ReferenceCitation: Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.

family: Landells

full_name: Ian Landells

given: Ian

family: Marano

full_name: Colleen Marano

given: Colleen

family: Hsu

full_name: Ming-Chun Hsu

given: Ming-Chun

family: Li

full_name: Shu Li

given: Shu

family: Zhu

full_name: Yaowei Zhu

given: Yaowei

family: Eichenfield

full_name: Lawrence F. Eichenfield

given: Lawrence F.

family: Hoeger

full_name: Peter H. Hoeger

given: Peter H.

family: Menter

full_name: Alan Menter

given: Alan

family: Paller

full_name: Amy S. Paller

given: Amy S.

family: Taieb

full_name: Alain Taieb

given: Alain

family: Philipp

full_name: Sandra Philipp

given: Sandra

family: Szapary

full_name: Philippe Szapary

given: Philippe

family: Randazzo

full_name: Bruce Randazzo

given: Bruce

journal_name: Journal of the American Academy of Dermatology

title: Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: Results of the randomized phase 3 CADMUS study

lead_sponsor: Janssen Research & Development, LLC

location_country:
Sweden
France
Hungary
Belgium
Russian Federation
Portugal
Germany
United Kingdom
Canada
Ukraine

acronym: CADMUS

title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

summary: This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.


type: EudraCT Number

title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1

summary: The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

family: Gottlieb

full_name: Alice Gottlieb

given: Alice

sequence: first

family: Lebwohl

full_name: Mark Lebwohl

given: Mark

sequence: additional

family: Liu

full_name: Clive Liu

given: Clive

family: Israel

full_name: Robert J. Israel

given: Robert J.

family: Jacobson

full_name: Abby Jacobson

given: Abby

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Clinical Dermatology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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

ipd_sharing: Yes

lead_sponsor: Bausch Health Americas, Inc.

location_country:
United States
Switzerland
France
Poland
Germany
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceType: result

ReferenceCitation: Squires K, Kityo C, Hodder S, Johnson M, Voronin E, Hagins D, Avihingsanon A, Koenig E, Jiang S, White K, Cheng A, Szwarcberg J, Cao H. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-e420. doi: 10.1016/S2352-3018(16)30016-9. Epub 2016 May 27.

family: Squires

full_name: Kathleen Squires

given: Kathleen

family: Kityo

full_name: Cissy Kityo

given: Cissy

family: Hodder

full_name: Sally Hodder

given: Sally

family: Johnson

full_name: Margaret Johnson

given: Margaret

family: Voronin

full_name: Evgeny Voronin

given: Evgeny

family: Hagins

full_name: Debbie Hagins

given: Debbie

family: Avihingsanon

full_name: Anchalee Avihingsanon

given: Anchalee

family: Koenig

full_name: Ellen Koenig

given: Ellen

family: Jiang

full_name: Shuping Jiang

given: Shuping

family: White

full_name: Kirsten White

given: Kirsten

family: Cheng

full_name: Andrew Cheng

given: Andrew

family: Szwarcberg

full_name: Javier Szwarcberg

given: Javier

family: Cao

full_name: Huyen Cao

given: Huyen

journal_name: The Lancet HIV

oa_host_type: repository

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.

ReferenceCitation: Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.

ReferenceCitation: Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.

ReferenceCitation: Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.

status: Completed

study_start_date_type: Actual

lead_sponsor: Gilead Sciences

location_country:
Italy
Mexico
Dominican Republic
France
Thailand
Uganda
Belgium
Puerto Rico
Russian Federation
Portugal
United States
United Kingdom

acronym: WAVES

location_facility: Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central

location_facility: GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: Hospital de Santa Maria - Serviço de Doenças Infecciosas

location_facility: Wexner Medical Center at the Ohio State University

location_facility: GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department

location_facility: St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department

location_facility: Federal State Budgetary Institution "Republic Clinical Infectious Hospital"

location_facility: George Washington University Medical Faculty Associates

location_facility: Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Homerton University Hospital NHS Foundation Trust

location_facility: Bamrasnaradura lnfectious Disease Institute

location_facility: Temple University Hospital- Internal General Medicine

location_facility: Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases

location_facility: Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital

location_facility: State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare

location_facility: Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"

location_facility: St. Joseph's Hospital Comprehensive Research Institute

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

location_facility: Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department

location_facility: East Carolina University The Brody School of Medicine Div. of Infectious Diseases

location_facility: University of North Carolina AIDS Clinical Trials Unit

location_facility: Salvador B Gautier Hospital, Infectious Diseases Department

location_facility: Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases

location_facility: Centro Hospitalar do Porto - Hospital Joaquim Urbano

location_facility: GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases

location_facility: GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Queen Elizabeth Hospital, South London Healthcare NHS Trust

location_facility: University of Southern California AIDS Clinical Trials Group

location_facility: Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: University of California, Davis Medical Center

location_facility: Clinica Malattie Infettive, Azienda Ospedaliero Universitaria

location_facility: Department of Health Sciences - University of Milan - San Paolo Hospital

location_facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

location_facility: Mortimer Market Centre and Central and North West London NHS Foundation Trust

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: Instituto Dominicano de Estudio Virologicos - IDEV

location_facility: Infectious Disease Specialists of Atlanta

source: euctr

title: A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

summary: The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.

status_simplified: Completed


lead_sponsor: Ipsen

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
Finland
France
Czechia
Poland
Israel
Slovakia
Ireland
Belgium
Russian Federation
Spain
Germany
Latvia
Ukraine

acronym: CAMPANULA

location_facility: Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Akademiska Hospital, Dept of Oncology & Endocrinology

location_facility: St-Petersburg State Medical University named after academician Pavlov I.P.

