ipd_sharing: Yes

acronym: ALTTO

intervention_type: Biological

title: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

lead_sponsor: Novartis Pharmaceuticals

type: Other Identifier

ReferenceCitation: Nader-Marta G, Debien V, Eiger D, Tsourti Z, Caparica R, Kassapian M, Napoleone S, Hultsch S, Korde L, Wang Y, Chumsri S, Pritchard KI, Untch M, Bellet-Ezquerra M, Dornelles Rosa D, Moreno-Aspitia A, Piccart M, Dafni U, de Azambuja E. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.

ReferenceCitation: Moreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.

ReferenceCitation: Sonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23.

ReferenceCitation: Eiger D, Pondé NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Láng I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16.

ReferenceCitation: Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195.

ReferenceCitation: McCullough AE, Dell'orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb;143(3):485-92. doi: 10.1007/s10549-013-2827-0. Epub 2014 Jan 7.

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

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

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Norway
Malaysia
Singapore
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Estonia
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands
Pakistan

summary:
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema.

The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Comparing the Efficacy of Bevacizumab in Combination With Rituximab and CHOP (R-CHOP + Bevacizumab) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

summary: This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602.

ReferenceCitation: Seymour JF, Pfreundschuh M, Trnĕný M, Sehn LH, Catalano J, Csinady E, Moore N, Coiffier B; MAIN Study Investigators. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014 Aug;99(8):1343-9. doi: 10.3324/haematol.2013.100818. Epub 2014 Jun 3.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Philippines
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Panama
Mexico
Malaysia
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
New Zealand
Ecuador
Thailand
Korea, Republic of
France
Colombia

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: First Affiliated Hospital of Soochow University

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: St Antonius Hospital; Haematologie/Onkologie

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: National Cancer Inst. ; Dept. of Chemotherapy

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

location_facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

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

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

location_facility: Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Research Inst. of Hematology & Blood Transfusion ; Hematology

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Royal Hallamshire Hospital; Haematology Dept

location_facility: Szpital Uniwersytecki W Krakowie; Klinika Hematologii

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

location_facility: Institut Gustave Roussy; Unite D'Hematologie

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Instituto Cancerologia Medellin; Clinica Las Americas

location_facility: Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika

location_facility: Christchurch Hospital; Canterbury Health Laboratories

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: University of Colorado Cancer Center Department of Hematology

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Hospital Carlos Andrade Marin; Servicio de Oncología

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Univ. Cattolica La Sapienza; Cattedra Di Ematologia

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Hospital das Clinicas - UFRGS; Hematologia

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology

location_facility: Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

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

location_facility: Uni of California - San Diego; Cancer Center & Dept of Medicine

location_facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

location_facility: Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych

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

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Hospital Universitario la Fe; Servicio de Medicina Intena

location_facility: Uni of Texas Southwestern Medical Center

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia

location_facility: Chu Estaing; Cons Hemato Medecine Interne

location_facility: Border Medical Oncology; Murray Valley Private Hospital

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Fakultni nemocnice Olomouc; Hemato-onkologicka klinika

location_facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hospital de Basurto; Servicio de Hematologia

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Helios Klinik Wuppertal; Medizinische Klinik I

location_facility: Semashko Central Clinical Hospital Moscow; Hematology

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Veterans General Hospital; Division of Oncology

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: St.-Marien-Hospital Klinik Knappenstraße; Klinik für Hämatologie und Onkologie

location_facility: Krankenhaus Nordwest Medizinische Klinik

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Hospital de Sao Joao; Servico de Hematologia Clinica

location_facility: St Marien Krankenhaus; Medizinische Klinik Iii

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Eberhard-Karls-Universität Tübingen; Medizinische Klinik I

location_facility: St. Joseph Mercy Hospital; Department of Oncology

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Asklepios Klinik St. Georg; Allgemeine Innere Medizin

location_facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: Carl-Thiem-Klinik Cottbus; Medizinische Klinik

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Fakultni nemocnice Brno; Interni hematoonkologicka klinika

location_facility: VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Hopital de L'Archet; Hematologie Clinique

location_facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Kliniken St. Antonius; Zentrum Für Innere Medizin, Haematologie/Onkologie

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Tianjin Institute of Hematology & Blood Diseases Hospital

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Birmingham Heartlands Hospital; Department of Haematology

location_facility: Greenslopes Private Hospital; Gallipoli Research Centre

location_facility: Col Instituto Tecnologico Y Estudios Superiores de Monterrey

location_facility: KRH Klinikum Siloah Medizinische Klinik III

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A

location_facility: North Hampshire Hospital; Dept. of Haematology

location_facility: Bradford Royal Infirmary; Haematology Department

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Haematology Research Center; Haematology

location_facility: Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik

location_facility: Alfred Hospital; Bone Marrow Transplant Unit

location_facility: Uni of Auckland; Dept of Molecular Medicine & Haematology

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Clinique Pont de Chaume; Oncologie Et Radiotherapie

location_facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia

location_facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: National Kidney and Transplant Institute; Chemotherapy Unit

