title: A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

acronym: COMBI-v

summary: This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Robert

full_name: Caroline Robert

given: Caroline

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

family: Tawbi

full_name: Hussein A. Tawbi

given: Hussein A.

family: Menzies

full_name: Alexander M. Menzies

given: Alexander M.

family: Banerjee

full_name: Hiya Banerjee

given: Hiya

family: Lau

full_name: Mike Lau

given: Mike

family: Long

full_name: Georgina V. Long

given: Georgina V.

journal_name: European Journal of Cancer

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandalá M, Haanen JBAG, Lebbé C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

name: From Institut Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Aix-Marseille University, Marseille (J.J.G.), and Assistance Publique–Hôpitaux de Paris Dermatology and Clinical Investigation Center, Unité 976, Université de Paris, Hôpital Saint-Louis, Paris (C.L.) — all in France; Moscow City Oncology Hospital, Moscow (D. Stroyakovskiy), and the Petrov Research Institute of Oncology, St. Petersburg (E.L.) — both in Russia; Przychodnia Lekarska Komed, Konin (B.K.), the University of...

family: Grob

full_name: Jean J. Grob

given: Jean J.

family: Stroyakovskiy

full_name: Daniil Stroyakovskiy

given: Daniil

family: Karaszewska

full_name: Boguslawa Karaszewska

given: Boguslawa

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Levchenko

full_name: Evgeny Levchenko

given: Evgeny

family: Chiarion Sileni

full_name: Vanna Chiarion Sileni

given: Vanna

family: Schachter

full_name: Jacob Schachter

given: Jacob

ReferenceCitation: Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

ReferenceCitation: Grob JJ, Amonkar MM, Karaszewska B, Schachter J, Dummer R, Mackiewicz A, Stroyakovskiy D, Drucis K, Grange F, Chiarion-Sileni V, Rutkowski P, Lichinitser M, Levchenko E, Wolter P, Hauschild A, Long GV, Nathan P, Ribas A, Flaherty K, Sun P, Legos JJ, McDowell DO, Mookerjee B, Schadendorf D, Robert C. Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial. Lancet Oncol. 2015 Oct;16(13):1389-98. doi: 10.1016/S1470-2045(15)00087-X.

ReferenceCitation: Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, Lichinitser M, Dummer R, Grange F, Mortier L, Chiarion-Sileni V, Drucis K, Krajsova I, Hauschild A, Lorigan P, Wolter P, Long GV, Flaherty K, Nathan P, Ribas A, Martin AM, Sun P, Crist W, Legos J, Rubin SD, Little SM, Schadendorf D. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30-9. doi: 10.1056/NEJMoa1412690. Epub 2014 Nov 16.

name: The authors' affiliations are listed in the Appendix.

title: Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib

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

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

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain


type: Other Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.

family: Rich

full_name: Phoebe Rich

given: Phoebe

sequence: first

family: Goldblum

full_name: Orin Goldblum

given: Orin

sequence: additional

family: Disch

full_name: Damon Disch

given: Damon

family: Lin

full_name: Chen-Yen Lin

given: Chen-Yen

family: Merola

full_name: Joseph Merola

given: Joseph

family: Elewski

full_name: Boni Elewski

given: Boni

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Drugs in Dermatology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: SanovaWorks

publisher_dissemination: SanovaWorks

publisher_group: SanovaWorks

publisher_normalized: SanovaWorks

ReferenceCitation: Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.

family: Leonardi

full_name: Craig Leonardi

given: Craig

family: Reich

full_name: Kristian Reich

given: Kristian

family: Foley

full_name: Peter Foley

given: Peter

family: Torii

full_name: Hideshi Torii

given: Hideshi

family: Gerdes

full_name: Sascha Gerdes

given: Sascha

family: Guenther

full_name: Lyn Guenther

given: Lyn

family: Gooderham

full_name: Melinda Gooderham

given: Melinda

family: Ferris

full_name: Laura K. Ferris

given: Laura K.

family: Griffiths

full_name: Christopher E. M. Griffiths

given: Christopher E. M.

family: ElMaraghy

full_name: Hany ElMaraghy

given: Hany

family: Crane

full_name: Heidi Crane

given: Heidi

family: Patel

full_name: Himanshu Patel

given: Himanshu

family: Burge

full_name: Russel Burge

given: Russel

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21. Review.

ReferenceCitation: Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9. Erratum in: Am J Clin Dermatol. 2018 Mar 29;:.

journal_name: American Journal of Clinical Dermatology

ReferenceCitation: Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.

ReferenceCitation: Armstrong AW, Lynde CW, McBride SR, Ståhle M, Edson-Heredia E, Zhu B, Amato D, Nikaï E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.

name: Keck School of Medicine at USC, University of Southern California, Los Angeles

name: Department of Medicine, University of Toronto, Toronto, Ontario, Canada

name: Royal Free London NHS Foundation Trust, London, England

name: Dermatology Unit B2:01, Karolinska University Hospital, Solna, Stockholm, Sweden

name: Eli Lilly and Company, Indianapolis, Indiana

name: Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

ReferenceCitation: Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.

ipd_sharing_description:
Plan Description:

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Austria
United States
Netherlands
Germany
France
Czechia
Poland
Romania
Australia
Spain
Canada
United Kingdom

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: REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)

acronym: REGISTRY

summary:
This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to:

obtain natural history data on many HD mutation carriers and individuals who are part of an HD family
relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)
expedite identification and recruitment of participants for clinical trials
develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care
plan for future research studies

study_type: Observational

time_perspective: Other

ReferenceType: result

ReferenceCitation: Rickards H, De Souza J, van Walsem M, van Duijn E, Simpson SA, Squitieri F, Landwehrmeyer B; European Huntington's Disease Network. Factor analysis of behavioural symptoms in Huntington's disease. J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):411-2. doi: 10.1136/jnnp.2009.181149. Epub 2010 Apr 14.

family: Rickards

full_name: H. Rickards

given: H.

family: De Souza

full_name: J. De Souza

given: J.

family: van Walsem

full_name: M. van Walsem

given: M.

family: van Duijn

full_name: E. van Duijn

given: E.

family: Simpson

full_name: S. A. Simpson

given: S. A.

family: Squitieri

full_name: F. Squitieri

given: F.

family: Landwehrmeyer

full_name: B. Landwehrmeyer

given: B.

name: The European Huntington's Disease Network

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_host_type: repository

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Factor analysis of behavioural symptoms in Huntington's disease

ReferenceCitation: Orth M, Handley OJ, Schwenke C, Dunnett SB, Craufurd D, Ho AK, Wild E, Tabrizi SJ, Landwehrmeyer GB; Investigators of the European Huntington's Disease Network. Observing Huntington's Disease: the European Huntington's Disease Network's REGISTRY. Version 2. PLoS Curr. 2010 Sep 28 [revised 2011 Jan 1];2:RRN1184.