location_facility: Royal Preston Hospital, Sharoe Green Lane, Lancashire

location_facility: Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan

location_facility: Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital

location_facility: Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"

location_facility: Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea

location_facility: University Hospital, Internal Medicine - Oncology

location_facility: Voronezh Regional Clinical Oncology Dispensary

location_facility: Latvian Oncology centre of Riga Eastern Clinical University Hospital

location_facility: Christie Hospital and Holt Radium Institute

location_facility: Fakultní nemocnice Na Bulovce, Ústav radiační onkologie

location_facility: St-Petersburg State Institution of Public Health City Clinical Oncology dispensary

location_facility: Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach

location_facility: Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi

title: Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

summary: The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.


lead_sponsor: Astellas Pharma Inc

location_country:
United States
United Kingdom
France
Spain

location_facility: Site US2149 Gabrail Cancer Center Research

location_facility: Site US55 Loyola University Hospital - Maywood

location_facility: Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel

location_facility: Site ES1346 Hospital Universitario de Salamanca

location_facility: Site GB2624 The Christie NHS Foundation Trust

location_facility: Site ES1339 Hospital Universitario Ramon y Cajal

location_facility: Site US402 University of Texas Health Science Center - San Antonio

location_facility: Site ES2967 Hosptial Universitario Madrid Sanchinarro

title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant

summary: The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.


title: Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study

summary: The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Guatemala
Malaysia
Russian Federation
Taiwan
Costa Rica
France
Panama
Thailand
Argentina
Indonesia
Canada
Colombia
South Africa
Chile
Singapore
Hungary
Puerto Rico
Portugal
United States
Italy
Brazil
Mexico
Dominican Republic
Spain

location_facility:
Infectious Disease Of Indiana, Psc
St Francis Memorial Hospital
Univ Of Kansas Sch Of Med
University Of Nebraska Medical Center
The Schrader Clinic
Cri Of New England
Rand Schrader Clinic
St Josephs Cmprhnsv Rsch Inst
Phoenix Body Positive, Inc
Tarrant County Inf Dis Assoc
Clinical Research Puerto Rico, Inc.
V.A. Medical Center
Jemsek Clinic
Local Institution
Sbma Research, Llc


title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

ReferenceCitation: McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.

family: McGarvey

full_name: Lorcan McGarvey

given: Lorcan

family: Morice

full_name: Alyn H Morice

given: Alyn H

family: Smith

full_name: Jaclyn A Smith

given: Jaclyn A

family: Birring

full_name: Surinder S Birring

given: Surinder S

family: Chuecos

full_name: Ferran Chuecos

given: Ferran

family: Seoane

full_name: Beatriz Seoane

given: Beatriz

family: Jarreta

full_name: Diana Jarreta

given: Diana

currency_apc_doaj: GBP

journal_name: BMJ Open Respiratory Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: King's College London - Research Portal

repository_normalized: Pure (Denmark)

repository_institution: Queen's University Belfast - Research Portal

repositories:
PubMed Central
Pure (Denmark)
pure.qub.ac.uk/portal

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.

family: Jones

full_name: Paul W. Jones

given: Paul W.

family: Leidy

full_name: Nancy K. Leidy

given: Nancy K.

family: Hareendran

full_name: Asha Hareendran

given: Asha

family: Lamarca

full_name: Rosa Lamarca

given: Rosa

ReferenceCitation: Jones PW, Lamarca R, Chuecos F, Singh D, Agustí A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.

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

repository_institution: The Pennsylvania State University - CiteSeer X

ReferenceCitation: Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. Epub 2012 Mar 22.

location_country:
Italy
South Africa
Peru
France
Poland
Hungary
Russian Federation
Spain
Germany
Czech Republic
Ukraine

location_facility:
Almirall Investigational Sites#16
Almirall Investigational Sites#10
Almirall Investigational Sites#20
Almirall Investigational Site#11
Almirall Investigational Sites#15
Almirall Investigational Sites#18
Almirall Investigational Sites#7
Almirall Investigational Sites#5
Almirall Investigational Sites#4
Almirall Investigational Sites#6
Almirall Investigational Site#2
Almirall Investigational Site#16
Almirall Investigational Sites#25
Almirall Investigational Sites#13
Almirall Investigational Sites#2
Almirall Investigational Sites#19
Almirall Investigational Sites#24
Almirall Investigational Site#10
Almirall Investigational Sites#1
Almirall Investigational Sites#23
Almirall Investigational Sites#3
Almirall Investigational Sites#14
Almirall Investigational Sites#21
Almirall Investigational Sites#9
Almirall Investigational Sites#8
Almirall Investigational Site#7
Almirall Investigational Sites#11
Almirall Investigational Sites#12


ReferenceType: background

ReferenceCitation: Kim TW, Peeters M, Thomas A, Gibbs P, Hool K, Zhang J, Ang AL, Bach BA, Price T. Impact of Emergent Circulating Tumor DNA RAS Mutation in Panitumumab-Treated Chemoresistant Metastatic Colorectal Cancer. Clin Cancer Res. 2018 Nov 15;24(22):5602-5609. doi: 10.1158/1078-0432.CCR-17-3377. Epub 2018 Jun 13.

ReferenceCitation: Price T, Ang A, Boedigheimer M, Kim TW, Li J, Cascinu S, Ruff P, Satya Suresh A, Thomas A, Tjulandin S, Peeters M. Frequency of S492R mutations in the epidermal growth factor receptor: analysis of plasma DNA from patients with metastatic colorectal cancer treated with panitumumab or cetuximab monotherapy. Cancer Biol Ther. 2020 Oct 2;21(10):891-898. doi: 10.1080/15384047.2020.1798695. Epub 2020 Oct 7.

