title: A Study to Assess the Safety, Tolerability and Preliminary Efficacy of GSK2251052 in the Treatment of Complicated Intra-abdominal Infection in Adults

summary: This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cIAI.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
France
Czechia
Russian Federation
Spain
United States
Canada


type: EudraCT Number

title: A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

summary:
Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.

Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.

This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

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: result

ReferenceCitation: Jagasia M, Scheid C, Socié G, Ayuk FA, Tischer J, Donato ML, Bátai Á, Chen H, Chen SC, Chin T, Boodée H, Mitri G, Greinix HT. Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv. 2019 Jul 23;3(14):2218-2229. doi: 10.1182/bloodadvances.2019000145.

name: Vanderbilt-Ingram Cancer Center, Nashville, TN;

family: Jagasia

full_name: Madan Jagasia

given: Madan

sequence: first

name: Stem Cell Transplantation Clinic I for Internal Medicine, University of Cologne, Köln, Germany;

family: Scheid

full_name: Christof Scheid

given: Christof

sequence: additional

name: APHP Hospital St. Louis, University Paris 7, Paris, France;

family: Socié

full_name: Gérard Socié

given: Gérard

name: Department of Stem Cell Transplantation, Universitäetsklinikum Hamburg-Eppendorf, Hamburg, Germany;

family: Ayuk

full_name: Francis Ayuketang Ayuk

given: Francis Ayuketang

name: Department of Internal Medicine III, University Hospital of Munich, Ludwig Maximilian University, Munich, Germany;

family: Tischer

full_name: Johanna Tischer

given: Johanna

name: John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ;

family: Donato

full_name: Michele L. Donato

given: Michele L.

name: Unified St. Istvan and St. Laszio Hospital, Budapest, Hungary;

family: Bátai

full_name: Árpád Bátai

given: Árpád

name: Vanderbilt University Medical Center, Nashville, TN;

family: Chen

full_name: Heidi Chen

given: Heidi

full_name: Sheau-Chiann Chen

given: Sheau-Chiann

name: Mallinckrodt Pharmaceuticals, Bedminster, NJ; and

family: Chin

full_name: Thomas Chin

given: Thomas

family: Boodée

full_name: Henri Boodée

given: Henri

family: Mitri

full_name: Ghaith Mitri

given: Ghaith

name: Division of Haematology, Medical University of Graz, Graz, Austria

family: Greinix

full_name: Hildegard T. Greinix

given: Hildegard T.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood Advances

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via observed oa rate)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ipd_sharing: No

lead_sponsor: Mallinckrodt

location_country:
Italy
Austria
Germany
France
Hungary
Spain
United States
United Kingdom

location_facility: Medical City Dallas Hospital,Transplant center

location_facility: Methodist healthcare system of san Antonio

location_facility: General Hospital of Vienna (Medical University of Vienna)

location_facility: Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,

location_facility: Universita de Genova - Ospedale S. Martino

location_facility: Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,

location_facility: Indiana Blood and Marrow Transplantation Research

location_facility: University of Birmingham: Queen Elizabeth Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Hoffmann-La Roche

primary_purpose: Prevention

location_country:
Brazil
Sweden
Mexico
Germany
France
Australia
Spain
United States
United Kingdom

location_facility: Uni of Utah Health Science Center; Pediatric Nephrology

location_facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Hospital Universitario La Paz: Nefrologia Pediatrica

location_facility: UCLA Center For Health Sciences; Division of Pediatric Nephrology

location_facility: KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover

location_facility: Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken

location_facility: Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln

location_facility: Children'S Hospital At Westmead; Department of Nephrology

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Royal Hospital For Sick Children; Dept. of Child Health

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: University of Florida Pediatric Nephrology

location_facility: Hop Necker Enfants Malades;Nephrologie Pediatrique

location_facility: Royal Children'S Hospital; Department of Nephrology

location_facility: Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg

source: euctr

title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

summary: This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.


type: Other Identifier

title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

summary: This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

ReferenceType: derived

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

name: Biometrics Genentech Inc. South San Francisco CA USA

family: He

full_name: Xian He

given: Xian

family: Zhang

full_name: Wei Zhang

given: Wei

name: Clinical Pharmacology Genentech‐Roche Marseille France

family: Bruno

full_name: René Bruno

given: René

currency_apc_doaj: USD

journal_name: Pharmacology Research & Perspectives

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

ReferenceCitation: Chiang AC, Sequist LVD, Gilbert J, Conkling P, Thompson D, Marcoux JP, Gettinger S, Kowanetz M, Molinero L, O'Hear C, Fassò M, Lam S, Gordon MS. Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Clin Lung Cancer. 2020 Sep;21(5):455-463.e4. doi: 10.1016/j.cllc.2020.05.008. Epub 2020 May 12.

family: Chiang

full_name: Anne C. Chiang

given: Anne C.

family: Sequist

full_name: Lecia Van Dam Sequist

given: Lecia Van Dam

family: Gilbert

full_name: Jill Gilbert

given: Jill

family: Conkling

full_name: Paul Conkling

given: Paul

family: Thompson

full_name: Dana Thompson

given: Dana

family: Marcoux

full_name: J. Paul Marcoux

given: J. Paul

ReferenceCitation: Molinero L, Li Y, Chang CW, Maund S, Berg M, Harrison J, Fassò M, O'Hear C, Hegde P, Emens LA. Tumor immune microenvironment and genomic evolution in a patient with metastatic triple negative breast cancer and a complete response to atezolizumab. J Immunother Cancer. 2019 Oct 23;7(1):274. doi: 10.1186/s40425-019-0740-8.

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Hamid O, Molinero L, Bolen CR, Sosman JA, Muñoz-Couselo E, Kluger HM, McDermott DF, Powderly JD, Sarkar I, Ballinger M, Fassò M, O'Hear C, Chen DS, Hegde PS, Hodi FS. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clin Cancer Res. 2019 Oct 15;25(20):6061-6072. doi: 10.1158/1078-0432.CCR-18-3488. Epub 2019 Jul 29.

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

ReferenceCitation: Liu JF, Gordon M, Veneris J, Braiteh F, Balmanoukian A, Eder JP, Oaknin A, Hamilton E, Wang Y, Sarkar I, Molinero L, Fassò M, O'Hear C, Lin YG, Emens LA. Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers. Gynecol Oncol. 2019 Aug;154(2):314-322. doi: 10.1016/j.ygyno.2019.05.021. Epub 2019 Jun 14.

