lead_sponsor: AstraZeneca

summary: The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

ReferenceCitation: Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.

sponsor_collaborators:
AstraZeneca
MedImmune Ltd

title: A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

location_country:
Germany
Italy
Poland
Hungary
United States
Spain
Czechia
Canada
France


title: Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)

summary: The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eldabe S, Kern M, Peul W, Green C, Winterfeldt K, Taylor RS. Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial. Trials. 2013 Jun 25;14:189. doi: 10.1186/1745-6215-14-189.

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

repository_institution: University of Exeter - Open Research Exeter

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: MedtronicNeuro

location_country:
Germany
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Clinique Mutualiste de la porte de l'Orient

location_facility: Märkische Kliniken GmbH / Marienhospital Letmathe

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

acronym: CONCERTO

summary: This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

study_start_date_type: Actual

status: Completed

ReferenceCitation: Comi G, Dadon Y, Sasson N, Steinerman JR, Knappertz V, Vollmer TL, Boyko A, Vermersch P, Ziemssen T, Montalban X, Lublin FD, Rocca MA, Volkinshtein R, Rubinchick S, Halevy N, Filippi M. CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. Mult Scler. 2022 Apr;28(4):608-619. doi: 10.1177/13524585211032803. Epub 2021 Aug 11.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: SAGE Publications