name: Clinical Oncology Research and Haematology and Medical Oncology Service Departments, The Queen Elizabeth Hospital and University of Adelaide, Woodville, Australia;

family: Price

full_name: Timothy Price

given: Timothy

name: Clinical Biomarkers, Amgen Inc, Thousand Oaks, CA, USA

family: Ang

full_name: Agnes Ang

given: Agnes

family: Boedigheimer

full_name: Michael Boedigheimer

given: Michael

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Kim

full_name: Tae Won Kim

given: Tae Won

name: Department of Oncology, Tongji University East Hospital, Shanghai, China

family: Li

full_name: Jin Li

given: Jin

name: Department of Medical Oncology, Universita Politecnica delle Marche, Ancona, Italy

family: Cascinu

full_name: Stefano Cascinu

given: Stefano

name: Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa

family: Ruff

full_name: Paul Ruff

given: Paul

name: Department of Medical Oncology, Apollo Hospital, Hyderabad, India

family: Satya Suresh

full_name: Attili Satya Suresh

given: Attili

name: Department of Oncology, University of Leicester, Leicester, UK

family: Thomas

full_name: Anne Thomas

given: Anne

name: Department of Clinical Pharmacology and Chemotherapy, N. N. Blokhin Cancer Research Center of RAMS, Moscow, Russia

family: Tjulandin

full_name: Sergei Tjulandin

given: Sergei

name: Department of Oncology, Antwerp University Hospital, Edegem, Belgium

family: Peeters

full_name: Marc Peeters

given: Marc

journal_name: Cancer Biology & Therapy

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Taniguchi H, Yamanaka T, Sakai D, Muro K, Yamazaki K, Nakata S, Kimura H, Ruff P, Kim TW, Peeters M, Price T. Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G. Cancers (Basel). 2020 Jun 28;12(7). pii: E1715. doi: 10.3390/cancers12071715.

family: Taniguchi

full_name: Hiroya Taniguchi

given: Hiroya

family: Yamanaka

full_name: Takeharu Yamanaka

given: Takeharu

family: Sakai

full_name: Daisuke Sakai

given: Daisuke

family: Muro

full_name: Kei Muro

given: Kei

family: Yamazaki

full_name: Kentaro Yamazaki

given: Kentaro

family: Nakata

full_name: Susumu Nakata

given: Susumu

family: Kimura

full_name: Hiroyuki Kimura

given: Hiroyuki

ReferenceCitation: Price T, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Guan X, Peeters M. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur J Cancer. 2016 Nov;68:51-59. doi: 10.1016/j.ejca.2016.08.010. Epub 2016 Oct 5.

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

ReferenceCitation: Graham CN, Maglinte GA, Schwartzberg LS, Price TJ, Knox HN, Hechmati G, Hjelmgren J, Barber B, Fakih MG. Economic Analysis of Panitumumab Compared With Cetuximab in Patients With Wild-type KRAS Metastatic Colorectal Cancer That Progressed After Standard Chemotherapy. Clin Ther. 2016 Jun;38(6):1376-1391. doi: 10.1016/j.clinthera.2016.03.023. Epub 2016 Apr 13.

ReferenceCitation: Price TJ, Peeters M, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Zhang K, Murugappan S, Sidhu R. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14.

repository_institution: University of Leicester - Leicester Research Archive

location_country:
Peru
Malaysia
Romania
Belgium
Australia
Russian Federation
Taiwan
India
France
Poland
Lithuania
Slovakia
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
China
United States
United Kingdom
Italy
Serbia
Czechia
Israel
Latvia

title: A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

summary: The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

acronym: DREAM

summary: The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

ReferenceCitation: Pavord I, Korn S, Howarth P, Bleecker E, Buhl R, Keene O, Ortega H, Chanez P. Mepolizumab (anti-IL-5) reduces exacerbations in patients with refractory eosinophilic asthma. [Lancet]. 2012;380(August 18, 2012):

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

family: Gibson

full_name: Peter G. Gibson

given: Peter G.

family: Prazma

full_name: Charlene M. Prazma

given: Charlene M.

family: Chupp

full_name: Geoffrey L. Chupp

given: Geoffrey L.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Forshag

full_name: Mark Forshag

given: Mark

family: Mallett

full_name: Stephen A. Mallett

given: Stephen A.

family: Yancey

full_name: Steve W. Yancey

given: Steve W.

family: Smith

full_name: Steven G. Smith

given: Steven G.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

journal_name: Respiratory Research

ReferenceCitation: Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

apc_source: doaj

full_name: Mi-Kyeong Kim

given: Mi-Kyeong

family: Park

full_name: Hae-Sim Park

given: Hae-Sim

full_name: Choon-Sik Park

given: Choon-Sik

family: Min

full_name: Soung-Jun Min

given: Soung-Jun

family: Albers

full_name: Frank C. Albers

given: Frank C.

full_name: Steven W. Yancey

given: Steven W.

family: Mayer

full_name: Bhabita Mayer

given: Bhabita

family: Kwon

full_name: Namhee Kwon

given: Namhee

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.

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

ReferenceCitation: Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

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

ReferenceCitation: Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC.

title: Cluster Analysis and Characterization of Response to Mepolizumab. A Step Closer to Personalized Medicine for Patients with Severe Asthma

ReferenceCitation: Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.

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


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 2 (LOXL2), in Subjects With Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

acronym: NASH

summary:
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (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: Bosch J, Harrison S, Ratziu V, Shiffman M, Diehl A, Caldwell S, et al. Impact of modest weight reduction on liver histology, portal pressure, and clinical events in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2017; 66 (1): S159-S160.

ReferenceCitation: Sanyal A, Goodman Z, Harrison S, Rockey DC, Diehl AM, Caldwell S, et al. Correlation between the hepatic venous pressure gradient and alpha-smooth muscle actin (SMA) expression in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2016; 64 (2): S251.

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: Bosch J, Ratziu V, Rockey DC, Ghalib RH, Thuluvath PJ, Shiefke I, et al. Correlation between noninvasive markers of fibrosis and the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 578A.

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: Sanyal AJ, Goodman ZD, Abdelmalek MF, Harrison SA, Rockey DC, Diehl AM, et al. Clinical and histologic correlates of the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 577A.

