_facility: NH Hospital, a.s., Ortopedicke oddeleni nemocnice Horovice

location_facility: Szpital sw. Lukasza BGL Sp z o.o. S.K.A.

location_facility: Fakultni nemocnice Brno - Ortopedicka klinika

location_facility: CHU de Saint-Etienne Hôpital Nord - Service orthopedie et traumatologie

location_facility: Samozdzielny Publiczny Wojewodzki Szpital Chirurgii Urazowej

location_facility: Hospital of Traumatology and Orthopaedics, Trauma Department

location_facility: Samozdzielny Publiczny Zaklad Opieki Zdrowotnej Miejskiego Szpitala Zespolonego

location_facility: JSC "SK Impeks Medicinos Diagnostikos Centras"

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Hôpital Ambroise Paré - Service de Chirurgie Orthopedique et Traumatologie

intervention_type: Procedure

status_simplified: Ongoing


title: A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer

summary: This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Hill AG, Findlay MP, Burge ME, Jackson C, Alfonso PG, Samuel L, Ganju V, Karthaus M, Amatu A, Jeffery M, Bartolomeo MD, Bridgewater J, Coveler AL, Hidalgo M, Kapp AV, Sufan RI, McCall BB, Hanley WD, Penuel EM, Pirzkall A, Tabernero J. Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer. Clin Cancer Res. 2018 May 15;24(10):2276-2284. doi: 10.1158/1078-0432.CCR-17-0646. Epub 2018 Mar 5.

family: Hill

full_name: Andrew G. Hill

given: Andrew G.

family: Findlay

full_name: Michael P. Findlay

given: Michael P.

family: Burge

full_name: Matthew E. Burge

given: Matthew E.

family: Jackson

full_name: Christopher Jackson

given: Christopher

family: Alfonso

full_name: Pilar Garcia Alfonso

given: Pilar Garcia

family: Samuel

full_name: Leslie Samuel

given: Leslie

family: Ganju

full_name: Vinod Ganju

given: Vinod

family: Karthaus

full_name: Meinolf Karthaus

given: Meinolf

family: Amatu

full_name: Alessio Amatu

given: Alessio

family: Jeffery

full_name: Mark Jeffery

given: Mark

family: Bartolomeo

full_name: Maria Di Bartolomeo

given: Maria Di

family: Bridgewater

full_name: John Bridgewater

given: John

family: Coveler

full_name: Andrew L. Coveler

given: Andrew L.

family: Hidalgo

full_name: Manuel Hidalgo

given: Manuel

family: Kapp

full_name: Amy V. Kapp

given: Amy V.

family: Sufan

full_name: Roxana I. Sufan

given: Roxana I.

family: McCall

full_name: Bruce B. McCall

given: Bruce B.

family: Hanley

full_name: William D. Hanley

given: William D.

family: Penuel

full_name: Elicia M. Penuel

given: Elicia M.

family: Pirzkall

full_name: Andrea Pirzkall

given: Andrea

family: Tabernero

full_name: Josep Tabernero

given: Josep

journal_name: Clinical Cancer Research

evidence: open (via free pdf)

repositories_institution: Aberdeen University - Aberdeen University Research Archive

publisher: American Association for Cancer Research (AACR)

location_country:
Italy
Germany
France
Romania
Belgium
Australia
New Zealand
Spain
United States
United Kingdom


title: A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

summary:
The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.

The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

ReferenceCitation: Riddle MC, Forst T, Aronson R, Sauque-Reyna L, Souhami E, Silvestre L, Ping L, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013 Sep;36(9):2497-503. doi: 10.2337/dc12-2462. Epub 2013 Apr 5.

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

family: Forst

full_name: Thomas Forst

given: Thomas

family: Aronson

full_name: Ronnie Aronson

given: Ronnie

family: Sauque-Reyna

full_name: Leobardo Sauque-Reyna

given: Leobardo

family: Souhami

full_name: Elisabeth Souhami

given: Elisabeth

family: Silvestre

full_name: Louise Silvestre

given: Louise

family: Ping

full_name: Lin Ping

given: Lin

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

journal_name: Diabetes Care

oa_colors: green other

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled With Newly Initiated and Continuously Titrated Basal Insulin Glargine

ReferenceCitation: Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

family: Davidson

full_name: Jaime A. Davidson

given: Jaime A.