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

location_country:
Germany
Poland
Bosnia and Herzegovina
Croatia
Czechia
Canada
Serbia
France
Belarus
Montenegro
Hungary
Slovakia
United States
Latvia
Ukraine
North Macedonia
Romania
Belgium
Moldova, Republic of
Estonia
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
Teva Investigational Site 10345
Teva Investigational Site 58078
Teva Investigational Site 32191
Teva Investigational Site 68011
Teva Investigational Site 53076
Teva Investigational Site 10319
Teva Investigational Site 55007
Teva Investigational Site 52042
Teva Investigational Site 31030
Teva Investigational Site 34015
Teva Investigational Site 61024
Teva Investigational Site 10347
Teva Investigational Site 10343
Teva Investigational Site 33015
Teva Investigational Site 32200
Teva Investigational Site 10334
Teva Investigational Site 59051
Teva Investigational Site 63029
Teva Investigational Site 80024
Teva Investigational Site 80021
Teva Investigational Site 50142
Teva Investigational Site 61018
Teva Investigational Site 11016
Teva Investigational Site 62012
Teva Investigational Site 53078
Teva Investigational Site 11015
Teva Investigational Site 60009
Teva Investigational Site 32183
Teva Investigational Site 70006
Teva Investigational Site 50135
Teva Investigational Site 32190
Teva Investigational Site 10339
Teva Investigational Site 32182
Teva Investigational Site 68010
Teva Investigational Site 53063
Teva Investigational Site 54049
Teva Investigational Site 59043
Teva Investigational Site 33014
Teva Investigational Site 58076
Teva Investigational Site 52046
Teva Investigational Site 53079
Teva Investigational Site 10350
Teva Investigational Site 69009
Teva Investigational Site 52040
Teva Investigational Site 50141
Teva Investigational Site 65012
Teva Investigational Site 52035
Teva Investigational Site 34010
Teva Investigational Site 65010
Teva Investigational Site 63026
Teva Investigational Site 33013
Teva Investigational Site 50143
Teva Investigational Site 32177
Teva Investigational Site 53084
Teva Investigational Site 87001
Teva Investigational Site 34017
Teva Investigational Site 58073
Teva Investigational Site 32203
Teva Investigational Site 65011
Teva Investigational Site 30040
Teva Investigational Site 10317
Teva Investigational Site 59055
Teva Investigational Site 52039
Teva Investigational Site 50147
Teva Investigational Site 69008
Teva Investigational Site 59038
Teva Investigational Site 10307
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Teva Investigational Site 50127
Teva Investigational Site 52041
Teva Investigational Site 30039
Teva Investigational Site 58087
Teva Investigational Site 32176
Teva Investigational Site 52048
Teva Investigational Site 61025
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Teva Investigational Site 33016
Teva Investigational Site 10310
Teva Investigational Site 30035
Teva Investigational Site 66002
Teva Investigational Site 31039
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Teva Investigational Site 53083
Teva Investigational Site 30025
Teva Investigational Site 53072
Teva Investigational Site 81015
Teva Investigational Site 50144
Teva Investigational Site 32195
Teva Investigational Site 10325
Teva Investigational Site 58083
Teva Investigational Site 34019
Teva Investigational Site 31031
Teva Investigational Site 59053
Teva Investigational Site 59054
Teva Investigational Site 50208
Teva Investigational Site 59042
Teva Investigational Site 10341
Teva Investigational Site 52049
Teva Investigational Site 50138
Teva Investigational Site 50136
Teva Investigational Site 58116
Teva Investigational Site 69006
Teva Investigational Site 70005
Teva Investigational Site 59039
Teva Investigational Site 58077
Teva Investigational Site 32181
Teva Investigational Site 62013
Teva Investigational Site 60011
Teva Investigational Site 30032
Teva Investigational Site 10316
Teva Investigational Site 10311
Teva Investigational Site 56005
Teva Investigational Site 53071
Teva Investigational Site 50129
Teva Investigational Site 10324
Teva Investigational Site 80023
Teva Investigational Site 10308
Teva Investigational Site 52038
Teva Investigational Site 58080
Teva Investigational Site 34011
Teva Investigational Site 50146
Teva Investigational Site 32173
Teva Investigational Site 51045
Teva Investigational Site 58081
Teva Investigational Site 58086
Teva Investigational Site 54048
Teva Investigational Site 34016
Teva Investigational Site 68013
Teva Investigational Site 53064
Teva Investigational Site 10323
Teva Investigational Site 59041
Teva Investigational Site 11013
Teva Investigational Site 53069
Teva Investigational Site 54046
Teva Investigational Site 61016
Teva Investigational Site 32186
Teva Investigational Site 10330
Teva Investigational Site 53070
Teva Investigational Site 55008
Teva Investigational Site 30028
Teva Investigational Site 81016
Teva Investigational Site 61022
Teva Investigational Site 52036
Teva Investigational Site 59040
Teva Investigational Site 50125
Teva Investigational Site 59046
Teva Investigational Site 31035
Teva Investigational Site 30030
Teva Investigational Site 10342
Teva Investigational Site 10315
Teva Investigational Site 30027
Teva Investigational Site 34013
Teva Investigational Site 68009
Teva Investigational Site 53068
Teva Investigational Site 53067
Teva Investigational Site 53065
Teva Investigational Site 30026
Teva Investigational Site 58072
Teva Investigational Site 81018
Teva Investigational Site 30034
Teva Investigational Site 53081
Teva Investigational Site 11014
Teva Investigational Site 32185
Teva Investigational Site 10318
Teva Investigational Site 35075
Teva Investigational Site 59045
Teva Investigational Site 10346
Teva Investigational Site 87002
Teva Investigational Site 50130
Teva Investigational Site 58089
Teva Investigational Site 80020
Teva Investigational Site 35073
Teva Investigational Site 61014
Teva Investigational Site 50128
Teva Investigational Site 58084
Teva Investigational Site 32188
Teva Investigational Site 50139
Teva Investigational Site 53066
Teva Investigational Site 37023
Teva Investigational Site 10349
Teva Investigational Site 61017
Teva Investigational Site 53074
Teva Investigational Site 58075
Teva Investigational Site 32174
Teva Investigational Site 59060
Teva Investigational Site 32184
Teva Investigational Site 55005
Teva Investigational Site 61015
Teva Investigational Site 59063
Teva Investigational Site 54042
Teva Investigational Site 31032
Teva Investigational Site 87003
Teva Investigational Site 30031
Teva Investigational Site 52043
Teva Investigational Site 61021
Teva Investigational Site 68008
Teva Investigational Site 61027
Teva Investigational Site 58082
Teva Investigational Site 58079
Teva Investigational Site 31036
Teva Investigational Site 52034
Teva Investigational Site 30037
Teva Investigational Site 32198
Teva Investigational Site 52044
Teva Investigational Site 54043
Teva Investigational Site 60010
Teva Investigational Site 63025
Teva Investigational Site 52047
Teva Investigational Site 32196
Teva Investigational Site 52037
Teva Investigational Site 53085
Teva Investigational Site 50149
Teva Investigational Site 81019
Teva Investigational Site 61019
Teva Investigational Site 51043
Teva Investigational Site 55006
Teva Investigational Site 35079
Teva Investigational Site 50140
Teva Investigational Site 31033
Teva Investigational Site 63024
Teva Investigational Site 32175
Teva Investigational Site 50137
Teva Investigational Site 10348
Teva Investigational Site 32189
Teva Investigational Site 51046
Teva Investigational Site 10340
Teva Investigational Site 32194
Teva Investigational Site 58088
Teva Investigational Site 59048
Teva Investigational Site 50132
Teva Investigational Site 50126
Teva Investigational Site 50134
Teva Investigational Site 35076
Teva Investigational Site 54041
Teva Investigational Site 61026
Teva Investigational Site 59050
Teva Investigational Site 59052
Teva Investigational Site 10338
Teva Investigational Site 30029
Teva Investigational Site 59058
Teva Investigational Site 59049
Teva Investigational Site 54045
Teva Investigational Site 56006
Teva Investigational Site 53073
Teva Investigational Site 52050
Teva Investigational Site 32179
Teva Investigational Site 81014
Teva Investigational Site 51044
Teva Investigational Site 32197
Teva Investigational Site 50133
Teva Investigational Site 35077
Teva Investigational Site 59061
Teva Investigational Site 10309
Teva Investigational Site 54044
Teva Investigational Site 50148
Teva Investigational Site 59062
Teva Investigational Site 31037
Teva Investigational Site 10332
Teva Investigational Site 63030
Teva Investigational Site 30024
Teva Investigational Site 52045
Teva Investigational Site 81017
Teva Investigational Site 31034
Teva Investigational Site 10331
Teva Investigational Site 32201
Teva Investigational Site 59057
Teva Investigational Site 10313
Teva Investigational Site 10329
Teva Investigational Site 59044
Teva Investigational Site 54047
Teva Investigational Site 30023
Teva Investigational Site 70008
Teva Investigational Site 32193
Teva Investigational Site 63028
Teva Investigational Site 50131
Teva Investigational Site 58074
Teva Investigational Site 10335
Teva Investigational Site 58115
Teva Investigational Site 50124
Teva Investigational Site 63027
Teva Investigational Site 37024
Teva Investigational Site 32199
Teva Investigational Site 32202

intervention_type: Drug

status_simplified: Completed


lead_sponsor: Hoffmann-La Roche

summary: This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.

ReferenceCitation: Cortes J, Dieras V, Lorenzen S, Montemurro F, Riera-Knorrenschild J, Thuss-Patience P, Allegrini G, De Laurentiis M, Lohrisch C, Oravcova E, Perez-Garcia JM, Ricci F, Sakaeva D, Serpanchy R, Sufliarsky J, Vidal M, Irahara N, Wohlfarth C, Aout M, Gelmon K. Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial. JAMA Oncol. 2020 Aug 1;6(8):1203-1209. doi: 10.1001/jamaoncol.2020.1796.