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

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

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

location_facility: Indiana University School of Medicine, Division of Gastroenterology/Hepatology

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: Nottingham University Hospitals Queen's Medical Centre

location_facility: University of California, San Diego (UCSD)

location_facility: University of California San Francisco (UCSF)

location_facility: Walter Reed National Military Medical Center

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena


title: A Randomised, Placebo-controlled Trial of Erythropoietin in ICU Patients With Traumatic Brain Injury

acronym: EPO-TBI

summary: This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

ReferenceCitation: Skrifvars MB, Bailey M, Moore E, Mårtensson J, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi YM, McArthur C, Cooper DJ, Bendel S, Bellomo R; Erythropoietin in Traumatic Brain Injury (EPO-TBI) Investigators and the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group. A Post Hoc Analysis of Osmotherapy Use in the Erythropoietin in Traumatic Brain Injury Study-Associations With Acute Kidney Injury and Mortality. Crit Care Med. 2021 Apr 1;49(4):e394-e403. doi: 10.1097/CCM.0000000000004853.

family: Skrifvars

full_name: Markus B. Skrifvars

given: Markus B.

family: Bailey

full_name: Michael Bailey

family: Moore

full_name: Elizabeth Moore

given: Elizabeth

family: Mårtensson

full_name: Johan Mårtensson

given: Johan

family: French

full_name: Craig French

given: Craig

family: Presneill

full_name: Jeffrey Presneill

given: Jeffrey

family: Nichol

full_name: Alistair Nichol

given: Alistair

family: Little

full_name: Lorraine Little

given: Lorraine

family: Duranteau

full_name: Jacques Duranteau

given: Jacques

family: Huet

full_name: Olivier Huet

given: Olivier

family: Haddad

full_name: Samir Haddad

given: Samir

family: Arabi

full_name: Yaseen M. Arabi

given: Yaseen M.

family: McArthur

full_name: Colin McArthur

given: Colin

family: Cooper

full_name: David James Cooper

given: David James

family: Bendel

full_name: Stepani Bendel

given: Stepani

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

journal_name: Critical Care Medicine

oa_colors: green other

evidence: open (via page says license)

repository_institution: University of Melbourne - Minerva Access

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: A Post Hoc Analysis of Osmotherapy Use in the Erythropoietin in Traumatic Brain Injury Study—Associations With Acute Kidney Injury and Mortality

ReferenceCitation: Skrifvars MB, Moore E, Mårtensson J, Bailey M, French C, Presneill J, Nichol A, Little L, Duranteau J, Huet O, Haddad S, Arabi Y, McArthur C, Cooper DJ, Bellomo R; EPO-TBI Investigators and the ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury associated acute kidney injury: A randomized controlled trial. Acta Anaesthesiol Scand. 2019 Feb;63(2):200-207. doi: 10.1111/aas.13244. Epub 2018 Aug 21.

name: Australian and New Zealand Intensive Care Research Centre; School of Public Health and Preventive Medicine; Monash University; Melbourne Victoria Australia

name: Division of Intensive Care; Department of Anaesthesiology, Intensive Care and Pain Medicine; Helsinki University Hospital and University of Helsinki; Helsinki Finland

name: Department of Emergency Medicine and Services; Helsinki University Hospital and University of Helsinki; Helsinki Finland

name: Department of Physiology and Pharmacology; Section of Anaesthesia and Intensive Care; Karolinska Institutet; Stockholm Sweden

name: Department of Intensive Care; Western Health; Melbourne Victoria Australia

name: Department of Intensive Care; Royal Melbourne Hospital; Melbourne Victoria Australia

name: School of Medicine and Medical Sciences; University College Dublin; Dublin Ireland

name: St Vincent's University Hospital; Dublin Ireland

name: Department of Intensive Care and Hyperbaric Medicine; The Alfred; Melbourne Victoria Australia

name: Department of Anaesthesia and Intensive Care; Hôpitaux universitaires Paris Sud (HUPS); Université Paris Sud XI; Orsay France

name: Departement d'anesthésie-réanimation; Hopital de la Cavale Blanche; Boulevard Tanguy Prigent; CHRU de Brest; Univeristé de Bretagne Occidental; Brest France

name: King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center; Riyadh Saudi Arabia

name: G&S Medical Associates; Urgent Care; Paterson New Jersey

name: Department of Critical Care Medicine; Auckland City Hospital; Auckland New Zealand

name: Department of Intensive Care; Austin Health; Melbourne Victoria Australia

name: The EPO-TBI Investigators and the ANZICS Clinical Trials Group

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Nichol A, French C, Little L, Haddad S, Presneill J, Arabi Y, Bailey M, Cooper DJ, Duranteau J, Huet O, Mak A, McArthur C, Pettilä V, Skrifvars M, Vallance S, Varma D, Wills J, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Erythropoietin in traumatic brain injury (EPO-TBI): a double-blind randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2499-506. doi: 10.1016/S0140-6736(15)00386-4. Epub 2015 Oct 6.

ReferenceCitation: Nichol A, French C, Little L, Presneill J, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial. Trials. 2015 Feb 8;16:39. doi: 10.1186/s13063-014-0528-6.

name: On behalf of the EPO-TBI Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group

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

ReferenceCitation: Presneill J, Little L, Nichol A, French C, Cooper DJ, Haddad S, Duranteau J, Huet O, Skrifvars M, Arabi Y, Bellomo R; EPO-TBI Investigators; ANZICS Clinical Trials Group. Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury. Trials. 2014 Dec 20;15:501. doi: 10.1186/1745-6215-15-501.