ReferenceCitation: Emens LA, Cruz C, Eder JP, Braiteh F, Chung C, Tolaney SM, Kuter I, Nanda R, Cassier PA, Delord JP, Gordon MS, ElGabry E, Chang CW, Sarkar I, Grossman W, O'Hear C, Fassò M, Molinero L, Schmid P. Long-term Clinical Outcomes and Biomarker Analyses of Atezolizumab Therapy for Patients With Metastatic Triple-Negative Breast Cancer: A Phase 1 Study. JAMA Oncol. 2019 Jan 1;5(1):74-82. doi: 10.1001/jamaoncol.2018.4224.

name: Bloomberg-Kimmel Institute for Cancer Immunotherapy, Department of Oncology, Johns Hopkins University, Baltimore, Maryland

name: now with Department of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh

name: Medical Oncology Department, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain

name: Department of Medicine (Oncology), Yale Cancer Center, New Haven, Connecticut

name: Comprehensive Cancer Centers of Nevada, University of Nevada Las Vegas School of Medicine, Las Vegas

name: The Angeles Clinic and Research Institute, Los Angeles, California

name: Department of Medicine,Dana-Farber Cancer Institute, Boston, Massachusetts

name: Department of Medicine, Hematology/Oncology, Massachusetts General Hospital, Boston

name: Section of Hematology/Oncology, University of Chicago, Chicago, Illinois

name: Department of Medical Oncology, Centre Léon-Bérard, Lyon, France

name: Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France

name: HonorHealth Research Institute, Scottsdale, Arizona

name: Ventana Medical Systems, Inc, Tucson, Arizona

name: Genentech, Inc, South San Francisco, California

name: now with Bellicum Pharmaceuticals, Inc, South San Francisco, California

name: Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, England

ReferenceCitation: Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fassò M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411.

ReferenceCitation: Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fassò M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. Eur J Cancer. 2018 Sep;101:201-209. doi: 10.1016/j.ejca.2018.06.031. Epub 2018 Aug 1.

ReferenceCitation: Lukas RV, Rodon J, Becker K, Wong ET, Shih K, Touat M, Fassò M, Osborne S, Molinero L, O'Hear C, Grossman W, Baehring J. Clinical activity and safety of atezolizumab in patients with recurrent glioblastoma. J Neurooncol. 2018 Nov;140(2):317-328. doi: 10.1007/s11060-018-2955-9. Epub 2018 Aug 2.

ReferenceCitation: Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O'Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncol. 2018 Apr 1;4(4):537-544. doi: 10.1001/jamaoncol.2017.5440.

name: Yale Cancer Center, New Haven, Connecticut

name: Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, United Kingdom

name: Bladder Cancer Center, Dana-Farber/Brigham and Women’s Cancer Center, Harvard Medical School, Boston, Massachusetts

name: University of Nevada School of Medicine, Las Vegas

name: US Oncology Research, Comprehensive Cancer Centers of Nevada, Las Vegas

name: Gustave Roussy Cancer Campus, University of Paris-Saclay, Villejuif, France

name: Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain

name: Oncology, Sarah Cannon Research Institute, Nashville, Tennessee

ReferenceCitation: McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fassò M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol. 2016 Mar 10;34(8):833-42. doi: 10.1200/JCO.2015.63.7421. Epub 2016 Jan 11.

name: David F. McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Jeffrey A. Sosman, Vanderbilt University School of Medicine; Jeffrey R. Infante, Sarah Cannon Research Institute, Nashville, TN; Mario Sznol, Yale Cancer Center, New Haven, CT; Christophe Massard, Gustave Roussy, Villejuif Cedex, France; Michael S. Gordon, Pinnacle Oncology Hematology, Scottsdale, AZ; Omid Hamid, Angeles Clinic and Research Institute, Santa Monica; Marcella Fassò, Yan V. Wang, Wei Zou, Priti S. Hedge, and Gregg D. Fine...

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Atezolizumab, an Anti–Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study

ReferenceCitation: Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

location_country:
United States
United Kingdom
France
Spain

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Stanford Univ Medical Center; Dept Central Pharmacy

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Carolina BioOncology Institute; Can Therapy & Res Ctr


title: An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies

summary: This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Pfizer

location_country:
Italy
United States
Brazil
Netherlands
Germany
France
Norway
Belgium
Australia
Spain
Canada
Czech Republic


title: A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

summary: The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

ReferenceCitation: Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.

name: Brigham and Women's Hospital; Boston Massachusetts

family: Weinblatt

full_name: Michael E. Weinblatt

given: Michael E.

name: Swedish Medical Center and University of Washington; Seattle

family: Mease

full_name: Philip Mease

given: Philip

name: Organización Medica de Investigación; Buenos Aires Argentina

family: Mysler

full_name: Eduardo Mysler

given: Eduardo

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

name: Csolnoky Ferenc Hospital; Veszprém Hungary

family: Drescher

full_name: Edit Drescher

given: Edit

name: Universidad Nacional de Tucuman and Centro Médico Privado de Reumatología; Tucuman Argentina

family: Berman

full_name: Alberto Berman

given: Alberto

name: Bristol-Myers Squibb; Princeton New Jersey

family: Xing

full_name: Jun Xing

given: Jun

family: Zilberstein

full_name: Moshe Zilberstein

given: Moshe

family: Banerjee

full_name: Subhashis Banerjee

given: Subhashis

name: NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital, and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Leeds UK

family: Emery

full_name: Paul Emery

journal_name: Arthritis & Rheumatology

oa_host_type: publisher

evidence: open (via free article)

title: The Efficacy and Safety of Subcutaneous Clazakizumab in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results From a Multinational, Phase IIb, Randomized, Double-Blind, Placebo/Active-Controlled, Dose-Ra

lead_sponsor: CSL Behring

location_country:
Italy
United States
Brazil
South Africa
Mexico
Netherlands
Germany
France
Czechia
Japan
Poland
Hungary
Belgium
Argentina
Russian Federation
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Centre De Recherche Musculo-Squelettique

location_facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc


title: A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

acronym: SAKURA

summary: The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

lead_sponsor: Santen Inc.

location_country:
Italy
Austria
Chile
Brazil
India
Peru
Germany
France
Japan
Poland
Israel
Argentina
Spain
Turkey
United States
United Kingdom
Colombia


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

acronym: MEASURE 1

summary: This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

ReferenceCitation: van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

family: van der Horst-Bruinsma

full_name: Irene van der Horst-Bruinsma

given: Irene

family: Miceli-Richard

full_name: Corinne Miceli-Richard

given: Corinne

family: Braun

full_name: Juergen Braun

given: Juergen

family: Marzo-Ortega

full_name: Helena Marzo-Ortega

given: Helena

family: Pavelka

full_name: Karel Pavelka

given: Karel

family: Kivitz

full_name: Alan J. Kivitz

given: Alan J.

family: Deodhar

full_name: Atul Deodhar

given: Atul

family: Bao

full_name: Weibin Bao

given: Weibin

family: Porter

full_name: Brian Porter

given: Brian

family: Pournara

full_name: Effie Pournara

given: Effie

journal_name: Rheumatology and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Østergaard M, Gupta AD, Mpofu S, Fox T, Winseck A, Porter B, Shete A, Gensler LS. Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies. J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15.

family: Schett

full_name: Georg Schett

given: Georg

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

family: Østergaard

full_name: Mikkel Østergaard

given: Mikkel

family: Gupta

full_name: Ayan Das Gupta

given: Ayan Das

family: Mpofu

full_name: Shephard Mpofu

given: Shephard

family: Fox

full_name: Todd Fox

given: Todd

family: Winseck

full_name: Adam Winseck

given: Adam

ReferenceCitation: Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Himmler S, Branner JC, Ostwald DA. The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab. J Comp Eff Res. 2021 Feb;10(2):143-155. doi: 10.2217/cer-2020-0077. Epub 2020 Nov 30.

name: WifOR Institute, Darmstadt 64283, Germany

name: School of International Business & Entrepreneurship (SIBE) Steinbeis University, Herrenberg 71083, Germany

journal_name: Journal of Comparative Effectiveness Research

ReferenceCitation: Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J Jr, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.

name: Oregon Health & Science University Portland

name: Paris Descartes University, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris, and European League Against Rheumatism Center of Excellence Paris France

name: Leeds Teaching Hospitals NHS Trust and University of Leeds Leeds UK

name: Hospital Universitario Marqués de Valdecilla Santander Spain

name: Novartis Healthcare Private Limited Hyderabad India

name: Novartis Pharmaceuticals Corporation East Hanover New Jersey

name: Oregon Health & Science University and Legacy Devers Eye Institute Portland

title: Incidence of Uveitis in Secukinumab‐treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies

ReferenceCitation: Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.