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Hospital Mutua de Terrassa; Servicio de Hematologia

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: Kath.Krankenhaus Hagen gem.GmbH St.-Marien-Hospital

location_facility: St. Johannes Hospital; Abt. Innere Medizin

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Princess Alexandra Hospital; Department of Haematology

location_facility: Uni Hospital Santariskiu Clinic; Haematology

location_facility: Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia

location_facility: Severance Hospital - Yonsei University; Medicine Dept.

location_facility: University of Kansas Medical Center; Department of Hematology

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

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

location_facility: Ospedale Ferrarotto; Divisione Di Ematologia

location_facility: Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii

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

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Fov. Onk. Egyesitett Szent Istvan es Szent Laszlo Korhaz; Dept Of Bone Marrow Transplant

location_facility: Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

location_facility: Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia

location_facility: Hospital Nacional Guillermo Almenara Irigoyen; Oncology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Centre Hospitalier Uni Ire; Service de Medecine D

location_facility: Universitätsspital Zürich; Klinik für Onkologie

location_facility: Uni Medical Center; Division Of Hemotology/Oncology

location_facility: DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie

location_facility: Royal Liverpool Uni Hospital; Haematology

location_facility: Medical University School; Dept. of Haematology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

location_facility: Evang.Krankenhaus Abt. Hämatologie und Onkologie

location_facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: Registry Identifier

title: ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

status: Completed

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Dhillon S. Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs. 2012 May 7;72(7):917-30. doi: 10.2165/11208940-000000000-00000. Review.

ReferenceType: result

ReferenceCitation: Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stähle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. doi: 10.1056/NEJMoa1103799. Erratum in: N Engl J Med. 2012 Jan 19;366(3):284.

ReferenceCitation: Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.

lead_sponsor: Medical Research Council

location_country:
United Kingdom
Australia
France
Norway
Germany

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: St. Luke's Cancer Centre at Royal Surrey County Hospital

location_facility: Charite University Hospital - Campus Virchow Klinikum

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Princess Royal Hospital at Hull and East Yorkshire NHS Trust

location_facility: Klinikum Dorothea Christiane Erxleben - Quedlingburg

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Portsmouth Oncology Centre at Saint Mary's Hospital

location_facility: Cancer Therapy Centre at Liverpool Hospital

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Mid Kent Oncology Centre at Maidstone Hospital

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Praxis Fuer Haemotologie Und Internistischer Onkologie

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Centre for Cancer Research and Cell Biology at Queen's University Belfast

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Kreiskrankenhaus Leonberg - Frauenklinik

location_facility: Gloucestershire Oncology Centre at Cheltenham General Hospital

location_facility: Murray Valley Private Hospital and Cancer Treatment Centre

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

status_simplified: Completed


title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

lead_sponsor: GlaxoSmithKline

type: EudraCT Number

source: euctr

ReferenceCitation: Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27.

ReferenceCitation: Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNγ Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.

ReferenceCitation: Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Ireland
Estonia
Finland
Thailand
Korea, Republic of
France
Netherlands

summary: The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


title: Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

acronym: RHAPSODY

summary:
Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study:

Subjects who failed another TNF inhibitor (etanercept, infliximab)
Subjects with advanced spinal ankylosis
Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

ReferenceCitation: Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.

ReferenceCitation: Rudwaleit M, Claudepierre P, Kron M, Kary S, Wong R, Kupper H. Effectiveness of adalimumab in treating patients with ankylosing spondylitis associated with enthesitis and peripheral arthritis. Arthritis Res Ther. 2010;12(2):R43. doi: 10.1186/ar2953. Epub 2010 Mar 15.

ReferenceCitation: Rudwaleit M, Claudepierre P, Wordsworth P, Cortina EL, Sieper J, Kron M, Carcereri-De-Prati R, Kupper H, Kary S. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol. 2009 Apr;36(4):801-8. doi: 10.3899/jrheum.081048. Epub 2009 Feb 27.