ReferenceCitation: Orth M; European Huntington's Disease Network, Handley OJ, Schwenke C, Dunnett S, Wild EJ, Tabrizi SJ, Landwehrmeyer GB. Observing Huntington's disease: the European Huntington's Disease Network's REGISTRY. J Neurol Neurosurg Psychiatry. 2011 Dec;82(12):1409-12. doi: 10.1136/jnnp.2010.209668. Epub 2010 Nov 19.

family: Orth

full_name: M. Orth

name: The European Huntington 's Disease Network

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

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
iris.uniroma1.it

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Busse M, Al-Madfai DH, Kenkre J, Landwehrmeyer GB, Bentivoglio A, Rosser A; European Huntington's Disease Network. Utilisation of Healthcare and Associated Services in Huntington's disease: a data mining study. PLoS Curr. 2011 Jan 21;3:RRN1206. doi: 10.1371/currents.RRN1206.

family: Busse

full_name: Monica Busse

given: Monica

family: Al-Madfai

full_name: Dr. Hasan Al-Madfai

given: Dr. Hasan

family: Kenkre

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repositories:
PubMed Central
https
pdfs.semanticscholar.org

repositories_institution: Cardiff University - ORCA Online Research @Cardiff

title: Utilisation of Healthcare and Associated Services in Huntington’s disease: a data mining study

ReferenceCitation: López-Sendón JL, Royuela A, Trigo P, Orth M, Lange H, Reilmann R, Keylock J, Rickards H, Piacentini S, Squitieri F, Landwehrmeyer B, Witjes-Ane MN, Jurgens CK, Roos RA, Abraira V, de Yébenes JG; European HD Network. What is the impact of education on Huntington's disease? Mov Disord. 2011 Jul;26(8):1489-95. doi: 10.1002/mds.23385. Epub 2011 Mar 22.

title: What is the impact of education on Huntington's disease?

ReferenceCitation: Ho AK, Hocaoglu MB; European Huntington's Disease Network Quality of Life Working Group. Impact of Huntington's across the entire disease spectrum: the phases and stages of disease from the patient perspective. Clin Genet. 2011 Sep;80(3):235-9. doi: 10.1111/j.1399-0004.2011.01748.x. Epub 2011 Aug 4.

name: School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK

name: for the European Huntington's Disease Network Quality of Life Working Group

repositories_institution:
PubMed Central - Europe PMC
University of Reading - CentAUR

ReferenceCitation: Quarrell OW, Handley O, O'Donovan K, Dumoulin C, Ramos-Arroyo M, Biunno I, Bauer P, Kline M, Landwehrmeyer GB; European Huntington's Disease Network. Discrepancies in reporting the CAG repeat lengths for Huntington's disease. Eur J Hum Genet. 2012 Jan;20(1):20-6. doi: 10.1038/ejhg.2011.136. Epub 2011 Aug 3.

name: on behalf of the European Huntington's Disease Network

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

ReferenceCitation: Saft C, Epplen JT, Wieczorek S, Landwehrmeyer GB, Roos RA, de Yebenes JG, Dose M, Tabrizi SJ, Craufurd D; REGISTRY Investigators of the European Huntington's Disease Network, Arning L. NMDA receptor gene variations as modifiers in Huntington disease: a replication study. PLoS Curr. 2011 Oct 4;3:RRN1247. doi: 10.1371/currents.RRN1247.

repository_institution: University of Florence - Florence Research

repositories:
PubMed Central
UCL Discovery
flore.unifi.it

repositories_institution: University of Florence - Florence Research

ReferenceCitation: Rickards H, De Souza J, Crooks J, van Walsem MR, van Duijn E, Landwehrmeyer B, Squitieri F, Simpson SA; European Huntington's Disease Network. Discriminant analysis of Beck Depression Inventory and Hamilton Rating Scale for Depression in Huntington's disease. J Neuropsychiatry Clin Neurosci. 2011 Fall;23(4):399-402. doi: 10.1176/jnp.23.4.jnp399.

journal_name: The Journal of Neuropsychiatry and Clinical Neurosciences

publisher: American Psychiatric Association Publishing

publisher_dissemination: American Psychiatric Association Publishing

publisher_group: American Psychiatric Association Publishing

publisher_normalized: American Psychiatric Association Publishing

title: Discriminant Analysis of Beck Depression Inventory and Hamilton Rating Scale for Depression in Huntington's Disease

ReferenceCitation: Lee JM, Ramos EM, Lee JH, Gillis T, Mysore JS, Hayden MR, Warby SC, Morrison P, Nance M, Ross CA, Margolis RL, Squitieri F, Orobello S, Di Donato S, Gomez-Tortosa E, Ayuso C, Suchowersky O, Trent RJ, McCusker E, Novelletto A, Frontali M, Jones R, Ashizawa T, Frank S, Saint-Hilaire MH, Hersch SM, Rosas HD, Lucente D, Harrison MB, Zanko A, Abramson RK, Marder K, Sequeiros J, Paulsen JS; PREDICT-HD study of the Huntington Study Group (HSG), Landwehrmeyer GB; REGISTRY study of the European Huntington's Disease Network, Myers RH; HD-MAPS Study Group, MacDonald ME, Gusella JF; COHORT study of the HSG. CAG repeat expansion in Huntington disease determines age at onset in a fully dominant fashion. Neurology. 2012 Mar 6;78(10):690-5. doi: 10.1212/WNL.0b013e318249f683. Epub 2012 Feb 8.

name: on behalf of the PREDICT-HD study of the Huntington Study Group (HSG)

name: on behalf of the REGISTRY study of the European Huntington's Disease Network

name: on behalf of the COHORT study of the HSG

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Henley SM, Ridgway GR, Scahill RI, Klöppel S, Tabrizi SJ, Fox NC, Kassubek J; EHDN Imaging Working Group. Pitfalls in the use of voxel-based morphometry as a biomarker: examples from huntington disease. AJNR Am J Neuroradiol. 2010 Apr;31(4):711-9. doi: 10.3174/ajnr.A1939. Epub 2009 Dec 24.

publisher: American Society of Neuroradiology (ASNR)

publisher_dissemination: American Society of Neuroradiology (ASNR)

publisher_group: American Society of Neuroradiology (ASNR)

publisher_normalized: American Society of Neuroradiology (ASNR)

title: Pitfalls in the Use of Voxel-Based Morphometry as a Biomarker: Examples from Huntington Disease

ReferenceCitation: Aziz NA, Jurgens CK, Landwehrmeyer GB; EHDN Registry Study Group, van Roon-Mom WM, van Ommen GJ, Stijnen T, Roos RA. Normal and mutant HTT interact to affect clinical severity and progression in Huntington disease. Neurology. 2009 Oct 20;73(16):1280-5. doi: 10.1212/WNL.0b013e3181bd1121. Epub 2009 Sep 23. Erratum in: Neurology. 2009 Nov 10;73(19):1608. Neurology. 2011 Jan 11;76(2):202. Ciarmielo, Andrea [corrected to Ciarmiello, Andrea].

