acronym: CARE-MS II

intervention_type: Biological

lead_sponsor: Genzyme, a Sanofi Company

summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.

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

ReferenceCitation: Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

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

repository_institution: University of Cambridge - Apollo

publisher_dissemination: SAGE Publications

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

repositories_concat: PubMed Central;www.repository.cam.ac.uk

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

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

repositories_institution:
UHasselt - Document Server@UHasselt
University of Plymouth - PEARL

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

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

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;www.repositoriosalud.es

repositories_institution: University of Melbourne - Minerva Access

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

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

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

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

ReferenceCitation: Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.

ReferenceCitation: Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.

repositories_institution:
PubMed Central - Europe PMC
University of Cambridge - Apollo

ReferenceCitation: Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014.

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

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location_facility: Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital

location_facility: Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine

location_facility: Servicio de Neurología Hospital Virgen de la Macarena

location_facility: University of Louisville Research Foundation

location_facility: University Hospital Leuven, Campus Gasthuisberg, Neurology

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: Indiana University School of Medicine, Department of Neurology

location_facility: Klinikum Rechts der Isar, Klinik für Neurologie

location_facility: Department Of Neurosciences, Addenbrookes Hospital

location_facility: St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences

location_facility: Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry

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

location_facility: Emory University, Department of Neurology

location_facility: Griffith School of Medicine, Gold Coast Campus, Griffith University

location_facility: Federal State Institution: Siberian District Medical Center

location_facility: St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"

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location_facility: Hôpital Pitié Salpétrière, Service de Neurologie

location_facility: Clinique Neuro rive-sud, Recherche sepmus inc

location_facility: SUNY Upstate Medical University, Department of Neurology

location_facility: Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis

location_facility: Azienda Ospedaliera Sant'Andrea Neurologia

location_facility: Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences

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

location_facility: Royal Melbourne Hospital, Department of Neurology

location_facility: CHU Clermont-Ferrand, Hôpital Gabriel Montpied

location_facility: Concord Repatriation General Hospital, Neurosciences Department

location_facility: Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica

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

location_facility: Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth

location_facility: University of Chicago Medical Center, Department of Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: Idaho Falls Multiple Sclerosis Center, PLLC

location_facility: Krajska zdravotni a.s. - Hospital Teplice

location_facility: Cliniques Universitaires Saint-Luc, Neurology

location_facility: University of Michigan Department of Neurology

location_facility: Louisiana State University Health Sciences Center

location_facility: University of New Mexico, Health Sciences Center, MS Specialty Clinic

location_facility: Klinikum Ingolstadt, Neurologische Klinik

location_facility: Orbis Medisch Centrum, Department of Neurology

location_facility: Department of Neurology, Keck School of Medicine, University of Southern California

location_facility: Unidad de Investigación en Salud de Chihuahua, S.C.

location_facility: St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic

location_facility: Århus Universitetshospital, Scleroseklinikken, Århus Sygehus

location_facility: North Central Neurology Associates, P.C.

location_facility: Partners Multiple Sclerosis Center/Brigham and Women's Hospital

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Cleveland Clinic Foundation, Mellen Center

location_facility: Ospedale Binaghi - Centro Sclerosi Multipla

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis

location_facility: Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital

location_facility: Mayo Clinic Arizona, Department of Neurology

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

location_facility: Ruan Neurology Clinic and Research Center

location_facility: Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)

location_facility: Lehigh Valley Hospital, Neuroscience and Pain Research

location_facility: Department of Neurology Glossop Road, Royal Hallamshire Hospital

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location_facility: University of North Carolina-Chapel Hill, Department of Neurology

location_facility: University of Florida Neuroscience Institute

location_facility: University of Colorado Hospital, Anschutz Outpatient Pavilioin

location_facility: University of California, Davis Medical Center

location_facility: Tel Aviv Sourasky Medical Center, Department of Neurology

location_facility: General Hospital " Sveti Duh", Department of neurology

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location_facility: Negroski, Stein, Sutherland and Hanes Neurology

location_facility: General Hospital Varazdin, Department of neurology

location_facility: Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz

location_facility: Neurology Consultants of Kansas City, Inc.

location_facility: Servicio de Neurología Hospital Carlos Haya

location_facility: Hospital Angeles del Pedregal; Camino a Santa Teresa

location_facility: Wake Forest University Health Science, Department of Neurology

location_facility: Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department

location_facility: Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple

location_facility: University of Pittsburgh, Kaufmann Medical Building

location_facility: George Washington University Medical Faculty Associates

location_facility: Clinical Centre Vojvodina Institute of Neurology

location_facility: State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"

location_facility: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

location_facility: Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center

location_facility: Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center

location_facility: London Health Sciences Centre- University Hospital

location_facility: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

location_facility: Liverpool Hospital, Neurology Department

location_facility: Renown Institute for Neurosciences / Renown regional Medical Center

location_facility: Clinic of Neurology, Clinical Centre of Serbia

location_facility: Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron

location_facility: Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"