family: Stager

full_name: William Stager

given: William

family: Paranjape

full_name: Sachin Paranjape

given: Sachin

family: Berria

full_name: Rachele Berria

given: Rachele

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

journal_name: Clinical Diabetes and Endocrinology

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

name: Dallas Diabetes Research Center at Medical City; Dallas Texas

name: Metabolic Institute of America; Tarzana California

name: Hospital Clinic of Barcelona; Barcelona Spain

name: Centro Investigación Biomédica en Red en Diabetes y Enfermeades Metabólicas (CIBERDEM); Madrid Spain

name: Clinic University Hospital of Valencia; Valencia Spain

name: University of Bari Aldo Moro; Bari Italy

name: BDM Consulting, Inc.; Somerset New Jersey

name: St Josef Hospital, Ruhr-University Bochum; Bochum Germany

ReferenceCitation: Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18.

journal_name: Journal of Diabetes and its Complications

repository_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.

title: Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by Established Basal Insulin

location_country:
Malaysia
Romania
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Denmark
Czech Republic
Taiwan
Ukraine
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France
Poland
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Netherlands
Hungary
Puerto Rico
United States
Germany
Italy
Brazil
Mexico
Israel
Estonia

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location_facility: Sanofi-Aventis Investigational Site Number 158203

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location_facility: Sanofi-Aventis Investigational Site Number 840201

location_facility: Sanofi-Aventis Investigational Site Number 152204

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location_facility: Sanofi-Aventis Investigational Site Number 458203

location_facility: Sanofi-Aventis Investigational Site Number 616203

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title: A 12-week Treatment, Randomized, Blinded, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of NVA237 (50 µg o.d.) Compared to Tiotropium (18 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

ReferenceCitation: Chapman KR, Beeh KM, Beier J, Bateman ED, D'Urzo A, Nutbrown R, Henley M, Chen H, Overend T, D'Andrea P. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med. 2014 Jan 17;14:4. doi: 10.1186/1471-2466-14-4.

family: Chapman

full_name: Kenneth R Chapman

given: Kenneth R

family: Beeh

full_name: Kai-Michael Beeh

given: Kai-Michael

family: Beier

full_name: Jutta Beier

given: Jutta

family: Bateman

full_name: Eric D Bateman

given: Eric D

family: D’Urzo

full_name: Anthony D’Urzo

given: Anthony

family: Nutbrown

full_name: Robert Nutbrown

given: Robert

family: Henley

full_name: Michelle Henley

given: Michelle

family: Chen

full_name: Hungta Chen

given: Hungta

family: Overend

full_name: Tim Overend

given: Tim

family: D’Andrea

full_name: Peter D’Andrea

given: Peter

journal_name: BMC Pulmonary Medicine

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

repository_normalized: localhost

repository_institution: University of Toronto - TSpace

repositories:
PubMed Central
localhost

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Novartis Pharmaceuticals

location_country:
South Africa
Guatemala
India
Philippines
Germany
Croatia
France
Lithuania
Poland
Latvia
Estonia
Canada
Czech Republic
Korea, Republic of
Taiwan


title: A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination With Pemetrexed (Alimta®) Versus Pemetrexed Alone in Patients With Locally-Advanced or Metastatic NSCLC

acronym: ZEAL

summary: Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.

ReferenceCitation: de Boer RH, Arrieta Ó, Yang CH, Gottfried M, Chan V, Raats J, de Marinis F, Abratt RP, Wolf J, Blackhall FH, Langmuir P, Milenkova T, Read J, Vansteenkiste JF. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small-cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2011 Mar 10;29(8):1067-74. doi: 10.1200/JCO.2010.29.5717. Epub 2011 Jan 31.

name: From the Western Hospital, Melbourne, Australia; Instituto Nacional de Cancerología, Mexico City, Mexico; National Taiwan University Hospital, Taipei, Taiwan; Meir Medical Center, Kfar Saba, Israel; Veterans Memorial Medical Center, Quezon City, Philippines; Panorama Medical Center and New Groote Schuur Hospital, Cape Town, South Africa; San Camillo-Forlanini Hospital, Rome, Italy; Center for Integrated Oncology, University Hospital Cologne, Cologne, Germany; Christie Hospital National Health Service...

family: de Boer

full_name: Richard H. de Boer

given: Richard H.