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repositories_concat: PubMed Central;diposit.ub.edu

unpaywall_oa_status: hybrid

publisher_dissemination: American Medical Association

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Instituto Oncologico de Ribeirao Preto - INORP

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: University Hospital of Patras Medical Oncology

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

title: Phase I Study of the Combination of Trastuzumab Emtansine (T-DM1) and Capecitabine in HER2-Positive Metastatic Breast Cancer and HER2-Positive Locally Advanced/Metastatic Gastric Cancer Patients, Followed by a Randomized, Open-Label Phase II Study of Trastuzumab Emtansine and Capecitabine Versus Trastuzumab Emtansine Alone in HER2-Positive Metastatic Breast Cancer

source: euctr

design_allocation: Non-Randomized

location_country:
Germany
Italy
Portugal
Slovakia
Argentina
Brazil
Spain
Greece
Canada
Serbia
Russian Federation
France


acronym: ENESTop

lead_sponsor: Novartis Pharmaceuticals

summary: A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.

ReferenceCitation: Mahon FX, Boquimpani C, Kim DW, Benyamini N, Clementino NCD, Shuvaev V, Ailawadhi S, Lipton JH, Turkina AG, De Paz R, Moiraghi B, Nicolini FE, Dengler J, Sacha T, Takahashi N, Fellague-Chebra R, Acharya S, Wong S, Jin Y, Hughes TP. Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2, Open-Label Study. Ann Intern Med. 2018 Apr 3;168(7):461-470. doi: 10.7326/M17-1094. Epub 2018 Feb 20.

publisher_dissemination: American College of Physicians

location_facility: USC Kenneth Norris Comprehensive Cancer Center USC

status: Active, not recruiting

title: A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib

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

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

study_completion_date_type: Anticipated

location_country:
Germany
Poland
Israel
Argentina
Singapore
Australia
Brazil
Japan
Mexico
Belgium
United Kingdom
United States
Korea, Republic of
Spain
Greece
Canada
Russian Federation
France

ipd_sharing: Yes

status_simplified: Ongoing


acronym: ROMULUS

lead_sponsor: Genentech, Inc.

summary: This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

evidence: open (via crossref license)

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

oa_host_type: publisher

publisher_dissemination: Informa

ReferenceCitation: Morschhauser F, Flinn IW, Advani R, Sehn LH, Diefenbach C, Kolibaba K, Press OW, Salles G, Tilly H, Chen AI, Assouline S, Cheson BD, Dreyling M, Hagenbeek A, Zinzani PL, Jones S, Cheng J, Lu D, Penuel E, Hirata J, Wenger M, Chu YW, Sharman J. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). Lancet Haematol. 2019 May;6(5):e254-e265. doi: 10.1016/S2352-3026(19)30026-2. Epub 2019 Mar 29.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

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

repositories_concat: HAL

publisher_dissemination: Elsevier

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Hematology Oncology Associates; Carol G. Simon Ctr

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

location_facility: Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

location_facility: Univ of Michigan Med School; Hematology Oncology

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Oncology & Hematolgy Associates of SW Va Inc. - Roanoke

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Florida Cancer Specialists - Fort Myers (Colonial Center Dr)

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Universitätsmedizin Johannes Gutenberg Universität; Klinik u. Poliklinik f. Neurologie

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

location_country:
Germany
Italy
Netherlands
United States
Canada
France


title: MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects With Severe Refractory Asthma

summary: This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100 mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase subjects will be maintained without any further OCS dose adjustment. Subjects who complete the 24 week double-blind period and meet the eligibility criteria, will be offered the opportunity to participate in an open label extension (OLE) study otherwise they will return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment. At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations will be assessed. The pharmacokinetic samples will be collected in the beginning of the treatment, prior to last dose, at the end of study (exit visit) and the follow up.

ReferenceCitation: Casale TB, Burnette A, Bourdin A, Howarth P, Hahn B, Stach-Klysh A, Khurana S. Oral corticosteroid-sparing effects of mepolizumab in severe eosinophilic asthma: evidence from randomized controlled trials and real-world studies. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107313. doi: 10.1177/17534666221107313.

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.

ReferenceCitation: Keene ON. Strategies for composite estimands in confirmatory clinical trials: Examples from trials in nasal polyps and steroid reduction. Pharm Stat. 2019 Jan;18(1):78-84. doi: 10.1002/pst.1909. Epub 2018 Oct 29.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

ReferenceCitation: Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.

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

location_country:
Germany
Poland
United Kingdom
Australia
Netherlands
Mexico
United States
Canada
Czech Republic
France


title: Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

summary: This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

ReferenceType: result

ReferenceCitation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

publisher_dissemination: IOS Press

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Germany
United Kingdom
United States
Greece
South Africa
Canada
France

