title: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

acronym: SPIRIT II

summary:
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

ReferenceCitation: Garg S, Serruys P, Onuma Y, Dorange C, Veldhof S, Miquel-Hébert K, Sudhir K, Boland J, Huber K, Garcia E, te Riele JA; SPIRIT II Investigators. 3-year clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1190-8. doi: 10.1016/j.jcin.2009.10.002.

ReferenceCitation: Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrié D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.

ReferenceCitation: Ruygrok PN, Desaga M, Van Den Branden F, Rasmussen K, Suryapranata H, Dorange C, Veldhof S, Serruys PW. One year clinical follow-up of the XIENCE V Everolimus-eluting stent system in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II study. EuroIntervention. 2007 Nov;3(3):315-20.

ReferenceCitation: Khattab AA, Richardt G, Verin V, Kelbaek H, Macaya C, Berland J, Miquel-Hebert K, Dorange C, Serruys PW. Differentiated analysis of an everolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial. EuroIntervention. 2008 Mar;3(5):566-73.

ReferenceCitation: Wiemer M, Seth A, Chandra P, Neuzner J, Richardt G, Piek JJ, Desaga M, Macaya C, Bol CJ, Miquel-Hebert K, De Roeck K, Serruys PW. Systemic exposure of everolimus after stent implantation: a pharmacokinetic study. Am Heart J. 2008 Oct;156(4):751.e1-7. doi: 10.1016/j.ahj.2008.07.005.

family: Wiemer

full_name: Marcus Wiemer

given: Marcus

family: Seth

full_name: Ashok Seth

given: Ashok

family: Chandra

full_name: Praveen Chandra

given: Praveen

family: Neuzner

full_name: Jörg Neuzner

given: Jörg

family: Richardt

full_name: Gert Richardt

given: Gert

family: Piek

full_name: Jan J. Piek

given: Jan J.

family: Desaga

full_name: Martin Desaga

given: Martin

family: Macaya

full_name: Carlos Macaya

given: Carlos

family: Bol

full_name: Cornelis J. Bol

given: Cornelis J.

family: Miquel-Hebert

full_name: Karine Miquel-Hebert

given: Karine

family: De Roeck

full_name: Karolien De Roeck

given: Karolien

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

journal_name: American Heart Journal

title: Systemic exposure of everolimus after stent implantation: A pharmacokinetic study

ReferenceCitation: SPIRIT II study: A clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions. Serruys Patrick W (Reprint). Erasmus MC, Ctr Thorax, Rotterdam, Netherlands. Journal of the American College of Cardiology 51 ( 10, Suppl. A ): p A261 MAR 11 2008

ReferenceCitation: A clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with cle novo native coronary artery lesions. Ruygrok Peter(Reprint). Auckland City Hosp, Auckland, New Zealand Journal: Journal of the American College of Cardiology 49 ( 9, Suppl. B ): p 28B-29B MAR 6 2007 2007 i2 Summit 2007 on Innovation in Intervention New Orleans, LA, USA March 24 -27, 2007; 20070324 ISSN: 0735-1097

ReferenceCitation: A clinical evaluation of the XIENCE V Everolimus Eluting CSS in the treatment of patients with de novo, native coronary artery lesions. Pharmaco kinetic substudy. Seth A (Reprint); Neuzner J; Richardt G; Wiemer M; Piek J J; Desaga M; Macaya C; Serruys P W; Spirit II Investigators (Reprint) Author Address: Max Hosp, Vasc Inst, New Delhi, India. European Heart Journal 27 ( Suppl. 1 ): p 767 AUG 2006 2006 World Congress of Cardiology Barcelona, SPAIN September 02 -06, 2006; 20060902 ISSN: 0195-668X Document Type: Meeting; Meeting Poster

ReferenceCitation: Caixeta A, Lansky AJ, Serruys PW, Hermiller JB, Ruygrok P, Onuma Y, Gordon P, Yaqub M, Miquel-Hebert K, Veldhof S, Sood P, Su X, Jonnavithula L, Sudhir K, Stone GW; SPIRIT II and III Investigators. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1220-8. doi: 10.1016/j.jcin.2010.07.017.

family: Caixeta

full_name: Adriano Caixeta

given: Adriano

family: Lansky

full_name: Alexandra J. Lansky

given: Alexandra J.

family: Hermiller

full_name: James B. Hermiller

given: James B.

family: Ruygrok

full_name: Peter Ruygrok

given: Peter

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

family: Gordon

full_name: Paul Gordon

given: Paul

title: Clinical Follow-Up 3 Years After Everolimus- and Paclitaxel-Eluting Stents

ReferenceCitation: Serruys, P. SPIRIT II Clinical Study: A clinical evaluation of the XIENCE™ V Everolimus Eluting CSS in the treatment of patients with de novo, native coronary artery lesions - IVUS substudy. Transcatheter Cardiovascular Therapeutics - TCT Congress 2006

ReferenceCitation: Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O, Suttorp MJ, Tijssen JG, Miquel-Hebert K, Veldhof S, Henriques JP, Serruys PW, Piek JJ. Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial. Circ Cardiovasc Interv. 2009 Aug;2(4):339-47. doi: 10.1161/CIRCINTERVENTIONS.108.831800.108.831800. Epub 2009 Jul 22.

name: From the Department of Cardiology (B.E.C., M.A.B., J.G.P.T., J.P.S.H., J.J.P.), Academic Medical Center, University of Amsterdam, The Netherlands; C.H.U. de Liege Sart Tilman (V.L.), Liege, Belgium; National Institute of Cardiology in Warsaw (W.R.), Warsaw, Poland; Azienda Ospedaliera Santa Maria Nuova (A.M.), Reggio Emilia, Italy; Hopital Cochin (O.V.), Paris, France; St. Antonius Ziekenhuis (M.J.S.), Nieuwegein, The Netherlands; Abbott Vascular (K.M.-H., S.V.), Diegem, Belgium; and Thoraxcenter (P...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions

ReferenceCitation: Généreux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5). pii: e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

name: From the Columbia University Medical Center, New York, NY (P.G., G.W.S.); Cardiovascular Research Foundation, New York, NY (P.G., G.W.S.); Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada (P.G.); Abbott Vascular, Santa Clara, CA (D.R.R., J.W., J.J.-M., K.S., C.A.S.); Istituto di Cardiologia, University of Bologna, Italy (T.P.); Escola Paulista de Medicina, Universidade Federal de São Paulo and Hospital Israelita Albert Einstein, São Paolo, Brazil (A.C.); Isala...

ReferenceCitation: Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, García-García HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

title: 1-Year Clinical Outcomes of Diabetic Patients Treated With Everolimus-Eluting Bioresorbable Vascular Scaffolds

ReferenceCitation: Onuma Y, Miquel-Hebert K, Serruys PW; SPIRIT II Investigators. Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial. EuroIntervention. 2013 Jan 22;8(9):1047-51. doi: 10.4244/EIJV8I9A161.