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

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

ReferenceCitation: Moore EM, Bellomo R, Nichol AD. Erythropoietin as a novel brain and kidney protective agent. Anaesth Intensive Care. 2011 May;39(3):356-72. Review.

location_country:
Saudi Arabia
Finland
France
Ireland
Australia
New Zealand
Germany

location_facility:
Royal North Shore Hospital
Wellington Regional Hospital
Helsinki University Central Hospital
Hôpital Michallon
Auckland City Hospital
Hôpital de Bicêtre
Hôpital universitaire Caremeau
Royal Adelaide Hosptial
The Townsville Hospital
St Vincent's Hospital Sydney
The Royal Melbourne Hospital
Hôpital Lariboisière
Dunedin Hospital
Canberra Hospital
John Hunter Hospital
King Fahad National Guard Hospital
Beaumont Hospital
Royal Hobart Hospital
Royal Prince Alfred Hospital
Kuopio University Hospital
CHU de Rouen
Liverpool Hospital
Westmead Hospital
Royal Perth Hospital
Johannes Gutenberg-Universtität
Christchurch Hospital
Gold Coast University Hospital
The Alfred Hospital


title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

enrollment_type: Anticipated

ReferenceCitation: Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.

name: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Pisana; Rome Italy

family: Stocchi

full_name: Fabrizio Stocchi

given: Fabrizio

name: Institut National de la Santé et de la Recherche Médicale (INSERM) CIC9302-UMR825 and Departments of Neurosciences and Clinical Pharmacology; Toulouse University Hospital and University of Toulouse III; Toulouse France

family: Rascol

full_name: Olivier Rascol

name: Lille North of France University, Lille University Hospital, Movement Disorders Unit; INSERM U837 Lille France

family: Destee

full_name: Alain Destee

given: Alain

name: Department of Neurology, Juntendo University School of Medicine; Tokyo Japan

family: Hattori

full_name: Nobutaka Hattori

given: Nobutaka

name: Department of Neurology; University of South Florida; Tampa Florida USA

family: Hauser

full_name: Robert A. Hauser

given: Robert A.

name: Edmond J. Safra Program in Parkinson's Disease; Toronto Western Hospital, University of Toronto; Toronto Ontario Canada

family: Lang

full_name: Anthony E. Lang

given: Anthony E.

name: Department of Neurology; Medical University of Innsbruck; Innsbruck Austria

family: Poewe

full_name: Werner Poewe

given: Werner

name: Department of Neurology; School of Medicine; Duke University Medical Center; Durham North Carolina USA

family: Stacy

full_name: Mark Stacy

given: Mark

name: Neurology Service, Hospital Clinic, Barcelona, Spain; Centro de Investigación Biomédica en Red Enfermedades Neurodegenerativas (CIBERNED), Barcelona, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS); Barcelona Spain

family: Tolosa

full_name: Eduardo Tolosa

given: Eduardo

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey USA

family: Gao

full_name: Haitao Gao

given: Haitao

family: Nagel

full_name: Jennifer Nagel

given: Jennifer

family: Merschhemke

full_name: Martin Merschhemke

given: Martin

family: Graf

full_name: Ana Graf

given: Ana

family: Kenney

full_name: Christopher Kenney

given: Christopher

name: Paracelsus-Elena-Klinik; Kassel; Department of Neurosurgery; University Medical Center of Goettingen; Goettingen Germany

family: Trenkwalder

full_name: Claudia Trenkwalder

given: Claudia

journal_name: Movement Disorders

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Novartis

location_country: Italy Finland France Japan Australia Spain Germany Canada

location_facility: Parkinson's and Neurodegenerative Disorders Clinic

location_facility: Quebec Memory & Motor Skills Disorders Clinic


type: Other Identifier

title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
To evaluate the effect of alirocumab on other lipid parameters
To evaluate the safety and tolerability of alirocumab

ReferenceCitation: Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121.

ReferenceCitation: Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16.

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

family: Blom

full_name: Dirk Blom

given: Dirk

family: McKenney

full_name: James M. McKenney

given: James M.

family: Lorenzato

full_name: Christelle Lorenzato

given: Christelle

family: Pordy

full_name: Robert Pordy

given: Robert

family: Chaudhari

full_name: Umesh Chaudhari

given: Umesh

family: Colhoun

full_name: Helen M. Colhoun

given: Helen M.

journal_name: European Heart Journal

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

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

repository_normalized: HAL

repository_institution: University of Edinburgh - Edinburgh Research Explorer

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

name: Li Ka Shing Knowledge Institute; St Michael's Hospital; University of Toronto; Toronto ON Canada

family: Leiter

full_name: L. A. Leiter

given: L. A.

name: Department of Clinical Endocrinology and Nutrition (IBIMA); Hospital Virgen de la Victoria; University of Málaga; CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn); Instituto de Salud Carlos III; Málaga Spain

name: Sidney Kimmel Medical College; Thomas Jefferson University; Philadelphia PA USA

name: Biostatistics and Programming Department; Sanofi, Chilly-Mazarin France

name: Regeneron Pharmaceuticals, Inc.; Tarrytown NY USA

name: Baylor College of Medicine; Houston TX USA

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

location_country:
South Africa
France
Korea, Republic of
Israel
Hungary
Russian Federation
Denmark
United States
Canada
Ukraine

location_facility:
Investigational Site Number 840912
Investigational Site Number 840971
Investigational Site Number 840946
Investigational Site Number 840979
Investigational Site Number 208908
Investigational Site Number 410924
Investigational Site Number 124902
Investigational Site Number 410913
Investigational Site Number 840920
Investigational Site Number 410921
Investigational Site Number 840921
Investigational Site Number 410915
Investigational Site Number 376906
Investigational Site Number 643904
Investigational Site Number 710913
Investigational Site Number 840973
Investigational Site Number 710918
Investigational Site Number 643911
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title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

summary: This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Brazil
Mexico
Germany
France
Czechia
Poland
Hungary
Belgium
Argentina
Russian Federation
Spain
United States
Ukraine


title: A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

acronym: PRINCIPAL

summary: The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

location_country:
Italy
Chile
Hong Kong
Mexico
Netherlands
Finland
France
Japan
Greece
Singapore
Belgium
Argentina
Australia
New Zealand
Russian Federation
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: University Of California, San Francisco/Sf General Hospital

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

location_facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism

summary: Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Poland
Australia
Belgium
Spain
Canada


title: Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

summary: The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Sequenom, Inc.

location_country:
United States
France

location_facility: Fetal Diagnostic Institution of the Pacific

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Regional et Universitaire - Hopital Bretonneau

location_facility: Spectrum Health - Maternal Fetal Medicine


ReferenceCitation: Judson MA, Mack M, Beaumont JL, Watt R, Barnathan ES, Victorson DE. Validation and important differences for the Sarcoidosis Assessment Tool. A new patient-reported outcome measure. Am J Respir Crit Care Med. 2015 Apr 1;191(7):786-95. doi: 10.1164/rccm.201410-1785OC.

family: Judson

full_name: Marc A. Judson

given: Marc A.

family: Mack

full_name: Michael Mack

given: Michael

family: Beaumont

full_name: Jennifer L. Beaumont

given: Jennifer L.

family: Watt

full_name: Rosemary Watt

given: Rosemary

family: Barnathan

full_name: Elliot S. Barnathan

given: Elliot S.

family: Victorson

full_name: David E. Victorson

given: David E.

