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). pii: e001395. doi: 10.1136/rmdopen-2020-001395.

ReferenceCitation: van der Heijde D, Landewé 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.

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;:.

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.

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.

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.

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

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

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

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

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

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Centre de Recherche Musculo-Squelettique

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

location_facility: Centro de Investigaciones Reumatologicas y Osteologicas -CIRO

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

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

location_facility: Professional Research Network of Kansas, LLC

location_facility: Clinica de Enfermedades Cronicas y Procedimientos Especiales SC

location_facility: Clinica Santa Maria, Seccion Reumatologia

location_facility: OMI- Organizacion Medica de Investigacion

location_facility: OMI - Organización Médica de Investigación

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

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

location_facility: Xijing Hospital, The Fourth Military Medical University

location_facility: Bronson Internal Medicine and Rheumatology

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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

location_facility: The Arthritis Program Research Group Inc.

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

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

location_facility: Centro de Diagnostico y Tratamiento Hospital San Borja Arriaran

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

location_facility: State Healthcare Institution Regional Clinical Hospital for War Veterans

location_facility: Krishna Institute of Medical Sciences Ltd

location_facility: Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Investigacion y Biomedica de Chihuahua, SC

location_facility: Chanre Rheumatology and Immunology Center and Research

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

location_facility: ClinicMed Badurski i wspolnicy Spolka Jawna

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

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

location_facility: Krankenhaus Friedrichstadt, I. Medizinische Klinik

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Xiangya Hospital of Centre-south University

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

location_facility: Hospital Civil. Hospital Regional Universitario Carlos Haya

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

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

location_facility: Delaware Arthritis and Osteoporosis Center

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

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

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

location_facility: Studienambulanz Universitaetsklinikum Erlangen Medizinische Klinik 3

location_facility: Stanford Health Services - Medical Specialty Clinics

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

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

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

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

location_facility: Centro de Investigacion Clinica Especializada, SC

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

location_facility: The Center for Rheumatology and Bone Research

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: Rheumatology Research Unit Sunshine Coast

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Reumatologicka ambulancia, Nestatne zdravotnicke zariadenie

location_facility: West Broward Rheumatology Associates, Inc.

location_facility: Schlosspark-Klinik Innere Medizin II, Rheumatologie

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

location_facility: Hospital Base Valdivia, Policlinico de Reumatologia

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: General Hospital Euromedica "KYANOUS STAVROS"

location_facility: Municipal City Clinical Hospital #4, Policlinic Care

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

location_facility: State Educational Institution of Higher Professional Education

location_facility: MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles

location_facility: Jacksonville Center for Clinical Research

location_facility: Skanes Universitetssjukhus i Malmo Reumamottagningen

location_facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC

location_facility: West Island Rheumatology Research Associates

location_facility: Reumatologicka ambulancia, Poliklinika Ruzinov

location_facility: CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

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

location_facility: Fakultni Nemocnice Brno, Interni hematoonkologicka klinika

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

location_facility: Revmatologichen kabinet, DKTs Sveti Pantaleimon OOD

location_facility: University of California San Diego Center for Innovative Therapy

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

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

location_facility: Angeles University Foundation Medical Center

location_facility: Cincinnati Rheumatic Disease Study Group, Inc.

location_facility: Ltd.Medical Association "Novaya Bolnitsa"

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Universitair Ziekenhuis Gent - Reumatologie

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

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

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Arthritis and Osteoporosis Associates, LLP

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

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

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

location_facility: Asheville Rheumatology & Osteoporosis Research Associates, PA

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

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

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

location_facility: Hospital Nacional IV Alberto Sabogal Sologuren

location_facility: Louisiana State University Health Sciences Center

location_facility: Clinic of Cardiology and Rheumatology Military Medical Academy

location_facility: Beijing Chaoyang Hospital, Capital University of Medical Science

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas

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

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

location_facility: Center for Arthritis and Rheumatic Diseases

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

location_facility: Cividino Medicine Professional Corporation

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

location_facility: Orszagos Reumatologiai Es Fizioterapias Intezet

location_facility: St. Luke's Intermountain Research Center

location_facility: Ecclesia, s.r.o Reumatologicka ambulancia

location_facility: University of Perpetual Help Rizal Dalta Medical Center

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

location_facility: Centro Medico Corpac/Investigaciones en Reumatologia

location_facility: "Department of Infectious Diseases & Immunology

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

location_facility: Queen Elizabeth Hospital, Department of Rheumatology

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

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

location_facility: Arthritis Research and Care Foundation Centre for Rheumatic Diseases

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

location_facility: Arthritis and Rheumatology of Georgia P.C.

location_facility: Revmatologichno Otdelenie, MBAL - Plovdiv

location_facility: Arthritis Research Center, Royal University Hospital

location_facility: Chanre Rheumatology & Immunology Center & Research

location_facility: Arthritis and Rheumatology Consultants, P.A.