ReferenceCitation: Rudwaleit M, Rødevand E, Holck P, Vanhoof J, Kron M, Kary S, Kupper H. Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study. Ann Rheum Dis. 2009 May;68(5):696-701. doi: 10.1136/ard.2008.092585. Epub 2008 Jul 28.

lead_sponsor: Abbott

location_country:
Denmark
Spain
Greece
Austria
Ireland
Italy
Finland
Netherlands
Switzerland
United Kingdom
Sweden
France
Belgium
Norway
Germany


title: APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

acronym: APPLES

summary: This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019

ipd_sharing: No

lead_sponsor: LEO Pharma

location_country:
Poland
United Kingdom
Ireland
Austria
Netherlands
Canada
United States
France
Germany

location_facility: University of N. Texas Health Science Center

location_facility: Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden

location_facility: Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie

location_facility: Leeds General Infirmary, Dept of Dermatology

location_facility: Allergy Associates, PA dba East Tennessee Center for Clinical Research

location_facility: Johns Hopkins University, Division of Pediatric Dermatolgy

location_facility: Harrogate & District Foundation NHS Trust Hospital

location_facility: Helendale Dermatology & Medical Spa, LLC

location_facility: Wales College of Medicine, Cardiff University, Heath Park

location_facility: Asthma & Allergy Center of North Jackson

location_facility: Amersham Hospital, Department of Dermatology

location_facility: Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie

location_facility: Capital Allergy & Respiratory Disease Center

location_facility: Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie

location_facility: Wake Forest University School of Medicine

location_facility: Haber Dermatology and Cosmetic Surgery, Inc

location_facility: University Dermatology Consultants, Inc.

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Children's Hospital of the Kings Daughters

location_facility: Cabinet de Dermatologie - Boulogne-Sur-Mer

location_facility: North Florida Dermatology Associates, P.A.

location_facility: Carolina Dermatology & Skin Cancer Surgery

location_facility: NZOZ Przychodnia Dermatologiczna DERMED s.c

location_facility: Fort Lauderdale Dermatology & Cosmetic Skin Center

location_facility: Dermatology Treatment and Research Center, PA

location_facility: Lubbock Dermatology and Skin Cancer Center

location_facility: HOPITAL CHARLES NICOLLE Service de Dermatologie

location_facility: Eastern Canada Cutaneous Research Association

location_facility: Department of Pediatric Allergy and Immunology

location_facility: Midwest Center for Dermatology and Cosmetic Surgery

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten

location_facility: Columbia University Medical Center., Dept. of Medicine

location_facility: Hautklinik des Universitaetsklinikums Erlangen

location_facility: North Texas Institute for Clinical Trials

location_facility: Dermatology Research Associates of Tyler

location_facility: Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A"

location_facility: Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie

location_facility: Georgia Pollens Clinical Research Centers, Inc

location_facility: Dermatology and Laser Center of Charleston

location_facility: Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem

location_facility: Allergy Associates of the Palm Beaches, PA

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Centre Hospitalier Service de Dermatologie

location_facility: Oklahoma University Health Sciences Center

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: University of Miami Miller School of Medicine

location_facility: SPZOZ Szpital Specjalistyczny im. S. Zeromskiego

location_facility: Pediatric & Adult Asthma and Allergy, P.C.

location_facility: University of Manchester, Dermatology-Pharmacology Unit Hope Hospital

location_facility: Richter - Fachaerztin fuer Kinder- und Jugendmedizin

location_facility: Dermatology Center for Children and Young Adults

location_facility: University of Arkansas for Medical Sciences

location_facility: AeroAllergy Research Labs of Savannah, Inc.

location_facility: Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital

location_facility: Connecticut Children's Medical Center Dept of Dermatology

location_facility: Universitaet Bonn Klinik und Poliklinik fuer Dermatologie

location_facility: National Allergy and Asthma Research, LLC


acronym: PERFlexS

title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

lead_sponsor: Janssen-Cilag International NV

ReferenceCitation: Schreiner A, Lahaye M, Peuskens J, Naber D, Dilbaz N, Millet B, Franco MA, Rancans E, Turczynski J, Smeraldi E, Lara E, Neznanov NG. Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Expert Opin Pharmacother. 2014 Apr;15(5):593-603. doi: 10.1517/14656566.2014.884071. Epub 2014 Feb 3.

location_country:
Croatia
Serbia
Spain
United Kingdom
Lithuania
Belgium
Poland
Portugal
Russian Federation
Israel
Turkey
Sweden
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Finland
France
Netherlands

summary: The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.


title: A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis

summary: The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

lead_sponsor: Pfizer

location_country:
Denmark
United Kingdom
Italy
Netherlands
Finland
Sweden
France
Norway
Germany

intervention_type: Device


title: Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

summary: This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crinò L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.

ReferenceCitation: Crinò L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Venezuela
Iceland
Romania
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Latvia
Estonia
Ecuador
Czech Republic
Finland
France
Colombia
Netherlands


title: An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

summary: This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.