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Validation and Important Differences for the Sarcoidosis Assessment Tool. A New Patient-reported Outcome Measure

ReferenceCitation: Crommelin HA, Vorselaars AD, van Moorsel CH, Korenromp IH, Deneer VH, Grutters JC. Anti-TNF therapeutics for the treatment of sarcoidosis. Immunotherapy. 2014;6(10):1127-43. doi: 10.2217/imt.14.65. Review.

family: Crommelin

full_name: Heleen A Crommelin

given: Heleen A

family: Vorselaars

full_name: Adriane DM Vorselaars

given: Adriane DM

family: van Moorsel

full_name: Coline HM van Moorsel

given: Coline HM

family: Korenromp

full_name: Ingrid HE Korenromp

given: Ingrid HE

family: Deneer

full_name: Vera HM Deneer

given: Vera HM

family: Grutters

full_name: Jan C Grutters

given: Jan C

journal_name: Immunotherapy

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Judson MA, Baughman RP, Costabel U, Drent M, Gibson KF, Raghu G, Shigemitsu H, Barney JB, Culver DA, Hamzeh NY, Wijsenbeek MS, Albera C, Huizar I, Agarwal P, Brodmerkel C, Watt R, Barnathan ES. Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis. Eur Respir J. 2014 Nov;44(5):1296-307. doi: 10.1183/09031936.00000914. Epub 2014 Jul 17.

family: Baughman

full_name: Robert P. Baughman

given: Robert P.

family: Costabel

full_name: Ulrich Costabel

given: Ulrich

family: Drent

full_name: Marjolein Drent

given: Marjolein

family: Gibson

full_name: Kevin F. Gibson

given: Kevin F.

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

family: Shigemitsu

full_name: Hidenobu Shigemitsu

given: Hidenobu

family: Barney

full_name: Joseph B. Barney

given: Joseph B.

location_country:
Netherlands
Germany
France
Norway
Romania
Belgium
Denmark
United States
United Kingdom

title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis

summary: This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally.


title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

summary:
This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this study were:

To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies.
To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

ReferenceCitation: CAMMS223 Trial Investigators, Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. doi: 10.1056/NEJMoa0802670.

ReferenceCitation: Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.

ReferenceCitation: Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.

ReferenceCitation: Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2021 Aug 11:13524585211032348. doi: 10.1177/13524585211032348. [Epub ahead of print]

name: Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland

family: Kuhle

full_name: Jens Kuhle

given: Jens

family: Daizadeh

full_name: Nadia Daizadeh

given: Nadia

name: Clinical Trial Unit Basel, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland

family: Benkert

full_name: Pascal Benkert

given: Pascal

family: Maceski

full_name: Aleksandra Maceski

given: Aleksandra

name: Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland Current affiliation: Ann Romney Center for Neurologic Diseases, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA, USA

family: Barro

full_name: Christian Barro

given: Christian

name: Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland Current affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland

family: Michalak

full_name: Zuzanna Michalak

given: Zuzanna

name: Department of Health Sciences, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genoa, Italy

family: Sormani

full_name: Maria Pia Sormani

given: Maria Pia

family: Godin

full_name: Jean Godin

given: Jean

family: Shankara

full_name: Srinivas Shankara

given: Srinivas

name: Current affiliation: Immunitas Therapeutics, Inc., Cambridge, MA, USA

family: Samad

full_name: Tarek A Samad

given: Tarek A

name: Current affiliation: Immunovant, New York, NY, USA

family: Jacobs

full_name: Alan Jacobs

given: Alan

name: Current affiliation: Immune-Onc Therapeutics, Palo Alto, CA, USA

family: Chung

full_name: Luke Chung

given: Luke

family: Rӧsch

full_name: Nora Rӧsch

given: Nora

family: Kaiser

full_name: Carina Kaiser

given: Carina

family: Mitchell

full_name: Colin P Mitchell

given: Colin P

family: Leppert

full_name: David Leppert

given: David

family: Havari

full_name: Evis Havari

given: Evis

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: Multiple Sclerosis Journal

oa_host_type: publisher

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing–remitting MS

ReferenceCitation: Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernández Ó, Havrdová EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.

name: Department of Clinical Neurosciences, University of Cambridge, Box 165, Addenbrooke’s Hospital, Cambridge CB2 0QQ, UK

name: NeuroRx Research, Montréal, Québec, Canada

name: Department of Neurology and Neurosurgery, Montréal Neurological Institute, McGill University, Montréal, Québec, Canada

name: Neurology Center of San Antonio, San Antonio, TX, USA

name: Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK

name: Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain

name: Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic

name: Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA

name: The University of British Columbia, Vancouver, British Columbia, Canada

name: Vertex Pharmaceuticals, Inc., Boston, MA, USA

name: Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland

journal_name: Therapeutic Advances in Neurological Disorders

ReferenceCitation: Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintoré M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.

journal_name: Multiple Sclerosis and Related Disorders

ReferenceCitation: Horáková D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.

name: Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic

name: The Boster Center for Multiple Sclerosis, Columbus, USA

name: University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada

name: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden,  Germany  *Employees of Sanofi  during study conduct  and analysis.

name: on behalf of the CARE-MS I, CARE-MS II, and CAMMS03409 Investigators

journal_name: Multiple Sclerosis Journal - Experimental, Translational and Clinical

ReferenceCitation: Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

name: CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators

ReferenceCitation: Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.