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

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Rockstock

location_facility: Hôpital Civil, Departement de Neurologie

location_facility: University of South Florida, Department of Neurology

location_facility: Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences"

location_facility: Danylo Halytsky Lviv National Medical University, Department of Neurology

location_facility: St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"

location_facility: Sahlgrenska University Hospital, Neurologkliniken

location_facility: AKH Wien, Universitätsklinikum für Neurologie

location_facility: Salford Royal NHS Foundation Trust, Clinical Trials Unit

location_facility: University of Kansas Medical Center, Department of Neurology

title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

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


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

ReferenceType: derived

ReferenceCitation: Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.

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evidence: oa repository (via pmcid lookup)

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repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: All Children'S Hospital; Pediatric Blood & Marrow Transplant Program

location_facility: Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV

location_facility: Institute of Nephrology AMS; Dept of Nephrology & dialysis

location_facility: Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie

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location_facility: KASMED, s.r.o.; Alergologie a klinicka imunologie

location_facility: Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine

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location_facility: UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis

location_facility: Centro de Investigaciones Clinicas S.A.S

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: University of Szeged; Transplantation Department

location_facility: Hopital Europeen Georges Pompidou; Service de Nephrologie

location_facility: University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan

location_facility: Fundacion Cardiovascular de Colombia - Instituto del Corazón

location_facility: Tartu University Hospital; Department of Infectious Diseases

location_facility: University of Chicago; Infectious Disease

location_facility: Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;

location_facility: Medical College of Georgia; Medicine/ Nephrology

location_facility: Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Wayne State University School of Medicine

location_facility: Latvia Transplantation Center P. Stradina Hospital; Transplantation

location_facility: University of Pennsylvania Health System

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Uni of Alabama At Birmingham; Division of Nephrology

location_facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

location_facility: Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital

location_facility: UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi

location_facility: Hospital Universitario La Paz; Hepatología y Trasplantes

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Phylaxis Clinical Research S de RL de CV

location_facility: University of Texas Health Science Center Transplant center

location_facility: Zaporozhye State Medical University; Dept of Transplantology

location_facility: Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.

location_facility: Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie

location_facility: Our Lady of Lourdes Medical Center; Transplant Dept

location_facility: Chaim Sheba MC; Pediatric Hematology Oncology

location_facility: UT Southwestern Medical Center; Pediatrics Dept.

location_facility: Uni of Cincinnati Medical Center; Nephrology & Hypertension

location_facility: West Tallinn Central Hospital; Nephrology

location_facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center

location_facility: Republican Tuberculosis and Infectious Diseases University H

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Texas Tech University Health Sciences Center; Department of Urology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas

location_facility: EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center

location_facility: Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive

location_facility: Hospital General de Agudos Juan Antonio Fernandez; infectología

location_facility: Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations

location_facility: Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology

location_facility: Hospital Universitario de Monterrey; Infectologia

location_facility: University of Utah Health Science Center Gastroenterology

location_facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

location_facility: Hospital General de Agudos Dr. Ignacio Pirovano

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali

location_facility: Tygerberg Hospital Pediatrics and Child Health

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Pediatria

location_facility: Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed

location_facility: Cleveland Clinic Foundation; Infectious Disease

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia

location_facility: Uni of Pennsylvania; Infectious Diseases

location_facility: Kaunas Clinics Public Institution; Clinic of Nephrology

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Medical University of South Carolina; Pediatric Cardiology

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie

location_facility: SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM

location_facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: Synexus Clinical Research Centres SA Stanza Bopape

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location_facility: Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation

location_facility: Scott and White Division of Nephrology Dept of Medicine

location_facility: University of Maryland School of Medicine

location_facility: Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease

location_facility: Hospital Roosevelt Guatemala; Clinica de Infecciosas

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location_facility: Hopital Saint Louis; Service de Nephrologie - Transplantation

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location_facility: The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf

location_facility: Manchester Royal Infirmary; Renal Transplant Unit

location_facility: University of Alabama at Birmingham; Pediatric Nephrology

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health

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location_facility: Children'S Hospital of Pittsburgh; Infectious Disease

location_facility: Western New England Renal & Transplant Associates, P.C.

location_facility: Baylor University Medical Center Transplant Administration

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: Mount Sinai Medical Center; Division of Liver Diseases

location_facility: North Estonia medical Centre; Hematology

status: Completed

title: A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Brazil
Chile
Czechia
Canada
France
Lithuania
Colombia
Hungary
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
Guatemala
United Kingdom
Mexico
Spain
South Africa
Bulgaria
Israel