ReferenceCitation: McAllister B, Gusella JF, Landwehrmeyer GB, Lee JM, MacDonald ME, Orth M, Rosser AE, Williams NM, Holmans P, Jones L, Massey TH; REGISTRY Investigators of the European Huntington's Disease Network. Timing and Impact of Psychiatric, Cognitive, and Motor Abnormalities in Huntington Disease. Neurology. 2021 May 11;96(19):e2395-e2406. doi: 10.1212/WNL.0000000000011893. Epub 2021 Mar 25.

name: on behalf of the REGISTRY Investigators of the European Huntington's Disease Network

ReferenceCitation: Cubo E, Ramos-Arroyo MA, Martinez-Horta S, Martínez-Descalls A, Calvo S, Gil-Polo C; European HD Network. Clinical manifestations of intermediate allele carriers in Huntington disease. Neurology. 2016 Aug 9;87(6):571-8. doi: 10.1212/WNL.0000000000002944. Epub 2016 Jul 8.

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Finland
France
Czechia
Poland
Norway
Belgium
Russian Federation
Portugal
Denmark
Germany
United Kingdom

location_facility: Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)

location_facility: St George's Hospital Medical School, South West Thames Regional Genetics Unit

location_facility: University Hospital Zurich, Dept. of Neurology

location_facility: Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica

location_facility: Hospital Universitario Mutua de Terrassa, Neurologia - Investigación

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital

location_facility: The Walton Centre for Neurology and Neurosurgery

location_facility: Hôpital La Pitié Salpétrière, Génétique & Inserm U679

location_facility: Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie

location_facility: Hospital Geral de Santo António, Neurology Dept.

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.

location_facility: CHU d'Amiens - Hôpital Nord, Service de Neurologie

location_facility: Chapel Allerton Hospital, Yorkshire Regional Genetics Service

location_facility: Complejo Hospitalario Universitario de Albacete, Neurología

location_facility: Sheffield Children's Hospital, Dept. of Clinical Genetics

location_facility: CHU La Timone, Service de Neurologie (9e étage)

location_facility: Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.

location_facility: Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica

location_facility: Norrlands Universitet Sjukhus, Dept. of Neurology

location_facility: Ninewells Hospital and Medical School, Human Genetics Unit

location_facility: Helsinki University Hospital, Dept. of Neurology

location_facility: HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie

location_facility: Hôpital Purpan, INSERM U825, Pôle Neurosciences

location_facility: Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz

location_facility: Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover

location_facility: Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK

location_facility: Technische Universität München, Abteilung Neurologie

location_facility: Fakultní nemocnice Olomouc, Neurologická klinika

location_facility: Hospital Clínic i Provincial, Neurología

location_facility: Gloucestershire Royal Hospital, Neurology Dept.

location_facility: Scottish Huntington Association, Units 105/106

location_facility: Leicestershire Partnership NHS Trust, EMD South School, OSL house

location_facility: University Hospital of Ulm, Dept. of Neurology

location_facility: Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement

location_facility: Medical University of Silesia, Dept. of Neurology

location_facility: Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik

location_facility: Skåne Universitetssjukhus, Neurologiska kliniken

location_facility: Cambridge Centre for Brain Repair, Forvie Site

location_facility: Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS

location_facility: Hospital Virgen del Camino, Medical Genetics

location_facility: NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk

location_facility: University of Manchester, Genetic Medicine, St. Mary's Hospital

location_facility: Sahlgren University Hospital, Dept. of Clinical Genetics

location_facility: Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung

location_facility: Hospital Clínico de Madrid, Servicio de Neurología

location_facility: Institute of Human Genetics, International Centre for Life

location_facility: Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale

location_facility: Poznan University of Medical Sciences, Dept. of Social Medicine

location_facility: Hospital Virgen de la Arrixaca, Neurology

location_facility: Rikshospitalet, Dept. of Medical Genetics

location_facility: Ulleval University Hospital, Medical Genetics

location_facility: Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)

location_facility: CHU Rouen Charles Nicolle, Service de Neurologie

location_facility: Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia

location_facility: Leiden University Medical Centre (LUMC), Neurology K5-Q

location_facility: Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.

location_facility: University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology

location_facility: Universtität Erlangen, Abteilung für Molekulare Neurologie

location_facility: Cardiff University, Life Sciences Building

location_facility: Hospital Clinico Universario, Department of Neurology

location_facility: Poole Hospital Foundation Trust, Brain Injury Service

location_facility: Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas

location_facility: Hôpital Henri Mondor, Service de Neurologie

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia

location_facility: The Family Federation of Finland Väestöliitto, Department of Medical Genetics

location_facility: Institute of Pathology and Genetics (IPG)

location_facility: Hospital La Fe, Consultas Externas de Neurología

location_facility: University of Florence, Dip. di Scienze Neurologiche e Psichiatriche

location_facility: Oulu University Hospital (OUH), Dept. of Neurology

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie

location_facility: Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility

location_facility: Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases

location_facility: University of Bari, Dept. of Neurological and Psychiatric Sciences

location_facility: Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology

location_facility: Institute of Psychiatry and Neurology, First Dept. of Neurology

location_facility: CHU d'Angers, Service de Neurologie Charcot

location_facility: Universitätsklinikum Aachen, Neurologische Klinik

location_facility: Derriford Hospital, Dept. of Clinical Neuropsychology

location_facility: Ålands Hälso- och Sjukvård, Långvårdsenheten

location_facility: Bucknall Hospital, Neuropsychiatry Service

location_facility: Specialistic Hospital in Gdansk, Dept. of Neurology

location_facility: Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17

location_facility: The Barberry Centre, Dept. of Psychiatry

location_facility: Neurologische Klinik des Inselspitals, Praxis

location_facility: Turku University Hospital, Dept. of Neurology

location_facility: The Finnish Parkinson Association, Suvituuli

location_facility: Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie

location_facility: Churchill Hospital, Dept. of Clinical Genetics

location_facility: Hospital Fernando Fonseca, Neurology Dept.