ReferenceCitation: Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016.

title: Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents

ReferenceCitation: Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.

title: Comparison of Everolimus- and Paclitaxel-Eluting Stents in Patients With Acute and Stable Coronary Syndromes

location_country:
Italy
Austria
South Africa
India
Switzerland
Netherlands
France
Poland
Belgium
New Zealand
Spain
Denmark
Germany

location_facility: Max Devki Devi Heart & Vascular Institute

location_facility: R.V. Hôpital Cantonal Universitaire de Geneve


title: A 4 Week, Dose-Ranging, Multi-Center, Randomized, Double-Masked, Parallel Study Comparing The Efficacy, Safety, And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma Aand Ocular Hypertension

summary: The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 μg/mL to latanoprost 50 μg/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9.

family: Eveleth

full_name: David Eveleth

given: David

sequence: first

family: Starita

full_name: Carla Starita

given: Carla

sequence: additional

family: Tressler

full_name: Charles Tressler

given: Charles

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Ophthalmology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

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

location_country:
Pakistan
France
Czechia
Greece
Thailand
Australia
Portugal
United Kingdom

location_facility: Specializovana Glaukomova Poradna, Blanicka 25

location_facility: Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital

location_facility: Akadimos Ophthalmology Center of Northern Greece

location_facility: Institute of Aviation Medicine, Generalal Piky 1

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

summary: This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

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


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

acronym: PERSIST

summary: This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

lead_sponsor: Sunovion

location_country:
Chile
Serbia
Croatia
Bulgaria
France
Japan
Poland
Slovakia
Hungary
Argentina
Australia
Russian Federation
United States
Czech Republic

location_facility: Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz

location_facility: Psychiatric Clinic Clinical Center Kragujevac

location_facility: Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu

location_facility: Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center

location_facility: Psychiatric Clinic, Military Medical Academy

location_facility: Nagano Prefectural Mental Wellness Center-Komagane

location_facility: Centro de Atencion E Invest. Clinica (CAICI)

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: State Healthcare and Forensic Psychiatric Expertise Institution

location_facility: Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria

location_facility: Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique

location_facility: CHRU de Nimes, Service de Psychiatrie adulte

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Clinic Hospital Centre Rijeka Clinic for Psychiatry

location_facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

location_facility: Mental Health Research Institute of Rams

location_facility: St.Petersburg State Healthcare Institution (SPSHI)

location_facility: RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz

location_facility: Prywatny Gabinet Lekarski Jaroslaw Strzelec

location_facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

location_facility: St. Petersburg State Healthcare Institution (SPSHI)

location_facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: Clinical Hospital Centre Dragisa Misovic

location_facility: Stanford University School of Medicine Research Program VA Palo Alto Health Care System

location_facility: University Multiprofiled Hospital for Active Treatment "Sveti Georgi"

location_facility: Multprofiled Hospital for Active Treatment "Sveta Marina"

location_facility: St Petersburg State Government Healthcare Institution

location_facility: IPEM-Instituto de Prevención de las Enfermedades Mentales.


title: A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

acronym: ATTAIN

summary: The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.

ReferenceCitation: Arnold DL, Shang S, Dong Q, Meergans M, Naylor ML. Peginterferon β-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord. 2018 Aug 28;11:1756286418795085. doi: 10.1177/1756286418795085. eCollection 2018.

name: Montreal Neurological Institute, McGill University, and NeuroRx Research, Montreal, QC, Canada

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

family: Shang

full_name: Shulian Shang

given: Shulian

family: Dong

full_name: Qunming Dong

given: Qunming

family: Meergans

full_name: Matthias Meergans

given: Matthias

name: Biogen, 225 Binney St., Cambridge, MA 02142, USA

family: Naylor

full_name: Maria L. Naylor

given: Maria L.

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Neurological Disorders

license: cc-by-nc

license_normalized: cc-by-nc

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Peginterferon β-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing–remitting multiple sclerosis

ReferenceCitation: Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA. Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study. Expert Opin Drug Deliv. 2014 Nov;11(11):1713-20. doi: 10.1517/17425247.2014.944159. Epub 2014 Jul 29.

name:
Biogen Idec, Inc.,
14 Cambridge Center, Cambridge, MA 02142, USA ;

family: Seddighzadeh

full_name: Ali Seddighzadeh

given: Ali

family: Hung

full_name: Serena Hung

given: Serena

name:
Medical University of Lodz, Department of Neurology,
Lodz, Poland

family: Selmaj

full_name: Krzysztof Selmaj

given: Krzysztof

family: Cui

full_name: Yue Cui

given: Yue

family: Liu

full_name: Shifang Liu

given: Shifang

family: Sperling

full_name: Bjoern Sperling

given: Bjoern

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

family: Calabresi

full_name: Peter A Calabresi

given: Peter A

journal_name: Expert Opinion on Drug Delivery

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Biogen

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


title: A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee

summary: This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.

ReferenceCitation: Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.

family: Chevalier

full_name: X Chevalier

given: X

family: Jerosch

full_name: J Jerosch

given: J

family: Goupille

full_name: P Goupille

given: P

family: van Dijk

full_name: N van Dijk

given: N

family: Luyten

full_name: F P Luyten

given: F P

family: Scott

full_name: D L Scott

given: D L

family: Bailleul

full_name: F Bailleul

given: F

family: Pavelka

full_name: K Pavelka

given: K

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Wiardi Beckman Foundation - Wiardi Beckman Foundation

version: submittedVersion

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United Kingdom
Netherlands
France
Belgium
Germany
Czech Republic

location_facility: Universitair Ziekenhuis Gastuisberg Leuven

intervention_type: Other


type: Other Identifier

title: A Phase III, Open-Label, Single Arm, Rollover Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.

summary: The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.

ReferenceCitation: Gane EJ, DeJesus E, Janczewska E, George J, Diago M, Da Silva MH, Reesink H, Nikitin I, Hinrichsen H, Bourgeois S, Ferenci P, Shukla U, Kalmeijer R, Lenz O, Fevery B, Corbett C, Beumont M, Jessner W. Simeprevir with peginterferon α-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study. BMC Infect Dis. 2017 Jun 2;17(1):389. doi: 10.1186/s12879-017-2444-3.

family: Gane

full_name: Edward J. Gane

given: Edward J.