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

summary: To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

design_allocation: Non-Randomized

lead_sponsor: Vertex Pharmaceuticals Incorporated

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Tibotec, Inc

location_country:
Germany
United Kingdom
Netherlands
Austria
United States
Canada
Puerto Rico
France

location_facility: Columbia Gastroenterology Associates, PA

location_facility: University of Miami Center for Liver Diseases

location_facility: University of Colorado Health Sciences Center

location_facility: University of British Columbia Vancouver General Hospital

location_facility: Virology Treatment Center, Maine Medical Center

location_facility: University of Massachusetts Memorial Medical Center


title: A 26-week Treatment, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study to Assess the Safety of Indacaterol (300 and 600 µg o.d.) in Patients With Moderate to Severe Persistent Asthma, Using Salmeterol (50 µg b.i.d.) as an Active Control

summary: This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26 weeks, in patients with moderate to severe persistent asthma.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Slovakia
Hungary
Argentina
United States
Spain
Turkey
Peru
Canada
Czech Republic
France

location_facility:
Novartis Investigative Site
Novartis Investigator Site
Novartis Investigator Site x 2 sites
Novartis Investigator site


title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS

acronym: ALLEGRO

summary: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

ReferenceCitation: Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun.

publisher_dissemination: Springer

ReferenceCitation: Filippi M, Rocca MA, Pagani E, De Stefano N, Jeffery D, Kappos L, Montalban X, Boyko AN, Comi G; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):851-8. doi: 10.1136/jnnp-2013-306132. Epub 2013 Sep 12.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: British Medical Journal

ReferenceCitation: Comi G, Jeffery D, Kappos L, Montalban X, Boyko A, Rocca MA, Filippi M; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med. 2012 Mar 15;366(11):1000-9. doi: 10.1056/NEJMoa1104318.

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

location_country:
Germany
Poland
Turkey
Czechia
Canada
Serbia
France
Lithuania
Hungary
United States
Latvia
Ukraine
Romania
Estonia
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
Teva Investigational Site 3138
Teva Investigational Site 5900
Teva Investigational Site 1085
Teva Investigational Site 3144
Teva Investigational Site 5023
Teva Investigational Site 3038
Teva Investigational Site 5705
Teva Investigational Site 6100
Teva Investigational Site 3248
Teva Investigational Site 3424
Teva Investigational Site 3809
Teva Investigational Site 5022
Teva Investigational Site 5901
Teva Investigational Site 1075
Teva Investigational Site 3140
Teva Investigational Site 5604
Teva Investigational Site 5704
Teva Investigational Site 1131
Teva Investigational Site 8033
Teva Investigational Site 3146
Teva Investigational Site 3241
Teva Investigational Site 1134
Teva Investigational Site 5319
Teva Investigational Site 5802
Teva Investigational Site 5026
Teva Investigational Site 5211
Teva Investigational Site 1097
Teva Investigational Site 1079
Teva Investigational Site 1102
Teva Investigational Site 5317
Teva Investigational Site 3526
Teva Investigational Site 3046
Teva Investigational Site 1092
Teva Investigational Site 5114
Teva Investigational Site 1076
Teva Investigational Site 5208
Teva Investigational Site 8034
Teva Investigational Site 3132
Teva Investigational Site 3525
Teva Investigational Site 1078
Teva Investigational Site 3238
Teva Investigational Site 5416
Teva Investigational Site 3301
Teva Investigational Site 1098
Teva Investigational Site 5031
Teva Investigational Site 3243
Teva Investigational Site 5320
Teva Investigational Site 3237
Teva Investigational Site 5209
Teva Investigational Site 5504
Teva Investigational Site 5027
Teva Investigational Site 3143
Teva Investigational Site 1094
Teva Investigational Site 3303
Teva Investigational Site 3246
Teva Investigational Site 1088
Teva Investigational Site 3249
Teva Investigational Site 3044
Teva Investigational Site 8030
Teva Investigational Site 3139
Teva Investigational Site 1090
Teva Investigational Site 1130
Teva Investigational Site 5030
Teva Investigational Site 1083
Teva Investigational Site 8032
Teva Investigational Site 3524
Teva Investigational Site 8031
Teva Investigational Site 5505
Teva Investigational Site 3142
Teva Investigational Site 5315
Teva Investigational Site 3136
Teva Investigational Site 6102
Teva Investigational Site 3528
Teva Investigational Site 5212
Teva Investigational Site 1073
Teva Investigational Site 1093
Teva Investigational Site 3425
Teva Investigational Site 5316
Teva Investigational Site 3137
Teva Investigational Site 5024
Teva Investigational Site 1126
Teva Investigational Site 3134
Teva Investigational Site 3236
Teva Investigational Site 5318
Teva Investigational Site 3135
Teva Investigational Site 5116
Teva Investigational Site 5801
Teva Investigational Site 1086
Teva Investigational Site 5210
Teva Investigational Site 3300
Teva Investigational Site 5903
Teva Investigational Site 1096
Teva Investigational Site 1087
Teva Investigational Site 5325
Teva Investigational Site 3242
Teva Investigational Site 3047
Teva Investigational Site 5417
Teva Investigational Site 4204
Teva Investigational Site 5804
Teva Investigational Site 4206
Teva Investigational Site 3041
Teva Investigational Site 5904
Teva Investigational Site 5021
Teva Investigational Site 5905
Teva Investigational Site 5803
Teva Investigational Site 5117
Teva Investigational Site 5322
Teva Investigational Site 4205
Teva Investigational Site 8100
Teva Investigational Site 1100
Teva Investigational Site 3302
Teva Investigational Site 5029
Teva Investigational Site 3250
Teva Investigational Site 8201
Teva Investigational Site 5800
Teva Investigational Site 1132
Teva Investigational Site 3040
Teva Investigational Site 8101
Teva Investigational Site 3251
Teva Investigational Site 3042
Teva Investigational Site 1101
Teva Investigational Site 3039
Teva Investigational Site 1082
Teva Investigational Site 1084
Teva Investigational Site 3245
Teva Investigational Site 3133
Teva Investigational Site 3810
Teva Investigational Site 3045
Teva Investigational Site 3811
Teva Investigational Site 3247
Teva Investigational Site 1129
Teva Investigational Site 3527
Teva Investigational Site 1081
Teva Investigational Site 3422
Teva Investigational Site 555
Teva Investigational Site 5902
Teva Investigational Site 5115
Teva Investigational Site 5028
Teva Investigational Site 3240
Teva Investigational Site 3239
Teva Investigational Site 1128
Teva Investigational Site 5025
Teva Investigational Site 3244
Teva Investigational Site 3529