ReferenceCitation: Braun J, Deodhar A, Landewé R, Baraliakos X, Miceli-Richard C, Sieper J, Quebe-Fehling E, Martin R, Porter B, Gandhi KK, van der Heijde D; MEASURE 1 and MEASURE 2 study groups. Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies. RMD Open. 2018 Nov 21;4(2):e000749. doi: 10.1136/rmdopen-2018-000749. eCollection 2018.

name: on behalf of the MEASURE 1 and MEASURE 2 study groups

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

ReferenceCitation: Wei JC, Baeten D, Sieper J, Deodhar A, Bhosekar V, Martin R, Porter B. Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies. Int J Rheum Dis. 2017 May;20(5):589-596. doi: 10.1111/1756-185X.13094. Epub 2017 May 25. Erratum in: Int J Rheum Dis. 2017 Jul;20(7):911.

name: Division of Allergy, Immunology and Rheumatology; Chung Shan Medical University Hospital; Institute of Medicine; Chung Shan Medical University; Graduate Institute of Integrated Medicine; China Medical University; Taichung Taiwan

name: Academic Medical Centre; Amsterdam The Netherlands

name: Charité University Medicine Berlin; Berlin Germany

name: Oregon Health & Science University; Portland Oregon USA

name: Novartis Healthcare Pvt. Ltd.; Hyderabad India

name: Novartis Pharmaceuticals Corporation; East Hanover New Hampshire USA

journal_name: International Journal of Rheumatic Diseases

ReferenceCitation: Braun J, Baraliakos X, Deodhar A, Baeten D, Sieper J, Emery P, Readie A, Martin R, Mpofu S, Richards HB; MEASURE 1 study group. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077. doi: 10.1136/annrheumdis-2016-209730. Epub 2016 Dec 13.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Deodhar AA, Dougados M, Baeten DL, Cheng-Chung Wei J, Geusens P, Readie A, Richards HB, Martin R, Porter B. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1). Arthritis Rheumatol. 2016 Dec;68(12):2901-2910. doi: 10.1002/art.39805.

name: Hôpital Cochin, Paris Descartes University; Paris France

name: University of Amsterdam; Amsterdam The Netherlands

name: Chung Shan Medical University; Taichung Taiwan

name: Maastricht University Hospital; Maastricht The Netherlands

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey

ReferenceCitation: Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.

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

repository_institution: Ghent University - Ghent University Academic Bibliography

location_country:
Italy
United States
Peru
Mexico
Netherlands
Germany
France
Bulgaria
Belgium
Russian Federation
Turkey
Canada
United Kingdom
Taiwan


title: An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

summary: The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Greece
Romania
Russian Federation
Denmark
France
Slovakia
Norway
Canada
South Africa
Saudi Arabia
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Latvia

location_facility: Saint-Petersburg State Pediatric Medical Academy

location_facility: Université Paris-Descartes, Hôpital Necker-Enfants Malades. Centre de référence national pour les Arthrites Juveniles

location_facility: Clinica Pediatrica Universita' di Torino

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: Bristol Royal Hospital for Children & Royal National Hospital for Rheumatic Diseases

location_facility: Centro de Reumatologia Pediatrico de Puerto Rico

location_facility: Samara Regional Clinical Cordiological Hospital

location_facility: State Institution Scientific Center of Children Health of Rams Moscow

location_facility: Aristotle University of Thessaloniki - Ippokration General Hospital

location_facility: Univ Klinik Fuer Kinder-und Jugendheilkunde

location_facility: Medical Center of New Brunswick (Rutgers)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Ospedale Santa Chiara, Università di Pisa

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: National Institute of Rheumatology and Physiotherapy

location_facility: IRCCS Istituto G. Gaslini, Università di Genova

location_facility: Seconda Universita' degli Studi di Napoli Dipartimento di Pediatria F.Fede Via L. De Crecchio 4

location_facility: Institution of Higher Professional Education Rostov State Medical University of Ministry of Health of Russian Federation

location_facility: PRI Pediatric Rheumatology Research Institute GmbH

location_facility: Skejby Sygehus, Aarhus University Hospital

location_facility: Specially for Children Seton Health Care

location_facility: V.A. Nasonova Research Institute of Rheumatology, Pediatric Department

location_facility: Randall Children's Hospital at Legacy Emanuel Children's Hospital

location_facility: Hospital Sant Joan de Deu, Universitat de Barcelona

location_facility: Charite University Hospital Berlin Kinderklinik, Rheumatologie

status_simplified: Ongoing


title: Evaluation of the Vascutek Ltd. Thoracic Endovascular Stent Graft System (ThoraflexTM)in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta

summary:
ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit technique may be required to allow access to the arterial system. The soft tapered tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed to provide excellent flexibility and control through tortuous arterial anatomy.

Each individual stent graft device is supplied sterile and pre-loaded in a single-use delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and nitinol ring stents, which are attached to the fabric with braided polyester sutures. The delivery system central catheter is a stainless steel braided co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide significant torque control and strength, while also maintaining superior flexibility. The outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant coating. These materials provide very low friction force during device insertion and deployment together with enhanced flexibility of the delivery system. The handle components are moulded from thermoplastic polyurethane.

The materials of the endoprosthesis are identical to those of the current Conformité Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal aortic aneurysm repair. The materials of the delivery system are well established in medical applications. The design of ThoraflexTM is based on the same principles as other clinically established thoracic endovascular devices. The endoprosthesis is constructed of self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal deployment position can be enhanced.