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

location_facility: Federal North-West Medical Research Centre

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Sozialmedizinisches Zentrum Sued - Kaiser Franz Josef Spital

location_facility: Vinnitsa Regional Clinical Hospital n.a. Pirogov

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

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

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

location_facility: State Healthcare Institution Regional Clinical Hospital

location_facility: Oklahoma Medical Research Foundation (OMRF)

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

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

location_facility: Centro de Reumatologia y Osteoporosis, Cartago

location_facility: Centro de Investigacion Clinica de Morelia

location_facility: Arthrocare, Arthritis Care & Research, PC

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

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

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

location_facility: Regional State Budget Institution Of Healthcare

location_facility: Daegu Catholic University Medical Center

location_facility: Centro de Estudos em Terapias Inovadoras

location_facility: Rheumatology Research Institute of Russian Academy of Medical Sciences

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

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

location_facility: Gangnam Severance Hospital-Yonsei University Health System

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

location_facility: Clinical Research Center of Cape Cod, Inc.

location_facility: Rheuma-Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy

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

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

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

location_facility: Arthritis, Rheumatic & Back Disease Associates

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Arthritis Associates and Osteoporosis Center of Colorado Springs

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

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Centre Hospitalier Universitaire de Liège

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

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

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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


status: Completed

primary_purpose: Prevention

intervention_type: Other

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.

study_completion_date_type: Actual

lead_sponsor: Shire

type: EudraCT Number

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

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.

enrollment_type: Actual

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

location_facility: Washington University School of Medicine

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Pittsburgh Cancer Institute

location_facility: Universitaetsklinikum Koeln, Clinic I for internal Medicine

location_facility: University of Kentucky Chandler Medical Center

location_facility: New York Presbyterian Hospital,Weill Cornell Medical Center

location_facility: University of Arkansas Myeloma Institute

location_facility: University Medical Center University of Louisville Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Cliniques Universitaires St,Luc Dept Hematology

location_facility: Ireland Cancer Center Case Western Reserve University

location_facility: CHU Sart -Tilman Department of Medicine, Hematology

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.

lead_sponsor_type: industriel

status_simplified: Completed


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.

primary_purpose: Treatment

ReferenceCitation: de Liaño 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.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Australia
United States
France
Singapore
Belgium
Germany

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

location_facility: University Chicago Hospital StudyCoordinator:CEPO906A2229

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

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

location_facility: Oregon Health & Science University StudyCoordinator:CEPO906A2229

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

location_facility: NorthWest Georgia Oncology Centers Marietta Center

location_facility: MD Anderson Cancer Center - Orlando CEPO906A2229

intervention_type: Drug


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-naïve 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.

lead_sponsor: Bristol-Myers Squibb

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

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.

status: Terminated

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

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

location_facility: U Of Rochester Gastroenterology And Hepatology

status_simplified: Unknown


title: Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

summary: The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

ReferenceCitation: Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Taiwan
United Kingdom
Greece
Russian Federation
New Zealand
Argentina
Ukraine
Korea, Republic of
United States
France
Turkey
South Africa

location_facility: 1012.56.01052 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88603 National Taiwan University Hospital

location_facility: 1012.56.01083 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01075 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01033 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01058 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01063 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01029 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01089 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01040 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01026 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54012 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01020 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01064 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01065 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01012 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA

location_facility: 1012.56.01011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01090 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01044 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01039 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01072 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01028 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01068 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54009 Instituto de Investigaciones Clínicas

location_facility: 1012.56.48010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01016 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.3304A Centre Médical Erdre Saint Augustin

location_facility: 1012.56.01003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01022 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01060 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01024 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01070 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01066 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01034 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01055 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01080 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01069 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01035 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01049 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01076 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01059 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01036 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01071 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44008 The Staploe Medical Centre

location_facility: 1012.56.01014 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44006 Colchester General Hospital

location_facility: 1012.56.01037 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01087 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01025 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01038 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01043 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88601 Chang Gung Memorial Hosp-Linkou

location_facility: 1012.56.38004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01050 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01045 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88604 Chang Gong Memorial Hospital

location_facility: 1012.56.01067 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54013 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01015 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01081 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01084 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01027 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01073 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88602 Taipei Veterans General Hospital

location_facility: 1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata

location_facility: 1012.56.01018 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01079 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01062 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01017 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01047 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54014 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01082 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01030 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54008 HOSPITAL ITALIANO de ROSARIO