location_facility: Clinical Genetics Centre, Ground Floor, Ashgrove House

location_facility: National Hospital for Neurology and Neurosurgery, Dept. for Neurology

location_facility: Università di Genova, Dept. of Neurosciences

location_facility: The Royal Hospital for Neuro-disability, Research and Development

location_facility: Medical University of Warsaw, Dept. of Neurology

location_facility: Medisch Spectrum Twente, Dept. of Neurology

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie

location_facility: Karolinska University Hospital - Huddinge Division, Neurology

location_facility: Hospital Donostia. Universidad del Pais Vasco, Neurociencias

location_facility: Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics

location_facility: Hospital Universitario Virgen del Rocío, Servicio de Neurología


title: Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Landwehrmeyer GB, Fitzer-Attas CJ, Giuliano JD, Gonçalves N, Anderson KE, Cardoso F, Ferreira JJ, Mestre TA, Stout JC, Sampaio C. Data Analytics from Enroll-HD, a Global Clinical Research Platform for Huntington's Disease. Mov Disord Clin Pract. 2016 Jun 22;4(2):212-224. doi: 10.1002/mdc3.12388. eCollection 2017 Mar-Apr.

name: Department of Neurology; University of Ulm; Ulm Germany

name: CHDI Management/CHDI Foundation; Princeton; New Jersey USA

full_name: Georg B. Landwehrmeyer

given: Georg B.

family: Fitzer-Attas

full_name: Cheryl J. Fitzer-Attas

given: Cheryl J.

family: Giuliano

full_name: Joseph D. Giuliano

given: Joseph D.

name: Faculty of Medicine; University of Lisbon; Lisbon Portugal

family: Gonçalves

full_name: Nilza Gonçalves

given: Nilza

name: MedStar Georgetown University Hospital & Georgetown University Medical Center-Huntington Disease Care, Education & Research Center; Washington DC USA

family: Anderson

full_name: Karen E. Anderson

given: Karen E.

name: Movement Disorders Clinic, Medical School; Universidade Federal de Minas Gerais; Belo Horizonte Brazil

family: Cardoso

full_name: Francisco Cardoso

given: Francisco

family: Ferreira

full_name: Joaquim J. Ferreira

given: Joaquim J.

name: Parkinson's disease and Movement Disorders Center; Division of Neurology; Department of Medicine; The Ottawa Hospital Research Institute; University of Ottawa; Ottawa Ontario Canada

family: Mestre

full_name: Tiago A. Mestre

given: Tiago A.

name: School of Psychological Sciences; Monash University; Melbourne Victoria Australia

family: Stout

full_name: Julie C. Stout

given: Julie C.

family: Sampaio

full_name: Cristina Sampaio

given: Cristina

journal_name: Movement Disorders Clinical Practice

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: CHDI Foundation, Inc.

location_country:
Italy
Austria
Chile
Switzerland
Netherlands
Spain
Germany
France
Poland
Portugal
Ireland
Argentina
Australia
Belgium
New Zealand
Denmark
United States
United Kingdom
Canada
Colombia

location_facility: University of Texas Health Science Center

location_facility: Booth Gardner Parkinson's Care Center (Evergreen Health)

location_facility: Hôpital Henri Mondor, Centre d'Investigation Clinique

location_facility: Università degli Studi di Genova (DINOGMI)

location_facility: Lille-Amiens - Huntington Disease Constituent site

location_facility: University of South Florida, HDSA Center of Excellence at USF

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta - Neurology

location_facility: Fundacion Clinic per a La Recerca Biomèdica

location_facility: Instituto de Neurociencias Buenos Aires (INEBA)

location_facility: New Zealand Brain Research Institute at University of Otago

location_facility: University of California - San Francisco

location_facility: Birmingham and Solihull Mental Health NHS Foundation Trust

location_facility: Northumberland, Tyne & Wear NHS Foundation Trust of St. Nicholas Hospital

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: Institute of Psychiatry and Neurology, Warsaw

location_facility: University of Tennessee Health Science Center

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Universidad de Antioquia, Grupo de Neurociencias

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta - Genetics

location_facility: Hospital de Santa Maria / Instituto de Medicina Molecular

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre-Service de Neurologie

location_facility: University of Alberta Hospital in Edmonton

location_facility: University of Maryland School of Medicine

location_facility: University of Calgary, Movement Disorders Program

location_facility: The Neurosciences Unit - North Metropolitan Hospital

location_facility: Virginia Commonwealth University Parkinson's and Movement Disorders Center

location_facility: Avon and Wiltshire Mental Health Partnership

location_facility: University of California - Irvine Medical Center

location_facility: CHU Angers, Centre de Référence Maladies Neurogénétiques

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Institut de Pathologie et de Génétique (IPG)

location_facility: Hôpital Purpan, Centre d'Investigation Clinique

location_facility: Guy's and St. Thomas's NHS Foundation Trust

location_facility: Bordeaux - Huntington Disease competencies center

location_facility: Rutgers, the State University of New Jersey

location_facility: University of Illinois College of Medicine at Rockford

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Copernicus Podmiotem Leczniczym sp. z o.o.

location_facility: North Staffordshire Combined Healthcare NHS Trust

location_facility: University of Melbourne, Royal Melbourne Hospital

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Emory University, Wesley Woods Health Center

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance

acronym: DEAP

summary: ING114916 is an open-label, multi-center, expanded access (EAP) study

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: ViiV Healthcare

location_country:
Italy
Austria
United States
Brazil
Germany
France
Poland
Belgium
Canada

intervention_type: Drug

status_simplified: Completed


title: A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma

summary: The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

ReferenceCitation: Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbé C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1). pii: e000391. doi: 10.1136/jitc-2019-000391. Erratum in: J Immunother Cancer. 2020 Jul;8(2):.

family: Ascierto

full_name: Paolo Antonio Ascierto

given: Paolo Antonio

family: Del Vecchio

full_name: Michelle Del Vecchio

given: Michelle

family: Mackiewicz

full_name: Andrzej Mackiewicz

given: Andrzej

family: Robert

full_name: Caroline Robert

given: Caroline

family: Chiarion-Sileni

full_name: Vanna Chiarion-Sileni

given: Vanna

family: Arance

full_name: Ana Arance

given: Ana

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

family: Svane

full_name: Inge Marie Svane

given: Inge Marie

family: McNeil

full_name: Catriona McNeil

given: Catriona

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Loquai

full_name: Carmen Loquai

given: Carmen

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: Hamid

full_name: Omid Hamid

given: Omid

family: Bastholt

full_name: Lars Bastholt

given: Lars

family: Dreno

full_name: Brigitte Dreno

given: Brigitte

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Garbe

full_name: Claus Garbe

given: Claus

family: Nyakas

full_name: Marta Nyakas

given: Marta

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Thomas

full_name: Luc Thomas

given: Luc

family: Liszkay

full_name: Gabriella Liszkay

given: Gabriella

family: Smylie

full_name: Michael Smylie

given: Michael

family: Hoeller

full_name: Christoph Hoeller

given: Christoph

ReferenceCitation: Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.