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Janczewska

full_name: Ewa Janczewska

given: Ewa

family: George

full_name: Jacob George

given: Jacob

family: Diago

full_name: Moises Diago

given: Moises

family: Da Silva

full_name: Mariliza Hendrique Da Silva

given: Mariliza Hendrique

family: Reesink

full_name: Henk Reesink

given: Henk

family: Nikitin

full_name: Igor Nikitin

given: Igor

family: Hinrichsen

full_name: Holger Hinrichsen

given: Holger

family: Bourgeois

full_name: Stefan Bourgeois

given: Stefan

family: Ferenci

full_name: Peter Ferenci

given: Peter

family: Shukla

full_name: Umesh Shukla

given: Umesh

family: Kalmeijer

full_name: Ronald Kalmeijer

given: Ronald

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Fevery

full_name: Bart Fevery

given: Bart

family: Corbett

full_name: Chris Corbett

given: Chris

family: Beumont

full_name: Maria Beumont

given: Maria

family: Jessner

full_name: Wolfgang Jessner

given: Wolfgang

journal_name: BMC Infectious Diseases

location_country:
Romania
Australia
Belgium
Russian Federation
Ukraine
France
Poland
Argentina
Canada
Netherlands
Bulgaria
Puerto Rico
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Mexico
Israel
New Zealand
Spain


title: Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients

summary: The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere based regimens.

lead_sponsor: Eisai Inc.

location_country:
Brazil
Chile
Peru
Croatia
France
Romania
Russian Federation
United States
Canada


title: A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099

summary: The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Brazil
South Africa
Mexico
Spain
France
Thailand
Israel
Singapore
Belgium
Argentina
Puerto Rico
Portugal
Russian Federation
Canada


title: A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD

summary: This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

ReferenceCitation: Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017 Jan;33(12):2188-2199. Epub 2016 Oct 28.

ReferenceCitation: Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G, Tabberer M, Harris S, Church A. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014 Jun;2(6):472-86. doi: 10.1016/S2213-2600(14)70065-7. Epub 2014 May 14.

family: Decramer

full_name: Marc Decramer

given: Marc

family: Anzueto

full_name: Antonio Anzueto

given: Antonio

family: Kerwin

full_name: Edward Kerwin

given: Edward

family: Kaelin

full_name: Thomas Kaelin

given: Thomas

family: Richard

full_name: Nathalie Richard

given: Nathalie

family: Crater

full_name: Glenn Crater

given: Glenn

family: Tabberer

full_name: Maggie Tabberer

given: Maggie

family: Harris

full_name: Stephanie Harris

given: Stephanie

family: Church

full_name: Alison Church

given: Alison

journal_name: The Lancet Respiratory Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: Yes

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.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Peru
Mexico
France
Poland
Romania
Russian Federation
Germany
Ukraine


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis Who Have Not Been Previously Treated With Disease-modifying Antirheumatic Drugs

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

study_start_date_type: Actual

ReferenceCitation: Wells AF, Edwards CJ, Kivitz AJ, Bird P, Guerette B, Delev N, Paris M, Teng L, Aelion JA. Apremilast monotherapy for long-term treatment of active psoriatic arthritis in DMARD-naive patients. Rheumatology (Oxford). 2021 Jun 8. pii: keab449. doi: 10.1093/rheumatology/keab449. [Epub ahead of print]

name: Aurora Rheumatology and Immunotherapy Center, Franklin, WI, USA

family: Wells

full_name: Alvin F Wells

given: Alvin F

name: NIHR Clinical Research Facility, University Hospital Southampton, Southampton, UK

family: Edwards

full_name: Christopher J Edwards

given: Christopher J

name: Altoona Center for Clinical Research, Duncansville, PA, USA

family: Kivitz

full_name: Alan J Kivitz

given: Alan J

name: Department of Medicine, University of New South Wales, Sydney, New South Wales, Australia

family: Bird

full_name: Paul Bird

given: Paul

name: Global Medical Affairs, Amgen Inc., Thousand Oaks, CA

family: Guerette

full_name: Benoit Guerette

given: Benoit

name: Clinical Development, Celgene Corporation, Summit, NJ

family: Delev

full_name: Nikolay Delev

given: Nikolay

family: Paris

full_name: Maria Paris

family: Teng

full_name: Lichen Teng

given: Lichen

name: West Tennessee Research Institute, Jackson, TN, USA

family: Aelion

full_name: Jacob A Aelion

given: Jacob A

journal_name: Rheumatology

oa_host_type: repository

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Apremilast monotherapy for long-term treatment of active psoriatic arthritis in DMARD-naïve patients

ReferenceCitation: Wells AF, Edwards CJ, Kivitz AJ, Bird P, Nguyen D, Paris M, Teng L, Aelion JA. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial. Rheumatology (Oxford). 2018 Jul 1;57(7):1253-1263. doi: 10.1093/rheumatology/key032.

name: NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK

name: Combined Rheumatology Practice, Kogarah, NSW, Australia

family: Nguyen

full_name: Dianne Nguyen

given: Dianne

evidence: open (via crossref license)

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

location_country:
Italy
United States
France
Bulgaria
Czechia
Lithuania
Poland
Romania
Hungary
Belgium
Australia
New Zealand
Russian Federation
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED

location_facility: Menzies Centre for Population Health Research

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Unifour Medical Research Associatets LLC

location_facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Bytomskie Centrum Medyczne Silesiana Sp. z o.o.

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

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Kemerovo State Medical Academy of Roszdrav

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Clinical Research Center of Reading, LLP

location_facility: Honvéd Kórház - Állami Egészségügyi Központ

location_facility: Departmental Hospital at Smolensk Station RZhD JSC

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: Research Institute of Clinical Immunology

location_facility: AOU della II Universita degli Studi di Napoli

location_facility: Veterans of Wars Regional Clinical Hospital

location_facility: St. Clare's Health Care Corporation of St. John's

location_facility: Multiprofile Hospital for Active Treatment Trimontsium

location_facility: 17 Diagnostic and Consulting Centre Sofia EOOD

location_facility: Atlanta Dermatology, Vein and Research Center, PC


title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with post-herpetic neuralgia (PHN).

location_country:
United States
France

location_facility: The Center For Pharmaceutical Research. Pc

location_facility: Comprehensive Clinical Development, Inc.


title: A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

summary: This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

ReferenceCitation: Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.

name: The Royal Hallamshire Hospital; Sheffield UK

family: Chapple

full_name: Christopher Chapple

given: Christopher

name: Praxisklinik Urologie Rhein/Ruhr; Mülheim Germany

family: Schneider

full_name: Tim Schneider

given: Tim

family: Haab

full_name: François Haab

given: François

family: Sun

full_name: Franklin Sun

given: Franklin

family: Whelan

full_name: Laurence Whelan

given: Laurence

family: Scholfield

full_name: David Scholfield

given: David

family: Dragon

full_name: Erika Dragon

given: Erika

family: Mangan

full_name: Erin Mangan

given: Erin

journal_name: BJU International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Pfizer

location_country:
Finland
Greece
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
France
Poland
Lithuania
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Philippines
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Egypt

location_facility: Premier Medical Group of the Hudson Valley

location_facility: The Office of Dr. Myron I. Murdock, MD, LLC

location_facility: Vinnitsa Regional Clinical Dispensary of Endocrinology

location_facility: Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education

location_facility: Columbus Center for Women's Health Research

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika

location_facility: Montgomery Women's Health Associates, P.C.

location_facility: Rostov State Medical University, Chair of Urology

location_facility: Toronto Western Hospital, University Health Network

location_facility: Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku

location_facility: Internal Medicine and Pediatric Associates of Bristol, PC

location_facility: Asan Medical Center, Department of Urology

location_facility: Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital

location_facility: Stanley Flax Medical Professional Corporation

location_facility: Women's and Family Care dba GTC Research

location_facility: Forusakutten AS, Avdeling for oppdragsforskning

location_facility: Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1

location_facility: Medical Affiliated Research Center, Inc.

location_facility: Nemocnica s Poliklinikou Svateho Lukasa Galanta

location_facility: Central Kentucky Research Associates, Inc.