location_facility:
Site Reference ID/Investigator# 84187
Site Reference ID/Investigator# 84393
Site Reference ID/Investigator# 84379
Site Reference ID/Investigator# 84374
Site Reference ID/Investigator# 84375
Site Reference ID/Investigator# 84391
Site Reference ID/Investigator# 84378
Site Reference ID/Investigator# 84186
Site Reference ID/Investigator# 84399
Site Reference ID/Investigator# 84390
Site Reference ID/Investigator# 84181
Site Reference ID/Investigator# 84383
Site Reference ID/Investigator# 84177
Site Reference ID/Investigator# 84380
Site Reference ID/Investigator# 84373
Site Reference ID/Investigator# 84183
Site Reference ID/Investigator# 84389
Site Reference ID/Investigator# 84182
Site Reference ID/Investigator# 84385
Site Reference ID/Investigator# 84185
Site Reference ID/Investigator# 84178
Site Reference ID/Investigator# 84175
Site Reference ID/Investigator# 84180
Site Reference ID/Investigator# 84174
Site Reference ID/Investigator# 84394
Site Reference ID/Investigator# 84388
Site Reference ID/Investigator# 84386
Site Reference ID/Investigator# 84376
Site Reference ID/Investigator# 84392
Site Reference ID/Investigator# 84397
Site Reference ID/Investigator# 84381
Site Reference ID/Investigator# 84176
Site Reference ID/Investigator# 84400
Site Reference ID/Investigator# 84377
Site Reference ID/Investigator# 84173
Site Reference ID/Investigator# 84179
Site Reference ID/Investigator# 84395
Site Reference ID/Investigator# 84398
Site Reference ID/Investigator# 84382


type: Other Identifier

title: Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors

summary: This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.

ReferenceCitation: Hargrave DR, Bouffet E, Tabori U, Broniscer A, Cohen KJ, Hansford JR, Geoerger B, Hingorani P, Dunkel IJ, Russo MW, Tseng L, Dasgupta K, Gasal E, Whitlock JA, Kieran MW. Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation-Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study. Clin Cancer Res. 2019 Dec 15;25(24):7303-7311. doi: 10.1158/1078-0432.CCR-19-2177.

evidence: oa repository (via page says license)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;aacr.figshare.com

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Kieran MW, Geoerger B, Dunkel IJ, Broniscer A, Hargrave D, Hingorani P, Aerts I, Bertozzi AI, Cohen KJ, Hummel TR, Shen V, Bouffet E, Pratilas CA, Pearson ADJ, Tseng L, Nebot N, Green S, Russo MW, Whitlock JA. A Phase I and Pharmacokinetic Study of Oral Dabrafenib in Children and Adolescent Patients with Recurrent or Refractory BRAF V600 Mutation-Positive Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7294-7302. doi: 10.1158/1078-0432.CCR-17-3572. Epub 2019 Sep 10.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Wang J, Yao Z, Jonsson P, Allen AN, Qin ACR, Uddin S, Dunkel IJ, Petriccione M, Manova K, Haque S, Rosenblum MK, Pisapia DJ, Rosen N, Taylor BS, Pratilas CA. A Secondary Mutation in BRAF Confers Resistance to RAF Inhibition in a BRAFV600E-Mutant Brain Tumor. Cancer Discov. 2018 Sep;8(9):1130-1141. doi: 10.1158/2159-8290.CD-17-1263. Epub 2018 Jun 7.

repository_institution: University of Illinois at Chicago - INDIGO

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


title: Osteonecrosis of the Jaw (ONJ) Case Registry

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.

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

lead_sponsor: Amgen

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Belgium
United States
Spain
Greece
Canada
France


type: Registry Identifier

title: A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

summary: The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

ReferenceCitation: Sanchorawala V, Palladini G, Kukreti V, Zonder JA, Cohen AD, Seldin DC, Dispenzieri A, Jaccard A, Schonland SO, Berg D, Yang H, Gupta N, Hui AM, Comenzo RL, Merlini G. A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis. Blood. 2017 Aug 3;130(5):597-605. doi: 10.1182/blood-2017-03-771220. Epub 2017 May 26. Erratum In: Blood. 2020 Mar 26;135(13):1071.

publisher_dissemination: American Society of Hematology

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Germany
Italy
Israel
United Kingdom
Denmark
Australia
Brazil
Netherlands
United States
Korea, Republic of
Spain
Greece
Czechia
Canada
France

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Hospital Universitario Clementino Fraga Filho (UFRJ)

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

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Royal Free and University College Medical School

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Severance Hospital at Yonsei University Health System - PPDS

location_facility: Institute of Hematology "Seragnoli" University of Bologna

location_facility: Arhus Universitetshospital Arhus Sygehus

location_facility: Hadasit Medical Research Services and Development Ltd

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University of Texas Southwestern Medical Center


title: A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in the treatment of faecal incontinence, compared against placebo

lead_sponsor: Norgine

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Spain
Czech Republic
France

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Lecznica Prosen SMO Private Medical Health Care Centre

location_facility: Osrodek Badawczo - Leczniczy Zbigniew Zegota

location_facility: Fakultni Nemocnice Na Bulovce, Gynekologicko-Porodnicka Klinika

location_facility: Hospital Clinico Universtiaria Lozana Blesa

location_facility: Unita Operativa Complessa Patologia Chirurgica A Indirizzo Gastroenterologico

location_facility: Unita Operativa Complessa Gastroenteroloogia A

location_facility: Polyclinic for Outpatients, Szakrendelo Intezet

location_facility: University of Szeged, Albert Szent-Gyorgyi Clinical Center, Faculty of Medicine

location_facility: Seconda Unita Operativa Di Chirurgia Generale

location_facility: Centrum Medyczne, Wyzszej Szkoly Informatycznej

location_facility: Chu Lyon Groupement Hospitalier Edouard Herriot

location_facility: Chu Nantes - Hotel Dieu - Institut Des Maladies De L'Appareil Digestif (IMAD)


title: A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

repository_institution: University of Plymouth - PEARL

repository_institution: University of California - eScholarship University of California

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. doi: 10.1016/S0140-6736(15)00667-4. Epub 2015 Dec 7. Erratum In: Lancet. 2016 Feb 20;387(10020):750.

repositories_institution: Ghent University - Ghent University Academic Bibliography