The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta, which is identical to other CE approved thoracic endovascular devices.

status: Withdrawn

design_allocation: Non-Randomized

lead_sponsor: Vascutek Ltd.

location_country:
Italy
Netherlands
France
Belgium
Germany
United Kingdom
Canada

location_facility: University of Maastricht, Department of Surgery

location_facility: Institute University de Cardiologie et de

location_facility: Service de Chirurgie Cardaque et Vasculaire

location_facility: Medisch Specturm Twente, Department of Surgery

location_facility: Cliniques Universitaires Saint-Luc (UCL)

location_facility: Academic Medical Centre (AMC), Department of Surgery

location_facility: Erasmus Medical Centre, Department of Surgery

intervention_type: Device

status_simplified: Unknown


title: A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)

acronym: STRASS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

status: Unknown status

ReferenceCitation: Bonvalot S, Gronchi A, Le Péchoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honoré C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litière S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.

family: Bonvalot

full_name: Sylvie Bonvalot

given: Sylvie

family: Gronchi

full_name: Alessandro Gronchi

given: Alessandro

family: Le Péchoux

full_name: Cécile Le Péchoux

given: Cécile

family: Swallow

full_name: Carol J Swallow

given: Carol J

family: Strauss

full_name: Dirk Strauss

given: Dirk

family: Meeus

full_name: Pierre Meeus

given: Pierre

family: van Coevorden

full_name: Frits van Coevorden

given: Frits

family: Stoldt

full_name: Stephan Stoldt

given: Stephan

family: Stoeckle

full_name: Eberhard Stoeckle

given: Eberhard

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Rastrelli

full_name: Marco Rastrelli

given: Marco

family: Raut

full_name: Chandrajit P Raut

given: Chandrajit P

family: Hompes

full_name: Daphne Hompes

given: Daphne

family: De Paoli

full_name: Antonino De Paoli

given: Antonino

family: Sangalli

full_name: Claudia Sangalli

given: Claudia

family: Honoré

full_name: Charles Honoré

given: Charles

family: Chung

full_name: Peter Chung

given: Peter

family: Miah

full_name: Aisha Miah

given: Aisha

family: Blay

full_name: Jean Yves Blay

given: Jean Yves

family: Fiore

full_name: Marco Fiore

family: Stelmes

full_name: Jean-Jacques Stelmes

given: Jean-Jacques

family: Dei Tos

full_name: Angelo P Dei Tos

given: Angelo P

family: Baldini

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Poland
Norway
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Maria Sklodowska-Curie Memorial Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Dana-Farber Cancer Institute & Harvard Medical School

location_facility: Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus


status: Active, not recruiting

location_country:
Italy
United States
France
Japan
Hungary
Argentina
Russian Federation
Spain
Germany

acronym: Safety FU Study of Amb in 8-17yr olds

title: An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired

summary:
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met:

the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons).

The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.


status: Terminated

title: A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years

summary: A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine the ambrisentan population pharmacokinetics in the paediatric population. The study will include a screening/baseline period and a treatment period. The treatment period will be 24 weeks or until the subject's clinical condition deteriorates to the point that alternative/additional treatment is necessary. Patients who participate in the study and in whom continued treatment with ambrisentan is desired will be eligible to enrol into a long term follow-up study. The primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups.


title: A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus

summary: To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

ReferenceCitation: Rockstroh JK, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J. Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial. Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.

family: Rockstroh

full_name: Juergen K Rockstroh

given: Juergen K

family: Plonski

full_name: Frank Plonski

given: Frank

family: Bansal

full_name: Meena Bansal

given: Meena

family: Fätkenheuer

full_name: Gerd Fätkenheuer

given: Gerd

family: Small

full_name: Catherine B Small

given: Catherine B

family: Asmuth

full_name: David M Asmuth

given: David M

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: Zhang-Roper

full_name: Rebecca Zhang-Roper

given: Rebecca

family: Wang

full_name: Ronnie Wang

given: Ronnie

family: Pineda

full_name: Juan A Pineda

given: Juan A

family: Heera

full_name: Jayvant Heera

given: Jayvant

journal_name: Antiviral therapy

oa_host_type: repository

repository_institution: University of California - eScholarship University of California

version: submittedVersion

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Rockstroh JK, Soriano V, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA. Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents. HIV Clin Trials. 2015 Mar-Apr;16(2):72-80. doi: 10.1179/1528433614Z.0000000011. Erratum in: HIV Clin Trials. 2015 Nov;16(6):236-8.

full_name: Juergen K. Rockstroh

given: Juergen K.

family: Soriano

full_name: Vicente Soriano

given: Vicente

full_name: Catherine B. Small

given: Catherine B.

full_name: David M. Asmuth

given: David M.

repository_normalized: California Digital Library - eScholarship

location_country:
United States
France
Czechia
Poland
Hungary
Puerto Rico
Spain
Germany
United Kingdom

location_facility: Centre Hospitalier Cochin Saint Vincent de Paul

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: University of South Florida Health - HIV Clinical Research Unit

location_facility: The Office of Dr. Franco Antonio Felizarta, M.D.

location_facility: University of Puerto Rico - School of Medicine

location_facility: Community AIDS Resource Inc dba Care Resource

location_facility: Kaiser Permanente Sunnybrook Medical Office

location_facility: Alameda Health System - Highland Hospital

location_facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust

location_facility: University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)

location_facility: Hospital Reina Sofia Hospital Provincial

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: University of Iowa Hospitals and Clinics

location_facility: Egyesített Szent István és Szent László Kórház Rendelőintézet

location_facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

location_facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

location_facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH

location_facility: Southwest Infectious Disease Clinical Research Inc.

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: University of California, San Francisco - Mt. Zion Hospital


title: A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

summary: This study will assess the safety and efficacy of INC280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-MET pathway.

ReferenceCitation: Schuler M, Berardi R, Lim WT, de Jonge M, Bauer TM, Azaro A, Gottfried M, Han JY, Lee DH, Wollner M, Hong DS, Vogel A, Delmonte A, Akimov M, Ghebremariam S, Cui X, Nwana N, Giovannini M, Kim TM. Molecular correlates of response to capmatinib in advanced non-small-cell lung cancer: clinical and biomarker results from a phase I trial. Ann Oncol. 2020 Jun;31(6):789-797. doi: 10.1016/j.annonc.2020.03.293. Epub 2020 Mar 30.

family: Schuler

full_name: M. Schuler

given: M.

family: Berardi

full_name: R. Berardi

given: R.

family: Lim

full_name: W.-T. Lim

family: de Jonge

full_name: M. de Jonge

family: Bauer

full_name: T.M. Bauer

family: Azaro

full_name: A. Azaro

given: A.

family: Gottfried

full_name: M. Gottfried

family: Han

full_name: J.-Y. Han

family: Lee

full_name: D.H. Lee

family: Wollner

full_name: M. Wollner

family: Hong

full_name: D.S. Hong

family: Vogel

full_name: A. Vogel

family: Delmonte

full_name: A. Delmonte

family: Akimov

full_name: M. Akimov

family: Ghebremariam

full_name: S. Ghebremariam

given: S.

family: Cui

full_name: X. Cui

given: X.

family: Nwana

full_name: N. Nwana

given: N.

family: Giovannini

full_name: M. Giovannini

family: Kim

full_name: T.M. Kim

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Bang YJ, Su WC, Schuler M, Nam DH, Lim WT, Bauer TM, Azaro A, Poon RTP, Hong D, Lin CC, Akimov M, Ghebremariam S, Zhao S, Giovannini M, Ma B. Phase 1 study of capmatinib in MET-positive solid tumor patients: Dose escalation and expansion of selected cohorts. Cancer Sci. 2020 Feb;111(2):536-547. doi: 10.1111/cas.14254. Epub 2019 Dec 30.