location_facility: 1012.56.27002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01078 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01074 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30013 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01031 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54015 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54001 Centro Médico de la Dra. De Salvo

location_facility: 1012.56.01093 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01013 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01053 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01077 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01048 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01021 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01042 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01088 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01056 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01085 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01019 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.3305A Centre hospitalier Germon & Gauthier

location_facility: 1012.56.54007 CLINICA PRIVADA de MONTE GRANDE

location_facility: 1012.56.44002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01051 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01023 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88605 Taichung Veterans General Hospital

location_facility: 1012.56.82005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30014 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01057 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01032 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01054 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90001 Boehringer Ingelheim Investigational Site


title: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

summary: The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

lead_sponsor: Pfizer

location_country:
Spain
United Kingdom
Australia
Argentina
Sweden
Korea, Republic of
United States
Chile
France
Mexico
Germany


title: Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg

summary: This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Brazil
Romania
United Kingdom
Russian Federation
Netherlands
Canada
Sweden
Hungary
Puerto Rico
United States
France
Belgium
Germany


title: Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

summary: The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.

ReferenceCitation: Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.

ReferenceCitation: Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.

ReferenceCitation: Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.

lead_sponsor: Bayer

location_country: Ireland Sweden Finland France


title: Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.

acronym: BUILD 3

summary: BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

ReferenceCitation: King TE Jr, Brown KK, Raghu G, du Bois RM, Lynch DA, Martinez F, Valeyre D, Leconte I, Morganti A, Roux S, Behr J. BUILD-3: a randomized, controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Jul 1;184(1):92-9. doi: 10.1164/rccm.201011-1874OC. Epub 2011 Apr 7.

lead_sponsor: Actelion

location_country:
Croatia
Serbia
Spain
Ireland
Austria
Australia
Italy
Canada
Czech Republic
Netherlands
Switzerland
United Kingdom
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility: Royal Perth Hospital; Advanced Lung Disease Unit

location_facility: Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern

location_facility: Kanagawa Cardiovascular Respiratory Center

location_facility: Hadassah Medical Organization: Ein Karem-Institute of Pulmonology

location_facility: National Jewish Medical & Research Center

location_facility: Fachkrankenhaus Coswig; Centre for Pulmonology and Thoracic Surgery

location_facility: Medizinische Universität Graz-Klinische Abteilung für Pulmonologie

location_facility: University Hospital Basel-Div of Pneumology

location_facility: Medical University of Innsbruck-Div. of Clinical & Internal Medicine

location_facility: University Hopital Zurich-Clinic for Pneumology & Lung Transplant Program

location_facility: Toronto General Hospital-Rosedale Medical Center PFT Lab

location_facility: Royal Adelaide Hospital-Respiratory Clinical Trials Unit

location_facility: SoonChunHyang University Bucheon Hospital

location_facility: Azienda Ospedaliera di Padova - Immunologia Clinica

location_facility: Klinik Löwenstein GmbH-Medizinische Klinik 1 Pneumologie-Kardiologie

location_facility: Inselspital Bern-Div of Pulmonary Medicine

location_facility: University degli Studi Siena, Policlinico le Scotte

location_facility: Highland Hospital - Pulmonary Department

location_facility: University of Virginia - Div. of Pulmonary & Critical Care

location_facility: Rambam Medical Centre-Div. for Pulmonary Disease

location_facility: Hospital Clinic Barcelona (Pneumology Service)

location_facility: St. Luke's Medical Group, Cardio-Pulmonary Research

location_facility: Walter C. Mackenzie Health Sciences Centre-Univeristy of Alberta

location_facility: UCLA-Division of Pulmonary & Critical Care

location_facility: Institut za Plucne bolest l TBC Klinickog Centra Srbije

location_facility: Thomayer Faculty Hospital Prague-Dept of Respiratory Disease

location_facility: The Health Care Corporation of St. John's-Eastern Health

location_facility: Institut za Plucne bolesti Vojvodine, Sremska Kamenica

location_facility: Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergic Diseases

location_facility: Prince Charles Hospital - Lung Transplant, Thoraic Dept.