title: Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma

summary: This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) [complete response (CR) or partial response (PR)] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.

ReferenceCitation: Dummer R, Duvic M, Scarisbrick J, Olsen EA, Rozati S, Eggmann N, Goldinger SM, Hutchinson K, Geskin L, Illidge TM, Giuliano E, Elder J, Kim YH. Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous T-cell lymphomas (CTCL) (Mycosis fungoides and Sezary syndrome). Ann Oncol. 2014 Sep;25(9):1807-1812. doi: 10.1093/annonc/mdu231. Epub 2014 Jun 19.

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

license: cc-by

license_normalized: cc-by

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Finland
Germany
Italy
United Kingdom
Australia
Switzerland
Austria
United States
Spain
France

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Ctr

location_facility: Wake Forest University Health Sceinces, Dept. of Dermatology

location_facility: Washington University School of Medicine

location_facility: University Hospitals Case Medical Center, Dept. of Dermatology

location_facility: Hillman Cancer Ctr., University of Pittsburgh

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie

location_facility: Hospital at the University of Pennsylvania

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: M.D. Anderson Cancer Center - Dermatology

location_facility: University of Wisconsin-Madison, Dept of Dermatology


title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

summary: This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

ipd_sharing: No

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
India
United Kingdom
United States
Bulgaria
Ukraine
Russian Federation
France


title: A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.

summary: Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

primary_purpose: Prevention

ReferenceCitation: Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R; PULSE Study group. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010 Jan 28;11(1):10. doi: 10.1186/1465-9921-11-10. Erratum In: Respir Res. 2010;11:88.

lead_sponsor: Bayer

location_country:
France
Germany
Ireland
Italy
Israel
Argentina
United Kingdom
Brazil
Mexico
United States
Spain
Greece
South Africa
Chile
Andorra


acronym: iINHALE 7

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

status: Terminated

title: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

location_country: Poland India Israel Argentina Austria Belgium Mexico Turkey Bulgaria Canada France

status_simplified: Unknown


summary:
This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

ReferenceType: result

ReferenceCitation: Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.

ReferenceCitation: Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.

title: A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

location_country:
Poland
India
Argentina
Romania
Sweden
Netherlands
Austria
Mexico
Spain
Malaysia
South Africa
Former Serbia and Montenegro
Czech Republic
Philippines
France


title: European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe

summary: The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Pfizer

location_country:
Germany
Ireland
Cyprus
Italy
Poland
Slovakia
Denmark
Sweden
Belgium
Spain
Greece
Czech Republic
France


title: A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

summary: The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

unpaywall_oa_status: hybrid

ReferenceCitation: Pineo GF, Gallus AS, Raskob GE, Chen D, Ramirez LM, Ramacciotti E, Lassen MR, Wang L. Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups. J Thromb Haemost. 2013 Mar;11(3):444-51. doi: 10.1111/jth.12109.