ReferenceCitation: Xu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Slovakia
Egypt
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Latvia
Estonia
Ecuador
Czech Republic
Finland
France
Colombia
Netherlands
Morocco


title: An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications

summary: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

ReferenceCitation: Leizorovicz A, Becker F, Buchmüller A, Quéré I, Prandoni P, Decousus H; CALISTO Study Group. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2013 Sep 5;122(10):1724-9. doi: 10.1182/blood-2013-04-498014. Epub 2013 Jul 2.

ReferenceCitation: Decousus H, Prandoni P, Mismetti P, Bauersachs RM, Boda Z, Brenner B, Laporte S, Matyas L, Middeldorp S, Sokurenko G, Leizorovicz A; CALISTO Study Group. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010 Sep 23;363(13):1222-32. doi: 10.1056/NEJMoa0912072.

location_country:
Poland
Spain
Greece
Italy
Estonia
Latvia
Netherlands
Czech Republic
Russian Federation
Switzerland
Ukraine
Hungary
France
Israel
Germany
Bulgaria
Slovakia


title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

lead_sponsor: Bayer

ReferenceCitation: EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

ReferenceCitation: Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28. Review.

ReferenceCitation: Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013 Jul 6;11(1):13. doi: 10.1186/1477-9560-11-13.

ReferenceCitation: Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.

ReferenceCitation: Wang Y, Wang C, Chen Z, Zhang J, Liu Z, Jin B, Ying K, Liu C, Shao Y, Jing Z, Meng IL, Prins MH, Pap AF, Müller K, Lensing AW; Chinese EINSTEIN Investigators. Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies. Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.

ReferenceCitation: Bamber L, Wang MY, Prins MH, Ciniglio C, Bauersachs R, Lensing AW, Cano SJ. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013 Oct;110(4):732-41. doi: 10.1160/TH13-03-0243. Epub 2013 Jul 11.

ReferenceCitation: van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AW. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.

ReferenceCitation: Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.

ReferenceCitation: Yang L, Wu J. Cost-effectiveness of rivaroxaban compared with enoxaparin plus warfarin for the treatment of hospitalised acute deep vein thrombosis in China. BMJ Open. 2020 Jul 30;10(7):e038433. doi: 10.1136/bmjopen-2020-038433.

ReferenceCitation: Ten Cate H, Lensing AWA, Weitz JI, Middeldorp S, Beyer-Westendorf J, Kubitza D, Brighton T, Raskob GE, Mismetti P, Prandoni P, Gebel M, Prins MH. The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients. Thromb Res. 2018 Oct;170:75-83. doi: 10.1016/j.thromres.2018.08.008. Epub 2018 Aug 15.

ReferenceCitation: Di Nisio M, Vedovati MC, Riera-Mestre A, Prins MH, Mueller K, Cohen AT, Wells PS, Beyer-Westendorf J, Prandoni P, Bounameaux H, Kubitza D, Schneider J, Pisters R, Fedacko J, Fontes-Carvalho R, Lensing AW. Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies. Thromb Haemost. 2016 Sep 27;116(4):739-46. doi: 10.1160/TH16-02-0087. Epub 2016 Aug 18.

ReferenceCitation: Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.

ReferenceCitation: Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap ÁF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.

ReferenceCitation: Bauersachs RM, Lensing AW, Prins MH, Kubitza D, Pap ÁF, Decousus H, Beyer-Westendorf J, Prandoni P. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014 Nov 24;12:25. doi: 10.1186/1477-9560-12-25. eCollection 2014.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
South Africa
Poland
Hong Kong
Austria
Australia
Indonesia
Puerto Rico
India
Israel
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

summary: This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).


ReferenceCitation: EINSTEIN-PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Philippines
South Africa
Poland
Hong Kong
Austria
Australia
Indonesia
Puerto Rico
India
Israel
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Latvia
Estonia
New Zealand
Finland
Czech Republic
Andorra
Thailand
Korea, Republic of
France
Netherlands

summary: This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).


primary_purpose: Prevention

acronym: The Einstein-Extension Study

title: Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

ReferenceCitation: Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
South Africa
Poland
Hong Kong
Austria
Australia
Indonesia
India
Israel
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France
Netherlands

summary: This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).


type: Other Grant/Funding Number

title: Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo).

summary: Maintenance treatment of myeloma.

ReferenceCitation: Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42.