location_facility: Pulmonary and Critical Care Medicine-Stanford University Medical Center

location_facility: Medizinische Universitätsklinik, Abteilung Pneumologie

location_facility: St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine

location_facility: Pulmonary Istitute-Rabin Medical Centre: Beilinson Campus

location_facility: University of Chicago - Section of Pulmonary, Dept of Medicine, Respiratory Clinical Research

location_facility: Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia

location_facility: Yale University School of Medicine-Dept of Internal Med-Pulmonary & Critical Care

location_facility: Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento

location_facility: University of Pennsylvania Medical Center

location_facility: Medical University of Vienna and AKH-Div of Pulmonology

location_facility: Institut de Cardiologie et de Pneumologie de l'Universite Laval

location_facility: Klinik Donaustauf-Zentrum für Pneumologie

location_facility: University Hospital Olomouc - Dept of Respiratory Disease-IP Pavlova

location_facility: University Hospital for Lung Disease "Jordanovac"

location_facility: University of Texas-Southwestern Dallas-Div. of Pulm & Critical Care Unit

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin

location_facility: Hopital Notre Dame - Centre Hospitalier de L'Universit de Montreal


title: A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

summary: To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

location_country: Poland Spain Netherlands Finland Switzerland Sweden France Belgium Norway Germany


type: U.S. NIH Grant/Contract

title: A Randomized Trial of Unruptured Brain Arteriovenous Malformations

acronym: ARUBA

summary: The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.

ReferenceType: background

ReferenceCitation: Stapf C, Mohr JP, Choi JH, Hartmann A, Mast H. Invasive treatment of unruptured brain arteriovenous malformations is experimental therapy. Curr Opin Neurol. 2006 Feb;19(1):63-8. Review.

ReferenceCitation: Mohr JP, Overbey JR, Hartmann A, Kummer RV, Al-Shahi Salman R, Kim H, van der Worp HB, Parides MK, Stefani MA, Houdart E, Libman R, Pile-Spellman J, Harkness K, Cordonnier C, Moquete E, Biondi A, Klijn CJM, Stapf C, Moskowitz AJ; ARUBA co-investigators. Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial. Lancet Neurol. 2020 Jul;19(7):573-581. doi: 10.1016/S1474-4422(20)30181-2.

ReferenceCitation: Mohr JP, Overbey JR, von Kummer R, Stefani MA, Libman R, Stapf C, Parides MK, Pile-Spellman J, Moquete E, Moy CS, Vicaut E, Moskowitz AJ, Harkness K, Cordonnier C, Biondi A, Houdart E, Berkefeld J, Klijn CJM, Barreau X, Kim H, Hartmann A; International ARUBA Investigators. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs. Neurology. 2017 Oct 3;89(14):1499-1506. doi: 10.1212/WNL.0000000000004532. Epub 2017 Sep 6.

ReferenceCitation: Mohr JP, Parides MK, Stapf C, Moquete E, Moy CS, Overbey JR, Al-Shahi Salman R, Vicaut E, Young WL, Houdart E, Cordonnier C, Stefani MA, Hartmann A, von Kummer R, Biondi A, Berkefeld J, Klijn CJ, Harkness K, Libman R, Barreau X, Moskowitz AJ; international ARUBA investigators. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014 Feb 15;383(9917):614-21. doi: 10.1016/S0140-6736(13)62302-8. Epub 2013 Nov 20.

ReferenceCitation: Stapf C. The rationale behind "A Randomized Trial of Unruptured Brain AVMs" (ARUBA). Acta Neurochir Suppl. 2010;107:83-5. doi: 10.1007/978-3-211-99373-6_13.

ReferenceCitation: Stapf C, Mohr JP. Unruptured brain arteriovenous malformations should be treated conservatively: yes. Stroke. 2007 Dec;38(12):3308-9. Epub 2007 Oct 25.

lead_sponsor: Columbia University

location_country:
Brazil
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
Switzerland
United Kingdom
Korea, Republic of
United States
France
Germany

location_facility: University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38

location_facility: Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52

location_facility: Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck

location_facility: Barrow Neurological Institute, 350 West Thomas Road

location_facility: Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16

location_facility: Department of Neurosurgery, Newcastle General Hospital, Westgate Road

location_facility: Institute of Neurology, Box 6, The National Hospital, Queen Square

location_facility: Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74

location_facility: Inselspital, Neurologische Klinik, 3010 Bern

location_facility: Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU

location_facility: Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15

location_facility: Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30

location_facility: Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400

location_facility: Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165

location_facility: Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré

location_facility: Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1

location_facility: European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10,

location_facility: University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,

location_facility: New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St

location_facility: Department of Neurology, Royal Hallamshire Hospital, Glossop Road

location_facility: Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road

location_facility: Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64

location_facility: Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street

location_facility: Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700

location_facility: Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis

location_facility: Hamilton General Hospital .237 Barton Street East

location_facility: Utrecht University Hospital, Heidelberglaan 100, 3584 CX

location_facility: Frenchay Hospital, Neuroradiology Department

location_facility: Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266

location_facility: John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120,

location_facility: University of Texas Medical School in Houston

location_facility: Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030

location_facility: Thomas Jefferson Hospital for Neuroscience

location_facility: Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat

location_facility: Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent

location_facility: Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights

location_facility: Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60

location_facility: CHU Henri Mondor, Service de Neuroradiologie

location_facility: Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55

location_facility: Walton Centre for Neurology, Lower Lane Fazakerley

location_facility: CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street

location_facility: Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road

location_facility: SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189

location_facility: Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136

location_facility: Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood

location_facility: University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza

location_facility: Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd

location_facility: University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212

location_facility: Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street

location_facility: Bellaria Hospital, Department of Neurosurgery

lead_sponsor_type: academique


title: A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis.

summary: This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).

