title: A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

summary: This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

ReferenceCitation: Krishnan P, Tripathi R, Schnell G, Reisch T, Beyer J, Irvin M, Xie W, Larsen L, Cohen D, Podsadecki T, Pilot-Matias T, Collins C. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir, and dasabuvir. Antimicrob Agents Chemother. 2015 Sep;59(9):5445-54. doi: 10.1128/AAC.00998-15. Epub 2015 Jun 22.

family: Krishnan

full_name: Preethi Krishnan

given: Preethi

family: Tripathi

full_name: Rakesh Tripathi

given: Rakesh

family: Schnell

full_name: Gretja Schnell

given: Gretja

family: Reisch

full_name: Thomas Reisch

given: Thomas

family: Beyer

full_name: Jill Beyer

given: Jill

family: Irvin

full_name: Michelle Irvin

given: Michelle

family: Xie

full_name: Wangang Xie

given: Wangang

family: Larsen

full_name: Lois Larsen

given: Lois

family: Cohen

full_name: Daniel Cohen

given: Daniel

family: Podsadecki

full_name: Thomas Podsadecki

family: Pilot-Matias

full_name: Tami Pilot-Matias

given: Tami

family: Collins

full_name: Christine Collins

given: Christine

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Resistance Analysis of Baseline and Treatment-Emergent Variants in Hepatitis C Virus Genotype 1 in the AVIATOR Study with Paritaprevir-Ritonavir, Ombitasvir, and Dasabuvir

ReferenceCitation: Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.

family: Kowdley

full_name: Kris V. Kowdley

given: Kris V.

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Poordad

full_name: Fred Poordad

given: Fred

full_name: Daniel E. Cohen

given: Daniel E.

title: Phase 2b Trial of Interferon-free Therapy for Hepatitis C Virus Genotype 1

location_country:
United States
Germany
France
Australia
Puerto Rico
New Zealand
Spain
Canada
United Kingdom

location_facility:
Site Reference ID/Investigator# 59130
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Site Reference ID/Investigator# 43588
Site Reference ID/Investigator# 55500
Site Reference ID/Investigator# 45671


title: A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL

summary: The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: MedImmune LLC

location_country:
United States
France
Czechia
Poland
Israel
Hungary
Russian Federation
Spain
Turkey
Germany
Canada

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

summary: The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

ReferenceType: derived

ReferenceCitation: Tap WD, Papai Z, Van Tine BA, Attia S, Ganjoo KN, Jones RL, Schuetze S, Reed D, Chawla SP, Riedel RF, Krarup-Hansen A, Toulmonde M, Ray-Coquard I, Hohenberger P, Grignani G, Cranmer LD, Okuno S, Agulnik M, Read W, Ryan CW, Alcindor T, Del Muro XFG, Budd GT, Tawbi H, Pearce T, Kroll S, Reinke DK, Schöffski P. Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1089-1103. doi: 10.1016/S1470-2045(17)30381-9. Epub 2017 Jun 23. Erratum in: Lancet Oncol. 2018 Feb;19(2):e78.

family: Tap

full_name: William D Tap

given: William D

sequence: first

family: Papai

full_name: Zsuzsanna Papai

given: Zsuzsanna

sequence: additional

family: Van Tine

full_name: Brian A Van Tine

given: Brian A

family: Attia

full_name: Steven Attia

given: Steven

family: Ganjoo

full_name: Kristen N Ganjoo

given: Kristen N

family: Jones

full_name: Robin L Jones

given: Robin L

family: Schuetze

full_name: Scott Schuetze

given: Scott

family: Reed

full_name: Damon Reed

given: Damon

family: Chawla

full_name: Sant P Chawla

given: Sant P

family: Riedel

full_name: Richard F Riedel

given: Richard F

family: Krarup-Hansen

full_name: Anders Krarup-Hansen

given: Anders

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: Grignani

full_name: Giovanni Grignani

given: Giovanni

family: Cranmer

full_name: Lee D Cranmer

given: Lee D

family: Okuno

full_name: Scott Okuno

family: Agulnik

full_name: Mark Agulnik

given: Mark

family: Read

full_name: William Read

given: William

family: Ryan

full_name: Christopher W Ryan

given: Christopher W

family: Alcindor

full_name: Thierry Alcindor

given: Thierry

family: del Muro

full_name: Xavier F Garcia del Muro

given: Xavier F Garcia

family: Budd

full_name: G Thomas Budd

given: G Thomas

family: Tawbi

ReferenceCitation: Chawla SP, Cranmer LD, Van Tine BA, Reed DR, Okuno SH, Butrynski JE, Adkins DR, Hendifar AE, Kroll S, Ganjoo KN. Phase II study of the safety and antitumor activity of the hypoxia-activated prodrug TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. J Clin Oncol. 2014 Oct 10;32(29):3299-306. doi: 10.1200/JCO.2013.54.3660. Epub 2014 Sep 2.