name: Seoul National University College of Medicine Seoul Korea

name: National Cheng Kung University Hospital Tainan Taiwan

name: Department of Medical Oncology West German Cancer Center University Duisburg‐Essen and German Cancer Consortium (DKTK), Partner Site University Hospital Essen Essen Germany

name: Sarah Cannon Research Institute/Tennessee Oncology PLLC Nashville Tennessee USA

name: Department of Medical Oncology Molecular Therapeutics Research Unit Vall d’Hebron University Hospital Barcelona Spain

name: Pharmacology Department The Autonomous University of Barcelona (UAB) Barcelona Spain

name: University of Texas/MD Anderson Cancer Center Houston Texas USA

name: National Taiwan University Hospital Taipei Taiwan

name: Novartis Pharmaceuticals Corporation East Hanover New Jersey USA

name: China Novartis Institutes for BioMedical Research Shanghai China

name: State Key Laboratory of Translational Oncology, Phase 1 Clinical Trial Centre The Chinese University of Hong Kong Hong Kong China

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

title: Phase 1 study of capmatinib in MET‐positive solid tumor patients: Dose escalation and expansion of selected cohorts

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

location_facility: University of Texas/MD Anderson Cancer Center Dept of Onc

location_facility: Sarah Cannon Research Institute Dept of Onc

location_facility: Karmanos Cancer Institute Wayne St Karmanos


title: A Phase Ib, Open-label, Dose-finding Study of the JAK Inhibitor INC424 Tablets Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-polycythemia Veramyelofibrosis (PPV-MF) or Post-essentialthrombocythemia-myelofibrosis (PET-MF) and Baseline Platelet Counts ≥50 x109/L and <100 x109/L (EXPAND)

summary: This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ^9/L

lead_sponsor: Incyte Corporation

location_country:
Italy
Austria
Netherlands
Germany
France
China
United States
United Kingdom


title: A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

location_country:
United States
France

location_facility: Comprehensive Clinical Development, Inc.

location_facility: The Center For Pharmaceutical Research. Pc


title: A Randomized, Open-label, Phase 3 Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma

acronym: FOCUS

summary: This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for subjects with multiple myeloma who have received all available approved treatment options and may therefore be considered candidates for palliative care.

ReferenceCitation: Hájek R, Masszi T, Petrucci MT, Palumbo A, Rosiñol L, Nagler A, Yong KL, Oriol A, Minarik J, Pour L, Dimopoulos MA, Maisnar V, Rossi D, Kasparu H, Van Droogenbroeck J, Yehuda DB, Hardan I, Jenner M, Calbecka M, Dávid M, de la Rubia J, Drach J, Gasztonyi Z, Górnik S, Leleu X, Munder M, Offidani M, Zojer N, Rajangam K, Chang YL, San-Miguel JF, Ludwig H. A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). Leukemia. 2017 Jan;31(1):107-114. doi: 10.1038/leu.2016.176. Epub 2016 Jun 24.

family: Hájek

full_name: R Hájek

given: R

family: Masszi

full_name: T Masszi

given: T

family: Petrucci

full_name: M T Petrucci

given: M T

family: Palumbo

full_name: A Palumbo

given: A

family: Rosiñol

full_name: L Rosiñol

given: L

family: Nagler

full_name: A Nagler

family: Yong

full_name: K L Yong

given: K L

family: Oriol

full_name: A Oriol

family: Minarik

full_name: J Minarik

given: J

family: Pour

full_name: L Pour

family: Dimopoulos

full_name: M A Dimopoulos

given: M A

family: Maisnar

full_name: V Maisnar

given: V

family: Rossi

full_name: D Rossi

given: D

family: Kasparu

full_name: H Kasparu

given: H

family: Van Droogenbroeck

full_name: J Van Droogenbroeck

family: Yehuda

full_name: D B Yehuda

given: D B

family: Hardan

full_name: I Hardan

given: I

family: Jenner

full_name: M Jenner

given: M

family: Calbecka

full_name: M Calbecka

family: Dávid

full_name: M Dávid

family: de la Rubia

full_name: J de la Rubia

family: Drach

full_name: J Drach

family: Gasztonyi

full_name: Z Gasztonyi

given: Z

repositories:
PubMed Central
UCL Discovery
ddd.uab.cat

repositories_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Hájek R, Bryce R, Ro S, Klencke B, Ludwig H. Design and rationale of FOCUS (PX-171-011): a randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM). BMC Cancer. 2012 Sep 19;12:415. doi: 10.1186/1471-2407-12-415.

title: Design and rationale of FOCUS (PX-171-011): A randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM)

location_country:
Italy
Austria
Sweden
Serbia
Spain
France
Czechia
Greece
Israel
Poland
Slovakia
Hungary
Australia
Belgium
New Zealand
Russian Federation
Germany
United Kingdom
Korea, Republic of


title: Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.

acronym: DESSOLVE-II

summary: The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.

ReferenceCitation: Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W; DESSOLVE II Investigators. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study. Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1141-50. doi: 10.1002/ccd.25610. Epub 2015 Sep 22.

name: Cardiovascular Research Center Aalst, OLV Clinic; Aalst Belgium

family: Rusinaru

full_name: Dan Rusinaru

given: Dan

family: Vrolix

full_name: Mathias Vrolix

given: Mathias

family: Verheye

full_name: Stefan Verheye

given: Stefan

name: South Manchester University Hospital; Manchester United Kingdom

family: Chowdhary

full_name: Saqib Chowdhary

given: Saqib

name: Brussels University Hospital; Brussels Belgium

family: Schoors

full_name: Danny Schoors

given: Danny

name: NIHR Cardiovascular Research Unit; Royal Brompton Hospital & Imperial College; London United Kingdom

family: Di Mario

full_name: Carlo Di Mario

given: Carlo

name: Department of Cardiovascular Diseases; UZ Leuven Belgium

family: Desmet

full_name: Walter Desmet

given: Walter

name: Micell Technologies; Durham North Carolina

family: Donohoe

full_name: Dennis J. Donohoe

given: Dennis J.

name: Auckland City Hospital; Auckland New Zealand

family: Ormiston

full_name: John A. Ormiston

given: John A.

family: Knape

full_name: Charlene Knape

given: Charlene

family: Bezerra

full_name: Hiram Bezerra

given: Hiram

name: Yale University School of Medicine; New Haven Connecticut

family: Lansky

full_name: Alexandra Lansky

given: Alexandra

family: Wijns

full_name: William Wijns

given: William

name: on behalf of the DESSOLVE II Investigators

journal_name: Catheterization and Cardiovascular Interventions

ReferenceCitation: Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J; DESSOLVE II Investigators. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention. 2015 Apr;10(12):1383-90. doi: 10.4244/EIJY14M05_03.

family: Slagboom

full_name: Ton Slagboom

given: Ton

family: Gosselink

full_name: Marcel Gosselink

given: Marcel

family: Benit

full_name: Edouard Benit

given: Edouard

full_name: Dennis Donohoe

location_country:
Sweden
Netherlands
France
Belgium
New Zealand
United Kingdom

location_facility:
Royal Brompton
Auckland City Hospital
Wellington Hospital
Mercy Angiography Unit
Norfolk/Norwich UHosp
Clinique Pasteur
Southampton UHT
KUL Cardiology Gasthuisberg
Papworth Hospital
Orebro University Hospital
Dunedin Hospital
Virga Jesse Ziekenhuis
Cardiovascular Center
Claude Galien Hospital
Hospital Weezenlanden
Jacques Cartier Hospital
St. Antonius Ziekenhuis
Antwerp Hospital, ZNA Middelheim
Sahlgrenska University Hospital
Ziekenhuis Oost-Limburg
TweeSteden Ziekenhuis
Royal Sussex Hosp
UMC Utrecht
OLV
Christchurch Hospital
University Hospital South Manchester
Brussels University Hospital
Guy's & St. Thomas'