family: Arrieta

full_name: Óscar Arrieta

given: Óscar

family: Yang

full_name: Chih-Hsin Yang

given: Chih-Hsin

family: Gottfried

full_name: Maya Gottfried

given: Maya

family: Chan

full_name: Valorie Chan

given: Valorie

family: Raats

full_name: Johann Raats

given: Johann

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

family: Abratt

full_name: Raymond P. Abratt

given: Raymond P.

family: Wolf

full_name: Jürgen Wolf

given: Jürgen

family: Blackhall

full_name: Fiona H. Blackhall

given: Fiona H.

family: Langmuir

full_name: Peter Langmuir

family: Milenkova

full_name: Tsveta Milenkova

given: Tsveta

family: Read

full_name: Jessica Read

given: Jessica

family: Vansteenkiste

full_name: Johan F. Vansteenkiste

given: Johan F.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Vandetanib Plus Pemetrexed for the Second-Line Treatment of Advanced Non–Small-Cell Lung Cancer: A Randomized, Double-Blind Phase III Trial

ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

family: Platt

full_name: Adam Platt

given: Adam

family: Morten

full_name: John Morten

given: John

family: Ji

full_name: Qunsheng Ji

given: Qunsheng

family: Elvin

full_name: Paul Elvin

given: Paul

family: Womack

full_name: Chris Womack

given: Chris

family: Su

full_name: Xinying Su

given: Xinying

family: Donald

full_name: Emma Donald

given: Emma

location_country:
Greece
Belgium
Australia
Taiwan
India
France
Argentina
Colombia
South Africa
Sweden
Hong Kong
Philippines
Portugal
Germany
United States
United Kingdom
Italy
Mexico
Venezuela
Israel
Spain


title: A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.

summary: The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

ReferenceCitation: Kovanda LL, Kolamunnage-Dona R, Neely M, Maertens J, Lee M, Hope WW. Pharmacodynamics of Isavuconazole for Invasive Mold Disease: Role of Galactomannan for Real-Time Monitoring of Therapeutic Response. Clin Infect Dis. 2017 Jun 1;64(11):1557-1563. doi: 10.1093/cid/cix198. Erratum in: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433.

name: Antimicrobial Pharmacodynamics and Therapeutics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, United Kingdom;

name: Astellas Pharma Global Development, Inc, Northbrook, Illinois;

family: Kovanda

full_name: Laura L. Kovanda

given: Laura L.

name: Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, United Kingdom;

family: Kolamunnage-Dona

full_name: Ruwanthi Kolamunnage-Dona

given: Ruwanthi

name: Laboratory of Applied Pharmacokinetics and Bioinformatics, Saban Research Institute, and Division of Pediatric Infectious Diseases, Children’s Hospital Los Angeles, University of Southern California; and

family: Neely

full_name: Michael Neely

given: Michael

name: Universitaire Ziekenhuizen, Leuven, Belgium

family: Maertens

full_name: Johan Maertens

given: Johan

family: Lee

full_name: Misun Lee

given: Misun

family: Hope

full_name: William W. Hope

given: William W.

journal_name: Clinical Infectious Diseases

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, Bow EJ, Rahav G, Neofytos D, Aoun M, Baddley JW, Giladi M, Heinz WJ, Herbrecht R, Hope W, Karthaus M, Lee DG, Lortholary O, Morrison VA, Oren I, Selleslag D, Shoham S, Thompson GR 3rd, Lee M, Maher RM, Schmitt-Hoffmann AH, Zeiher B, Ullmann AJ. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016 Feb 20;387(10020):760-9. doi: 10.1016/S0140-6736(15)01159-9. Epub 2015 Dec 10.

full_name: Johan A Maertens

given: Johan A

family: Raad

full_name: Issam I Raad

given: Issam I

family: Marr

full_name: Kieren A Marr

given: Kieren A

family: Patterson

full_name: Thomas F Patterson

given: Thomas F

family: Kontoyiannis

full_name: Dimitrios P Kontoyiannis

given: Dimitrios P

family: Cornely

full_name: Oliver A Cornely

given: Oliver A

family: Bow

full_name: Eric J Bow

given: Eric J

family: Rahav

full_name: Galia Rahav

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Malaysia
Belgium
Australia
Russian Federation
India
Spain
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Chile
Switzerland
Netherlands
Hungary
China
Germany
United States
Italy
Brazil
Mexico
Israel
Egypt
New Zealand
Turkey

location_facility: Hospital de Clinicas da FMUSP - Ribeirao Preto

location_facility: The 1st Affiliated Hospital of Guangxi Medical University

location_facility: Tata Memorial Hopital, Department of Anesthesia

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: Republican Hospital named after V.A. Baranov

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: State Institution "Hematology Research Center" RAMS

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

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: University of Texas MD Anderson Cancer Center

location_facility: The Third Xiangya Hospital of Central South University

location_facility: The Affiliated Union Hospital of Fujian Medical University

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: The First Affiliated Hospital, Med. School, Zhejiang Uni.