ReferenceCitation: Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Brazil
Chile
France
Czech Republic
Colombia
Hungary
Denmark
Ukraine
India
Belgium
China
Malaysia
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel


title: A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

summary: This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, Tan DM, Chen XY, Gane E, Piratvisuth T, Chen L, Xie Q, Sung JJ, Wat C, Bernaards C, Cui Y, Marcellin P. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology. 2011 Nov;54(5):1591-9. doi: 10.1002/hep.24555.

location_country:
Germany
New Zealand
Hong Kong
Singapore
Australia
Brazil
United States
China
Korea, Republic of
Thailand
Taiwan
Russian Federation
France


type: Other Identifier

title: A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade

summary: The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.

lead_sponsor: Janssen-Cilag International NV

location_country: Germany Portugal Austria Belgium Spain Luxembourg Greece France


summary: This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

ReferenceCitation: Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.

ReferenceCitation: Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3. Erratum In: Obstet Gynecol. 2008 Dec;112(6):1392.

title: A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

location_country:
Finland
Hungary
Norway
Denmark
Sweden
Czech Republic
France


title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination With Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects With FIGO Stage IVB or Recurrent or Persistent Cervical Cancer With Zero or One Prior Chemotherapy Regimen

summary: This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

ReferenceCitation: Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.

ReferenceCitation: Monk BJ, Pandite LN. Survival data from a phase II, open-label study of pazopanib or lapatinib monotherapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2011 Dec 20;29(36):4845. doi: 10.1200/JCO.2011.38.8777. Epub 2011 Nov 14. No abstract available.

ReferenceCitation: de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Ireland
Italy
India
Argentina
Mexico
Belgium
United States
Spain
Thailand
Canada
Estonia
France


title: A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

ReferenceCitation: Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.

ReferenceCitation: Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.

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

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: Jazz Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Netherlands
United States
Spain
France

location_facility: Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie

location_facility: Clinical Research Group of St. Petersburg, Inc

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Anderson & Collins Clinical Research, Inc.

location_facility: Fibromyalgia Treatment Centers of America

location_facility: Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara

location_facility: Professional Clinical Research at Crystal Lake Health Center

location_facility: Hill Top Physicians Inc./Hightop Medical Research Center

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hopital Hotel Dieu service de medicine interne

location_facility: Hopital Claude Huriez Service de medecine interne

location_facility: Centre Catherine de Sienne unite d evaluation et de traitement de la douleur

location_facility: Professional Clinical Research, Inc. at Crystal Lake Health Center

location_facility: Praxis fur Innere Medizin und Rheumatologie


title: A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

summary: The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

ReferenceCitation: Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.

location_country:
Germany
Poland
Argentina
Australia
Canada
France
Hungary
Denmark
United States
Ukraine
India
Romania
Belgium
China
Norway
United Kingdom
Sweden
Mexico
Spain
Russian Federation
Israel

location_facility: Advanced Orthopedic And Sports Medicine Specilists


title: A Ten-week, Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled, Paralleled-Group, Flexible-Dose Study Evaluating the Efficacy, Safety and Tolerability of GSK372475 or Paroxetine Compared to Placebo in Adult Subjects Diagnosed With Major Depressive Disorder

summary: To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

ReferenceType: background

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Results of Two Double-Blind, Placebo- and Active-Controlled Studies of GSK372475, a Triple Monoamine Reuptake Inhibitor, in the Treatment of Major Depressive Disorder. [J Psychopharmacol EPublication ahead of print. DOI 10.1177/0269881111424931]. 2011;

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.

location_country:
Germany
Italy
Poland
India
Costa Rica
Croatia
Chile
Bulgaria
Canada
France


title: A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

summary:
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

ReferenceCitation: Mueller RB, Schulze-Koops H, Furst DE, Cohen SB, Kwok K, Wang L, Killeen T, von Kempis J. Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel). Clin Rheumatol. 2022 Apr;41(4):1045-1055. doi: 10.1007/s10067-021-05908-z. Epub 2022 Jan 1.

ReferenceCitation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

repositories_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.

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

publisher_dissemination: Oxford University Press

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_concat: PubMed Central;eprint.ncl.ac.uk

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Kaine J, Tesser J, Takiya L, DeMasi R, Wang L, Snyder M, Soma K, Fan H, Bandi V, Wollenhaupt J. Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis. Clin Rheumatol. 2020 Jul;39(7):2127-2137. doi: 10.1007/s10067-020-04956-1. Epub 2020 Feb 12.

ReferenceCitation: Wollenhaupt J, Lee EB, Curtis JR, Silverfield J, Terry K, Soma K, Mojcik C, DeMasi R, Strengholt S, Kwok K, Lazariciu I, Wang L, Cohen S. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019 Apr 5;21(1):89. doi: 10.1186/s13075-019-1866-2.