ReferenceCitation: Ferrer M, Giménez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, Risson V. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018 Jul - Aug;6(4):1191-1197.e5. doi: 10.1016/j.jaip.2018.04.003. Epub 2018 Apr 12. Erratum in: J Allergy Clin Immunol Pract. 2018 Sep - Oct;6(5):1810.

family: Ferrer

full_name: Marta Ferrer

given: Marta

family: Giménez-Arnau

full_name: Ana Giménez-Arnau

given: Ana

family: Saldana

full_name: Diego Saldana

given: Diego

family: Janssens

full_name: Nico Janssens

given: Nico

family: Balp

full_name: Maria-Magdalena Balp

given: Maria-Magdalena

family: Khalil

full_name: Sam Khalil

given: Sam

family: Risson

full_name: Valéry Risson

given: Valéry

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

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

ReferenceCitation: Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: Review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017 Apr;118(4):500-504. doi: 10.1016/j.anai.2017.02.003. Review.

family: Goldstein

full_name: Stanley Goldstein

given: Stanley

family: Gabriel

full_name: Susan Gabriel

given: Susan

family: Kianifard

full_name: Farid Kianifard

given: Farid

family: Ortiz

full_name: Benjamin Ortiz

given: Benjamin

family: Skoner

full_name: David P. Skoner

given: David P.

journal_name: Annals of Allergy, Asthma & Immunology

ReferenceCitation: Saini SS, Omachi TA, Trzaskoma B, Hulter HN, Rosén K, Sterba PM, Courneya JP, Lackey A, Chen H. Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria. J Invest Dermatol. 2017 Apr;137(4):958-961. doi: 10.1016/j.jid.2016.11.025. Epub 2016 Dec 6. Erratum in: J Invest Dermatol. 2019 Feb;139(2):496-497.

family: Saini

full_name: Sarbjit S. Saini

given: Sarbjit S.

family: Omachi

full_name: Theodore A. Omachi

given: Theodore A.

family: Trzaskoma

full_name: Benjamin Trzaskoma

family: Hulter

full_name: Henry N. Hulter

ReferenceCitation: Gimenéz-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosén K, Omachi TA, Stull D, Balp MM, Murphy T. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0. eCollection 2016.

ReferenceCitation: Zazzali JL, Kaplan A, Maurer M, Raimundo K, Trzaskoma B, Solari PG, Antonova E, Mendelson M, Rosén KE. Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):370-377.e1. doi: 10.1016/j.anai.2016.06.024. Epub 2016 Jul 14.

ReferenceCitation: Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, Grattan CE, Gimenéz-Arnau A, Kaplan AP, Rosén K. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.

ReferenceCitation: Maurer M, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24. Erratum in: N Engl J Med. 2013 Jun 13;368(24):2340-1.

title: Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria

location_country:
Italy
Germany
France
Poland
Spain
Turkey
Denmark
United States

title: A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.


title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

acronym: ANDANTE

summary: This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

ReferenceCitation: Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.

name: Clinical Pharmacology/Pharmacometrics, Clinical Research; Pfizer Inc.; Cambridge MA USA

family: Li

full_name: Cheryl Li

given: Cheryl

name: Pharmacometrics/Clinical Pharmacology, Clinical Research; Pfizer Japan Inc.; Yoyogi, Shibuya-ku Tokyo Japan

family: Shoji

full_name: Satoshi Shoji

given: Satoshi

family: Beebe

full_name: Jean Beebe

given: Jean

journal_name: British Journal of Clinical Pharmacology

ReferenceCitation: Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

family: Danese

full_name: Silvio Danese

given: Silvio

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Hellstern

full_name: Paul Hellstern

given: Paul

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Rogler

full_name: Gerhard Rogler

given: Gerhard

family: Fraser

full_name: Gerald Fraser

given: Gerald

family: Kohn

full_name: Anna Kohn

given: Anna

family: Desreumaux

full_name: Pierre Desreumaux

given: Pierre

family: Leong

full_name: Rupert W Leong

given: Rupert W

family: Comer

full_name: Gail M Comer

given: Gail M

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

family: Banerjee

full_name: Anindita Banerjee

given: Anindita

family: Maguire

full_name: Mary K Maguire

given: Mary K

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.zora.uzh.ch

title: Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn’s disease (ANDANTE I and II)

location_country:
Italy
United States
Brazil
Switzerland
United Kingdom
Germany
France
Greece
Israel
Romania
Hungary
Belgium
Australia
Ireland
New Zealand
Denmark
Canada
Czech Republic

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Weill Cornell Medical College of Cornell University-Greenberg

location_facility: The University of Chicago Medical Center

location_facility: McGill University Health Centre - Royal Victoria Hospital

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Azienda Ospedaliera - Universita di Padova

location_facility: The Institute Of Gastroenterology & Liver Diseases

location_facility: Pioneer Research Solutions, Inc. (Admin. Office)

location_facility: University of Louisville Research Foundation

location_facility: University of California - San Francisco

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai

location_facility: Gastroenterology Associates of Western Michigan

location_facility: University of California San Francisco at Mount Zion

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: Royal Free Hospital (Royal Free London NHS Foundation Trust)

location_facility: The University of Chicago Medical Center (Ucmc)

location_facility: Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: The University of Texas Medical School at Houston

location_facility: Klinicke centrum ISCARE I.V.F. - gastroenterologie

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: The University of Texas Health Science Center at Houston

location_facility: An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: International Clinical Research - US, LLC

location_facility: Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

location_facility: Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hopital Saint-Antoine - Service De Gastroenterologie

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

location_facility: London Health Science Centre - University Hospital

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Physicians Endoscopy Center (Colonoscopy)

location_facility: Weill Cornell Imaging at New York Presbyterian Hospital

location_facility: University Of Louisville Healthcare Outpatient Center

location_facility: Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group

location_facility: Houston Hospital for Specialized Surgery (Endoscopy Only)

location_facility: Research Protocol Management Specialists

location_facility: Hospital Universitário Fraga Filho da UFRJ

location_facility: Colonoscopy and X-rays: OU Physicians Building

location_facility: Medicinsk Afdeling, Gastroenterologisk Sektion

location_facility: Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Institut klinicke a experimentalni mediciny

location_facility: VCU Medical Investigational Drug Service (IDS)

location_facility: Addenbrooke's Hospital, Department of Gastroenterology

location_facility: A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and

location_facility: Maryland Diagnostics & Therapeutic Endo Center

location_facility: Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital


family: Ferrer

full_name: Marta Ferrer

given: Marta

family: Giménez-Arnau

full_name: Ana Giménez-Arnau

given: Ana

family: Saldana

full_name: Diego Saldana

given: Diego

family: Janssens

full_name: Nico Janssens

given: Nico

family: Balp

full_name: Maria-Magdalena Balp

given: Maria-Magdalena

family: Khalil

full_name: Sam Khalil

given: Sam

family: Risson

full_name: Valéry Risson

given: Valéry

repositories_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

title: Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis

family: Goldstein

full_name: Stanley Goldstein

given: Stanley

family: Gabriel

full_name: Susan Gabriel

given: Susan

family: Kianifard

full_name: Farid Kianifard

given: Farid

family: Ortiz

full_name: Benjamin Ortiz

given: Benjamin

family: Skoner

full_name: David P. Skoner

given: David P.