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group

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

location_facility: Clinical Research Center of Cape Cod, Inc.

location_facility: Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Department of Urology, Korea University Anam Hospital

location_facility: Clinical Investigation Specialists, Inc.

location_facility: CRS Clinical Research Service Moenchengladbach GmbH

location_facility: Kvinnokliniken Karolinska Universitetssjukhuset Huddinge

location_facility: Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo

location_facility: Fleming Island Center for Clinical Research

location_facility: RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology

location_facility: Florida Sleep Disorder Center of Brandon

location_facility: Klinische Forschung Hannover - Mitte GmbH

location_facility: Women's Healthcare Associates dba Rosemark WomenCare Specialists

location_facility: City Hospital #4 of Donetsk, Woman Consultative Department

location_facility: Clinica Urologica Centro Trapianti di rene

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: Norsk Helseklinikk AS, c/o Heiaklinikken

location_facility: ACRC Trials (Administrative/Mailing Site)

location_facility: MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,

location_facility: Wake Internal Medicine Consultants, Inc.

location_facility: Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates

location_facility: Memorial Clinical Associates dba MCA Research

location_facility: Adams Patterson Gynocology and Obstetrics, PLLC

location_facility: Uzhorod City Outpatient Clinic, Prophylaxis Department

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly

location_facility: University General Hospital of Larisa/ Urology Department

location_facility: Jacksonville Center for Clinical Research

location_facility: FN a LFUK Hradec Kralove/Urologicka klinika

location_facility: GYNPOR SK, s.r.o. Urogynekologicka ambulancia

location_facility: Severance Hospital, Yonsei University College of Medicine, Department of Urology

location_facility: Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia

location_facility: Taipei Veterans General Hospital/Division of Urology

location_facility: Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD

location_facility: Roskilde sygehus, Gynaekologisk/obstetrisk afdeling

location_facility: Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly

location_facility: Hôpital CAREMEAU - Service Urologie/Andrologie

location_facility: McMaster Institute of Urology, St Joseph's Healthcare Hamilton

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Cambridge University Hospital Trials NHS Trust


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

summary: Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection

ReferenceCitation: Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.

family: Shaw

full_name: Monica Shaw

given: Monica

family: Pediconi

full_name: Claudio Pediconi

given: Claudio

family: McVey

full_name: Donna McVey

given: Donna

family: Mondou

full_name: Elsa Mondou

given: Elsa

family: Quinn

full_name: Joe Quinn

given: Joe

family: Chamblin

full_name: Beth Chamblin

given: Beth

family: Rousseau

full_name: Franck Rousseau

given: Franck

journal_name: Diseases of the Colon & Rectum

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Safety and Efficacy of Ulimorelin Administered Postoperatively to Accelerate Recovery of Gastrointestinal Motility Following Partial Bowel Resection

lead_sponsor: Tranzyme, Inc.

location_country:
France
Bulgaria
Lithuania
Romania
United States
Czech Republic

location_facility: Institute regional de Gastroenterologie si Hepatologie

location_facility: University of Iowa Hospitals and Clinics

location_facility: Institute of Oncology at Vilnius University, Clinic of Surgery

location_facility: Texas Tech University Health Sciences Center

location_facility: Vilnius City Univ. Hospital Clinic of Surgery


title: A 6-month, Randomised, Double-blind, Parallel-group, Risperidone-controlled, Fixed-dose Study Evaluating the Safety and Efficacy of Zicronapine in Patients With Schizophrenia

summary: To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment.

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
France
Poland
Estonia
Czech Republic


title: A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

summary: This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Brazil
Germany
France
Japan
Poland
Singapore
Belgium
Australia
Russian Federation
Spain
Canada

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Oklahoma Health Sciences Center OU Health

location_facility: Sarah Cannon Research Institute SCRI (2)

location_facility: Cancer Care Northwest CC Northwest- Spokane South(3)

location_facility: South Texas Oncology and Hematology, PA South Tex Onc

location_facility: Carolinas HealthCare Systems Blumenthal Cancer Center

location_facility: St. Joseph's Hospital & Medical Center St Joseph's


lead_sponsor: Bayer

location_country:
Austria
Finland
France
Spain
Germany
Czech Republic

acronym: VISADO

source: euctr

title: A Multi-center, Open Label, Single-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of 2 mg Dienogest Tablets for the Treatment of Endometriosis in Adolescents Over a Treatment Period of 52 Weeks

summary: A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.


title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

summary: To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

ReferenceType: background

ReferenceCitation: Khamashta M, Merrill JT, Werth VP, Furie R, Kalunian K, Illei GG, Drappa J, Wang L, Greth W; CD1067 study investigators. Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Nov;75(11):1909-1916. doi: 10.1136/annrheumdis-2015-208562. Epub 2016 Mar 23.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: MedImmune LLC

location_country:
Peru
Romania
India
France
Poland
Thailand
Argentina
Canada
South Africa
Chile
Netherlands
Philippines
Jamaica
Bulgaria
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain


title: A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents

acronym: DELTA

summary:
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.

Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.

ReferenceType: result

ReferenceCitation: Salles GA, Kahl, BS, Wagner-Johnston ND, et al. Interim results from a phase 2 study of PI3Kδ inhibitor idelalisib in patients with relapsed indolent non-Hodgki lymphoma (iNHL) refractory to both rituximab and an alkylating agent. 12th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, June 19-22, 2013 Abstract No: 064bis.

ReferenceCitation: Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22.

family: Gopal

full_name: Ajay K. Gopal

given: Ajay K.

family: Kahl

full_name: Brad S. Kahl

given: Brad S.

family: de Vos

full_name: Sven de Vos

given: Sven

family: Wagner-Johnston

full_name: Nina D. Wagner-Johnston

given: Nina D.

family: Schuster

full_name: Stephen J. Schuster

given: Stephen J.

family: Jurczak

full_name: Wojciech J. Jurczak

given: Wojciech J.

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

family: Flowers

full_name: Christopher R. Flowers

given: Christopher R.

family: Martin

full_name: Peter Martin

given: Peter

family: Viardot

full_name: Andreas Viardot

given: Andreas

family: Blum

full_name: Kristie A. Blum

given: Kristie A.

family: Goy

full_name: Andre H. Goy

given: Andre H.

family: Davies

full_name: Andrew J. Davies

given: Andrew J.