ReferenceCitation: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

lead_sponsor: University Hospital, Toulouse

location_country: France Switzerland Belgium

location_facility: Center of Oncology/Hematology and transfusion Medicine, Kantonsspital

location_facility: Institute of Oncology and Hematology Stadtspital Triemli

location_facility: Onkologie/Hämatologie Kantonsspital st Gallen

location_facility: Centre hospitalier de la région d'Annecy

location_facility: Centre hospitalier Argenteuil Victor Dupouy

location_facility: Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli

lead_sponsor_type: academique


title: A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

summary: To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

design_allocation: Non-Randomized

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
United Kingdom
United States
Costa Rica
Belgium
Romania
Hong Kong
Portugal
Austria
Australia
Argentina
Puerto Rico
India
Mexico
Malaysia
Canada
Switzerland
Germany
Taiwan
Dominican Republic
Greece
Ireland
France
Chile
Netherlands

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Infectious Diseases Associates of Central Virginia

location_facility: Department of HIV Medicine (I D Clinic), Jaslok Hospital & Research Centre

location_facility: Infectious Disease Associates of Memphis

location_facility: Desert Medical Group, Clinical Research Center

location_facility: Maternal-Child and Adolescent Clinic of Infectious Diseases and Virology

location_facility: Clinica Universitaria di Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: SOD Malattie Infettive, La Piastra dei Servizi

location_facility: Tarrant County Infectious Disease Associates

location_facility: Spitalul de Boli Infectioase si Tropicale Victor Babes

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Istituto di Malattie Infettive e Tropicali

location_facility: Cliniques Universitaires Saint-Luc, Maladies Infectieuses

location_facility: Instituut voor Tropische Geneeskunde, Inwendige Geneeskunde

location_facility: Internal Medicine Associates of Lee County

location_facility: Uni. Politecnica delle Marche, Ist. Malattie Infettive e Medicina P.

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Orange County Center for Special Immunology

location_facility: Instituto Dominicano de Estudios Virologicos

location_facility: Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde

location_facility: Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

location_facility: Kansas University Internal Medicine Midtown Clinic

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Garden State Infectious Disease Associates, PA

location_facility: Hopital Pellegrin - Service des Maladies Infectieuses et Medecine Interne

location_facility: Medizinische Hochschule Hannover, Klinische Immunologie, Zentrum Innere Medizin

location_facility: YR Gaitonde Centre for AIDS Research and Education (YRG CARE)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Toledo - Health Science Campus

location_facility: University Hepatitis Center at Bach & Godofsky, MD,PA

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: Hospital General Universitario de Alicante

location_facility: Fundacion Huesped, Departamento de Investigacion Clinica

location_facility: The Office of Dr. Gordon E. Crofoot, MD.

location_facility: IRCCS Lazzaro Spallanzani, Istituto Nazionale per le Malattie Infettive

location_facility: Dipartimento di Malattie Infettive e Tropicali, Universita' di Roma La Sapienza

location_facility: Clinica Malattie Infettive e Tropicali, Universita' degli Studi di Modena Reggio Emilia

location_facility: Denver Infectious Disease Consultants, PLLC

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Erlmed Corp ABA Lim-Keith Muiltispecialty Clinic Inc.

location_facility: Sozialmedizinisches Zentrum Baumgartner Hoehe / 2. Interne Lungenabteilung

location_facility: Universita'Cattolica del Sacro Cuore Policlinico Gemelli

location_facility: Kaiser Permanente-Northwest Region, Immune Deficiency Clinic

location_facility: Community Research Initiative of New England

location_facility: Centre Hospitalier Universitaire Saint-Pierre, Maladies Infectieuses

location_facility: Instituto Nacional de Ciencias Medicas Y Nutricion Dr Salvador Zubiran

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Spitalul Clinic de Boli Infectioase Constanta

location_facility: Clinical Alliance for Research & Education - Infectious Diseases

location_facility: IRCCS Lazzaro Spallanzani Istituto Nazionale per le Malattie Infettive

location_facility: Unita' Operativa Clinica Malattie Infettive, Dipartimento di Medicina Interna e Malattie Infettive

location_facility: Chu Pontchaillou, Service des maladies infectieuses

location_facility: Spitalul Clinic de Boli Infectioase Sf. Parascheva

location_facility: Centre Hospitalier Cochin Saint Vincent de Paul

location_facility: Complejo Hospitalario Nuestra Señora de Valme

location_facility: Universitaetsklinikum Essen, HIV-Ambulanz, Hautklinik

location_facility: Landeskrankenhaus Graz West / Abteilung fuer Innere Medizin 1

location_facility: Unita Operativa di Malattie Infettive e Tropicali

location_facility: IRCCS Lazzaro Spallanzani Istituto Nazionale per la Malattie Infettive

location_facility: North Shore University Hospital, Department of Infectious Disease

location_facility: Hôpital Necker-Service des Maladies Infectieuses et Tropicales

location_facility: Institutul de Boli Infectioase "Prof. Matei Bals"

location_facility: Universita' degli Studi di Bari, Clinica Malattie Infettive, Policlinico

location_facility: Hamilton Health Sciences - McMaster University Medical Centre

location_facility: Canadian Immunodeficiency Research Collaborative

location_facility: The Office of Dr. Nicholaos C. Bellos, MD

location_facility: Fundación para el Desarrollo de la Lucha contra el SIDA

location_facility: Brighton and Sussex University Hospitals NHS Trust, The Elton John Centre