name: Clinical Pharmacology and Pharmacometrics Bristol‐Myers Squibb Princeton New Jersey USA

name: Metrum Research Group Tariffville Connecticut USA

journal_name: CPT: Pharmacometrics & Systems Pharmacology

title: Linking Tumor Growth Dynamics to Survival in Ipilimumab‐Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling

ReferenceCitation: Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbé C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.

location_country:
Australia
Belgium
Denmark
France
Poland
Norway
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain

location_facility: St. Luke's Cancer Center - Anderson Campus

location_facility: The Angeles Clinic And Research Institute


title: A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

summary: This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

ReferenceCitation: Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis

acronym: ENABLE

summary: The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

ReferenceType: background

ReferenceCitation: Macdonell R, Nagels G, Laplaud DA, Pozzilli C, de Jong B, Martins da Silva A, Nicholas R, Lechner-Scott J, Gaebler JA, Agarwal S, Wang P, Yeh M, Hovenden M, Soelberg Sørensen P. Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine. Mult Scler. 2016 Jun;22(7):944-54. doi: 10.1177/1352458515606809. Epub 2015 Oct 7.

lead_sponsor: Biogen

location_country:
Italy
Netherlands
France
Belgium
Australia
Portugal
Denmark
Germany
United Kingdom


title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib±onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.

family: Koeppen

full_name: Hartmut Koeppen

given: Hartmut

family: Yu

full_name: Wei Yu

given: Wei

family: Zha

full_name: Jiping Zha

given: Jiping

family: Pandita

full_name: Ajay Pandita

given: Ajay

family: Penuel

full_name: Elicia Penuel

given: Elicia

family: Rangell

full_name: Linda Rangell

given: Linda

family: Raja

full_name: Rajiv Raja

given: Rajiv

family: Mohan

full_name: Sankar Mohan

given: Sankar

family: Patel

full_name: Rajesh Patel

given: Rajesh

family: Desai

full_name: Rupal Desai

given: Rupal

family: Fu

full_name: Ling Fu

given: Ling

family: Do

full_name: An Do

given: An

family: Parab

full_name: Vaishali Parab

given: Vaishali

family: Xia

full_name: Xiaoling Xia

given: Xiaoling

family: Januario

full_name: Tom Januario

given: Tom

family: Louie

full_name: Sharianne G. Louie

given: Sharianne G.

family: Filvaroff

full_name: Ellen Filvaroff

given: Ellen

family: Shames

full_name: David S. Shames

given: David S.

family: Wistuba

full_name: Ignacio Wistuba

given: Ignacio

family: Lipkind

full_name: Marina Lipkind

given: Marina

family: Huang

full_name: Jenny Huang

given: Jenny

family: Lazarov

full_name: Mirella Lazarov

given: Mirella

family: Ramakrishnan

full_name: Vanitha Ramakrishnan

given: Vanitha

publisher: American Association for Cancer Research (AACR)

title: Biomarker Analyses from a Placebo-Controlled Phase II Study Evaluating Erlotinib ± Onartuzumab in Advanced Non–Small Cell Lung Cancer: MET Expression Levels Are Predictive of Patient Benefit

location_country:
Peru
Belgium
Australia
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Israel
Spain


title: A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)

acronym: PrefHER

summary: This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

primary_purpose: Health Services Research

ReferenceCitation: Pivot X, Verma S, Fallowfield L, Müller V, Lichinitser M, Jenkins V, Sánchez Muñoz A, Machackova Z, Osborne S, Gligorov J; PrefHer Study Group. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90. doi: 10.1016/j.ejca.2017.08.019. Epub 2017 Sep 28.

family: Pivot

full_name: X. Pivot

given: X.

family: Verma

full_name: S. Verma

given: S.

family: Fallowfield

full_name: L. Fallowfield

given: L.

family: Müller

full_name: V. Müller

given: V.

family: Lichinitser

full_name: M. Lichinitser

given: M.

family: Jenkins

full_name: V. Jenkins

family: Sánchez Muñoz

full_name: A. Sánchez Muñoz

given: A.

family: Machackova

full_name: Z. Machackova

given: Z.

family: Osborne

full_name: S. Osborne

family: Gligorov

full_name: J. Gligorov

given: J.

repository_institution: University of Sussex - Sussex Research Online

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gligorov J, Curigliano G, Müller V, Knoop A, Jenkins V, Verma S, Osborne S, Lauer S, Machackova Z, Fallowfield L, Pivot X. Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial. Breast. 2017 Aug;34:89-95. doi: 10.1016/j.breast.2017.05.004. Epub 2017 May 23.

full_name: Joseph Gligorov

given: Joseph

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

full_name: Volkmar Müller

given: Volkmar

family: Knoop

full_name: Ann Knoop

given: Ann

full_name: Valerie Jenkins

given: Valerie

full_name: Sunil Verma

given: Sunil

full_name: Stuart Osborne

given: Stuart

family: Lauer

full_name: Sabine Lauer

given: Sabine

full_name: Zuzana Machackova

given: Zuzana

ReferenceCitation: De Cock E, Pivot X, Hauser N, Verma S, Kritikou P, Millar D, Knoop A. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016 Mar;5(3):389-97. doi: 10.1002/cam4.573. Epub 2016 Jan 25.

name: United BioSource Corporation; Barcelona Spain

name: Department of Gynecology and Obstetrics; Kantonsspital Baden AG; Baden Switzerland

name: Sunnybrook Odette Cancer Centre; Toronto Ontario Canada

name: United BioSource Corporation; Hammersmith United Kingdom

name: F. Hoffmann-La Roche Ltd; Basel Switzerland

name: Copenhagen University Hospital; Copenhagen Denmark

ReferenceCitation: Pivot X, Gligorov J, Müller V, Curigliano G, Knoop A, Verma S, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014 Oct;25(10):1979-1987. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.

ReferenceCitation: Pivot X, Gligorov J, Müller V, Barrett-Lee P, Verma S, Knoop A, Curigliano G, Semiglazov V, López-Vivanco G, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962-70. doi: 10.1016/S1470-2045(13)70383-8. Epub 2013 Aug 19.

location_country:
Italy
Sweden
Switzerland
Germany
France
Poland
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

summary: This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

ReferenceCitation: Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

name: Department of Medicine (Division of Gastroenterology) and Farncombe Family Digestive Health Research Institute McMaster University  Hamilton Ontario Canada

family: Narula

full_name: Neeraj Narula

given: Neeraj

family: Aruljothy

full_name: Achuthan Aruljothy

given: Achuthan

family: Wong

full_name: Emily C. L. Wong

given: Emily C. L.

family: Homenauth

full_name: Ravi Homenauth

given: Ravi

name: Department of Gastroenterology Najran University  Najran Saudi Arabia

family: Alshahrani

full_name: Abdul‐Aziz Alshahrani

given: Abdul‐Aziz

family: Marshall

full_name: John K. Marshall

given: John K.