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Dreyling

full_name: Martin Dreyling

given: Martin

family: Johnson

full_name: Dave Johnson

given: Dave

family: Miller

full_name: Langdon L. Miller

given: Langdon L.

family: Holes

full_name: Leanne Holes

given: Leanne

family: Li

full_name: Daniel Li

given: Daniel

family: Dansey

full_name: Roger D. Dansey

given: Roger D.

family: Godfrey

full_name: Wayne R. Godfrey

given: Wayne R.

family: Salles

full_name: Gilles A. Salles

given: Gilles A.

title: PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma

ReferenceCitation: Ma S, Chan RJ, Gu L, Xing G, Rajakumaraswamy N, Ruzicka BB, Wagner-Johnston ND. Retrospective Analysis of the Impact of Adverse Event-Triggered Idelalisib Interruption and Dose Reduction on Clinical Outcomes in Patients With Relapsed/Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 May;21(5):e432-e448. doi: 10.1016/j.clml.2020.12.016. Epub 2020 Dec 24.

title: Retrospective Analysis of the Impact of Adverse Event–Triggered Idelalisib Interruption and Dose Reduction on Clinical Outcomes in Patients With Relapsed/Refractory B-Cell Malignancies

ReferenceCitation: Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

name: Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA

name: St. James’s University Hospital, Leeds, UK

name: Hospices Civils de Lyon, University Claude Bernard, Pierre Benite, France

name: Willamette Valley Cancer Institute and Research Center/US Oncology Research, Springfield, OR, USA

name: Department of Medicine III, University of Ulm, Ulm, Germany

name: Gilead Sciences, Inc, Foster City, CA, USA

name: Università Vita-Salute San Raffaele and IRCCS Instituto Scientifico San Raffaele, Milano, Italy

name: Swedish Cancer Institute, Seattle, WA, USA

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

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Italy
United States
France
Poland
Germany
United Kingdom

location_facility: Klinikum der Universität München-Großhadern

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Washington University School of Medicine

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: University of Medicine and Dentistry of NJ

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Weill Cornell -New York Presbyterian Hospital

location_facility: John Theurer Cancer Center Hackensack University Medical Center


ReferenceCitation: Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Badalamenti G, Blackstein M, Le Cesne A, Schöffski P, Maki RG, Bauer S, Nguyen BB, Xu J, Nishida T, Chung J, Kappeler C, Kuss I, Laurent D, Casali PG; GRID study investigators. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302. doi: 10.1016/S0140-6736(12)61857-1. Epub 2012 Nov 22.

family: Demetri

full_name: George D Demetri

given: George D

family: Reichardt

full_name: Peter Reichardt

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Hohenberger

full_name: Peter Hohenberger

family: Leahy

full_name: Michael Leahy

given: Michael

family: von Mehren

full_name: Margaret von Mehren

given: Margaret

family: Joensuu

full_name: Heikki Joensuu

given: Heikki

family: Badalamenti

full_name: Giuseppe Badalamenti

given: Giuseppe

family: Blackstein

full_name: Martin Blackstein

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Maki

full_name: Robert G Maki

given: Robert G

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

family: Nguyen

full_name: Binh Bui Nguyen

given: Binh Bui

family: Xu

full_name: Jianming Xu

given: Jianming

family: Nishida

full_name: Toshirou Nishida

given: Toshirou

family: Chung

full_name: John Chung

given: John

family: Kappeler

full_name: Christian Kappeler

given: Christian

family: Kuss

full_name: Iris Kuss

given: Iris

family: Laurent

full_name: Dirk Laurent

given: Dirk

family: Casali

full_name: Paolo G Casali

given: Paolo G

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

repositories:
LIRIAS (KU Leuven)
PubMed Central
iris.unipa.it

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Poole CD, Connolly MP, Chang J, Currie CJ. Health utility of patients with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib: findings from GRID, a randomized, double-blind, placebo-controlled phase III study of regorafenib versus placebo. Gastric Cancer. 2015 Jul;18(3):627-34. doi: 10.1007/s10120-014-0391-x. Epub 2014 Jun 24.

ReferenceCitation: Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.

journal_name: International Journal of Clinical Oncology

ReferenceCitation: Mross K, Frost A, Steinbild S, Hedbom S, Büchert M, Fasol U, Unger C, Krätzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

publisher: American Association for Cancer Research (AACR)

title: A Phase I Dose–Escalation Study of Regorafenib (BAY 73–4506), an Inhibitor of Oncogenic, Angiogenic, and Stromal Kinases, in Patients with Advanced Solid Tumors

location_country:
Italy
Austria
United States
Netherlands
Spain
Germany
Finland
France
Japan
Poland
Israel
Singapore
Belgium
China
Canada
United Kingdom
Korea, Republic of

title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care for Subjects With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) Whose Disease Has Progressed Despite Prior Treatment With at Least Imatinib and Sunitinib

summary:
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.

Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.

Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review.

Subjects receiving placebo who experience disease progression may be offered active treatment.

Subjects who experience progression during regorafenib treatment may continue open label treatment.

All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.


title: BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain

acronym: Break MB

summary: This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.

ReferenceCitation: Long GV, Trefzer U, Davies MA, Kefford RF, Ascierto PA, Chapman PB, Puzanov I, Hauschild A, Robert C, Algazi A, Mortier L, Tawbi H, Wilhelm T, Zimmer L, Switzky J, Swann S, Martin AM, Guckert M, Goodman V, Streit M, Kirkwood JM, Schadendorf D. Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Nov;13(11):1087-95. doi: 10.1016/S1470-2045(12)70431-X. Epub 2012 Oct 8.

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

family: Santiago-Walker

full_name: Ademi Santiago-Walker

given: Ademi

family: Gagnon

full_name: Robert Gagnon

given: Robert

family: Mazumdar

full_name: Jolly Mazumdar

given: Jolly

family: Casey

full_name: Michelle Casey

given: Michelle

family: Long

full_name: Georgina V. Long

given: Georgina V.

family: Schadendorf

full_name: Dirk Schadendorf

family: Flaherty

full_name: Keith Flaherty

given: Keith

family: Kefford

full_name: Richard Kefford

given: Richard

family: Hauschild

full_name: Axel Hauschild

family: Hwu

full_name: Patrick Hwu

family: Haney

full_name: Patricia Haney

given: Patricia

family: O'Hagan

full_name: Anne O'Hagan

given: Anne

family: Carver

full_name: Jennifer Carver

given: Jennifer

family: Goodman

full_name: Vicki Goodman

given: Vicki

family: Legos

full_name: Jeffrey Legos

given: Jeffrey

family: Martin

full_name: Anne-Marie Martin

given: Anne-Marie

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

name: GlaxoSmithKline; Research Triangle Park; NC USA

family: Ouellet

full_name: Daniele Ouellet

given: Daniele

family: Gibiansky

full_name: Ekaterina Gibiansky

given: Ekaterina

family: Leonowens

full_name: Cathrine Leonowens

given: Cathrine

title: Population pharmacokinetics of dabrafenib, a BRAF inhibitor: Effect of dose, time, covariates, and relationship with its metabolites

location_country:
Italy
United States
Germany
France
Australia
Canada


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

summary: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

ReferenceCitation: Gottenberg JE, Dörner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.