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: Seoul National University - Seoul National University Open Repository

ReferenceCitation: Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157.

ReferenceCitation: Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

ReferenceCitation: Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017.

ReferenceCitation: Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7.

ReferenceCitation: Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, Biswas P, Riese R, Takiya L, Jones TV. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016 Jun 23;18:145. doi: 10.1186/s13075-016-1049-3.

ReferenceCitation: Winthrop KL, Silverfield J, Racewicz A, Neal J, Lee EB, Hrycaj P, Gomez-Reino J, Soma K, Mebus C, Wilkinson B, Hodge J, Fan H, Wang T, Bingham CO 3rd. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis. 2016 Apr;75(4):687-95. doi: 10.1136/annrheumdis-2014-207191. Epub 2015 Mar 20.

ReferenceCitation: Boyle DL, Soma K, Hodge J, Kavanaugh A, Mandel D, Mease P, Shurmur R, Singhal AK, Wei N, Rosengren S, Kaplan I, Krishnaswami S, Luo Z, Bradley J, Firestein GS. The JAK inhibitor tofacitinib suppresses synovial JAK1-STAT signalling in rheumatoid arthritis. Ann Rheum Dis. 2015 Jun;74(6):1311-6. doi: 10.1136/annrheumdis-2014-206028. Epub 2014 Nov 14.

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Costa Rica
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
United States
Dominican Republic
Ukraine
India
Romania
Belgium
China
Malaysia
Peru
Puerto Rico
Philippines
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden

location_facility: State Healthcare Institution City Hospital # 40 of Administrative Health Resort District

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas

location_facility: Arthritis Care and Diagnostic Center, P.A.

location_facility: Rheuma-Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy

location_facility: "Multifield Medical Center of Odesa National Medical University ""University Clinic #1"""

location_facility: Reumatologicka ambulancia, REUMEX, s.r.o.

location_facility: Division of Allergy-Immunology-Rheumatology, Department of Medicine, Faculty of Medicine

location_facility: A.O.U. Careggi - SOD Medicina Interna 1 e Reumatologia

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S CIREEM S.A.S

location_facility: Charite Campus Mitte, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

location_facility: J.W.-Goethe-Universitaetsklinik, Medizinische Klinik II, Abteilung fuer Rheumatologie

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Studienambulanz Universitaetsklinikum Erlangen Medizinische Klinik 3

location_facility: University of Southern California (USC) Norris Comprehensive Cancer Center-

location_facility: Krishna Institute of Medical Sciences Ltd

location_facility: West Broward Rheumatology Associates, Inc.

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute

location_facility: Hospital Base Valdivia, Policlinico de Reumatologia

location_facility: Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Asheville Rheumatology & Osteoporosis Research Associates, PA

location_facility: Wojewodzki Zespol Reumatologiczny im. dr Jadwigi Titz-Kosko

location_facility: Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital

location_facility: Cincinnati Rheumatic Disease Study Group, Inc.

location_facility: Hospital Nacional IV Alberto Sabogal Sologuren

location_facility: Chanre Rheumatology and Immunology Center and Research

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Reumatologicka ambulancia, Nestatne zdravotnicke zariadenie

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Arthritis and Rheumatology of Georgia P.C.

location_facility: Clinical Research Center of Cape Cod, Inc.

location_facility: State Healthcare Institution Regional Clinical Hospital for War Veterans

location_facility: Skanes Universitetssjukhus i Malmo Reumamottagningen

location_facility: Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency

location_facility: St. John's Medical College and Hospital.

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.

location_facility: Schlosspark-Klinik Innere Medizin II, Rheumatologie

location_facility: Municipal Establishment "City Hospital#7of Zaporizhzhia State Medical University

location_facility: General Hospital Euromedica "KYANOUS STAVROS"

location_facility: Beijing Chaoyang Hospital, Capital University of Medical Science

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Reliant Medical Group, Inc. at Worcester Medical Center

location_facility: Arthritis and Rheumatology Consultants, P.A.