ReferenceCitation: Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernández Ó, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

name: Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy

name: Department of Medicine, Amiri Hospital, Sharq, Kuwait

name: OhioHealth Neurological Physicians, Columbus, OH, USA

name: Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA

name: Research Institute and Hospital, National Cancer Center, Goyang, South Korea

name: Klinik für Neurologie und Palliativmedizin, Cologne, Germany

name: Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden

name: Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia

name: NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK

name: Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France

name: Department of Neurology, University of Münster, Münster, Germany

name: Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

ReferenceCitation: Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernández Ó, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.

name: Rehabilitation and MS Center Overpelt; BIOMED, Hasselt University, Hasselt, Belgium

name: The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA

name: School of Medicine, Griffith University, Southport, QLD, Australia

name: Fundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain

name: University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada

name: Virgen Macarena University Hospital, Seville, Spain

name: Institution of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

name: Sapienza University of Rome, Rome, Italy

name: Fort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA

name: Sanofi, Cambridge, MA, USA; Cerevance, Boston, MA, USA

name: Sanofi, Cambridge, MA, USA; EMD Serono, Billerica, MA, USA

name: University of Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France

title: Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

ReferenceCitation: Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

name: the CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators

ReferenceCitation: Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.

name: Department of Neurology, Hospital Universitario Quirónsalud, Madrid, Spain

name: Contractor to Sanofi Genzyme, Cambridge, MA, USA

name: Sanofi, Cambridge, MA, USA; Bristol-Myers Squibb, Lawrence Township, NJ, USA

name: Sanofi, Cambridge, MA, USA; Cerevance, Inc., Boston, MA, USA

name: Department of Medical Social Sciences, Center for Patient-Centered Outcomes, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

location_country:
Australia
Belgium
Russian Federation
Denmark
Ukraine
Croatia
France
Poland
Argentina
Canada
Sweden
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain

location_facility: University of Maryland, Maryland Center for MS

location_facility: Wayne State University, The School of Medicine, Department of Neurology

location_facility: University of South Florida College of Medicine

location_facility: Clinical Centre Nis, Clinic of Neurology

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department

location_facility: Baylor College of Medicine, Maxine Mesinger MS Clinic

location_facility: Lehigh Valley Hospital Neurosciences and Pain Research

location_facility: St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital

location_facility: Samara Regional Clinical Hospital n.a. Kalinin

location_facility: London Health Sciences Centre - University Hospital

location_facility: Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department

location_facility: Emory University Department of Neurology

location_facility: University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

location_facility: Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii

location_facility: Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego

location_facility: East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation

location_facility: Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade

location_facility: Neurology Research Center under the Russian Academy of Medical Sciences

location_facility: St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital

location_facility: Universitätsklinikum Ulm, Klinik für Neurologie im RKU

location_facility: Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System

location_facility: University of Colorado Health Science Center - Aurora

location_facility: Hospital da Restauração, Neurology department

location_facility: Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS

location_facility: SUNY Upstate Medical University, Department of Neurology

location_facility: Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department

location_facility: Indiana University Multiple Sclerosis Center

location_facility: Institute of Human Brain RAS, Laboratory of Neuroimmunology

location_facility: Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

location_facility: Wake Forest University Health Science Department of Neurology

location_facility: AKH Wien-Universitätskliniken für Neurologie

location_facility: Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde

location_facility: Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf

location_facility: Shepherd Center Multiple Sclerosis Institute

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: University of Calgary, Department of Neurology

location_facility: Hospital Clínico Universitario San Carlos

location_facility: University of Kansas Medical Center, Department of Neurology

location_facility: Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology

location_facility: St. Petersburg General Hospital #2, Neurology Department #2

location_facility: General Hospital Varazdin, Department for Neurology

location_facility: Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin

location_facility: Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency

location_facility: Municipal Treatment and Prevention Institution, City Hospital #33

location_facility: University of Florida Neuroscience Institute

location_facility: University Hospital of Wales, Dept of Neurology

location_facility: Negroski, Stein, Sutherland and Hanes Neurology

location_facility: Universitätsklinik Carl Gustav Carus Dresden

location_facility: Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.

location_facility: Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center

location_facility: North Central Neurology Associates, P.C.

location_facility: State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov

location_facility: Winthrop University Hospital Multiple Sclerosis Treatment Center

location_facility: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

location_facility: Rhode Island Hospital MS Center - The Neurology Foundation, Inc

location_facility: Clinical Centre Kragujevac, Clinic of Neurology

location_facility: Universita Degli Studi di Roma "La Sapienza"

location_facility: Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic

location_facility: Military Medical Academy, Institute of Neurology

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu

location_facility: OMRF Multiple Sclerosis Center of Excellence

location_facility: The University of North Carolina at Chapel Hill

location_facility: The George Washington University Medical Faculty Associates

location_facility: University of New Mexico, Dept. of Neurology

location_facility: Hospital Teplice, Neurology Department, MS centrum

location_facility: Russian State Medical University, Department of Neurology and Neurosurgery

location_facility: Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department


location_country:
France
Poland
Spain
United States
Portugal

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase

summary: The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill patients with a diagnosis of active cancer.


title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias

summary: MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose escalations will continue based on predefined parameters until a maximum tolerated dose is established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or refractory leukaemias (AML, MDS or CMML) will be determined.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United States
Belgium
France


ReferenceCitation: Pinter T, Klippel Z, Cesas A, Croitoru A, Decaestecker J, Gibbs P, Hotko Y, Jassem J, Kurteva G, Novotny J, O'Reilly S, Salek T, Reiner M, Morrow PK, Choi MR, Whittaker S, Blanke C. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES). Clin Colorectal Cancer. 2017 Jun;16(2):103-114.e3. doi: 10.1016/j.clcc.2016.08.008. Epub 2016 Sep 7.

primary_purpose: Supportive Care

location_country:
Italy
United States
Mexico
France
Bulgaria
Czechia
Poland
Slovakia
Romania
Hungary
Belgium
Australia
Ireland
Russian Federation
Canada
Latvia
Ukraine

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)

summary:
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).