name: Sant P. Chawla, Sarcoma Oncology Center, Santa Monica; Andrew E. Hendifar, Cedars Sinai Medical Center, Los Angeles; Stew Kroll, Threshold Pharmaceuticals, South San Francisco; Kristen N. Ganjoo, Stanford University Medical Center, Stanford, CA; Lee D. Cranmer, University of Arizona Cancer Center, Tucson, AZ; Brian A. Van Tine and Douglas R. Adkins, Washington University in St Louis, St Louis, MO; Damon R. Reed, Moffitt Cancer Center and Research Institute, Tampa, FL; Scott H. Okuno, Mayo Clinic,...

publisher: American Society of Clinical Oncology (ASCO)

title: Phase II Study of the Safety and Antitumor Activity of the Hypoxia-Activated Prodrug TH-302 in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma

location_country:
Italy
Austria
United States
Germany
France
Poland
Israel
Hungary
Belgium
Russian Federation
Spain
Denmark
Canada

location_facility: H.Lee Moffitt Cancer Center and Research Institute

location_facility: Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1

location_facility: Winship Cancer Institute of Emory University, Midtown Campus

location_facility: Virginia Commonwealth Universtiy-Massey Cancer Center

location_facility: ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia

location_facility: Kootenai Health - Kootenai Cancer Center

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Carolinas Hematology-oncology Associates-Blumenthal Cancer Center

location_facility: Fondazione del Piemonte per l'Oncologia, Instituto per la Ricerca e la Cura del cancro (I.R.C.C.), Dipartimento Oncologico, Direzione Operativa Oncologia Medica a Direzione Universitaria

location_facility: Mayo Clinic-Florida-Cancer Clinical Studies Unit

location_facility: The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center

location_facility: Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center

location_facility: University of Iowa Health Care - University of Iowa Hospital

location_facility: Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg

location_facility: Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem

location_facility: Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre

location_facility: Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly

location_facility: Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck

location_facility: University Hospitals Seidman Cancer Center

location_facility: BCCA- Vancouver Cancer Centre - Division of Medical Oncology

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie

location_facility: Wake Forest University Baptist Medical Center

location_facility: H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont

location_facility: Washington University School of Medicine

location_facility: GUZ "Regional Oncology Dispensay", Kazan

location_facility: Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology

location_facility: Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm

location_facility: Centrum Onkologii Instytut im M. Sklodowskiej-Curie

location_facility: Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital

location_facility: FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology

location_facility: IRCCS Centro di Riferimento Oncologico-Struttura Operativa

location_facility: Hospital Sant Joan de Deu, Department de Oncologia

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation

location_facility: University Hospital Herlev at Copenhagen

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: South Florida Center for Gynecologic Oncology

location_facility: Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco


type: EudraCT Number

title: A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.

summary: This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

ReferenceCitation: Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP(2) receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2). pii: 1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.

family: Bateman

full_name: Eric D. Bateman

given: Eric D.

family: Guerreros

full_name: Alfredo G. Guerreros

given: Alfredo G.

family: Brockhaus

full_name: Florian Brockhaus

given: Florian

family: Holzhauer

full_name: Björn Holzhauer

given: Björn

family: Pethe

full_name: Abhijit Pethe

given: Abhijit

family: Kay

full_name: Richard A. Kay

given: Richard A.

family: Townley

full_name: Robert G. Townley

given: Robert G.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

title: Fevipiprant, an oral prostaglandin DP2receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Guatemala
Greece
Romania
Russian Federation
India
France
Japan
Poland
Argentina
Canada
Colombia
South Africa
Netherlands
Bulgaria
Hungary
United States
United Kingdom
Italy
Austria
Mexico
Turkey

intervention_type: Drug


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension

acronym: ASCEND in SPMS

summary:
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.

status: Terminated

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

family: Koch

full_name: Marcus W. Koch

given: Marcus W.

family: Mostert

full_name: Jop Mostert

given: Jop

family: Zhang

full_name: Yinan Zhang

given: Yinan

family: Wolinsky

full_name: Jerry S. Wolinsky

given: Jerry S.

family: Lublin

full_name: Fred D. Lublin

given: Fred D.

family: Strijbis

full_name: Eva Strijbis

given: Eva

family: Cutter

full_name: Gary Cutter

given: Gary

journal_name: Neurology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Kapoor R, Ho PR, Campbell N, Chang I, Deykin A, Forrestal F, Lucas N, Yu B, Arnold DL, Freedman MS, Goldman MD, Hartung HP, Havrdová EK, Jeffery D, Miller A, Sellebjerg F, Cadavid D, Mikol D, Steiner D; ASCEND investigators. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension. Lancet Neurol. 2018 May;17(5):405-415. doi: 10.1016/S1474-4422(18)30069-3. Epub 2018 Mar 12.

family: Kapoor

full_name: Raju Kapoor

given: Raju

family: Ho

full_name: Pei-Ran Ho

given: Pei-Ran

family: Campbell

full_name: Nolan Campbell

given: Nolan

family: Chang

full_name: Ih Chang

given: Ih

family: Deykin

full_name: Aaron Deykin

given: Aaron

family: Forrestal

full_name: Fiona Forrestal

given: Fiona

family: Lucas

full_name: Nisha Lucas

given: Nisha

family: Yu

full_name: Bei Yu

given: Bei

family: Arnold

full_name: Douglas L Arnold

given: Douglas L

family: Freedman

full_name: Mark S Freedman

given: Mark S

family: Goldman

full_name: Myla D Goldman

given: Myla D

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Havrdová

full_name: Eva Kubala Havrdová

given: Eva Kubala

family: Jeffery

repository_institution: University of Florence - Florence Research

location_country:
Italy
United States
Sweden
Netherlands
Germany
Finland
France
Czechia
Poland
Israel
Ireland
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom


title: Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 18 to 35 Years of Age

summary:
The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.

Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.

primary_purpose: Prevention

ReferenceCitation: Apter D, Briggs P, Tuppurainen M, Grunert J, Lukkari-Lax E, Rybowski S, Gemzell-Danielsson K. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016 Jul;106(1):151-157.e5. doi: 10.1016/j.fertnstert.2016.02.036. Epub 2016 Mar 24.

family: Apter

full_name: Dan Apter

given: Dan

family: Briggs

full_name: Paula Briggs

given: Paula

family: Tuppurainen

full_name: Marjo Tuppurainen

given: Marjo

family: Grunert

full_name: Julia Grunert

given: Julia

family: Lukkari-Lax

full_name: Eeva Lukkari-Lax

given: Eeva

family: Rybowski

full_name: Sarah Rybowski

given: Sarah

family: Gemzell-Danielsson

full_name: Kristina Gemzell-Danielsson

given: Kristina

journal_name: Fertility and Sterility

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Bayer

location_country:
Sweden
Finland
France
Norway
Australia
United Kingdom


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

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

family: Narula

full_name: Neeraj Narula

given: Neeraj

family: Aruljothy

full_name: Achuthan Aruljothy

given: Achuthan

family: Wong

full_name: Emily C. L. Wong

given: Emily C. L.

family: Homenauth

full_name: Ravi Homenauth

given: Ravi

name: Department of Gastroenterology Najran University  Najran Saudi Arabia

family: Alshahrani

full_name: Abdul‐Aziz Alshahrani

given: Abdul‐Aziz

family: Marshall

full_name: John K. Marshall

given: John K.

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

family: Reinisch

full_name: Walter Reinisch

given: Walter

journal_name: United European Gastroenterology Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2021 Feb 19. pii: S1542-3565(21)00203-2. doi: 10.1016/j.cgh.2021.02.025. [Epub ahead of print]

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Rebuck

full_name: Rory Rebuck

given: Rory

family: Wang

full_name: Yuhua Wang

given: Yuhua

family: Zou

full_name: Bin Zou

given: Bin

family: Adedokun

full_name: Omoniyi J. Adedokun

given: Omoniyi J.

family: Gasink

full_name: Christopher Gasink

given: Christopher

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Hanauer

full_name: Stephen B. Hanauer

given: Stephen B.

family: Targan

full_name: Stephan Targan

given: Stephan

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

family: de Villiers

full_name: Willem J.S. de Villiers

given: Willem J.S.

family: Colombel

full_name: Jean-Frederic Colombel

given: Jean-Frederic

family: Feagan

full_name: Brian G. Feagan

journal_name: Clinical Gastroenterology and Hepatology

title: Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn’s Disease: The IM-UNITI Trial

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

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

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

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

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

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

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

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

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

ReferenceCitation: Hanauer SB, Sandborn WJ, Feagan BG, Gasink C, Jacobstein D, Zou B, Johanns J, Adedokun OJ, Sands BE, Rutgeerts P, de Villiers WJS, Colombel JF, Ghosh S. IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease. J Crohns Colitis. 2020 Jan 1;14(1):23-32. doi: 10.1093/ecco-jcc/jjz110.

name: Northwestern University Feinberg School of Medicine, Chicago, IL, USA

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

name: Robarts Clinical Trials, Western University, London, ON, Canada

name: University Hospital, Gasthuisberg, Leuven, Belgium

name: Stellenbosch University, Stellenbosch, South Africa

name: NIHR Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK

repository_institution: University of Birmingham - University of Birmingham Research Portal

title: IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn’s Disease

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

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

repository_institution: California Digital Library - eScholarship

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

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

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

ReferenceCitation: Sandborn WJ, Rutgeerts P, Gasink C, Jacobstein D, Zou B, Johanns J, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy. Aliment Pharmacol Ther. 2018 Jul;48(1):65-77. doi: 10.1111/apt.14794. Epub 2018 May 24.

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

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

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

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

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

publisher: Korean Association for the Study of Intestinal Diseases

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

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

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

summary: The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)

summary: This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

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

family: Narula

full_name: Neeraj Narula

given: Neeraj

family: Aruljothy

full_name: Achuthan Aruljothy

given: Achuthan

family: Wong

full_name: Emily C. L. Wong

given: Emily C. L.