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

location_country:
Germany
Ireland
Poland
Brazil
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Ukraine
Belgium
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

summary: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

ReferenceCitation: Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

publisher_dissemination: Oxford University Press

ipd_sharing: Undecided

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
Singapore
Japan
Switzerland
Austria
United States
Vietnam
Czechia
Bulgaria
Canada
France


title: An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis

acronym: ENVISION

summary: The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

lead_sponsor: Knopp Biosciences

sponsor_collaborators:
Knopp Biosciences
Biogen

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

location_facility: Sheffield Institute for Transnational Neuroscience

location_facility: University of South Florida Medical Center

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of Miami Miller School of Medicine

location_facility: Barrow Neurological Institute - St. Joseph's Hospital

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Washington University School of Medicine

location_facility: Sunnybrook and Women's College and Health Sciences Centre

location_facility: Johns Hopkins University School of Medicine

location_facility: University of California at San Francisco - Fresno

location_facility: Newcastle University Hospital - Clinical Ageing Research Unit

location_facility: University of Texas Health Sciences Center

location_facility: Research Foundation of the State University of New York


title: Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

ReferenceCitation: Davies MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syren A, Umpierrez GE. Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016 Feb;39(2):222-30. doi: 10.2337/dc14-2883. Epub 2015 Dec 17.

repository_institution: Swansea University - Cronfa

publisher_dissemination: American Diabetes Association

ReferenceCitation: Zobel EH, von Scholten BJ, Goldman B, Persson F, Hansen TW, Rossing P. Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment. Diabetes Obes Metab. 2019 May;21(5):1261-1265. doi: 10.1111/dom.13638. Epub 2019 Feb 22.

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

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Kim JD, Park CY, Cha BY, Ahn KJ, Kim IJ, Park KS, Lee HW, Min KW, Won JC, Chung MY, Kim JT, Kang JG, Park SW. Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes. Clin Ther. 2018 May;40(5):752-761.e2. doi: 10.1016/j.clinthera.2018.04.002. Epub 2018 May 3.

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
United Kingdom
United States
Ukraine
Russian Federation
France


title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness

summary: LY2495655 is an investigational drug being tested for muscle wasting.

ReferenceCitation: Becker C, Lord SR, Studenski SA, Warden SJ, Fielding RA, Recknor CP, Hochberg MC, Ferrari SL, Blain H, Binder EF, Rolland Y, Poiraudeau S, Benson CT, Myers SL, Hu L, Ahmad QI, Pacuch KR, Gomez EV, Benichou O; STEADY Group. Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):948-57. doi: 10.1016/S2213-8587(15)00298-3. Epub 2015 Oct 27.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Argentina
Australia
Sweden
United States
France

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


title: A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

summary: This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

ReferenceCitation: Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.

publisher_dissemination: British Medical Journal

lead_sponsor: Humanigen, Inc.

location_country:
Poland
United Kingdom
Australia
United States
Ukraine
France

intervention_type: Other


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Tabalumab in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma

summary: The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Germany
Italy
Poland
United Kingdom
Brazil
Netherlands
Mexico
United States
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Canada
France


title: A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

location_country:
France
Poland
United Kingdom
Belgium
United States
Spain
Puerto Rico
Russian Federation
Israel


title: An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

acronym: DASCERN

summary: The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

ReferenceCitation: Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo

repositories_concat: PubMed Central;Zenodo

lead_sponsor: Bristol-Myers Squibb

collaborators: MD Anderson Symptom Inventory (MDASI-CML)

location_country:
Italy
Poland
Hungary
Argentina
Brazil
Austria
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Czechia
Canada
France

location_facility: Northern Indiana Cancer Research Consortium

location_facility: University Of Southern California University Hospital

location_facility: Institute of Oncology Hematology Biomedical Research


lead_sponsor: Pierre Fabre Medicament

summary: Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Complejo Hospitalario de Pontevedra- Montecelo

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

title:
EFFECT OF V0251 IN ACUTE VERTIGO.
 A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.

location_country:
Germany
Hungary
Spain
Czech Republic
France


acronym: POSTURE

summary: Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

ReferenceCitation: Gladman DD, Kavanaugh A, Gomez-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.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

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

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.

repositories_concat: PubMed Central;aleph.bib-bvb.de

ReferenceCitation: Taylor PC, van der Heijde D, Landewe R, McCue S, Cheng S, Boonen A. A Phase III Randomized Study of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Active Ankylosing Spondylitis. J Rheumatol. 2021 Aug;48(8):1259-1267. doi: 10.3899/jrheum.201088. Epub 2021 Feb 15.

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

publisher_dissemination: The Journal of Rheumatology

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

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

location_facility: National Multiprofile Transport Hospital Tzar Boris III

location_facility: Departmental Hospital at Smolensk Station RZhD JSC

location_facility: Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH

location_facility: MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia

location_facility: IPROS - CHR ORLEANS - Hôpital de la Source

location_facility: NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

location_facility: Cristei R. Rodica - Private Medical Practice

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: NZOZ Osteo-Medic sc A. Racewicz J. Supronik

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW)

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Nizhniy Novgorod State Medical Academy of Roszdrav

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n

location_facility: University of Utah Hospitals and Clinics

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Cividino Medicine Professional Corporation

location_facility: Diagnostic and Consulting Center Sv. Pantaleymon

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet

location_facility: The Arthritis Program Research Group Inc.

location_facility: Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Federal State Budget Institution "Rheumatology Research Institute RAMS"

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS

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:
Germany
Poland
Slovakia
Hungary
United Kingdom
Romania
Australia
Estonia
Netherlands
Austria
Sweden
United States
Spain
Czechia
Bulgaria
Canada
Russian Federation
France


title: A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma

summary: The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

enrollment_type: Anticipated

ReferenceCitation: Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.