location_facility: State Institution Republican Clinical Hospital of the Ministry of Health of Ukraine

location_facility: IMA Brasil -Instituto de Pesquisa Clinica e Medicina Avancada

location_facility: Delaware Arthritis and Osteoporosis Center

location_facility: Klinikum der Universitaet Muenchen, Campus Innenstadt, Rheuma-Einheit

location_facility: ARTHROMED, s. r. o. Revmatologicka ambulance

location_facility: Investigacion y Biomedica de Chihuahua, SC

location_facility: Asan Medical Center-University of Ulsan College of Medicine

location_facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda

location_facility: Xiangya Hospital of Centre-south University

location_facility: Arthritis, Rheumatic & Back Disease Associates

location_facility: Revmatologichno Otdelenie, MBAL - Plovdiv

location_facility: Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR

location_facility: Arthritis Research Center, Royal University Hospital

location_facility: AAGS, s.r.o. , nestatne zdravotnicke zariadenie

location_facility: Daegu Catholic University Medical Center

location_facility: The Center for Rheumatology and Bone Research

location_facility: Professional Research Network of Kansas, LLC

location_facility: Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

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

location_facility: Arthritis Research and Care Foundation Centre for Rheumatic Diseases

location_facility: Reumatologicka ambulancia, Poliklinika Ruzinov

location_facility: "Consultative Diagnostic Rheumatology Center ""Healthy Joints"", LLC"

location_facility: Angeles University Foundation Medical Center

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: Xijing Hospital, The Fourth Military Medical University

location_facility: Southeastern Integrated Medical PL d/b/a Florida Medical Research Institute

location_facility: Universitair Ziekenhuis Gent - Reumatologie

location_facility: The Arthritis Program Research Group Inc.

location_facility: Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Reumatologia y Osteoporosis

location_facility: Centro Medico Corpac/Investigaciones en Reumatologia

location_facility: Wirral University Teaching Hospital NHS Foundation Trust-Arrowe Park Hospital

location_facility: Clinica Santa Maria, Seccion Reumatologia

location_facility: Fakultni Nemocnice Brno, Interni hematoonkologicka klinika

location_facility: NOVAPHARM s.r.o -Zeleznicna NaP, Reumatologicka ambulancia

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Oklahoma Medical Research Foundation (OMRF)

location_facility: University Hospital Split, Department for Internal Medicine, Division of Clinical Rheumatology

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Ltd.Medical Association "Novaya Bolnitsa"

location_facility: Queen Elizabeth Hospital, Department of Rheumatology

location_facility: The Third Affiliated Hospital of Sun Yat-Sen University

location_facility: MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Clinical Rheumathology Hospital #25"

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

location_facility: Louisiana State University Health Sciences Center

location_facility: Russian State Medical University Moscow Faculty City Clinical Hospital #4

location_facility: University of California San Diego Center for Innovative Therapy

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

location_facility: ClinicMed Badurski i wspolnicy Spolka Jawna

location_facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

location_facility: The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital

location_facility: Gangnam Severance Hospital-Yonsei University Health System

location_facility: Crimean Republican Institution "Clinical Territorial Medical Association "University Clinic",

location_facility: Centro de Investigacion Clinica de Morelia

location_facility: Centro de Diagnostico y Tratamiento Hospital San Borja Arriaran

location_facility: OMI- Organizacion Medica de Investigacion

location_facility: Ecclesia, s.r.o Reumatologicka ambulancia

location_facility: Municipal City Clinical Hospital #4, Policlinic Care

location_facility: Rheumatology Research Institute of Russian Academy of Medical Sciences

location_facility: Chanre Rheumatology & Immunology Center & Research

location_facility: Bronson Internal Medicine and Rheumatology

location_facility: Rheumatology Research Unit Sunshine Coast

location_facility: Peking University People's Hospital/Rheumatology and Immunology Department

location_facility: Universitaetsklinik Leipzig, Klinik fur Gastroenterologie und Rheumatologie, Sektion Rheumatologie

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

location_facility: West Island Rheumatology Research Associates

location_facility: DKTs "Sveta Anna" Sofia, Konsultativen kabinet po Revmatologia

location_facility: Federal North-West Medical Research Centre

location_facility: Krankenhaus Friedrichstadt, I. Medizinische Klinik

location_facility: Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

location_facility: Nestatna reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.

location_facility: Regional State Budgetary Healthcare Institution of Tomsk Regional Clinical Hospital

location_facility: Clinic of Cardiology and Rheumatology Military Medical Academy

location_facility: University of Perpetual Help Rizal Dalta Medical Center

location_facility: CRIMEAN Republican Institution, "Clinical Hospital n.a. M.O. Semashko"

location_facility: DKTs "Sveta Anna", Sofia / Diagnostic Consultative Center "Sveta Anna"

location_facility: Asheville Rheumatology & Osteoporosis Research Associates, P.A.

location_facility: Hospital Civil. Hospital Regional Universitario Carlos Haya

location_facility: Centro de Investigaciones Reumatologicas y Osteologicas -CIRO

location_facility: Orszagos Reumatologiai Es Fizioterapias Intezet

location_facility: Arthrocare, Arthritis Care & Research, PC

location_facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC

location_facility: Regional State Budget Institution Of Healthcare

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Jacksonville Center for Clinical Research

location_facility: St. Luke's Intermountain Research Center

location_facility: Stanford Health Services - Medical Specialty Clinics

location_facility: CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

location_facility: Centro de Reumatologia y Osteoporosis, Cartago

location_facility: State Educational Institution of Higher Professional Education

location_facility: De La Salle University Health Sciences Campus Clinical Epidemiology Unit