name: Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares; CNRS; Institut de Biologie Moléculaire et Cellulaire; Immunopathologie et Chimie Thérapeutique; Laboratory of Excellence MEDALIS; Strasbourg University Hospital; Strasbourg France

family: Gottenberg

full_name: Jacques-Eric Gottenberg

given: Jacques-Eric

name: Charité University Hospital Berlin; Berlin Germany

family: Dörner

full_name: Thomas Dörner

given: Thomas

name: University of Groningen; Groningen The Netherlands

family: Bootsma

full_name: Hendrika Bootsma

given: Hendrika

name: INSERM 1227; Brest University Medical School; Brest France

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

family: Bowman

full_name: Simon J. Bowman

given: Simon J.

name: Université Paris-Sud, AP-HP; Hôpitaux Universitaires Paris-Sud; INSERM U1184; Le Kremlin-Bicêtre France

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Bartz

full_name: Holger Bartz

given: Holger

family: Oortgiesen

full_name: Marga Oortgiesen

given: Marga

family: Shock

full_name: Anthony Shock

given: Anthony

family: Koetse

full_name: Willem Koetse

given: Willem

family: Galateanu

full_name: Catrinel Galateanu

given: Catrinel

family: Bongardt

full_name: Sabine Bongardt

given: Sabine

family: Wegener

full_name: William A. Wegener

given: William A.

family: Goldenberg

full_name: David M. Goldenberg

given: David M.

family: Meno-Tetang

full_name: Guy Meno-Tetang

given: Guy

family: Kosutic

full_name: Gordana Kosutic

given: Gordana

name: University of Birmingham and NIHR/Wellcome Trust Clinical Research Facility; University Hospitals Birmingham NHS Foundation Trust; Birmingham UK

family: Gordon

full_name: Caroline Gordon

given: Caroline

journal_name: Arthritis & Rheumatology

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories:
PubMed Central
Pure (Denmark)
pure.rug.nl

ReferenceCitation: Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczyński P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

name: Duke University Medical Center; Durham North Carolina

name: Cedars-Sinai Medical Center; Los Angeles California

name: Johns Hopkins University School of Medicine; Baltimore Maryland

name: MedPharm Consulting; Cambridge Massachusetts

name: Poznan University of Medical Sciences; Poznan Poland

name: Alameda County Health System; Oakland California

name: Denver Arthritis Clinic; Denver Colorado

name: Pontifical Catholic University; Porto Alegre Brazil

name: University of California San Diego School of Medicine; La Jolla

name: University of Birmingham and University Hospital Birmingham NHS Foundation Trust; Birmingham UK

name: on behalf of the EMBODY Investigator Group

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
India
France
Lithuania
Korea, Republic of
Bulgaria
Puerto Rico
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Estonia


title: A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension

acronym: EMBARK

summary: This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

ReferenceCitation: Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewé R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.

family: Maksymowych

full_name: Walter P. Maksymowych

given: Walter P.

family: Claudepierre

full_name: Pascal Claudepierre

given: Pascal

family: de Hooge

full_name: Manouk de Hooge

given: Manouk

family: Lambert

full_name: Robert G. Lambert

given: Robert G.

family: Landewé

full_name: Robert Landewé

given: Robert

family: Molto

full_name: Anna Molto

given: Anna

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Bukowski

full_name: Jack F. Bukowski

given: Jack F.

family: Jones

full_name: Heather Jones

given: Heather

family: Pedersen

full_name: Ron Pedersen

given: Ron

family: Szumski

full_name: Annette Szumski

given: Annette

family: Vlahos

full_name: Bonnie Vlahos

given: Bonnie

family: Dougados

full_name: Maxime Dougados

given: Maxime

journal_name: Arthritis Research & Therapy

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Dougados M, van der Heijde D, Tsai WC, Saaibi D, Marshall L, Jones H, Pedersen R, Vlahos B, Tarallo M. Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study. Health Qual Life Outcomes. 2020 Jan 3;18(1):4. doi: 10.1186/s12955-019-1260-4.

ReferenceCitation: Dougados M, Maksymowych WP, Landewé RBM, Moltó A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Maksymowych WP, Wichuk S, Dougados M, Jones HE, Pedersen R, Szumski A, Marshall L, Bukowski JF, Lambert RG. Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2018 Jan;77(1):78-84. doi: 10.1136/annrheumdis-2017-211605. Epub 2017 Sep 29.

ReferenceCitation: Brown MA, Bird PA, Robinson PC, Mease PJ, Bosch FVD, Surian C, Jones H, Szumski A, Marshall L, Wiid Z, Dougados M. Evaluation of the effect of baseline MRI sacroiliitis and C reactive protein status on etanercept treatment response in non-radiographic axial spondyloarthritis: a post hoc analysis of the EMBARK study. Ann Rheum Dis. 2018 Jul;77(7):1091-1093. doi: 10.1136/annrheumdis-2017-211313. Epub 2017 Jul 3.

repository_institution: Queensland University of Technology - QUT ePrints

ReferenceCitation: Maksymowych WP, Wichuk S, Dougados M, Jones H, Szumski A, Bukowski JF, Marshall L, Lambert RG. MRI evidence of structural changes in the sacroiliac joints of patients with non-radiographic axial spondyloarthritis even in the absence of MRI inflammation. Arthritis Res Ther. 2017 Jun 6;19(1):126. doi: 10.1186/s13075-017-1342-9.

ReferenceCitation: Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Lenaerts J, van den Bosch F, Wei JC, Pedersen R, Bonin R, Jones H, Marshall L, Logeart I, Vlahos B, Bukowski JF, Maksymowych WP. Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1590-1598. doi: 10.1002/acr.23276. Epub 2017 Aug 31.

name: Paris-Descartes University, Hôpital Cochin; Paris France

name: Leiden University Medical Center; Leiden The Netherlands

name: Charité - Universitätsmedizin Berlin; Berlin Germany

name: Instituto de Rehabilitación Psicofísica de Buenos Aires; Buenos Aires Argentina

name: Institute of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University; Taichung Taiwan

name: Pfizer International Operations; Paris France

ReferenceCitation: Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, Marshall L, Bonin R, Pedersen R, Vlahos B, Kotak S, Bukowski JF. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.