ReferenceCitation: Brandes AA, Carpentier AF, Kesari S, Sepulveda-Sanchez JM, Wheeler HR, Chinot O, Cher L, Steinbach JP, Capper D, Specenier P, Rodon J, Cleverly A, Smith C, Gueorguieva I, Miles C, Guba SC, Desaiah D, Lahn MM, Wick W. A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma. Neuro Oncol. 2016 Aug;18(8):1146-56. doi: 10.1093/neuonc/now009. Epub 2016 Feb 21.

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

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


title: A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

acronym: ALCANZA

summary: The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma [mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) ]compared to that achieved with therapy in the control arm.

ReferenceCitation: Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. doi: 10.1182/bloodadvances.2021004710.

evidence: open (via page says license)

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
cris.unibo.it

repositories_concat: LIRIAS (KU Leuven);PubMed Central;cris.unibo.it

ReferenceCitation: Kim YH, Prince HM, Whittaker S, Horwitz SM, Duvic M, Bechter O, Sanches JA, Stadler R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown LC, Ortiz-Romero PL, Akilov OE, Trotman J, Taylor K, Weichenthal M, Walewski J, Fisher D, McNeeley M, Gru AA, Brown L, Palanca-Wessels MC, Lisano J, Onsum M, Bunn V, Little M, Trepicchio WL, Dummer R. Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis. Eur J Cancer. 2021 May;148:411-421. doi: 10.1016/j.ejca.2021.01.054. Epub 2021 Mar 29.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_concat: LIRIAS (KU Leuven);PubMed Central;University of Melbourne - Minerva Access;cris.unibo.it;escholarship.org;www.zora.uzh.ch

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

ReferenceCitation: Dummer R, Prince HM, Whittaker S, Horwitz SM, Kim YH, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown L, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Huen A, Walewski J, Wang Y, Lisano J, Richhariya A, Feliciano J, Zhu Y, Bunn V, Little M, Zagadailov E, Dalal MR, Duvic M. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study. Eur J Cancer. 2020 Jul;133:120-130. doi: 10.1016/j.ejca.2020.04.010. Epub 2020 Jun 2.

ReferenceCitation: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dreno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. doi: 10.1016/S0140-6736(17)31266-7. Epub 2017 Jun 7.

sponsor_collaborators:
Millennium Pharmaceuticals, Inc.
Seagen Inc.

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


title: Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects

acronym: REPLACE

summary: The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
United Kingdom
Austria
Belgium
Spain
France


title: Patient Retrospective Outcomes (PRO)

acronym: PRO

summary: This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

status: Recruiting

time_perspective: Retrospective

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Switzerland
United States
Spain
Puerto Rico
France

location_facility: UCSD Medical Center - Jacobs Medical Center

location_facility: Twin Cities Pain Clinic & Surgery Center

location_facility: Advanced Diagnostic Pain Treatment Centers

location_facility: Willis-Knighton River Cities Clinical Research Center

location_facility: Pres. Osp. Civile Santi Antonio e Biagio

location_facility: Advanced Interventional Pain Management and Research Clinic, Inc.

location_facility: Basildon and Thurrock University Hospitals NHS

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: West Florida Orthopedics and Spine Surgery

location_facility: Interventional Pain Specialists of Wisconsin

location_facility: Vidant Roanoke - Chowan Hospital Pain Center

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: Multidisciplinary Pain Management Services

location_facility: Western Reserve Spine and Pain Institute

location_facility: Integrative Pain and Wellness Associates

location_facility: Womens Health and Research Institute of Australia


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

summary: This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

ReferenceCitation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

location_country:
Germany
United Kingdom
United States
Greece
South Africa
Canada
France

location_facility:
Site Reference ID/Investigator# 66523
Site Reference ID/Investigator# 67786
Site Reference ID/Investigator# 69959
Site Reference ID/Investigator# 68704
Site Reference ID/Investigator# 68729
Site Reference ID/Investigator# 71794
Site Reference ID/Investigator# 68730
Site Reference ID/Investigator# 67783
Site Reference ID/Investigator# 68706
Site Reference ID/Investigator# 77833
Site Reference ID/Investigator# 66527
Site Reference ID/Investigator# 67784
Site Reference ID/Investigator# 66525
Site Reference ID/Investigator# 71796
Site Reference ID/Investigator# 68765
Site Reference ID/Investigator# 66528
Site Reference ID/Investigator# 71573
Site Reference ID/Investigator# 66524
Site Reference ID/Investigator# 68764
Site Reference ID/Investigator# 66530
Site Reference ID/Investigator# 67585
Site Reference ID/Investigator# 71793
Site Reference ID/Investigator# 69960
Site Reference ID/Investigator# 67586
Site Reference ID/Investigator# 71795
Site Reference ID/Investigator# 68767
Site Reference ID/Investigator# 69602
Site Reference ID/Investigator# 67582
Site Reference ID/Investigator# 66531
Site Reference ID/Investigator# 68732
Site Reference ID/Investigator# 68733
Site Reference ID/Investigator# 66522
Site Reference ID/Investigator# 67584
Site Reference ID/Investigator# 67785
Site Reference ID/Investigator# 66526
Site Reference ID/Investigator# 71798
Site Reference ID/Investigator# 66529
Site Reference ID/Investigator# 68731
Site Reference ID/Investigator# 68768
Site Reference ID/Investigator# 67583
Site Reference ID/Investigator# 67787
Site Reference ID/Investigator# 68735
Site Reference ID/Investigator# 68705


title: A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.