title: Clinical features of adolescents with chronic idiopathic or spontaneous urticaria

family: Saini

full_name: Sarbjit S. Saini

given: Sarbjit S.

family: Omachi

full_name: Theodore A. Omachi

given: Theodore A.

family: Trzaskoma

full_name: Benjamin Trzaskoma

family: Hulter

full_name: Henry N. Hulter

title: Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria

title: Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies

title: Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies

title: Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy

ReferenceCitation: Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bülbül Baskan E, Bradley MS, Canvin J, Rahmaoui A, Georgiou P, Alpan O, Spector S, Rosén K. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015 Jan;135(1):67-75. doi: 10.1038/jid.2014.306. Epub 2014 Jul 21. Erratum in: J Invest Dermatol. 2015 Mar;135(3):925.

title: Efficacy and Safety of Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic on H 1 Antihistamines: A Randomized, Placebo-Controlled Study

title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.


title: An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients With Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

summary: This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.

ReferenceCitation: Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. doi: 10.1016/S1470-2045(16)30166-8. Epub 2016 Jul 23.

family: Brose

full_name: Marcia S Brose

given: Marcia S

family: Cabanillas

full_name: Maria E Cabanillas

given: Maria E

family: Cohen

full_name: Ezra E W Cohen

given: Ezra E W

family: Wirth

full_name: Lori J Wirth

given: Lori J

family: Riehl

full_name: Todd Riehl

given: Todd

family: Yue

full_name: Huibin Yue

given: Huibin

family: Sherman

full_name: Steven I Sherman

given: Steven I

full_name: Eric J Sherman

given: Eric J

journal_name: The Lancet Oncology

version: acceptedVersion

title: Vemurafenib in patients with BRAFV600E-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial

location_country:
Italy
United States
France
Netherlands


title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

summary: The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

ReferenceCitation: Nair P, Bardin P, Humbert M, Murphy KR, Hickey L, Garin M, Vanlandingham R, Chanez P. Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):555-564. doi: 10.1016/j.jaip.2019.09.036. Epub 2019 Oct 15.

family: Nair

full_name: Parameswaran Nair

given: Parameswaran

family: Bardin

full_name: Philip Bardin

given: Philip

family: Humbert

full_name: Marc Humbert

given: Marc

family: Murphy

full_name: Kevin R. Murphy

given: Kevin R.

family: Hickey

full_name: Lisa Hickey

given: Lisa

family: Garin

full_name: Margaret Garin

given: Margaret

family: Vanlandingham

full_name: Rebecca Vanlandingham

given: Rebecca

family: Chanez

full_name: Pascal Chanez

given: Pascal

title: Efficacy of Intravenous Reslizumab in Oral Corticosteroid–Dependent Asthma

ReferenceCitation: Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):240-249. doi: 10.2500/aap.2019.40.4225.

name: From the Allergy and Asthma Associates, Mission Viejo, California

family: Carr

full_name: Warner W. Carr

given: Warner W.

name: Teva Branded Pharmaceutical Products R&D Inc., Malvern, Pennsylvania

family: McDonald

full_name: Mirna McDonald

given: Mirna

family: Meizlik

full_name: Paige Meizlik

given: Paige

journal_name: Allergy and Asthma Proceedings

publisher: Oceanside Publications Inc.

publisher_dissemination: Oceanside Publications Inc.

publisher_group: Oceanside Publications Inc.

publisher_normalized: Oceanside Publications Inc.

ReferenceCitation: Han S, Kim S, Kim H, Suh HS. Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting β(2)-agonists in South Korea. Curr Med Res Opin. 2019 Sep;35(9):1597-1605. doi: 10.1080/03007995.2019.1605159. Epub 2019 May 16.

name: College of Pharmacy, Pusan National University, Busan, Republic of Korea

family: Han

full_name: Sola Han

given: Sola

family: Kim

full_name: Siin Kim

given: Siin

full_name: Hyungtae Kim

given: Hyungtae

family: Suh

full_name: Hae Sun Suh

given: Hae Sun

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

title: Cost–utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting β2-agonists in South Korea

ReferenceCitation: Bateman ED, Djukanović R, Castro M, Canvin J, Germinaro M, Noble R, Garin M, Buhl R. Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):489-495. doi: 10.1164/rccm.201708-1668OC.

name: University of Cape Town, Cape Town, South Africa

name: Southampton University Hospital, Southampton, United Kingdom

name: Washington University School of Medicine, St. Louis, Missouri

name: Teva Pharmaceuticals Europe BV, Amsterdam, the Netherlands

name: Teva Pharmaceuticals, Frazer, Pennsylvania; and

name: Johannes Gutenberg University Mainz, Mainz, Germany

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, Bateman ED, Hoyte FCL, Germinaro M. Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2019 Feb;7(2):589-596.e3. doi: 10.1016/j.jaip.2018.08.021. Epub 2018 Sep 5.

ReferenceCitation: Brusselle G, Germinaro M, Weiss S, Zangrilli J. Reslizumab in patients with inadequately controlled late-onset asthma and elevated blood eosinophils. Pulm Pharmacol Ther. 2017 Apr;43:39-45. doi: 10.1016/j.pupt.2017.01.011. Epub 2017 Jan 31.

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23. Erratum in: Lancet Respir Med. 2015 Apr;3(4):e15. Lancet Respir Med. 2016 Oct;4(10 ):e50.

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

location_country:
Brazil
United States
Peru
Mexico
Germany
France
Greece
Slovakia
Romania
Argentina
Russian Federation
Canada
Korea, Republic of
Taiwan
Ukraine