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: Reparto di Malattie Infettive, Azienda Sanitaria Locale

location_facility: The Office of Dr. Daniel R. Coulston, MD

location_facility: General Hospital of Athens G. Gennimatas

location_facility: Daniel Warner M.D., P.A. Consultive Medicine

location_facility: Universitair Ziekenhuis Gent, Inwendige Geneeskunde

location_facility: The Office of Dr. Zale P. Bernstein, MD.

location_facility: Universitaetsklinikum Koeln, Klinik I fuer Innere Medizin,

location_facility: Department of Medicine, St. John's Medical College Hospital

location_facility: Gemeinschaftspraxis Dres. Rump und Usadel

location_facility: Hopital Bichat-Claude Bernard, Service des Maladies Infectieuses

location_facility: Centre Hospitalier Universitaire de Charleroi, Médecine Interne

location_facility: Hospital Regional Lic. Adolfo Lopez Mateos

location_facility: Policlinico Tor Vergata, Divisione Malattie Infettive

location_facility: South Dayton Acute Care Consultants Inc.

location_facility: Clinical Research Unit, Infectious Diseases

location_facility: Department of Infectious Disease, E-Da Hospital

location_facility: Arcispedale S. Anna Azienda Ospedaliera Universitaria di Ferrara

location_facility: University of Oklahoma - Schusterman Clinic

location_facility: Hopital de l'Hotel-Dieu, Service d'Hepato-Gastroenterologie

location_facility: Fund. de Gest. Sanitaria de L' Hospital de La Sta. Creu I Sant Pau

location_facility: Department of Medicine Queen Elizabeth Hospital

location_facility: The University of Texas Health Sciences Center at Houston

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Dipartimento di Scienze Cliniche, Divisione Clinicizzata Malattie Infettive


title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.

ReferenceCitation: Louis E, Löfberg R, Reinisch W, Camez A, Yang M, Pollack PF, Chen N, Chao J, Mulani PM. Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn's disease: results from the CARE trial. J Crohns Colitis. 2013 Feb;7(1):34-43. doi: 10.1016/j.crohns.2012.02.017. Epub 2012 Apr 4.

location_country:
Denmark
Portugal
Spain
Greece
Austria
Ireland
Italy
Finland
Czech Republic
Switzerland
United Kingdom
Sweden
France
Belgium
Norway
Germany
Slovakia