ReferenceCitation: Dougados M, van der Heijde D, Sieper J, Braun J, Maksymowych WP, Citera G, Miceli-Richard C, Wei JC, Pedersen R, Bonin R, Rahman MU, Logeart I, Wajdula J, Koenig AS, Vlahos B, Alvarez D, Bukowski JF. Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2014 Aug;66(8):2091-102. doi: 10.1002/art.38721.

name: Université Pierre et Marie Curie Paris 6, Hôpital Cochin, AP‐HP, INSERM U1153, and PRES Sorbonne Paris CitéParisFrance

name: Leiden University Medical CenterLeidenThe Netherlands

name: University of AlbertaEdmonton, AlbertaCanada

name: Instituto de Rehabilitación PsicofísicaBuenos AiresArgentina

name: Hôpital de Bicêtre, AP‐HP, and Université Paris‐Sud 11, Le Kremlin‐BicêtreParisFrance

name: Chung Shan Medical University HospitalTaichungTaiwan

title: Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

location_country:
United Kingdom
Netherlands
Finland
France
Hungary
Belgium
Argentina
Russian Federation
Spain
Germany
Czech Republic
Korea, Republic of
Taiwan
Colombia

location_facility: MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University

location_facility: Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie

location_facility: Saint-Petersburg State Budgetary Healthcare Institution

location_facility: Limited Liability Company NMC Tomography

location_facility: Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen

location_facility: Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology

location_facility: Rheumatology Research Institute of Russian Academy of Medical Sciences

location_facility: Norfolk and Norwich University Hospital NHS Trust

location_facility: Leiden University Medical Center, Reumatologie

location_facility: Russian Cardiology Research-and-Production Complex


title: A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye

summary: The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).

lead_sponsor: Lux Biosciences, Inc.

location_country:
Italy
Austria
Brazil
United Kingdom
Germany
France
United States
Czech Republic
Canada


title: A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.

summary: Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

ReferenceCitation: Baulac M, Rosenow F, Toledo M, Terada K, Li T, De Backer M, Werhahn KJ, Brock M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017 Jan;16(1):43-54. doi: 10.1016/S1474-4422(16)30292-7. Epub 2016 Nov 24. Erratum in: Lancet Neurol. 2017 Feb;16(2):102.

family: Baulac

full_name: Michel Baulac

given: Michel

family: Rosenow

full_name: Felix Rosenow

given: Felix

family: Toledo

full_name: Manuel Toledo

given: Manuel

family: Terada

full_name: Kiyohito Terada

given: Kiyohito

family: Li

full_name: Ting Li

given: Ting

family: De Backer

full_name: Marc De Backer

given: Marc

family: Werhahn

full_name: Konrad J Werhahn

given: Konrad J

family: Brock

full_name: Melissa Brock

given: Melissa

journal_name: The Lancet Neurology

ReferenceCitation: Mintzer S, Dimova S, Zhang Y, Steiniger-Brach B, De Backer M, Chellun D, Roebling R. Effects of lacosamide and carbamazepine on lipids in a randomized trial. Epilepsia. 2020 Dec;61(12):2696-2704. doi: 10.1111/epi.16745. Epub 2020 Nov 17.

name: Department of Neurology Jefferson Comprehensive Epilepsy Center Thomas Jefferson University Philadelphia PA USA

family: Mintzer

full_name: Scott Mintzer

given: Scott

family: Dimova

full_name: Svetlana Dimova

given: Svetlana

family: Zhang

full_name: Ying Zhang

given: Ying

family: Steiniger‐Brach

full_name: Björn Steiniger‐Brach

given: Björn

family: Chellun

full_name: Daya Chellun

given: Daya

family: Roebling

full_name: Robert Roebling

journal_name: Epilepsia

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Lindauer A, Laveille C, Stockis A. Time-to-Seizure Modeling of Lacosamide Used in Monotherapy in Patients with Newly Diagnosed Epilepsy. Clin Pharmacokinet. 2017 Nov;56(11):1403-1413. doi: 10.1007/s40262-017-0530-8.

location_country:
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Thailand
Canada
Korea, Republic of
Sweden
Switzerland
Philippines
Bulgaria
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Spain
Latvia


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

acronym: GAMMA

summary:
AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.

Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.

The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

status: Terminated

ReferenceCitation: Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Świeboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

lead_sponsor: NantCell, Inc.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Japan
Lithuania
Poland
Slovakia
Canada
Slovenia
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Spain

status_simplified: Unknown


title: A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

summary: The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

ReferenceCitation: Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hézode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.

name: National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology; Hôpital Henri Mondor, Université Paris-Est; Créteil France

family: Pawlotsky

full_name: Jean-Michel Pawlotsky

given: Jean-Michel

name: Medical University of Bialystok; Bialystok Poland

family: Flisiak

full_name: Robert Flisiak

given: Robert

name: Institute of Liver and Biliary Sciences; New Delhi India

family: Sarin

full_name: Shiv K. Sarin

given: Shiv K.

name: Klinikum der Albert-Ludwigs-Universität; Freiburg Germany

family: Rasenack

full_name: Jens Rasenack

given: Jens

name: Prince of Songkla University, Songklanagarind Hospital; Hat-Yai Songkhla Thailand

family: Piratvisuth

full_name: Teerha Piratvisuth

given: Teerha

name: Kaohsiung Medical University, Chang-Ho Memorial Hospital; Kaohsiung Taiwan

family: Chuang

full_name: Wan-Long Chuang

given: Wan-Long

name: School of Medicine; China Medical University; Taichung Taiwan

family: Peng

full_name: Cheng-Yuan Peng

given: Cheng-Yuan

name: Bart's and The London School of Medicine; Queen Mary's University of London; London United Kingdom

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: Shah

full_name: Samir Shah

given: Samir

name: Hannover Medical School; Hannover Germany

family: Wedemeyer

full_name: Heiner Wedemeyer

given: Heiner

name: Department of Hepatology and Gastroenterology; Hôpital Henri Mondor, Université Paris-Est; Créteil France

family: Hézode

full_name: Christophe Hézode

given: Christophe

name: Beijing Novartis Pharma Co Ltd; Shanghai China

full_name: Wei Zhang

given: Wei

name: Novartis Institute of Biomedical Research; Emeryville CA

family: Wong

full_name: Kelly A. Wong

given: Kelly A.

name: Novartis Institute of Biomedical Research; Cambridge MA

full_name: Bin Li

given: Bin

family: Avila

full_name: Claudio Avila

given: Claudio

family: Naoumov

full_name: Nikolai V. Naoumov

given: Nikolai V.

journal_name: Hepatology

evidence: open (via free article)

lead_sponsor: Debiopharm International SA

location_country:
Italy
United States
India
Germany
France
Poland
Thailand
Belgium
Australia
Puerto Rico
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility:
Island View Gastroenterology Associates
Sharp Rees-Stealy Medical Group, Inc.
Liver Associates of Texas
Alamo Medical Research
Novartis Inestigative Center
Novartis Korea Ltd.
Novartis Inestigative Site
Columbia University Medical Center
Dartmouth-Hitchcock Medical Center
Scripps Clinic
Research and Education Inc.
Fundacion de Investigacion de Diego
Cotton O'Neil Clinical Research
Hawai Medical Center East LLC
Novartis Investigative Site
Saint Louis University
The Office of Dr. Claudia Martorell
Liver Specialist of Texas
The North Texas Research Institute
Weill Cornell Medical Center
Mount Sinai Medical Center
Novartis Investigative Center