name: Department of Internal Medicine III Division of Gastroenterology and Hepatology Medical University of Vienna  Vienna Austria

family: Reinisch

full_name: Walter Reinisch

given: Walter

journal_name: United European Gastroenterology Journal

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum in: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

name: University of California San Diego, La Jolla, CA, USA

family: Sandborn

full_name: William J Sandborn

given: William J

name: Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada

family: Feagan

full_name: Brian G Feagan

given: Brian G

name: Humanitas Clinical Research Center-IRCCS and Humanitas University, Department of Biomedical Sciences, Milan, Italy

family: Danese

full_name: Silvio Danese

given: Silvio

family: O’Brien

full_name: Christopher D O’Brien

given: Christopher D

name: Janssen Scientific Affairs, LLC, Horsham, PA, USA

family: Ott

full_name: Elyssa Ott

given: Elyssa

family: Marano

full_name: Colleen Marano

given: Colleen

family: Baker

full_name: Thomas Baker

given: Thomas

family: Zhou

full_name: Yiying Zhou

given: Yiying

family: Volger

full_name: Sheri Volger

given: Sheri

family: Tikhonov

full_name: Ilia Tikhonov

given: Ilia

family: Gasink

full_name: Christopher Gasink

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

name: Institute of Translational Medicine and NIHR Biomedical Research Center, University of Birmingham, United Kingdom

ReferenceCitation: Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

title: Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn’s Disease

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: California Digital Library - eScholarship

title: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

ReferenceCitation: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

title: Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn’s Disease

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

ReferenceCitation: Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

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

name: Janssen Pharmaceutical K.K., Tokyo, Japan.

name: Janssen Research & Development, LLC, Spring House, PA, USA.

publisher: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.

location_country:
Australia
Belgium
Denmark
Czech Republic
Iceland
France
Japan
Poland
Canada
Korea, Republic of
South Africa
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Austria
Brazil
Serbia
Israel
New Zealand
Spain


title: A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)

summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

ReferenceCitation: Bossi P, Peris K, Calzavara-Pinton P, Queirolo P, Alfieri S, Palla M, Rossi MT, Spagnolo F, Tambone S, Astolfi C, Ascierto PA. Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study. Future Oncol. 2020 Jun;16(16):1091-1100. doi: 10.2217/fon-2019-0664. Epub 2020 May 6.

name: Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy

family: Bossi

full_name: Paolo Bossi

given: Paolo

name: Institute of Dermatology, Catholic University, Rome, Italy

name: Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy

family: Peris

full_name: Ketty Peris

given: Ketty

name: Dermatology Department, University of Brescia, ASST Spedali Civili, Brescia, Italy

family: Calzavara-Pinton

full_name: Piergiacomo Calzavara-Pinton

given: Piergiacomo

name: Melanoma, Sarcoma & Rare Tumors Division, European Institute of Oncology (IEO), Milan, Italy

family: Queirolo

full_name: Paola Queirolo

given: Paola

name: Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy

family: Alfieri

full_name: Salvatore Alfieri

given: Salvatore

name: Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale” Naples, Italy

family: Palla

full_name: Marco Palla

given: Marco

family: Rossi

full_name: Maria Teresa Rossi

given: Maria Teresa

name: IRCCS Policlinico San Martino, Genova, Italy

family: Spagnolo

full_name: Francesco Spagnolo

given: Francesco

family: Tambone

full_name: Sara Tambone

given: Sara

family: Astolfi

full_name: Cinzia Astolfi

given: Cinzia

family: Ascierto

full_name: Paolo A Ascierto

given: Paolo A

journal_name: Future Oncology

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Basset-Séguin N, Hauschild A, Kunstfeld R, Grob J, Dréno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Meyer N, Guillot B, Dummer R, Arenberger P, Fife K, Raimundo A, Dika E, Dimier N, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017 Nov;86:334-348. doi: 10.1016/j.ejca.2017.08.022. Epub 2017 Nov 5.

family: Basset-Séguin

full_name: N. Basset-Séguin

given: N.

family: Hauschild

full_name: A. Hauschild

given: A.

family: Kunstfeld

full_name: R. Kunstfeld

given: R.

family: Grob

full_name: J. Grob

given: J.

family: Dréno

full_name: B. Dréno

given: B.

family: Mortier

full_name: L. Mortier

given: L.

full_name: P.A. Ascierto

family: Licitra

full_name: L. Licitra

family: Dutriaux

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

ReferenceCitation: Basset-Seguin N, Hauschild A, Grob JJ, Kunstfeld R, Dréno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Jouary T, Meyer N, Guillot B, Dummer R, Fife K, Ernst DS, Williams S, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015 Jun;16(6):729-36. doi: 10.1016/S1470-2045(15)70198-1. Epub 2015 May 13.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Croatia
France
Lithuania
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Colombia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: LKH Salzburg; Universitätsklinik für Dermatologie

location_facility: Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia

location_facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

location_facility: Clinica Universitaria de Navarra; Servicio de Dermatologia

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

location_facility: Azienda Ospedaliera Umberto I; Clinica Dermatologica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Clinic i Provincial; Servicio de dermatología

location_facility: Fondazione Ptv Policlinico Tor Vergata; Dermatologia

location_facility: Gazi Universitesi Tip Facultesi; Dept. of Dermatology

location_facility: Fakultní nemocnice Ostrava; Kožní oddělení

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Hospital Universitario del Sureste; Servicio de Dermatologia

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Hôpital Larrey Université Paul Sabatier; Service Dermatologie

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: CMAX A division of IDT Australia Limited

location_facility: Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

location_facility: University General Hospital of loannina; Dermatology and Venereal Diseases Clinic

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Klinikum d.Stadt Ludwigshafen Hautklinik

location_facility: Universitätsspital Zürich; Dermatologische Klinik

location_facility: Dokuz Eylul University Medicine Faculty; Dermatology

location_facility: Elbekliniken Buxtehude; Klinik für Dermatologie

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Hospital Univ. Central de Asturias; Servicio de Dermatologia

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Skånes Onkologiska Klinik, Universitetssjukhuset

location_facility: Cork University Hospital; Dermatology Dept

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

location_facility: National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Ankara Numune Training and Research Hospital; Dermatology

location_facility: Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: District Oncology Dispensary; Department for Oncology and Dermatology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: S.C. Life Search S.R.L; Medical Oncology Clinic

location_facility: Maastricht University Medical Centre; Dermatologie

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

location_facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

location_facility: I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Dermatologia