location_facility:
Site Ref # / Investigator 3066
Site Ref # / Investigator 4595
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Site Ref # / Investigator 2970
Site Ref # / Investigator 4591
Site Ref # / Investigator 3083
Site Ref # / Investigator 4351
Site Ref # / Investigator 2978
Site Ref # / Investigator 3090
Site Ref # / Investigator 3953
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Site Ref # / Investigator 2974
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Site Ref # / Investigator 3036
Site Ref # / Investigator 2983
Site Ref # / Investigator 4606
Site Ref # / Investigator 4383
Site Ref # / Investigator 3595
Site Ref # / Investigator 3005
Site Ref # / Investigator 4578
Site Ref # / Investigator 4581
Site Ref # / Investigator 3493
Site Ref # / Investigator 3325
Site Ref # / Investigator 3007
Site Ref # / Investigator 3093
Site Ref # / Investigator 3326
Site Ref # / Investigator 3033
Site Ref # / Investigator 4972
Site Ref # / Investigator 3045
Site Ref # / Investigator 2969
Site Ref # / Investigator 3617
Site Ref # / Investigator 3042
Site Ref # / Investigator 3011
Site Ref # / Investigator 2982
Site Ref # / Investigator 3500
Site Ref # / Investigator 3089
Site Ref # / Investigator 3052
Site Ref # / Investigator 2972
Site Ref # / Investigator 3051
Site Ref # / Investigator 3773
Site Ref # / Investigator 2973
Site Ref # / Investigator 4659
Site Ref # / Investigator 3014
Site Ref # / Investigator 3484
Site Ref # / Investigator 3324
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Site Ref # / Investigator 4597
Site Ref # / Investigator 3034
Site Ref # / Investigator 2979
Site Ref # / Investigator 3023
Site Ref # / Investigator 3896
Site Ref # / Investigator 4579
Site Ref # / Investigator 4626
Site Ref # / Investigator 3055
Site Ref # / Investigator 2995
Site Ref # / Investigator 3072
Site Ref # / Investigator 3022
Site Ref # / Investigator 3013
Site Ref # / Investigator 2976
Site Ref # / Investigator 3041
Site Ref # / Investigator 4353
Site Ref # / Investigator 3062
Site Ref # / Investigator 4275
Site Ref # / Investigator 2988
Site Ref # / Investigator 3017
Site Ref # / Investigator 3893
Site Ref # / Investigator 3618
Site Ref # / Investigator 3075
Site Ref # / Investigator 3082
Site Ref # / Investigator 3016
Site Ref # / Investigator 2991
Site Ref # / Investigator 3027
Site Ref # / Investigator 4586
Site Ref # / Investigator 3000
Site Ref # / Investigator 3064
Site Ref # / Investigator 3094
Site Ref # / Investigator 3048
Site Ref # / Investigator 3073
Site Ref # / Investigator 3035
Site Ref # / Investigator 4588
Site Ref # / Investigator 3065
Site Ref # / Investigator 4359
Site Ref # / Investigator 3489
Site Ref # / Investigator 3015
Site Ref # / Investigator 3625
Site Ref # / Investigator 3076
Site Ref # / Investigator 3081
Site Ref # / Investigator 2990
Site Ref # / Investigator 3037
Site Ref # / Investigator 4590
Site Ref # / Investigator 2977
Site Ref # / Investigator 2989
Site Ref # / Investigator 3085
Site Ref # / Investigator 2999
Site Ref # / Investigator 4357
Site Ref # / Investigator 3044
Site Ref # / Investigator 4589
Site Ref # / Investigator 2994
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Site Ref # / Investigator 3077
Site Ref # / Investigator 3057
Site Ref # / Investigator 3029
Site Ref # / Investigator 3368
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Site Ref # / Investigator 3895
Site Ref # / Investigator 3026
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Site Ref # / Investigator 2986
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Site Ref # / Investigator 2998
Site Ref # / Investigator 2993
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Site Ref # / Investigator 3794
Site Ref # / Investigator 3070
Site Ref # / Investigator 3078
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Site Ref # / Investigator 3596
Site Ref # / Investigator 3086
Site Ref # / Investigator 2997
Site Ref # / Investigator 2981
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Site Ref # / Investigator 3025
Site Ref # / Investigator 2996
Site Ref # / Investigator 4584
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Site Ref # / Investigator 2980
Site Ref # / Investigator 3620
Site Ref # / Investigator 3623
Site Ref # / Investigator 3079
Site Ref # / Investigator 3019
Site Ref # / Investigator 3053
Site Ref # / Investigator 4603
Site Ref # / Investigator 3056
Site Ref # / Investigator 3488
Site Ref # / Investigator 4660
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Site Ref # / Investigator 3088
Site Ref # / Investigator 3071
Site Ref # / Investigator 3049
Site Ref # / Investigator 2975
Site Ref # / Investigator 3892
Site Ref # / Investigator 3097
Site Ref # / Investigator 3448
Site Ref # / Investigator 3594
Site Ref # / Investigator 3322
Site Ref # / Investigator 3043
Site Ref # / Investigator 3031
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Site Ref # / Investigator 4598
Site Ref # / Investigator 3619
Site Ref # / Investigator 3087
Site Ref # / Investigator 3498
Site Ref # / Investigator 3003
Site Ref # / Investigator 3030
Site Ref # / Investigator 4607
Site Ref # / Investigator 3002
Site Ref # / Investigator 3032
Site Ref # / Investigator 3047
Site Ref # / Investigator 4657
Site Ref # / Investigator 3008
Site Ref # / Investigator 3050


title: A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ReferenceCitation: Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.

ReferenceCitation: Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.

ReferenceCitation: Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.

ReferenceCitation: Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Impact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF. Am Heart J. 2018 Jun;200:102-109. doi: 10.1016/j.ahj.2018.02.013. Epub 2018 Feb 27.

ReferenceCitation: Leef GC, Hellkamp AS, Patel MR, Becker RC, Berkowitz SD, Breithardt G, Halperin JL, Hankey GJ, Hacke W, Nessel CC, Singer DE, Fox KAA, Mahaffey KW, Piccini JP. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial. J Am Heart Assoc. 2017 Jun 14;6(6). pii: e004663. doi: 10.1161/JAHA.116.004663.

ReferenceCitation: Balla SR, Cyr DD, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial). Am J Cardiol. 2017 Jun 15;119(12):1989-1996. doi: 10.1016/j.amjcard.2017.03.028. Epub 2017 Mar 29.

ReferenceCitation: Sun Y, Hu D, Stevens S, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Fox KAA, Patel MR. Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial. Thromb Res. 2017 Aug;156:184-190. doi: 10.1016/j.thromres.2017.04.010. Epub 2017 Apr 13.