This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

acronym: ADVANCE

summary: The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

ReferenceCitation: Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A; ADVANCE Study Investigators. Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.

family: Calabresi

full_name: Peter A Calabresi

given: Peter A

family: Kieseier

full_name: Bernd C Kieseier

given: Bernd C

family: Arnold

full_name: Douglas L Arnold

given: Douglas L

family: Balcer

full_name: Laura J Balcer

given: Laura J

family: Boyko

full_name: Alexey Boyko

given: Alexey

family: Pelletier

full_name: Jean Pelletier

family: Liu

full_name: Shifang Liu

given: Shifang

family: Zhu

full_name: Ying Zhu

given: Ying

family: Seddighzadeh

full_name: Ali Seddighzadeh

given: Ali

family: Hung

full_name: Serena Hung

given: Serena

family: Deykin

full_name: Aaron Deykin

given: Aaron

journal_name: The Lancet Neurology

title: Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study

ReferenceCitation: Calabresi PA, Arnold DL, Sangurdekar D, Singh CM, Altincatal A, de Moor C, Engle B, Goyal J, Deykin A, Szak S, Kieseier BC, Rudick RA, Plavina T. Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring. Mult Scler. 2021 Sep;27(10):1497-1505. doi: 10.1177/1352458520972573. Epub 2020 Dec 14.

name: Department of Neurology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA

name: Montreal Neurological Institute, McGill University, Montreal, QC, Canada/NeuroRx, Montreal, QC, Canada

family: Sangurdekar

full_name: Dipen Sangurdekar

given: Dipen

family: Singh

full_name: Carol M Singh

given: Carol M

family: Altincatal

full_name: Arman Altincatal

given: Arman

family: de Moor

full_name: Carl de Moor

given: Carl

family: Engle

full_name: Bob Engle

given: Bob

family: Goyal

full_name: Jaya Goyal

given: Jaya

family: Szak

name: Department of Neurology, Medical Faculty, Heinrich Heine University, Dusseldorf, Germany/Biogen, Cambridge, MA, USA

ReferenceCitation: Cleanthous S, Cano S, Kinter E, Marquis P, Petrillo J, You X, Wakeford C, Sabatella G. Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT). Mult Scler J Exp Transl Clin. 2017 Aug 15;3(3):2055217317725917. doi: 10.1177/2055217317725917. eCollection 2017 Jul-Sep.

ReferenceCitation: Scott TF, Kieseier BC, Newsome SD, Arnold DL, You X, Hung S, Sperling B. Improvement in relapse recovery with peginterferon beta-1a in patients with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316676644. doi: 10.1177/2055217316676644. eCollection 2016 Jan-Dec.

name: Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA

name: Department of Neurology, Drexel University College of Medicine, Pittsburgh, PA, USA

name: Department of Neurology, Heinrich-Heine University, Düsseldorf, Germany

name: Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA

name: Montreal Neurological Institute, McGill University, Montreal, Canada

ReferenceCitation: Newsome SD, Kieseier BC, Liu S, You X, Kinter E, Hung S, Sperling B. Peginterferon beta-1a reduces disability worsening in relapsing-remitting multiple sclerosis: 2-year results from ADVANCE. Ther Adv Neurol Disord. 2017 Jan;10(1):41-50. doi: 10.1177/1756285616676065. Epub 2016 Nov 16.

name: Johns Hopkins Neuroimmunology and Neuroinfectious Diseases, Johns Hopkins Hospital, 600 North Wolfe Street, Pathology 627, Baltimore, MD 21287, USA

name: Department of Neurology, Medical Faculty, Henrich-Heine University, Düsseldorf, Germany Biogen, Cambridge, MA, USA

title: Peginterferon beta-1a reduces disability worsening in relapsing–remitting multiple sclerosis: 2-year results from ADVANCE

ReferenceCitation: Arnold DL, Calabresi PA, Kieseier BC, Liu S, You X, Fiore D, Hung S. Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial. BMC Neurol. 2017 Feb 10;17(1):29. doi: 10.1186/s12883-017-0799-0.

ReferenceCitation: Newsome SD, Guo S, Altincatal A, Proskorovsky I, Kinter E, Phillips G, You X, Sabatella G. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):350-7. doi: 10.1016/j.msard.2015.06.004. Epub 2015 Jun 14.

ReferenceCitation: Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S. Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis. BMC Neurol. 2014 Dec 31;14:240. doi: 10.1186/s12883-014-0240-x.

ReferenceCitation: Kieseier BC, Arnold DL, Balcer LJ, Boyko AA, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A, Sheikh SI, Calabresi PA. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015 Jul;21(8):1025-35. doi: 10.1177/1352458514557986. Epub 2014 Nov 28.

name: Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany

name: Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada/NeuroRx Research, Montreal, Quebec, Canada

name: Department of Neurology, New York University, School of Medicine, New York, USA

name: Moscow MS Center at 11 City Hospital and Department of Neurology & Neurosurgery of the RSMRU, Moscow, Russia

name: Departments of Neurology and Research, Aix-Marseille Université, CHU Timone, Marseille, France

name: Biogen Idec Incorporated, Cambridge, USA

name: Department of Neurology, Johns Hopkins University, Baltimore, USA

ReferenceCitation: Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S. Pharmacokinetics and pharmacodynamics of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis in the randomized ADVANCE study. Br J Clin Pharmacol. 2015 Mar;79(3):514-22. doi: 10.1111/bcp.12521.

journal_name: British Journal of Clinical Pharmacology

title: Pharmacokinetics and pharmacodynamics of peginterferon beta‐1a in patients with relapsing‐remitting multiple sclerosis in the randomized ADVANCE study

location_country:
Peru
Greece
Romania
Belgium
Russian Federation
Czech Republic
Ukraine
India
Croatia
France
Poland
Canada
Colombia
Chile
Netherlands
Bulgaria
United States
Germany
United Kingdom
Serbia
Mexico
Georgia
New Zealand
Spain
Estonia
Latvia