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Universitätsklinikum Marburg Klinik f. Dermatologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department

location_facility: LKH Graz; Abteilung für allgemeine Dermatologie

location_facility: Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica

location_facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

location_facility: Waitemata District Health; General Surgery

location_facility: Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Laiko General Hospital; 1St Pathological Clinic

location_facility: Università di Brescia; Dipartimento di Dermatologia

location_facility: Policlinico Sant'Orsola Malpighi; U.O. Dermatologia

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)

location_facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte

location_facility: Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

location_facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Helsinki University Central Hospital; Skin & Allergy Hospital

location_facility: Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Fundacion Hospital de Alcorcon; Servicio de Dermatologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

location_facility: Hospital Reina Sofia; Servicio de dermatología

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

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

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Inst. Nacional de Cancerologia; Clinica de Seno

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

location_facility: IRCCS Istituto Clinico Humanitas; Farmacia

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia


ReferenceCitation: Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

family: Thiery-Vuillemin

full_name: A. Thiery-Vuillemin

family: Fizazi

full_name: K. Fizazi

given: K.

family: Sartor

full_name: O. Sartor

given: O.

family: Oudard

full_name: S. Oudard

given: S.

family: Bury

full_name: D. Bury

given: D.

family: Thangavelu

full_name: K. Thangavelu

family: Ozatilgan

full_name: A. Ozatilgan

family: Poole

full_name: E.M. Poole

family: Eisenberger

full_name: M. Eisenberger

given: M.

family: de Bono

full_name: J. de Bono

currency_apc_doaj: EUR

journal_name: ESMO Open

oa_colors: green gold

evidence: oa journal (via doaj)

ReferenceCitation: Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Macé S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

apc_source: openAPC

family: Mehra

full_name: Niven Mehra

given: Niven

family: Dolling

full_name: David Dolling

given: David

family: Sumanasuriya

full_name: Semini Sumanasuriya

given: Semini

family: Christova

full_name: Rossitza Christova

given: Rossitza

family: Pope

full_name: Lorna Pope

given: Lorna

family: Carreira

full_name: Suzanne Carreira

given: Suzanne

family: Seed

full_name: George Seed

given: George

family: Yuan

full_name: Wei Yuan

given: Wei

family: Goodall

full_name: Jane Goodall

given: Jane

ReferenceCitation: Eisenberger M, Hardy-Bessard AC, Kim CS, Géczi L, Ford D, Mourey L, Carles J, Parente P, Font A, Kacso G, Chadjaa M, Zhang W, Bernard J, de Bono J. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Epub 2017 Aug 15.

name: Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie–Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l’Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National...

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer—PROSELICA

ReferenceCitation: Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91.

location_country:
Peru
Romania
Belgium
Australia
Russian Federation
Taiwan
France
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Hungary
Germany
United States
United Kingdom
Brazil
Tunisia
Spain
Turkey

location_facility:
Investigational Site Number 826007
Investigational Site Number 250005
Investigational Site Number 840016
Investigational Site Number 642004
Investigational Site Number 616002
Investigational Site Number 036010
Investigational Site Number 056008
Investigational Site Number 710002
Investigational Site Number 036013
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Investigational Site Number 348006
Investigational Site Number 604004
Investigational Site Number 788002
Investigational Site Number 056011
Investigational Site Number 642012
Investigational Site Number 036008
Investigational Site Number 643010
Investigational Site Number 604002
Investigational Site Number 724001
Investigational Site Number 276006
Investigational Site Number 840011
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Investigational Site Number 076003
Investigational Site Number 840008
Investigational Site Number 056002
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Investigational Site Number 410001
Investigational Site Number 250010
Investigational Site Number 710004
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Investigational Site Number 642002
Investigational Site Number 124003
Investigational Site Number 036002
Investigational Site Number 076013
Investigational Site Number 056001
Investigational Site Number 724007
Investigational Site Number 840007
Investigational Site Number 276003
Investigational Site Number 032004
Investigational Site Number 036016
Investigational Site Number 724002
Investigational Site Number 152002
Investigational Site Number 642006
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 528005
Investigational Site Number 250009
Investigational Site Number 250001
Investigational Site Number 616004
Investigational Site Number 826005
Investigational Site Number 840020
Investigational Site Number 643007
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title: Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

summary:
Primary Objective:

- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².

To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;
PSA Progression;
Pain progression;
Tumor response in participants with measurable disease (RECIST 1.1);
PSA response;
Pain response in participants with stable pain at baseline.
To compare Health-related Quality of Life (HRQoL).
To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.


title: A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

ReferenceCitation: Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

ReferenceCitation: Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

ReferenceCitation: Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril JG, Domingo P, Brennan C, Almond S, Min S; extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013 Nov;13(11):927-35. doi: 10.1016/S1473-3099(13)70257-3. Epub 2013 Sep 25.

family: Raffi

full_name: François Raffi

given: François

family: Jaeger

full_name: Hans Jaeger

given: Hans

family: Quiros-Roldan

full_name: Eugenia Quiros-Roldan

given: Eugenia

family: Albrecht

full_name: Helmut Albrecht

given: Helmut

family: Belonosova

full_name: Elena Belonosova

given: Elena

family: Gatell

full_name: Jose M Gatell

given: Jose M

family: Baril

full_name: Jean-Guy Baril

given: Jean-Guy

family: Domingo

full_name: Pere Domingo

given: Pere

family: Brennan

full_name: Clare Brennan

given: Clare

family: Almond

full_name: Steve Almond

given: Steve

family: Min

full_name: Sherene Min

given: Sherene

journal_name: The Lancet Infectious Diseases

location_country:
Italy
United States
Germany
France
Australia
Russian Federation
Spain
Canada
United Kingdom

intervention_type: Other


title: A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer

summary: This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Finland
Australia
Belgium
Czech Republic
Taiwan
France
Poland
Canada
South Africa
Sweden
Netherlands
Singapore
China
Germany
United Kingdom
Italy
Austria
Israel
New Zealand
Spain


title: A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY

summary: The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

ReferenceCitation: Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M. Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol. 2015 Dec;26(12):2457-63. doi: 10.1093/annonc/mdv388. Epub 2015 Sep 18.

family: Kang

full_name: Y.-K. Kang

family: Yau

full_name: T. Yau

given: T.

family: Park

full_name: J.-W. Park

family: Lim

full_name: H.Y. Lim

family: Lee

full_name: T.-Y. Lee

family: Obi

full_name: S. Obi

given: S.

family: Chan

full_name: S.L. Chan

family: Qin

full_name: S.K. Qin

family: Kim

full_name: R.D. Kim

family: Casey

full_name: M. Casey

given: M.

family: Chen

full_name: C. Chen

given: C.

family: Bhattacharyya

full_name: H. Bhattacharyya

given: H.

family: Williams

full_name: J.A. Williams

family: Valota

full_name: O. Valota

given: O.

family: Chakrabarti

full_name: D. Chakrabarti

given: D.

family: Kudo

full_name: M. Kudo

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
United States
Hong Kong
France
Japan
Slovakia
Hungary
Belgium
China
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Hospital of the University of Pennsylvania