family: Homenauth

full_name: Ravi Homenauth

name: Department of Gastroenterology Najran University  Najran Saudi Arabia

title: The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies

full_name: William J Sandborn

given: William J

full_name: Brian G Feagan

given: Brian G

family: Danese

full_name: Silvio Danese

given: Silvio

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

family: O’Brien

full_name: Christopher D O’Brien

given: Christopher D

family: Ott

full_name: Elyssa Ott

given: Elyssa

family: Marano

full_name: Colleen Marano

given: Colleen

family: Baker

full_name: Thomas Baker

given: Thomas

family: Zhou

full_name: Yiying Zhou

given: Yiying

family: Volger

full_name: Sheri Volger

given: Sheri

family: Tikhonov

full_name: Ilia Tikhonov

given: Ilia

title: Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies

repository_normalized: California Digital Library - eScholarship

repositories_institution: University of Birmingham - University of Birmingham Research Portal

title: Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

title: Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies

location_country:
Belgium
Australia
Russian Federation
Iceland
Croatia
France
Japan
Poland
Canada
Korea, Republic of
South Africa
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Brazil
Serbia
Israel
New Zealand
Spain


title: A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema

acronym: VIVID-DME

summary: To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

ReferenceType: result

ReferenceCitation: Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.

family: Korobelnik

full_name: Jean-François Korobelnik

given: Jean-François

family: Do

full_name: Diana V. Do

given: Diana V.

family: Schmidt-Erfurth

full_name: Ursula Schmidt-Erfurth

given: Ursula

family: Boyer

full_name: David S. Boyer

given: David S.

family: Holz

full_name: Frank G. Holz

given: Frank G.

family: Heier

full_name: Jeffrey S. Heier

given: Jeffrey S.

family: Midena

full_name: Edoardo Midena

given: Edoardo

family: Kaiser

full_name: Peter K. Kaiser

given: Peter K.

family: Terasaki

full_name: Hiroko Terasaki

given: Hiroko

family: Marcus

full_name: Dennis M. Marcus

given: Dennis M.

family: Nguyen

full_name: Quan D. Nguyen

given: Quan D.

family: Jaffe

full_name: Glenn J. Jaffe

given: Glenn J.

family: Slakter

full_name: Jason S. Slakter

given: Jason S.

family: Simader

full_name: Christian Simader

given: Christian

family: Soo

full_name: Yuhwen Soo

given: Yuhwen

family: Schmelter

full_name: Thomas Schmelter

family: Yancopoulos

full_name: George D. Yancopoulos

given: George D.

family: Stahl

full_name: Neil Stahl

given: Neil

family: Vitti

full_name: Robert Vitti

given: Robert

family: Berliner

full_name: Alyson J. Berliner

given: Alyson J.

family: Zeitz

full_name: Oliver Zeitz

given: Oliver

family: Metzig

full_name: Carola Metzig

given: Carola

family: Brown

full_name: David M. Brown

given: David M.

ReferenceCitation: Brown DM, Schmidt-Erfurth U, Do DV, Holz FG, Boyer DS, Midena E, Heier JS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Korobelnik JF. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015 Oct;122(10):2044-52. doi: 10.1016/j.ophtha.2015.06.017. Epub 2015 Jul 18.

ReferenceCitation: Keating GM. Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Drugs. 2015 Jul;75(10):1153-60. doi: 10.1007/s40265-015-0421-y. Review.

ReferenceCitation: Midena E, Gillies M, Katz TA, Metzig C, Lu C, Ogura Y. Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies. J Ophthalmol. 2018 Mar 29;2018:3640135. doi: 10.1155/2018/3640135. eCollection 2018.

name: Department of Ophthalmology, University of Padova, Padua, Italy

name: Save Sight Institute, Sydney Medical School, University of Sydney, Sydney Eye Hospital, Sydney, NSW, Australia

name: Department of Ophthalmology & Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

repositories_institution:
Hindawi - Hindawi
PubMed Central - Europe PMC

ReferenceCitation: Staurenghi G, Feltgen N, Arnold JJ, Katz TA, Metzig C, Lu C, Holz FG; VIVID-DME and VISTA-DME study investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018 Jul;102(7):954-958. doi: 10.1136/bjophthalmol-2017-310664. Epub 2017 Oct 19.

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

ReferenceCitation: Wykoff CC, Marcus DM, Midena E, Korobelnik JF, Saroj N, Gibson A, Vitti R, Berliner AJ, Williams Liu Z, Zeitz O, Metzig C, Schmelter T, Heier JS. Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials. JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.

name: Retina Consultants of Houston, Houston, Texas

name: Southeast Retina Center, Augusta, Georgia

name: Department of Ophthalmology, University of Padova, Padova, Italy

name: Service d’Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France5University Bordeaux, Institut de Santé Publique, d’Epidémiologie et de Développement (ISPED), Bordeaux, France6Institut National de la Santé et de la Récherche Médicale Unité 1219, Bordeaux Population Health Research Center, Bordeaux, France

name: Regeneron Pharmaceuticals, Inc, Tarrytown, New York

name: Bayer HealthCare Pharmaceuticals, Berlin, Germany9University Medical Center Hamburg-Eppendorf, Hamburg, Germany

name: Ophthalmic Consultants of Boston, Boston, Massachusetts

ReferenceCitation: Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data. Int J Retina Vitreous. 2016 Jul 11;2:16. eCollection 2016.

location_country:
Italy
Austria
France
Japan
Poland
Hungary
Australia
Spain
Denmark
Germany
Czech Republic
Taiwan


lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
South Africa
Netherlands
France
Bulgaria
Korea, Republic of
Lithuania
Poland
Romania
Hungary
Latvia
Slovakia
Thailand
China
United States
Czech Republic
Canada
Taiwan
Ukraine

source: euctr

title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy

summary: This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.