ReferenceCitation: Sundel R, Solomons N, Lisk L; Aspreva Lupus Management Study (ALMS) Group. Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial. Lupus. 2012 Nov;21(13):1433-43. doi: 10.1177/0961203312458466. Epub 2012 Aug 24.

ReferenceCitation: Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.

ReferenceCitation: Dall'Era M, Stone D, Levesque V, Cisternas M, Wofsy D. Identification of biomarkers that predict response to treatment of lupus nephritis with mycophenolate mofetil or pulse cyclophosphamide. Arthritis Care Res (Hoboken). 2011 Mar;63(3):351-7. doi: 10.1002/acr.20397. Epub 2010 Nov 15.

ReferenceCitation: Ginzler EM, Wofsy D, Isenberg D, Gordon C, Lisk L, Dooley MA; ALMS Group. Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial. Arthritis Rheum. 2010 Jan;62(1):211-21. doi: 10.1002/art.25052. Erratum in: Arthritis Rheum. 2010 Oct;62(10):3005.

ReferenceCitation: Isenberg D, Appel GB, Contreras G, Dooley MA, Ginzler EM, Jayne D, Sánchez-Guerrero J, Wofsy D, Yu X, Solomons N. Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. Rheumatology (Oxford). 2010 Jan;49(1):128-40. doi: 10.1093/rheumatology/kep346. Epub 2009 Nov 20.

location_country:
Brazil
Portugal
Spain
Greece
Italy
Australia
Mexico
Argentina
Canada
Czech Republic
United Kingdom
Hungary
United States
France
China
Belgium
Germany


title: A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis

summary: To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm

lead_sponsor: Astellas Pharma Inc

location_country:
Croatia
Poland
Brazil
Belgium
Spain
Italy
Argentina
Czech Republic
Hungary
France
Colombia
Germany


title: A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy

summary: To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

ReferenceCitation: Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.

ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Spain
Italy
United Kingdom
United States
Philippines
Hong Kong
Australia
Argentina
Indonesia
India
Mexico
Norway
Brazil
Canada
China
Germany
Denmark
Taiwan
Thailand
Korea, Republic of
France
Netherlands


title: An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy

summary: The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.

location_country:
Spain
Italy
Australia
Netherlands
Argentina
Canada
Sweden
United States
France
Belgium
Germany

location_facility: University of Iowa Hospitals and Clinics

location_facility: Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.

location_facility: H. Lee Moffit Cancer Center & Research Institute

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Arthur G. James Cancer Hospital/Ohio State University


title: A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients

summary:
BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled:

Cohort I: Patients previously treated with one taxane containing regimen.
Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen.
Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.

Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.

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


title: A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

acronym: TRANSFORMS

summary: This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

ReferenceCitation: Cohen JA, Khatri B, Barkhof F, Comi G, Hartung HP, Montalban X, Pelletier J, Stites T, Ritter S, von Rosenstiel P, Tomic D, Kappos L; TRANSFORMS (TRial Assessing injectable interferoN vS. FTY720 Oral in RRMS) Study Group. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J Neurol Neurosurg Psychiatry. 2016 May;87(5):468-75. doi: 10.1136/jnnp-2015-310597. Epub 2015 Jun 25.

ReferenceCitation: Khatri BO, Pelletier J, Kappos L, Hartung HP, Comi G, Barkhof F, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Cohen JA; TRANSFORMS Study Group. Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon β-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Mult Scler Relat Disord. 2014 May;3(3):355-63. doi: 10.1016/j.msard.2013.11.006. Epub 2013 Dec 12.

ReferenceCitation: Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.

ReferenceCitation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

ReferenceCitation: Khatri B, Barkhof F, Comi G, Hartung HP, Kappos L, Montalban X, Pelletier J, Stites T, Wu S, Holdbrook F, Zhang-Auberson L, Francis G, Cohen JA; TRANSFORMS Study Group. Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol. 2011 Jun;10(6):520-9. doi: 10.1016/S1474-4422(11)70099-0. Epub 2011 May 13.