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

location_facility: Bichat-Beaujon Service Inter Hospitalier De Cancerologie

location_facility: Unita Operativa Oncologia Medica IRCCS Fondazione Salvatore Maugeri

location_facility: Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. E A. Seragnoli"

location_facility: Alta Bates Summit Comprehensive Cancer Center

location_facility: Klinikum der Ludwig-Maximilians-Universitaet , Campus Grosshadern

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Florida Hospital Transplant Center, Liver Unit

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

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria aile Scotte

location_facility: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori IRST

location_facility: Semmelweis Egyetem I.sz. Belgyógyászati Klinika

location_facility: Moffitt Cancer Center & Research Institute

location_facility: National Cancer Center/ Center for Liver Cancer

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: Royal Liverpool and Broadgreen University Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Aichi Cancer Center Central Hospital, Diagnostic and Interventional Radiology

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University

location_facility: Istituto di Ematologia ed Oncologia Medica, Lorenzo ed Ariosto Seragnoli,

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: CHRU Montpellier-Hopital Saint Eloi - Departement Oncologie Medicale

location_facility: University of California Irvine Medical Center

location_facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Chang Gung Medical Foundation Linkou Branch


ReferenceCitation: Czuczman MS, Trněný M, Davies A, Rule S, Linton KM, Wagner-Johnston N, Gascoyne RD, Slack GW, Brousset P, Eberhard DA, Hernandez-Ilizaliturri FJ, Salles G, Witzig TE, Zinzani PL, Wright GW, Staudt LM, Yang Y, Williams PM, Lih CJ, Russo J, Thakurta A, Hagner P, Fustier P, Song D, Lewis ID. A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Cancer Res. 2017 Aug 1;23(15):4127-4137. doi: 10.1158/1078-0432.CCR-16-2818. Epub 2017 Apr 5.

family: Czuczman

full_name: Myron S. Czuczman

given: Myron S.

family: Trněný

full_name: Marek Trněný

given: Marek

family: Davies

full_name: Andrew Davies

given: Andrew

family: Rule

full_name: Simon Rule

given: Simon

family: Linton

full_name: Kim M. Linton

given: Kim M.

family: Wagner-Johnston

full_name: Nina Wagner-Johnston

given: Nina

family: Gascoyne

full_name: Randy D. Gascoyne

given: Randy D.

family: Slack

full_name: Graham W. Slack

given: Graham W.

family: Brousset

full_name: Pierre Brousset

given: Pierre

family: Eberhard

full_name: David A. Eberhard

given: David A.

family: Hernandez-Ilizaliturri

full_name: Francisco J. Hernandez-Ilizaliturri

given: Francisco J.

family: Salles

full_name: Gilles Salles

given: Gilles

family: Witzig

full_name: Thomas E. Witzig

given: Thomas E.

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Wright

full_name: George W. Wright

given: George W.

family: Staudt

full_name: Louis M. Staudt

given: Louis M.

family: Yang

full_name: Yandan Yang

given: Yandan

full_name: P. Mickey Williams

given: P. Mickey

family: Lih

full_name: Chih-Jian Lih

given: Chih-Jian

family: Russo

full_name: Jacqueline Russo

given: Jacqueline

family: Thakurta

full_name: Anjan Thakurta

given: Anjan

family: Hagner

full_name: Patrick Hagner

given: Patrick

family: Fustier

full_name: Pierre Fustier

family: Song

full_name: Dale Song

given: Dale

family: Lewis

full_name: Ian D. Lewis

given: Ian D.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, Pileri SA, Malik F, Macon WR, Goy A, Witzig TE, Czuczman MS. Higher response to lenalidomide in relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in germinal center B-cell-like phenotype. Cancer. 2011 Nov 15;117(22):5058-66. doi: 10.1002/cncr.26135. Epub 2011 Apr 14.

location_country:
Italy
Austria
Sweden
France
Czechia
Australia
Spain
United States
United Kingdom

location_facility: Universita Federico II di Napoli Nuovo Policlinico

location_facility: The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team

location_facility: CHU de Grenoble-Hopital Albert Michallon

location_facility: Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri

location_facility: Southhampton University Hospital NHS Trust

location_facility: Hosptial Clinico Universitario de Salamanca

location_facility: Providence St Joseph Medical Center/Cancer Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Michigan, Comprehensive Cancer Center

location_facility: Royal Devon and Exeter Hospital Haematology Department

location_facility: Royal Mardsen Hospital - Fulham (Satellite Site)

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: Policlinico Tor Vergata (Universta Tor Vergata)

location_facility: Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico

location_facility: Washington University Siteman Cancer Center

title: A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

summary: The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.


ReferenceCitation: Regueiro M, Feagan BG, Zou B, Johanns J, Blank MA, Chevrier M, Plevy S, Popp J, Cornillie FJ, Lukas M, Danese S, Gionchetti P, Hanauer SB, Reinisch W, Sandborn WJ, Sorrentino D, Rutgeerts P; PREVENT Study Group. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection. Gastroenterology. 2016 Jun;150(7):1568-1578. doi: 10.1053/j.gastro.2016.02.072. Epub 2016 Mar 3.

family: Regueiro

full_name: Miguel Regueiro

given: Miguel

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

family: Zou

full_name: Bin Zou

given: Bin

family: Johanns

full_name: Jewel Johanns

given: Jewel

family: Blank

full_name: Marion A. Blank

given: Marion A.

family: Chevrier

full_name: Marc Chevrier

given: Marc

family: Plevy

full_name: Scott Plevy

given: Scott

family: Popp

full_name: John Popp

given: John

family: Cornillie

full_name: Freddy J. Cornillie

given: Freddy J.

family: Lukas

full_name: Milan Lukas

given: Milan

family: Danese

full_name: Silvio Danese

given: Silvio

family: Gionchetti

full_name: Paolo Gionchetti

given: Paolo

family: Hanauer

full_name: Stephen B. Hanauer

given: Stephen B.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Sorrentino

full_name: Dario Sorrentino

given: Dario

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Debinski

full_name: H. Debinski

given: H.

family: Florin

full_name: T. Florin

given: T.

family: Hetzel

full_name: D. Hetzel

given: D.

family: Lawrance

full_name: I. Lawrance

given: I.

family: Radford-Smith

full_name: G. Radford-Smith

given: G.

family: Sloss

full_name: A. Sloss

given: A.

full_name: D. Sorrentino

family: Gassner

full_name: S. Gassner

given: S.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: University of Liège - Open Repository and Bibliography

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

title: Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection

location_country:
Austria
United States
United Kingdom
Netherlands
Germany
France
Poland
Israel
Hungary
Australia
Belgium
New Zealand
Canada
Czech Republic

title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence

summary: REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.