ReferenceCitation: Lindner SM, Fordyce CB, Hellkamp AS, Lokhnygina Y, Piccini JP, Breithardt G, Mahaffey KW, Singer DE, Hacke W, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Becker RC, Fox KA, Patel MR; ROCKET AF Steering Committee and Investigators. Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin: A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis. Circulation. 2017 Mar 7;135(10):1001-1003. doi: 10.1161/CIRCULATIONAHA.116.024666.

ReferenceCitation: Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC, Berkowitz SD, Breithardt G, Fox KA, Mahaffey KW, Nessel CC, Singer DE, Patel MR; ROCKET AF Steering Committee and Investigators. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation. 2016 Jul 5;134(1):37-47. doi: 10.1161/CIRCULATIONAHA.116.021890. Erratum in: Circulation. 2016 Aug 23;134(8):e114. Erratum in: Circulation. 2020 Feb 25;141(8):e98.

ReferenceCitation: Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL, Breithardt G, Singer DE, Hankey GJ, Hacke W, Becker RC, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Steering Committee & Investigators; ROCKET AF Steering Committee Investigators. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016 Mar 8;5(3):e002197. doi: 10.1161/JAHA.115.002197.

ReferenceCitation: Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Lokhnygina Y, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Califf RM, Fox KA, Patel MR; ROCKET AF Steering Committee & Investigators. Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban. Heart. 2016 Jul 1;102(13):1036-43. doi: 10.1136/heartjnl-2015-308120. Epub 2016 Feb 17.

ReferenceCitation: Piccini JP, Hellkamp AS, Washam JB, Becker RC, Breithardt G, Berkowitz SD, Halperin JL, Hankey GJ, Hacke W, Mahaffey KW, Nessel CC, Singer DE, Fox KA, Patel MR. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2016 Jan 26;133(4):352-60. doi: 10.1161/CIRCULATIONAHA.115.018544. Epub 2015 Dec 16.

ReferenceCitation: Bansilal S, Bloomgarden Z, Halperin JL, Hellkamp AS, Lokhnygina Y, Patel MR, Becker RC, Breithardt G, Hacke W, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Piccini JP, Mahaffey KW, Fox KA; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J. 2015 Oct;170(4):675-682.e8. doi: 10.1016/j.ahj.2015.07.006. Epub 2015 Jul 17.

ReferenceCitation: Washam JB, Stevens SR, Lokhnygina Y, Halperin JL, Breithardt G, Singer DE, Mahaffey KW, Hankey GJ, Berkowitz SD, Nessel CC, Fox KA, Califf RM, Piccini JP, Patel MR; ROCKET AF Steering Committee and Investigators. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet. 2015 Jun 13;385(9985):2363-70. doi: 10.1016/S0140-6736(14)61836-5. Epub 2015 Mar 6.

ReferenceCitation: Singer DE, Hellkamp AS, Yuan Z, Lokhnygina Y, Patel MR, Piccini JP, Hankey GJ, Breithardt G, Halperin JL, Becker RC, Hacke W, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2015 Mar 3;4(3):e001349. doi: 10.1161/JAHA.114.001349.

ReferenceCitation: Girgis IG, Patel MR, Peters GR, Moore KT, Mahaffey KW, Nessel CC, Halperin JL, Califf RM, Fox KA, Becker RC. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF. J Clin Pharmacol. 2014 Aug;54(8):917-27. doi: 10.1002/jcph.288. Epub 2014 Mar 26.

ReferenceCitation: Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.

ReferenceCitation: Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KA, Califf RM; ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.

ReferenceCitation: Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.

ReferenceCitation: van Diepen S, Hellkamp AS, Patel MR, Becker RC, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Califf RM, Fox KA, Mahaffey KW. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013 Jul;6(4):740-7. doi: 10.1161/CIRCHEARTFAILURE.113.000212. Epub 2013 May 30.

ReferenceCitation: Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA; ROCKET AF Investigators. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.

ReferenceCitation: Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.

ReferenceCitation: Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM; ROCKET AF Steering Committee and Investigators. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation. 2013 Jan 15;127(2):224-32. doi: 10.1161/CIRCULATIONAHA.112.107128. Epub 2012 Dec 3.

ReferenceCitation: Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener HC, Donnan GA, Halperin JL, Mahaffey KW, Mas JL, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KA, Hacke W; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315-22. doi: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.

ReferenceCitation: Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.

ReferenceCitation: ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.

location_country:
Spain
United Kingdom
Lithuania
Ukraine
Venezuela
United States
Peru
Belgium
Philippines
Romania
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

summary: The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).


title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis

summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Carrera F, Lok CE, de Francisco A, Locatelli F, Mann JF, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC; PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010 Dec;25(12):4009-17. doi: 10.1093/ndt/gfq305. Epub 2010 Jun 3.

location_country:
Denmark
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
Switzerland
United Kingdom
France
Belgium
Germany