location_facility:
Teva Investigational Site 120
Teva Investigational Site 226
Teva Investigational Site 635
Teva Investigational Site 361
Teva Investigational Site 560
Teva Investigational Site 628
Teva Investigational Site 620
Teva Investigational Site 205
Teva Investigational Site 624
Teva Investigational Site 631
Teva Investigational Site 625
Teva Investigational Site 633
Teva Investigational Site 41
Teva Investigational Site 203
Teva Investigational Site 220
Teva Investigational Site 622
Teva Investigational Site 557
Teva Investigational Site 521
Teva Investigational Site 523
Teva Investigational Site 540
Teva Investigational Site 142
Teva Investigational Site 368
Teva Investigational Site 554
Teva Investigational Site 341
Teva Investigational Site 559
Teva Investigational Site 227
Teva Investigational Site 381
Teva Investigational Site 144
Teva Investigational Site 102
Teva Investigational Site 520
Teva Investigational Site 682
Teva Investigational Site 223
Teva Investigational Site 67
Teva Investigational Site 632
Teva Investigational Site 150
Teva Investigational Site 59
Teva Investigational Site 522
Teva Investigational Site 372
Teva Investigational Site 370
Teva Investigational Site 209
Teva Investigational Site 143
Teva Investigational Site 543
Teva Investigational Site 46
Teva Investigational Site 221
Teva Investigational Site 362
Teva Investigational Site 207
Teva Investigational Site 53
Teva Investigational Site 104
Teva Investigational Site 382
Teva Investigational Site 45
Teva Investigational Site 629
Teva Investigational Site 681
Teva Investigational Site 367
Teva Investigational Site 126
Teva Investigational Site 765
Teva Investigational Site 541
Teva Investigational Site 121
Teva Investigational Site 369
Teva Investigational Site 683
Teva Investigational Site 621
Teva Investigational Site 123
Teva Investigational Site 25
Teva Investigational Site 222
Teva Investigational Site 764
Teva Investigational Site 27
Teva Investigational Site 685
Teva Investigational Site 225
Teva Investigational Site 204
Teva Investigational Site 763
Teva Investigational Site 360
Teva Investigational Site 47
Teva Investigational Site 524
Teva Investigational Site 342
Teva Investigational Site 140
Teva Investigational Site 365
Teva Investigational Site 40
Teva Investigational Site 562
Teva Investigational Site 229
Teva Investigational Site 561
Teva Investigational Site 57
Teva Investigational Site 28
Teva Investigational Site 680
Teva Investigational Site 364
Teva Investigational Site 630
Teva Investigational Site 760
Teva Investigational Site 105
Teva Investigational Site 371
Teva Investigational Site 563
Teva Investigational Site 544
Teva Investigational Site 366
Teva Investigational Site 145
Teva Investigational Site 623
Teva Investigational Site 202
Teva Investigational Site 380
Teva Investigational Site 363
Teva Investigational Site 686
Teva Investigational Site 48
Teva Investigational Site 626
Teva Investigational Site 558
Teva Investigational Site 556
Teva Investigational Site 761
Teva Investigational Site 44
Teva Investigational Site 69
Teva Investigational Site 343


title: A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis

summary: This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

ReferenceCitation: Reinisch W, Panés J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Panés

full_name: Julián Panés

given: Julián

family: Khurana

full_name: Sunil Khurana

given: Sunil

family: Toth

full_name: Gabor Toth

given: Gabor

family: Hua

full_name: Fei Hua

given: Fei

family: Comer

full_name: Gail M Comer

given: Gail M

family: Hinz

full_name: Michelle Hinz

given: Michelle

family: Page

full_name: Karen Page

given: Karen

family: O'Toole

full_name: Margot O'Toole

given: Margot

family: Moorehead

full_name: Tara McDonnell Moorehead

given: Tara McDonnell

family: Zhu

full_name: Hua Zhu

given: Hua

family: Sun

full_name: YanHui Sun

given: YanHui

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

journal_name: Gut

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_country:
Austria
Netherlands
Germany
France
Bulgaria
Poland
Romania
Hungary
Spain
United States
Canada

location_facility: MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia

location_facility: Vancouver General Hospital - The Gordon and Leslie Diamond Centre

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Centennial Medical Center Tower Medical Imaging

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Oklahoma Foundation for Digestive Research

location_facility: International Clinical Research - US, LLC

location_facility: Centennial Medical Center Physicians Park

location_facility: Gastroenterology Research of San Antonio

location_facility: Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Vancouver Coastal Health - Vancouver General Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Columbia Medical Group - The First Clinic Inc.

location_facility: The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: DKTs Sveta Anna, Gastroenterologichen cabinet

location_facility: MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly

intervention_type: Other


title: A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations

acronym: LYNX

summary: This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.

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

location_country:
Italy
Peru
Sweden
Spain
France
Czechia
Greece
Slovakia
Belgium
Portugal
Denmark
Germany
United Kingdom
Colombia

location_facility: Universitair Ziekenhuis Leuven - Campus Sint-Raphaël

location_facility: Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande

location_facility: Universitaetsklinikum Giessen und Marburg

location_facility: Istituto Giannina Gaslini, Divisione di Oculistica

location_facility: Birmingham and Midland Eye Centre, Consultant Ophthalmologist

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Detska Fakultna nemocnica s poliklinikou Bratislava

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie

location_facility: AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem


ReferenceCitation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

name: Vall d'Hebron University Hospital Independent University of Barcelona Barcelona Spain

family: Toledo

full_name: Manuel Toledo

given: Manuel

name: UCB Pharma Raleigh North Carolina U.S.A.

family: Whitesides

full_name: John Whitesides

given: John

family: Schiemann

full_name: Jimmy Schiemann

given: Jimmy

family: Johnson

full_name: Martin E. Johnson

given: Martin E.

family: Eckhardt

full_name: Klaus Eckhardt

given: Klaus

family: McDonough

full_name: Belinda McDonough

given: Belinda

family: Borghs

full_name: Simon Borghs

given: Simon

name: University of Melbourne and Royal Melbourne Hospital Parkville Victoria Australia

name: Department of Medicine and Therapeutics The Chinese University of Hong Kong Hong Kong China

family: Kwan

full_name: Patrick Kwan

given: Patrick

journal_name: Epilepsia

title: Safety, tolerability, and seizure control during long‐term treatment with adjunctive brivaracetam for partial‐onset seizures

ReferenceCitation: Ben-Menachem E, Mameniškienė R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Mameniškienė

full_name: Rūta Mameniškienė

given: Rūta

family: Quarato

full_name: Pier Paolo Quarato

given: Pier Paolo

family: Klein

full_name: Pavel Klein

given: Pavel

family: Gamage

full_name: Jessica Gamage

given: Jessica

journal_name: Neurology

evidence: open (via page says license)

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

name: Mid‐Atlantic Epilepsy and Sleep Center Bethesda Maryland U.S.A

name: Thomas Jefferson University Philadelphia Pennsylvania U.S.A

name: Bethel Epilepsy Centre Mara Hospital Bielefeld Germany

name: Chinese University of Hong Kong Hong Kong Hong Kong SAR China

title: A randomized, double‐blind, placebo‐controlled, multicenter, parallel‐group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial‐onset seizures

ReferenceCitation: Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

ReferenceCitation: Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

ReferenceCitation: Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained ≥50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

name: Mid-Atlantic Epilepsy and Sleep Center; Bethesda Maryland U.S.A

name: UCB Pharma; Raleigh North Carolina U.S.A

ReferenceCitation: Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum in: Epilepsy Res. 2017 Nov;137:165-166.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

ReferenceCitation: Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

ReferenceCitation: Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

name: Mid‐Atlantic Epilepsy and Sleep Center Bethesda MD USA

title: Time course of 75%–100% efficacy response of adjunctive brivaracetam

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

ReferenceCitation: Toledo M, Brandt C, Quarato PP, Schulz AL, Cleveland JM, Wagener G, Klein P. Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial. Epilepsy Behav. 2021 May;118:107897. doi: 10.1016/j.yebeh.2021.107897. Epub 2021 Mar 27.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

title: Brivaracetam: First Global Approval

location_country:
Finland
Belgium
Russian Federation
Taiwan
India
France
Japan
Lithuania
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Estonia
Latvia

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures

summary: This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.