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Upstate Infectious Diseases Association LLP

location_facility: University of Chicago, Division of Infectious Diseases

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: West China Hospital of Sichuan University

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi

location_facility: University of California at San Francisco

location_facility: Charité Universitaetsmedizin Berlin- Campus Charité Mitte

location_facility: Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Huashan Hospital, Insitute of Antibiotics

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda


ReferenceCitation: Ison MG, Szakaly P, Shapira MY, Kriván G, Nist A, Dutkowski R. Efficacy and safety of oral oseltamivir for influenza prophylaxis in transplant recipients. Antivir Ther. 2012;17(6):955-64. doi: 10.3851/IMP2192. Epub 2012 Jun 22.

family: Ison

full_name: Michael G Ison

given: Michael G

family: Szakaly

full_name: Peter Szakaly

given: Peter

family: Shapira

full_name: Michael Y Shapira

given: Michael Y

family: Kriván

full_name: Gergely Kriván

given: Gergely

family: Nist

full_name: Ann Nist

given: Ann

family: Dutkowski

full_name: Regina Dutkowski

given: Regina

journal_name: Antiviral Therapy

lead_sponsor: Hoffmann-La Roche

primary_purpose: Prevention

location_country:
Italy
United States
United Kingdom
Germany
France
Poland
Lithuania
Israel
Hungary
Belgium
Spain
Estonia
Canada
Czech Republic

title: A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

summary: This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

ReferenceCitation: Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

family: Gupta

full_name: Sneha V. Gupta

given: Sneha V.

family: Fanget

full_name: Marie C. Fanget

given: Marie C.

family: MacLauchlin

full_name: Christopher MacLauchlin

given: Christopher

family: Clausen

full_name: Valerie A. Clausen

given: Valerie A.

family: Li

full_name: Jing Li

given: Jing

family: Cloutier

full_name: Daniel Cloutier

given: Daniel

family: Shen

full_name: Ling Shen

given: Ling

family: Robbie

full_name: Gabriel J. Robbie

given: Gabriel J.

family: Mogalian

full_name: Erik Mogalian

given: Erik

journal_name: Drugs in R&D

ReferenceCitation: Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

family: Zhou

full_name: Xuan Zhou

given: Xuan

full_name: Tsung-I Lee

given: Tsung-I

family: Zhu

full_name: Min Zhu

given: Min

family: Ma

full_name: Peiming Ma

given: Peiming

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3). pii: e001747. doi: 10.1136/rmdopen-2021-001747.

family: Brunner

full_name: Hermine I Brunner

given: Hermine I

family: Abud-Mendoza

full_name: Carlos Abud-Mendoza

given: Carlos

ReferenceCitation: Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.

ReferenceCitation: Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1). pii: e000459. doi: 10.1136/lupus-2020-000459.

ReferenceCitation: Gomez A, Hani Butrus F, Johansson P, Åkerström E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.

name: Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden

name: Rheumatology, Karolinska University Hospital, Stockholm, Sweden

name: Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden

ReferenceCitation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

name: Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands

name: University of Santo Tomas Hospital, Manila, Philippines

name: Rio de Janeiro State University, Pedro Ernesto University Hospital, Rio de Janeiro, Brazil

name: Kerala Institute of Medical Sciences (KIMS), Kerala, India

ReferenceCitation: Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.

name: Cedars-Sinai Medical Center; University of California; Los Angeles

name: The Feinstein Institute for Medical Research; Manhasset New York

name: GlaxoSmithKline; Research Triangle Park North Carolina

ReferenceCitation: Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.