ReferenceCitation: Pettengell R, Długosz-Danecka M, Andorsky D, Belada D, Georgiev P, Quick D, Singer JW, Singh SB, Pallis A, Egorov A, Salles G. Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306). Br J Haematol. 2020 Jan;188(2):240-248. doi: 10.1111/bjh.16255. Epub 2019 Dec 27.

family: Pettengell

full_name: Ruth Pettengell

given: Ruth

name: Department of Haematology Jagiellonian University Krakow Poland

family: Długosz‐Danecka

full_name: Monika Długosz‐Danecka

given: Monika

name: Rocky Mountain Cancer CentersUS Oncology Research Boulder CO USA

family: Andorsky

full_name: David Andorsky

given: David

name: Clinical Haematology 4th Department of Internal Medicine Charles University, Hospital and Faculty of Medicine Hradec Králové Czech Republic

family: Belada

full_name: David Belada

name: Clinic of Oncology and Haematology University Multiprofile Hospital for Active Treatment "Sveti Georgi" and Medical University Plovdiv Bulgaria

family: Georgiev

full_name: Pencho Georgiev

given: Pencho

name: Joe Arrington Cancer Research Treatment Center Lubbock TX USA

family: Quick

full_name: Donald Quick

given: Donald

name: Elson S. Floyd School of Medicine Washington State University WA USA

family: Singer

full_name: Jack W. Singer

given: Jack W.

family: Singh

full_name: Simran B. Singh

given: Simran B.

name: Institut de Recherches Internationales Servier SuresnesFrance

family: Pallis

full_name: Athanasios Pallis

given: Athanasios

family: Egorov

full_name: Anton Egorov

given: Anton

name: Haematology Department Hospices Civils de LyonUniversité Claude Bernard Lyon‐1 Pierre‐Bénite France

family: Salles

full_name: Gilles Salles

given: Gilles

journal_name: British Journal of Haematology

evidence: open (via free article)

title: Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B‐cell non‐Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306)

ReferenceCitation: Belada D, Georgiev P, Dakhil S, Inhorn LF, Andorsky D, Beck JT, Quick D, Pettengell R, Daly R, Dean JP, Pavlyuk M, Failloux N, Hübel K. Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma. Future Oncol. 2016 Aug;12(15):1759-68. doi: 10.2217/fon-2016-0137. Epub 2016 Apr 20.

name: 4th Department of Internal Medicine – Hematology, Charles University Hospital & Faculty of Medicine, Hradec Králové, Czech Republic

name: UMHAT “Sveti Georgi”, Plovdiv, Clinical Haematology Clinic, Plovdiv, Bulgaria

name: Cancer Center of Kansas, Wichita, KS, USA

family: Dakhil

full_name: Shaker Dakhil

given: Shaker

name: Blue Ridge Cancer Care, Roanoke, VA, USA

family: Inhorn

full_name: Lowell F Inhorn

given: Lowell F

name: Rocky Mountain Cancer Center, Boulder, CO, USA

name: Highlands Oncology Group, Fayetteville, AR, USA

family: Beck

full_name: J Thaddeus Beck

given: J Thaddeus

name: Joe Arrington Cancer Research & Treatment Center, Lubbock, TX, USA

name: St George's Healthcare NHS Trust, Tooting, London, UK

family: Daly

full_name: Robert Daly

family: Dean

full_name: James P Dean

given: James P

name: Institut de Recherches Internationales Servier, Suresnes, France

name: University Hospital of Cologne, Cologne, Germany

repository_institution: St George's University of London - St George's Online Research Archive

title: Pixantrone–rituximab versus gemcitabine–rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma

location_country:
Italy
Austria
Germany
France
Czechia
Bulgaria
Poland
Slovakia
Romania
Hungary
Belgium
Russian Federation
Spain
Denmark
United States
United Kingdom
Ukraine

location_facility: Aalborg University Hospital, Department of Hematology

location_facility: J. A. Reiman University Hospital with Polyclinic in Presov

location_facility: Integrated Community Oncology Network-Southside

location_facility: Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

location_facility: Integrated Community Oncology Network-St. Vincent's

location_facility: Christie Hospital, Department of Medical Oncology

location_facility: General Hospital Turnhout, Hematology Department

location_facility: University Hospital Ostrava, Institute of Clinical Hematology

location_facility: State Medical Institution: Republican Hospital named after V.A. Baranov

location_facility: St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care

location_facility: Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital

location_facility: Independent Public Healthcare Facility Municipal Hospital Group

location_facility: Hanusch Hospital, Department of Internal Medicine III

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"

location_facility: Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation

location_facility: State Healthcare Institution: Republican Clinical Oncology Center

location_facility: North Shore Hematology/Oncology Associates

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology

location_facility: George Washington University Department of Medicine

location_facility: Cancer Care Specialists of Central Illinois

location_facility: University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology

location_facility: University Hospital Kralovske Vinohrady, Department of Clinical Hematology

location_facility: University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

location_facility: Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense

location_facility: Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Green Bay Oncology-St. Mary's Hospital MC