lead_sponsor: CSL Behring

location_country:
Germany
Italy
Poland
India
Hungary
Hong Kong
Israel
United Kingdom
Netherlands
Austria
Mexico
Switzerland
United States
Korea, Republic of
Taiwan
Czechia
Canada
France

location_facility: Premier Medical Group Of The Hudson Valley, Pc

intervention_type: Biological


title: A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

summary:
Primary Objective:

- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;

Secondary Objectives:

To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
To evaluate the durability of splenic response
To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
To evaluate the splenic response to SAR302503 at the end of Cycle 3
To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
To evaluate the safety and tolerability of SAR302503 in this population
To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted

ReferenceCitation: Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Tiu RV, Zachee P, Jourdan E, Winton E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Lager J, Shun Z, Mesa RA. Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study. Lancet Haematol. 2017 Jul;4(7):e317-e324. doi: 10.1016/S2352-3026(17)30088-1. Epub 2017 Jun 8.

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

repositories_concat: PubMed Central;air.unimi.it

lead_sponsor: Sanofi

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

location_facility:
Investigational Site Number 276005
Investigational Site Number 840013
Investigational Site Number 056002
Investigational Site Number 826001
Investigational Site Number 250002
Investigational Site Number 724002
Investigational Site Number 250004
Investigational Site Number 840009
Investigational Site Number 840004
Investigational Site Number 840002
Investigational Site Number 276003
Investigational Site Number 840001
Investigational Site Number 840014
Investigational Site Number 250006
Investigational Site Number 840022
Investigational Site Number 276006
Investigational Site Number 380003
Investigational Site Number 040001
Investigational Site Number 840007
Investigational Site Number 124001
Investigational Site Number 250001
Investigational Site Number 840019
Investigational Site Number 380001
Investigational Site Number 040002
Investigational Site Number 380004
Investigational Site Number 840003
Investigational Site Number 528002
Investigational Site Number 724001
Investigational Site Number 528003
Investigational Site Number 276007
Investigational Site Number 528001
Investigational Site Number 840017
Investigational Site Number 276001
Investigational Site Number 840018
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 840024
Investigational Site Number 380002
Investigational Site Number 250003
Investigational Site Number 840005
Investigational Site Number 840015
Investigational Site Number 056003


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

acronym: C-early

summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

ReferenceCitation: Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naive patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10.

repository_institution: Leiden University - Leiden Repository

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

ReferenceCitation: Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

lead_sponsor: UCB Pharma

location_country:
Germany
Ireland
Poland
Argentina
Australia
Czechia
Canada
France
Colombia
Hungary
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Monaco
Sweden


summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

lead_sponsor: UCB Pharma SA


lead_sponsor: Novartis Pharmaceuticals

summary: This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

ReferenceCitation: Sommerwerck U, Virella-Lowell I, Angyalosi G, Viegas A, Cao W, Debonnett L. Long-term safety of tobramycin inhalation powder in patients with cystic fibrosis: phase IV (ETOILES) study. Curr Med Res Opin. 2016 Nov;32(11):1789-1795. doi: 10.1080/03007995.2016.1211516. Epub 2016 Sep 9.

title: A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

location_country:
Germany
Italy
Hungary
Argentina
Australia
Mexico
United States
Spain
Canada
France


title: A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

summary: This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

ReferenceCitation: Pozniak A, Flamm J, Antinori A, Bloch M, Ward D, Berenguer J, Cote P, Andreatta K, Garner W, Szwarcberg J, Nguyen-Cleary T, McColl DJ, Piontkowsky D. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.

ReferenceCitation: Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

lead_sponsor: Gilead Sciences

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

location_facility: Tarrant County Infectious Disease Associates

location_facility: SEAMEO Regional Centre for Tropical Medicine

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: HIV Program Hennepin County Medical Center

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Southwest Infectious Disease Clinical Researach Inc

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: Azienda Ospedaliera Ospedale di Circolo Busto Arsizio

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Infectious Diseases Associates of Northwest Florida

location_facility: La Playa Medical Group and Clinical Research

location_facility: Clinical Alliance for Research & Education - Infectious Disease


title: Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.

acronym: ATTRACT

summary:
Study objectives:

To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

lead_sponsor: Galderma R&D

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Bulgaria
Ukraine
Czech Republic
Russian Federation
France

location_facility:
Galderma Invetigational site
Galderma Investigational Site


title: Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)

acronym: TRACE

summary: The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.

lead_sponsor: Abbott Medical Devices

sponsor_collaborators:
Abbott Medical Devices
Thoratec Europe Ltd

location_country:
Germany
Austria
United States
Czechia
France

location_facility: Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere


title: Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator

summary: This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

lead_sponsor: Forest Laboratories

location_country:
France
Germany
Italy
Poland
Israel
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Canada
Czech Republic

location_facility:
Forest Investigative Site 041
Forest Investigative Site 016
Forest Investigative Site 058
Forest Investigative Site 007
Forest Investigative Site 350
Forest Investigative Site 059
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title: Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

summary: The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

ReferenceCitation: Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + asunaprevir + beclabuvir +/- ribavirin for chronic HCV genotype 1-infected treatment-naive patients. Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964. Epub 2015 Dec 6.