ReferenceCitation: Twiss J, Doward LC, McKenna SP, Eckert B. Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS). Health Qual Life Outcomes. 2010 Oct 11;8:117. doi: 10.1186/1477-7525-8-117.

ReferenceCitation: Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):402-15. doi: 10.1056/NEJMoa0907839. Epub 2010 Jan 20.

lead_sponsor: Novartis

location_country:
Brazil
Portugal
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
Switzerland
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany
Egypt

location_facility: The Walton Centre for Neurology and Neurosurgery

location_facility: Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny

location_facility: Pecsi Tudomanyegyetem Neurologiai Klinika

location_facility: The Neurology Center, 3907 Waring Road, Suite 3

location_facility: West Virginia University Health Associates

location_facility: Landes-Nervenklinik Christian Doppler Klinik

location_facility: Neurology & Neuroscience Associates, Inc

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street

location_facility: Centre Hospitalier de Poissy, 10 rue du Champ Gaillard

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza

location_facility: Nationaal Multiple Sclerose Centrum v.z.w

location_facility: Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North

location_facility: National Cancer Center, 809 Madu 1-dong, Ilsan-gu

location_facility: Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku

location_facility: Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen

location_facility: Integra Clinical Research, 4242 Medical Drive, Suite 6100

location_facility: Hoppital Pasteur, Archet II, 30 avenue de la Voie

location_facility: Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron

location_facility: Azienda Ospedaliera di Padova - Università degli Studi

location_facility: Az. Osp. Ospedale S. Martino - Università degli Studi

location_facility: Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18

location_facility: Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS

location_facility: Universitätsklinik f. Neurologie Innsbruck

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat

location_facility: University of Miami, Department of Neurology

location_facility: Box Hill Hopsital, Level 3, 16 Arnold Street

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Raleigh Neurology Associates, 1540 Sunday Drive

location_facility: Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201

location_facility: Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio

location_facility: Errikos Dinan General Hospital, 107 Mesogion Ave.

location_facility: Az. Osp. Universitaria Policlinico Tor Vergata

location_facility: Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef

location_facility: Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street

location_facility: Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff

location_facility: Debreceni Egyetem Orvos es Egszstd. Centr.

location_facility: Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401

location_facility: Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1

location_facility: Az. Osp. Ospedale Consorziale e Policlinico

location_facility: Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100

location_facility: Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1

location_facility: Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4

location_facility: Hopital La Timone Cpcet, Rue Jean Moulin

location_facility: University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304

location_facility: General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.

location_facility: Nepean Medical Centre, 1 Centrepointe Drive, Suite 407

location_facility: Absher Neurology, 274-A Commonwealth Drive

location_facility: Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi

location_facility: Azienda Ospedaliera Careggi - Università degli Studi

location_facility: St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing

location_facility: Policlinico - Università degli Studi Federico II

location_facility: Center for Neurological Disorders - Aurora St. Luke's Med Center

location_facility: University of Florida Health Science Center

location_facility: University of Pittsburgh, Department of Neurology

location_facility: Universitätsspital Basel, Neurochirugishen Poliklinik

location_facility: Montreal Neurological Institute, 3801 University Street

location_facility: Yale University Multiple Sclerosis Center

location_facility: Associated Neurologists, PC, 69 Sand Pit Road, Suite 300

location_facility: North Central Neurology Associates, PC, 1809 Kress Street

location_facility: The Ottawa General Hospital, 501 Smyth Rd.

location_facility: Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.

location_facility: University of South Florida, Department of Neurology

location_facility: Istituto di Scienze Neurologiche Università di Catania

location_facility: General University Hospital of Patra-RIO


title: A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.

summary: This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Canada
Ukraine
Hungary
France
South Africa
Romania
Germany
Bulgaria
Czechia


title: A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

summary: To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

ReferenceCitation: Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.

ReferenceCitation: Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.

ReferenceCitation: McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.

ReferenceCitation: Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Brazil
Portugal
Spain
Greece
Argentina
Canada
Puerto Rico
United States
France
Romania
Slovakia

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


acronym: CLASSIC I

title: A Phase III Randomized, Double-blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens

publications_result: Clofarabine + Ara-c improves response rates and event-free survival, not overall survival, in older patients with relapsed/refractory AML compared to Ara-c alone: Updated CLASSIC I study results. H.M. Kantarjian, M. Wetzler, D. Rizzieri, G. J. Schiller, M. H. Jagasia, R. K. Stuart, S. Ganguly, D. Avigan, M. Craig, R. Collins, M. B. Maris, T. Kovacsovics, S. Goldberg, K. Seiter, P. Hari, J. Greiner, N. Vey, C. Recher, F. Ravandi, E.S. Wang, S. Eckert, D. Huebner and S. Faderl. Haematologica - 16th Congress of EHA Abstracts. 2011; 96(S2): 196.