location_facility: Silesia Medical University, Department of Hematology and Bone Marrow Transplantation

location_facility: Metro Minnesota Community Clinical Oncology Program

location_facility: Siena University Hospital Authority Santa Maria alle Scotte Polyclinic

location_facility: Oncology Center of Lublin Land, Department of Clinical Oncology

location_facility: Malopolskie Medical Center S.C. , Department of Hematology

location_facility: University Hospital Martin, Department of Hematology and Transfusiology

location_facility: MHAT Hristo Botev, Vratsa, First Department of Internal Medicine

location_facility: Institute of Hematology and Transfusion Medicine, Clinic of Hematology

location_facility: Saint Vincent Hospital Green Bay Oncology

location_facility: Marine Hospital of Polish Red Cross, Department of Chemotheraphy

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Polyclinique de Bordeaux nord Acquitaine

location_facility: Saint Luc University Hospital, Department of Hematology

location_facility: UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology

location_facility: State Institution: Institute of Blood Pathology and Transfusion Medicine

location_facility: Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"

location_facility: Hautepierre Hospital, Department of Hematology and Oncology

location_facility: University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology

location_facility: National Cancer Institute, Department of Hematology and Transfusiology

location_facility: Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.

location_facility: UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic

location_facility: General Hospital Delta, Hematology Department

location_facility: Cancer Care Centers of South Texas-HOAST

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

location_facility: General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology

location_facility: Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic

location_facility: Service d'hématologie clinique, Avenue Laennec Salouel

location_facility: Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin

location_facility: Saint Quentin Hospital Center, Department of Oncology-Hematology

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Bucharest University Emergency Hospital, Hematology Clinic

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

location_facility: Institut Català de Oncologia (ICO), Hospital Dr Trueta

location_facility: State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology

location_facility: Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

location_facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square

location_facility: MHAT "Tokuda Hospital Sofia", Hematology Clinic

location_facility: "Ospedali Riuniti Villa Sofia-Cervello" Hospital

location_facility: Cancer & Hematology Center of Western Michigan

title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

summary: The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.


title: An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

summary: An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

lead_sponsor: GlaxoSmithKline

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Hong Kong
Switzerland
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain
Estonia

status_simplified: Unknown


title: A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

summary: A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Norway
Canada
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain
Estonia


ReferenceCitation: Österborg A, Udvardy M, Zaritskey A, Andersson PO, Grosicki S, Mazur G, Kaplan P, Steurer M, Schuh A, Montillo M, Kryachok I, Middeke JM, Kulyaba Y, Rekhtman G, Gorczyca M, Daly S, Chang CN, Lisby S, Gupta I. Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2016 Sep;57(9):2037-46. doi: 10.3109/10428194.2015.1122783. Epub 2016 Jan 19.

family: Österborg

full_name: Anders Österborg

given: Anders

family: Udvardy

full_name: Miklós Udvardy

given: Miklós

family: Zaritskey

full_name: Andrey Zaritskey

given: Andrey

family: Andersson

full_name: Per-Ola Andersson

given: Per-Ola

family: Grosicki

full_name: Sebastian Grosicki

given: Sebastian

family: Mazur

full_name: Grzegorz Mazur

given: Grzegorz

family: Kaplan

full_name: Polina Kaplan

given: Polina

family: Steurer

full_name: Michael Steurer

given: Michael

family: Schuh

full_name: Anna Schuh

given: Anna

family: Montillo

full_name: Marco Montillo

given: Marco

family: Kryachok

full_name: Iryna Kryachok

given: Iryna

family: Middeke

full_name: Jan Moritz Middeke

given: Jan Moritz

family: Kulyaba

full_name: Yaroslav Kulyaba

given: Yaroslav

family: Rekhtman

full_name: Grygoriy Rekhtman

given: Grygoriy

family: Gorczyca

full_name: Michele Gorczyca

given: Michele

full_name: Siobhan Daly

given: Siobhan

family: Chang

full_name: Chai-Ni Chang

given: Chai-Ni

family: Lisby

full_name: Steen Lisby

given: Steen

family: Gupta

full_name: Ira Gupta

given: Ira

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Phase III, randomized study of ofatumumab versus physicians’ choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia

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

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

location_country:
Italy
Austria
Sweden
France
Czechia
Bulgaria
Israel
Poland
Singapore
Hungary
Belgium
Ireland
Russian Federation
Slovakia
Germany
United Kingdom
Ukraine

ipd_sharing: Undecided

title: An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

summary: The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.


title: A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

ReferenceCitation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.

family: Delafont

full_name: Bruno Delafont

given: Bruno

name: KJC Statistics Ltd; Bramhall Cheshire UK

family: Carroll

full_name: Kevin Carroll

given: Kevin

family: Vilain

full_name: Claire Vilain

given: Claire

family: Pham

full_name: Emmanuel Pham

given: Emmanuel

journal_name: Pharmaceutical Statistics

ReferenceCitation: O'Dell MW, Brashear A, Jech R, Lejeune T, Marque P, Bensmail D, Ayyoub Z, Simpson DM, Volteau M, Vilain C, Picaut P, Gracies JM. Dose-Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study. PM R. 2018 Jan;10(1):1-10. doi: 10.1016/j.pmrj.2017.06.008. Epub 2017 Jun 19.