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion

acronym: PALACE 3

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

ReferenceCitation: Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, Vessey A, Zhan X, Bird P. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016 Jun;75(6):1065-73. doi: 10.1136/annrheumdis-2015-207963. Epub 2016 Jan 20.

family: Edwards

full_name: Christopher J Edwards

given: Christopher J

family: Blanco

full_name: Francisco J Blanco

given: Francisco J

family: Crowley

full_name: Jeffrey Crowley

given: Jeffrey

family: Birbara

full_name: Charles A Birbara

given: Charles A

family: Jaworski

full_name: Janusz Jaworski

given: Janusz

family: Aelion

full_name: Jacob Aelion

given: Jacob

family: Stevens

full_name: Randall M Stevens

given: Randall M

family: Vessey

full_name: Adele Vessey

given: Adele

family: Zhan

full_name: Xiaojiang Zhan

given: Xiaojiang

family: Bird

full_name: Paul Bird

given: Paul

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

repository_institution: Universidade Da Coruña - RUC

ReferenceCitation: Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.

ReferenceCitation: Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

name: Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine Seattle

family: Mease

full_name: Philip J. Mease

given: Philip J.

name: Toronto Western Hospital Toronto Ontario Canada

family: Gladman

full_name: Dafna D. Gladman

name: University of California San Diego La Jolla

name: Hospital Universitario Central de Asturias Oviedo Spain

name: Medical University of Vienna Vienna Austria

title: Treatment‐to‐Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

title: Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis

ReferenceCitation: Gladman DD, Kavanaugh A, Gómez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

title: Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1–3 studies

location_country:
Italy
United States
Switzerland
Germany
Finland
France
Poland
Lithuania
Slovakia
Romania
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Menzies Centre for Population Health Research

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Hospital of Lithuanian University Health and Sciences

location_facility: REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Baia Mare, Emergency County Hospital "Dr. Constantin Opris"

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

location_facility: Catalina Pointe Clinical Research Incorporated

location_facility: Centre Hospitalier Sud Francilien - Site Gilles de Corbeil


title: Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients With Chronic Hepatitis B Virus Infection Who Are HBeAg-positive

acronym: LIRA-B

summary:
At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB)

Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach

ReferenceCitation: Phillips S, Mistry S, Riva A, Cooksley H, Hadzhiolova-Lebeau T, Plavova S, Katzarov K, Simonova M, Zeuzem S, Woffendin C, Chen PJ, Peng CY, Chang TT, Lueth S, De Knegt R, Choi MS, Wedemeyer H, Dao M, Kim CW, Chu HC, Wind-Rotolo M, Williams R, Cooney E, Chokshi S. Peg-Interferon Lambda Treatment Induces Robust Innate and Adaptive Immunity in Chronic Hepatitis B Patients. Front Immunol. 2017 May 29;8:621. doi: 10.3389/fimmu.2017.00621. eCollection 2017.

family: Phillips

full_name: Sandra Phillips

given: Sandra

suffix: Phillips

family: Mistry

full_name: Sameer Mistry

given: Sameer

family: Riva

full_name: Antonio Riva

given: Antonio

family: Cooksley

full_name: Helen Cooksley

given: Helen

family: Hadzhiolova-Lebeau

full_name: Tanya Hadzhiolova-Lebeau

given: Tanya

family: Plavova

full_name: Slava Plavova

given: Slava

family: Katzarov

full_name: Krum Katzarov

given: Krum

family: Simonova

full_name: Marieta Simonova

given: Marieta

family: Zeuzem

full_name: Stephan Zeuzem

given: Stephan

family: Woffendin

full_name: Clive Woffendin

given: Clive

family: Chen

full_name: Pei-Jer Chen

given: Pei-Jer

family: Peng

full_name: Cheng-Yuan Peng

given: Cheng-Yuan

family: Chang

full_name: Ting-Tsung Chang

given: Ting-Tsung

family: Lueth

full_name: Stefan Lueth

given: Stefan

family: De Knegt

full_name: Robert De Knegt

given: Robert

family: Choi

full_name: Moon-Seok Choi

given: Moon-Seok

family: Wedemeyer

full_name: Heiner Wedemeyer

given: Heiner

family: Dao

full_name: Michael Dao

given: Michael

family: Kim

full_name: Chang-Wook Kim

given: Chang-Wook

family: Chu

full_name: Heng-Chen Chu

given: Heng-Chen

family: Wind-Rotolo

full_name: Megan Wind-Rotolo

given: Megan

family: Williams

full_name: Roger Williams

given: Roger

family: Cooney

full_name: Elizabeth Cooney

repositories_institution:
Erasmus University, Rotterdam - RePub
PubMed Central - Europe PMC

ReferenceCitation: Chan HLY, Ahn SH, Chang TT, Peng CY, Wong D, Coffin CS, Lim SG, Chen PJ, Janssen HLA, Marcellin P, Serfaty L, Zeuzem S, Cohen D, Critelli L, Xu D, Wind-Rotolo M, Cooney E; LIRA-B Study Team. Peginterferon lambda for the treatment of HBeAg-positive chronic hepatitis B: A randomized phase 2b study (LIRA-B). J Hepatol. 2016 May;64(5):1011-1019. doi: 10.1016/j.jhep.2015.12.018. Epub 2015 Dec 29.

location_country:
Italy
United States
Hong Kong
Netherlands
Germany
France
Singapore
Australia
Canada
Korea, Republic of
Taiwan

location_facility: Heritage Medical Research Clinic, University Of Calgary

location_facility: Atlanta Gastroenterology Associates, Llc

location_facility: University Of California, Davis Medical Center

location_facility: Toronto Western Hospital University Health Network


ReferenceCitation: Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.

family: Banerji

full_name: Donald Banerji

given: Donald

family: Kulich

full_name: Károly Kulich

given: Károly

family: Keininger

full_name: Dorothy L Keininger

given: Dorothy L

family: Tiplady

full_name: Brian Tiplady

given: Brian

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

evidence: oa repository (semantic scholar lookup)

publisher: Informa UK Limited

location_country:
United States
South Africa
Guatemala
Switzerland
Philippines
Germany
France
Bulgaria
Japan
Poland
Slovakia
Hungary
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Taiwan

acronym: SHINE

location_facility:
Novartis INvestigative Site
Novartis Investigative site
Novartis Investigative Site
Novartis Inverstigative Site

title: A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.


lead_sponsor: Novartis

location_country:
Guatemala
Switzerland
Finland
France
Poland
Belgium
Spain
Canada
United Kingdom

location_facility:
Novartis Investigative Site
Novartis Investigational Site

title: A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)

summary: This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.