ReferenceCitation: Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.

name: Johns Hopkins University School of Medicine; Baltimore Maryland

name: New York University Langone Medical Center; New York New York

name: Hospital Universitário Pedro Ernesto-Universidade do Estado do Rio de Janeiro; Rio de Janeiro Brazil

name: University of Santo Tomas Hospital; Manila Philippines

name: Human Genome Sciences, Inc.; Rockville Maryland

name: on behalf of the BLISS-52 and BLISS-76 Study Groups

title: Baseline Predictors of Systemic Lupus Erythematosus Flares: Data From the Combined Placebo Groups in the Phase III Belimumab Trials

ReferenceCitation: Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.

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

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.

name: Cedars-Sinai Medical Center/David Geffen School of Medicine at UCLA, Los Angeles, California, USA

name: Johns Hopkins University, Baltimore, Maryland, USA

name: Hospital Británico de Buenos Aires, Argentina

name: Kerala Institute of Medical Sciences, Trivandrum, Kerala, India

name: North Shore–LIJ Health System, Lake Success, New York, USA

name: Hospital Universitário Pedro Ernesto, UERJ, Rio de Janeiro, Brazil

name: The Karolinska Institute, Stockholm, Sweden

name: Human Genome Sciences, Inc., Rockville, Maryland, USA

name: Hospital Clinic, Barcelona, Catalonia, Spain

name: for the BLISS-52 and -76, and LBSL02 Study Groups

ReferenceCitation: Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzová D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; BLISS-76 Study Group. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012 Aug;39(8):1632-40. Epub 2012 Jun 15.

ReferenceCitation: van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.

ReferenceCitation: Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.

ReferenceCitation: Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. doi: 10.1002/art.30613.

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:
Italy
Austria
United States
Sweden
Costa Rica
United Kingdom
Mexico
Netherlands
Germany
France
Poland
Israel
Slovakia
Romania
Belgium
Puerto Rico
Spain
Canada
Czech Republic

location_facility: Kentuckiana Center for Better Bone and Joint Health

location_facility: Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin

location_facility: Azienda Ospedaliero University-Santa Maria della Misericordia

location_facility: Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Instituto de Seguridad Social del Estado de Mexico y Municipios

location_facility: University of Michigan Medical Center - Regents of University of Michigan

location_facility: The Rheumatic Disease Clinical Research Center

location_facility: Hospital Central de S.L.P. "Iganico Morones Prieto"

location_facility: Instituto Jalisciense de Investigacion Clinica

location_facility: Szpital Uniwerytecki nr Zim. dr. Jana Biziela

location_facility: Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik

location_facility: Low Country Rheumatology, PA/Low Country Research Center

location_facility: University of Texas - Southwestern Medical Center

location_facility: Southwest Florida Clinical Research Center

location_facility: McGill University Health Centre, Montreal General Hospital

location_facility: Centre for Prognosis Studies in Rheaumatic Diseases

location_facility: Hospital Regional Universitario de SAS - Carlos Haya

location_facility: University of Miami-Division of Rheumatology and Immunology

location_facility: Hospital Regional 1o de Octubre - ISSSTE

location_facility: Arthritis Clinic of Northern Virginia, P.C.

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: University of North Carolina at Chapel Hill

location_facility: Centre Hospitalier Universitarie (CHU) - PURPAA

location_facility: Washington University School of Medicine

location_facility: Rheumatology Associates of Central Florida

location_facility: Arthritis Associates of Colorado Springs

location_facility: The University of Arizona Arthritis Center

location_facility: Palmetto Clinical Trial at Piedmont Arthritis Clinic

location_facility: Texas Tech University Health Sciences Center

location_facility: Oklahoma Center For Arthritis Therapy & Research

location_facility: U.O. di reumatologia Presidio Ospedaliero di Scafati

location_facility: Beilinson Hospital, Rabin Medical Center

location_facility: A. O. Ospedaliera-Universitaria Arcispedale

location_facility: Arizona Arthritis and Rheumatology Research, PPLC

location_facility: Klinika Reumatologii im Prof. Eleonory Reicher

location_facility: North Shore-LIJ Health System/Rheumatology and Allergy Clinic

location_facility: Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique

location_facility: University of Puerto Rico Medical Center

location_facility: Gabinety Profesorow Osrodek Baden Klinicznych

location_facility: Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych

location_facility: Universitatsklinik Schleswig-Holstein, Campus Kiel


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease

summary: This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

lead_sponsor: Novartis

location_country:
Italy
Brazil
Netherlands
Germany
France
Portugal
United States
United Kingdom
Canada