ReferenceCitation: Clofarabine plus cytarabine compared to cytarabine alone in older patients with relapsed or refractory (R/R) acute myelogenous leukemia (AML): Results from the phase III CLASSIC 1 trial. S. Faderl, M. Wetzler, D. Rizzieri, G. J. Schiller, M. H. Jagasia, R. K. Stuart, S. Ganguly, D. Avigan, M. Craig, R. Collins, M. B. Maris, T. Kovacsovics, S. Goldberg, K. Seiter, P. Hari, F. Ravandi, E. S. Wang, S. Eckert, D. Huebner, and H. Kantarjian JCO - ASCO Meeting Abstracts. 2011; 29:6503.

ReferenceCitation: Faderl S, Wetzler M, Rizzieri D, Schiller G, Jagasia M, Stuart R, Ganguly S, Avigan D, Craig M, Collins R, Maris M, Kovacsovics T, Goldberg S, Seiter K, Hari P, Greiner J, Vey N, Recher C, Ravandi F, Wang ES, Vasconcelles M, Huebner D, Kantarjian HM. Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial. J Clin Oncol. 2012 Jul 10;30(20):2492-9. doi: 10.1200/JCO.2011.37.9743. Epub 2012 May 14.

ReferenceCitation: Ganguly S, Kantarjian HM, Wetzler M, Rizzieri D, Schiller G, Jagasia M, et al. Subsequent hematopoietic stem cell transplantation (HSCT) associated with longer survival in patients with relapsed/refractory (R/R) acute myelogenous leukemia (AML) after Clo+Ara-C or Ara-C alone: a landmark analysis from the CLASSIC I trial. Biol Blood Marrow Transplant 2012;18(2Suppl):S211-S212.

ReferenceCitation: Ganguly S, Kantarjian HM, Wetzler M, Rizzieri D, Schiller G, Jagasia M, et al. Subsequent HSCT in the CLASSIC I Study Associated with Longer Survival in Patients With Relapsed/Refractory AML After Clo+Ara-C Or Ara-C Alone: A Landmark Analysis. Haematologica - 17th Congress of EHA Abstracts. 2012; 97(s1):32

location_country:
Italy
Canada
United States
France
Germany

location_facility: Wake Forest University School of Medicine

location_facility: UT Southwestern Medical Center, Simmons Comprehensive Cancer Center

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: University of Southern California, Kenneth Norris Cancer Center

location_facility: Medizinische Klinik der Technischen, Universität München

location_facility: Azienda Ospedaliera "Antonio Cardarelli"

location_facility: Louisiana State University Health Science Center

location_facility: University of Kentucky, Markey Cancer Center

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: University of Colorado Health Science Center

location_facility: University of Texas Health Sciences Center

location_facility: University of Arkansas for Medical Sciences, Arkansas Cancer Research Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Medizinische Hochschule Hannover, Zentrum fur Innere Medizin, Abt. Haematologie / Onkologie

location_facility: West Virginia University Hospitals, Mary Babb Randolph Cancer Center

summary:
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in older patients. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is benefit by combining clofarabine with cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either placebo in combination with cytarabine or clofarabine in combination with cytarabine. Randomization was stratified by remission status following the first induction regimen (no remission [i.e., CR1 = refractory] or remission <6 months vs CR1 = remission ≥6 months). CR1 is defined as remission after first pre-study induction regimen. The safety and tolerability of clofarabine in combination with cytarabine and cytarabine alone will be monitored throughout the study.


title: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

summary: GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

lead_sponsor: ViiV Healthcare

location_country:
Brazil
Portugal
Spain
Italy
United Kingdom
United States
Chile
France


title: Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

summary: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.

ReferenceCitation: Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Döhner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2022 Mar 1;107(3):615-624. doi: 10.3324/haematol.2020.251561.

ReferenceCitation: Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Döhner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.

ReferenceCitation: Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7:CD012022. doi: 10.1002/14651858.CD012022.pub2.

ReferenceCitation: Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Böttcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.

ReferenceCitation: Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Böttcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Döhner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20.

ReferenceCitation: Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Döhner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.

ReferenceCitation: Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Döhner H, Jäger U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.

ReferenceCitation: Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Döhner K, Bühler A, Böttcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jäger U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Döhner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20.

ReferenceCitation: Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.