family: O'Dell

full_name: Michael W. O'Dell

given: Michael W.

family: Brashear

full_name: Allison Brashear

given: Allison

family: Jech

full_name: Robert Jech

given: Robert

family: Lejeune

full_name: Thierry Lejeune

given: Thierry

family: Marque

full_name: Philippe Marque

given: Philippe

family: Bensmail

full_name: Djamel Bensmail

given: Djamel

family: Ayyoub

full_name: Ziyad Ayyoub

given: Ziyad

family: Simpson

full_name: David M. Simpson

given: David M.

family: Volteau

full_name: Magali Volteau

given: Magali

family: Picaut

full_name: Philippe Picaut

family: Gracies

full_name: Jean Michel Gracies

given: Jean Michel

journal_name: PM&R

ReferenceCitation: Marciniak C, McAllister P, Walker H, Brashear A, Edgley S, Deltombe T, Khatkova S, Banach M, Gul F, Vilain C, Picaut P, Grandoulier AS, Gracies JM; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. PM R. 2017 Dec;9(12):1181-1190. doi: 10.1016/j.pmrj.2017.06.007. Epub 2017 Jun 16.

family: Marciniak

full_name: Christina Marciniak

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

ReferenceCitation: Gracies JM, Brashear A, Jech R, McAllister P, Banach M, Valkovic P, Walker H, Marciniak C, Deltombe T, Skoromets A, Khatkova S, Edgley S, Gul F, Catus F, De Fer BB, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015 Oct;14(10):992-1001. doi: 10.1016/S1474-4422(15)00216-1. Epub 2015 Aug 26.

location_country:
Italy
France
Czechia
Poland
Slovakia
Hungary
Belgium
Russian Federation
United States

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: National Institut for Medical Rehabilitation

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Rancho Los Amigos National Rehabilitation Center

location_facility: Associated Neurologist of Southern CT, PT

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton


title: LY2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder

summary:
The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period.

This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

ReferenceCitation: Oakes TM, Dellva MA, Waterman K, Greenbaum M, Poppe C, Goldberger C, Ahl J, Perahia DG. Edivoxetine compared to placebo as adjunctive therapy to selective serotonin reuptake inhibitors in the prevention of symptom re-emergence in major depressive disorder. Curr Med Res Opin. 2015 Jun;31(6):1179-89. doi: 10.1185/03007995.2015.1037732. Epub 2015 May 6.

name: aLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

family: Oakes

full_name: Tina M. Oakes

given: Tina M.

family: Dellva

full_name: Mary Anne Dellva

given: Mary Anne

family: Waterman

full_name: Karen Waterman

given: Karen

name: bCapstone Clinical Research, Libertyville, IL, USA

family: Greenbaum

full_name: Michael Greenbaum

given: Michael

family: Poppe

full_name: Christopher Poppe

given: Christopher

family: Goldberger

full_name: Celine Goldberger

given: Celine

family: Ahl

full_name: Jonna Ahl

given: Jonna

name: cNeurosciences, Lilly Research Centre, Windlesham, Surrey, UK

family: Perahia

full_name: David G. Perahia

given: David G.

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Mexico
Spain
Germany
Croatia
France
Greece
Slovakia
Romania
Belgium
Argentina
Puerto Rico
Russian Federation
Turkey
United States
Korea, Republic of

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


title: A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

acronym: OPERA II

summary: This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

ReferenceCitation: D'Haens GR, Reinisch W, Lee SD, Tarabar D, Louis E, Kłopocka M, Klaus J, Schreiber S, Il Park D, Hébuterne X, Nagy P, Cataldi F, Martin SW, Nayak S, Banerjee A, Gorelick KJ, Sandborn WJ. Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn's Disease: The OPERA II Study. Inflamm Bowel Dis. 2021 Aug 24. pii: izab215. doi: 10.1093/ibd/izab215. [Epub ahead of print]

name: Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands

family: D’Haens

full_name: Geert R D’Haens

given: Geert R

name: Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria

family: Reinisch

full_name: Walter Reinisch

given: Walter

name: Division of Gastroenterology, University of Washington, Seattle, WA, USA

family: Lee

full_name: Scott D Lee

given: Scott D

name: Clinic of Gastroenterology and Hepatology, Military Medical Academy, Belgrade, Serbia

family: Tarabar

full_name: Dino Tarabar

given: Dino

name: Department of Clinical Sciences, University Hospital Centre Hospitalier Universitaire of Liège, Liège, Belgium

family: Louis

full_name: Edouard Louis

given: Edouard

name: Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland

family: Kłopocka

full_name: Maria Kłopocka

given: Maria

name: Clinic for Internal Medicine, University Hospital Ulm, Ulm, Germany

family: Klaus

full_name: Jochen Klaus

given: Jochen

name: Clinic for Internal Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University of Kiel, Kiel, Germany