ReferenceCitation: Everson GT, Sims KD, Rodriguez-Torres M, Hezode C, Lawitz E, Bourliere M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014 Feb;146(2):420-9. doi: 10.1053/j.gastro.2013.10.057. Epub 2013 Oct 30.

evidence: oa repository (semantic scholar lookup)

location_country:
United States
Puerto Rico
France

location_facility: Va Greater Los Angeles Healthcare System

location_facility: University Of Colorado Denver And Hospital

location_facility: Atlanta Gastroenterology Associates, Llc


title: PROTEAse Inhibitor (DRV/Rtv) in Mono- or Triple Therapy in Suppressed HIV-1 Infected Subjects

acronym: PROTEA

summary: The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

ReferenceCitation: Girard PM, Antinori A, Arribas JR, Ripamonti D, Bicer C, Netzle-Sveine B, Hadacek B, Moecklinghoff C. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. HIV Med. 2017 Jan;18(1):5-12. doi: 10.1111/hiv.12386. Epub 2016 Jun 9.

location_country:
Germany
Ireland
Poland
Hungary
Israel
Denmark
United Kingdom
Sweden
Switzerland
Austria
Belgium
Spain
France


title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

summary: The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

ReferenceCitation: Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
New Zealand
Slovakia
Hungary
Netherlands
Mexico
Belgium
United States
Czechia
Russian Federation
France


title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Of Lurasidone For The Maintenance Treatment Of Subjects With Schizophrenia

summary: Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Italy
Slovakia
United States
South Africa
Serbia
Russian Federation
France

location_facility: Limited Liability Company (LLC) Research Center for Treatment and rehabilitation "Phoenix"

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

location_facility: City Psychoneurological Dispensary #7 (with Hospital)

location_facility: St. Petersburg State Budgetary Healthcare Institution City Psychoneurology Dispensary #7 (with in-patient dept.) (SPb SBHI CPNDD-7), at daycare facility #1

location_facility: Centre Hospitalier Specialise du Jura - Centre Medico Psychiatric

location_facility: St. Petersburg State Government Healthcare Institution City Psychiatric Hospital #4 (St. Petersburg Insane Asylum Distributor)

location_facility: Specialized Hospital for psychiatric diseases "Sveti Vracevi"

location_facility: Psychiaticke oddelenie Vseobecna nemocnica Riimavska Sobota, NaP n.o.

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: St. Petersburg State Healthcare Institution (SPbSH) "City Psychiatric Hospital #6"

location_facility: Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia

location_facility: Medical Research Group of Central Florida

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex

location_facility: Military Medical Academy, Clinic for Psychiatry

location_facility: Clinical Centre Vojvodina, Clinic for Psychiatry

location_facility: Center for Psychiatry and Behavioral Medicine, Inc.

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: California Neuropsychopharmacology Clinical Research Instit

location_facility: Regional Government Institution Kipetsk Regional Psychoneurology Hospital

location_facility: Nemonnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

location_facility: Department of Psychiatry, University of Utah Health Sciences Center

location_facility: SC SPDC-Edificio n. 7, Ospedale S. Andrea

location_facility: Clinical Centre Kragujevac, Clinic for Psychiatry

location_facility: University of New York, Dept. of Psychiatry

location_facility: Psychiatricke oddelenie, Nemocnica s poliklinikou sv. Barbory Roznava, a.s.

location_facility: Behavioral Medical Research of Staten Island

location_facility: CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: Hopital Chalucet, Centre hospitalier intercommunal de toulon la Seyne sur mer (CHITS)


title: A Phase 1a/1b, Multi-center, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma.

summary: The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.

ReferenceCitation: Rasco DW, Papadopoulos KP, Pourdehnad M, Gandhi AK, Hagner PR, Li Y, Wei X, Chopra R, Hege K, DiMartino J, Shih K. A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies. Clin Cancer Res. 2019 Jan 1;25(1):90-98. doi: 10.1158/1078-0432.CCR-18-1203. Epub 2018 Sep 10.

ReferenceCitation: Cubillos-Zapata C, Cordoba R, Avendano-Ortiz J, Arribas-Jimenez C, Hernandez-Jimenez E, Toledano V, Villaescusa T, Moreno V, Lopez-Collazo E. CC-122 immunomodulatory effects in refractory patients with diffuse large B-cell lymphoma. Oncoimmunology. 2016 Sep 16;5(12):e1231290. doi: 10.1080/2162402X.2016.1231290. eCollection 2016.

ReferenceCitation: Hagner P, et al. CC-122 Has Potent Anti-Lymphoma Activity through Destruction of the Aiolos and Ikaros Transcription Factors and Induction of Interferon Response Pathways. Presented at American Society of Hematology 2014, December 6-9, 2014, San Francisco, CA. Abstract No. 3035.

ReferenceCitation: Carpio C, Bouabdallah R, Ysebaert L, Sancho JM, Salles G, Cordoba R, Pinto A, Gharibo M, Rasco D, Panizo C, Lopez-Martin JA, Santoro A, Salar A, Damian S, Martin A, Verhoef G, Van den Neste E, Wang M, Couto S, Carrancio S, Weng A, Wang X, Schmitz F, Wei X, Hege K, Trotter MWB, Risueno A, Buchholz TJ, Hagner PR, Gandhi AK, Pourdehnad M, Ribrag V. Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier. Blood. 2020 Mar 26;135(13):996-1007. doi: 10.1182/blood.2019002395. Erratum In: Blood. 2021 Apr 15;137(15):2126.

lead_sponsor: Celgene

location_country:
Italy
Belgium
United States
Spain
France

location_facility: Swedish Medical Center Cancer Institute Research

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: UCSF Helen Diller Medical Center at Parnassus Heights

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: Rutgers Cancer Institute of New Jersey University

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: Henry Ford Medical Center - New Center One

location_facility: Sarah Cannon Research Institute Drug Development Unit


title: A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

acronym: SCULPTURE

summary: This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

location_country:
France
Germany
Italy
Poland
India
Slovakia
United Kingdom
Singapore
Japan
Switzerland
Austria
United States
Vietnam
Bulgaria
Canada
Czech Republic