ReferenceCitation: Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grünhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jäger U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Bühler A, Winkler D, Zenz T, Böttcher S, Ritgen M, Mendila M, Kneba M, Döhner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.

location_country:
Denmark
Spain
Italy
Austria
Australia
New Zealand
Czech Republic
France
Israel
Belgium
Germany

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Staedtisches Krankenhaus Muenchen - Harlaching

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: St. Marien-Hospital Hamm - Klinik Knappenstrasse

location_facility: Fondazione Centro San Raffaele Del Monte Tabor

location_facility: Krankenhaus Barmherzige Brueder Regensburg

location_facility: Klinik fuer Onkologie - Katharinenhospital Stuttgart

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

location_facility: Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Onkologische Gemeinschaftspraxis - Dresden

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Haematologisch - Onkologische Gemeinschaftspraxis

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Internistische Gemeinschaftspraxis - Magdeburg

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: Praxis fuer Haematologie und Interne Onkologie

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

location_facility: Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

location_facility: Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Internistische Gemeinschaftspraxis - Stuttgart

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: First Medical Clinic of Charles University Hospital

location_facility: Praxis Fuer Internistische Haematologie / Onkologie

location_facility: Internistische Gemeinschaftspraxis - Forchheim

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

location_facility: Schwerpunktpraxis Hamatologie/Onkologie - Wesel

location_facility: University Medical Center Hamburg - Eppendorf

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

location_facility: Onkologische Schwerpunktpraxis Dr. Schmidt

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: University Hospital in Pilsen - Lochotin

location_facility: Hamatologisch - Onkologische Praxis Wurzburg

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Praxis Fur Hamatologie und Onkologie Ahaus

location_facility: Marienhospital at Ruhr University Bochum

location_facility: Riverview Cancer Care Medical Associates, PC

location_facility: Clinic for Bone Marrow Transplantation and Hematology and Oncology

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Copenhagen County Herlev University Hospital


title: A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.

summary: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

location_country:
United Kingdom
Italy
Austria
Russian Federation
France
Belgium
Germany

location_facility: Scientific Research Institute of Pediatric Hematology

location_facility: Medical Faculty of Russian People Friendship University

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Univ.-Klinik für Kinder- und Jugendheilkunde Wien

location_facility: Gottfried Preyersches Kinderspital d. Stadt Wien


title: Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

summary: A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Germany

location_facility: Community Research Initiative of New England

location_facility: Wake Forest University Baptist Medical Center

location_facility: Rush-Presbytarian-St Luke's Medical Center

location_facility: Hospital Clínico y Provincial de Barcelona - HIV

location_facility: Fondazione Centro S. Raffaele del Monte Tabor

location_facility: Montreal Chest Institute - McGill University Health Centre

location_facility: 4th Floor Research Office (St Stephens Centre)


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

summary: Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

ReferenceCitation: Irving G, Pénzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
Spain
Australia
New Zealand
Canada
Switzerland
Sweden
Hungary
United States
France
South Africa
Norway
Netherlands


title: Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.

summary: The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

ReferenceCitation: Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, Workman C, Dierynck I, Sekar V, Abeele CV, Lavreys L. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009 Aug 24;23(13):1679-88. doi: 10.1097/QAD.0b013e32832d7350.

ReferenceCitation: Orkin C, DeJesus E, Khanlou H, Stoehr A, Supparatpinyo K, Lathouwers E, Lefebvre E, Opsomer M, Van de Casteele T, Tomaka F. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial. HIV Med. 2013 Jan;14(1):49-59. doi: 10.1111/j.1468-1293.2012.01060.x. Epub 2012 Oct 23.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Spain
United Kingdom
United States
Costa Rica
Belgium
South Africa
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Panama
Mexico
Malaysia
Singapore
Canada
Switzerland
Guatemala
Germany
Denmark
Taiwan
Greece
Thailand
France
Chile


title: A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

summary: The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

lead_sponsor: Warner Chilcott

location_country:
Poland
Brazil
Spain
Australia
Estonia
Argentina
Canada
Finland
Lebanon
Hungary
United States
France
Belgium
Norway


title: A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (ATHOS Study)

summary: The primary objective of this study was test non-inferiority of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with predominantly systolic hypertension.

location_country:
Denmark
Spain
Ireland
Italy
Netherlands
Finland
France
South Africa
Belgium
Germany

location_facility: Adelaide and Meath Hospitals (incorrporating NCH)

location_facility: Hämeenlinnan lääkäriasema Oy, Linnan klinikka

location_facility: Azienda Ospedaliera "Maggiore della Carità"


title: A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes

summary: A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes

ReferenceCitation: Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Czech Republic
Sweden
Puerto Rico
United States
France
South Africa
Mexico
Netherlands