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Vinnitsa Regional Clinical Hospital n.a. Pirogov

location_facility: State Educational Institution of Higher Professional Education Ural State Medical Academy of Federal

location_facility: "Department of Infectious Diseases & Immunology

location_facility: Clinica de Enfermedades Cronicas y Procedimientos Especiales SC

location_facility: Centro de Estudos em Terapias Inovadoras

location_facility: Revmatologichen kabinet, DKTs Sveti Pantaleimon OOD

location_facility: Centro de Reumatologia y Ortopedia S.A.S.

location_facility: State Establishment "Institute of Gerontology of NAMS of Ukraine n.a. D.F. Chebotareva"

location_facility: Sozialmedizinisches Zentrum Sued - Kaiser Franz Josef Spital

location_facility: Arthritis Associates and Osteoporosis Center of Colorado Springs

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Center for Arthritis and Rheumatic Diseases

location_facility: Arthritis and Osteoporosis Associates, LLP

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Municipal Establishment of Health Care "Kharkiv City Clinical Hospital #8", Dept. of Rheumatology

location_facility: Clinic of Rheumatology Multiprofile Hospital for Active treatment Sveti Ivan Rilski

location_facility: "ZDROWIE OSTEO-MEDIC" s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik

location_facility: State Healthcare Institution Regional Clinical Hospital

location_facility: Universitaetsklinikum Koeln Klinik I fuer Innere Medizin, Haus 16, 1. OG, Raum 1.008

location_facility: Centro de Investigacion Clinica Especializada, SC

location_facility: Cividino Medicine Professional Corporation

location_facility: Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine

location_facility: OMI - Organización Médica de Investigación

location_facility: Multifield Medical Center of Odesa National Medical University "University Clinic #1"

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Chang Gung Medical Foundation-Linkou Branch


lead_sponsor: Shire

summary: The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.

ReferenceCitation: Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, Rodriguez T, Maertens J, Schmitt M, Einsele H, Ferrant A, Lipton JH, Villano SA, Chen H, Boeckh M; Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011 Apr;11(4):284-92. doi: 10.1016/S1473-3099(11)70024-X. Epub 2011 Mar 21. Erratum In: Lancet Infect Dis. 2011 May;11(5):343.

location_facility: University of Pittsburgh Cancer Institute

location_facility: Cliniques Universitaires St,Luc Dept Hematology

location_facility: Universitaetsklinikum Koeln, Clinic I for internal Medicine

location_facility: Ireland Cancer Center Case Western Reserve University

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Arkansas Myeloma Institute

location_facility: CHU Sart -Tilman Department of Medicine, Hematology

location_facility: Washington University School of Medicine

location_facility: New York Presbyterian Hospital,Weill Cornell Medical Center

location_facility: University Medical Center University of Louisville Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Kentucky Chandler Medical Center

title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.

location_country:
Germany
Italy
United Kingdom
Sweden
Belgium
United States
Spain
Canada
France


title: A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

summary: The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

ReferenceCitation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

location_country:
Germany
Italy
Singapore
Australia
Belgium
United States
Spain
France

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center

location_facility: Oregon Health & Science University StudyCoordinator:CEPO906A2229

location_facility: NorthWest Georgia Oncology Centers Marietta Center

location_facility: MD Anderson Cancer Center - Orlando CEPO906A2229

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: University of California San Diego Dept of Moores Cancer Center

location_facility: University Chicago Hospital StudyCoordinator:CEPO906A2229

location_facility: H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology


title: A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study

summary: The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

ReferenceCitation: Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, Sievert W, Wong D, Lovegren M, Cohen D, Llamoso C. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):619-628.e1. doi: 10.1053/j.gastro.2012.05.037. Epub 2012 May 27.

location_country:
Italy
Poland
India
Argentina
Australia
Brazil
Mexico
United States
South Africa
Turkey
Canada
Russian Federation
France

location_facility: Maryland Digestive Disease Research, Llc


title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

summary: The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

ReferenceCitation: Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.

location_country:
France
Germany
Italy
Poland
India
Denmark
Australia
Brazil
Netherlands
Mexico
Belgium
Switzerland
United States
South Africa
Canada
Puerto Rico
Czech Republic

location_facility: U Of Rochester Gastroenterology And Hepatology

location_facility: Gastroenterology Center Of The Midsouth, P.C.

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Gastrointestinal & Liver Diseases Consultants

location_facility: University Of North Carolina At Chapel Hill

location_facility: Kansas City Gastroenterology And Hepatology