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

name: Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University, Seoul, South Korea

family: Il Park

full_name: Dong Il Park

given: Dong

name: University Côte d’Azur, Centre Hospitalier Universitaire of Nice, Nice, France

family: Hébuterne

full_name: Xavier Hébuterne

given: Xavier

name: Shire, a Takeda company, Zug, Switzerland

family: Nagy

full_name: Peter Nagy

given: Peter

name: Shire, a Takeda company, Lexington, MA, USA

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

family: Martin

full_name: Steven W Martin

given: Steven W

family: Nayak

full_name: Satyaprakash Nayak

given: Satyaprakash

family: Banerjee

full_name: Anindita Banerjee

given: Anindita

name: Zymo Consulting Group, Newtown Square, PA, USA

family: Gorelick

full_name: Kenneth J Gorelick

given: Kenneth J

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

family: Sandborn

full_name: William J Sandborn

given: William J

journal_name: Inflammatory Bowel Diseases

license: cc-by-nc

license_normalized: cc-by-nc

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

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

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn’s Disease: The OPERA II Study

lead_sponsor: Shire

location_country:
Austria
United States
South Africa
Serbia
Netherlands
Germany
France
Japan
Poland
Slovakia
Norway
Belgium
Spain
Canada
Korea, Republic of

location_facility: Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Nassau Gastroenterology Associates, P.C.

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Center for Digestive and Liver Diseases, Inc.

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Barnes-Jewish Hospital - Investigational Drug Services

location_facility: North Carolina Memorial Hospital Endoscopy Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: "Charite - Campus Berlin Mitte Medizinische Klinik

location_facility: Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology

location_facility: University of Miami Crohn's and Colitis Center

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Washington University School of Medicine

location_facility: Nassau Gastroenterology Associates Office Based Surgery

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: University of Miami Hospital and Clinic (IP Shipment Only)

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum


title: A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

summary: The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

ReferenceCitation: Heidenreich A, Chowdhury S, Klotz L, Siemens DR, Villers A, Ivanescu C, Holmstrom S, Baron B, Wang F, Lin P, Shore ND. Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial. Eur Urol. 2017 Apr;71(4):534-542. doi: 10.1016/j.eururo.2016.07.027. Epub 2016 Aug 3.

family: Heidenreich

full_name: Axel Heidenreich

given: Axel

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

family: Klotz

full_name: Laurence Klotz

given: Laurence

family: Siemens

full_name: David Robert Siemens

given: David Robert

family: Villers

full_name: Arnauld Villers

given: Arnauld

family: Ivanescu

full_name: Cristina Ivanescu

given: Cristina

family: Holmstrom

full_name: Stefan Holmstrom

family: Baron

full_name: Benoit Baron

given: Benoit

family: Wang

full_name: Fong Wang

given: Fong

family: Lin

full_name: Ping Lin

given: Ping

family: Shore

full_name: Neal D. Shore

given: Neal D.

journal_name: European Urology

ReferenceCitation: Shore ND, Chowdhury S, Villers A, Klotz L, Siemens DR, Phung, van Os S, Hasabou N, Wang F, Bhattacharya S, Heidenreich A. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Oncol. 2016 Feb;17(2):153-163. doi: 10.1016/S1470-2045(15)00518-5. Epub 2016 Jan 14.

full_name: Neal D Shore

given: Neal D

full_name: D Robert Siemens

given: D Robert

family: Phung

full_name: De Phung

given: De

family: van Os

full_name: Steve van Os

given: Steve

family: Hasabou

full_name: Nahla Hasabou

given: Nahla

family: Bhattacharya

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
United States
Germany
France
Romania
Belgium
Denmark
Canada
United Kingdom

location_facility:
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title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy

acronym: PROMISE

summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Fevery

full_name: Bart Fevery

given: Bart

family: Tambuyzer

full_name: Lotke Tambuyzer

given: Lotke

family: Vijgen

full_name: Leen Vijgen

given: Leen

family: Peeters

full_name: Monika Peeters

given: Monika

family: Buelens

full_name: Annemie Buelens

given: Annemie

family: Ceulemans

full_name: Hugo Ceulemans

given: Hugo

family: Beumont

full_name: Maria Beumont

given: Maria

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

journal_name: Journal of Hepatology

ReferenceCitation: Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, Horban A, Brown A, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, Scott J, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014 Jun;146(7):1669-79.e3. doi: 10.1053/j.gastro.2014.02.051. Epub 2014 Mar 3.

family: Forns

full_name: Xavier Forns

given: Xavier

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Gane

full_name: Ed Gane

given: Ed

family: Bronowicki

full_name: Jean Pierre Bronowicki

given: Jean Pierre

family: Andreone

full_name: Pietro Andreone

given: Pietro

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Brown

full_name: Ashley Brown

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

title: Simeprevir With Peginterferon and Ribavirin Leads to High Rates of SVR in Patients With HCV Genotype 1 Who Relapsed After Previous Therapy: A Phase 3 Trial

location_country:
Austria
United States
Spain
Germany
France
Poland
Australia
Belgium
New Zealand
Puerto Rico
Russian Federation
Canada
United Kingdom


ReferenceCitation: Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Ahn

full_name: Sang Hoon Ahn

given: Sang Hoon

family: Ma

full_name: Xiaoli Ma

given: Xiaoli

family: Caruntu

full_name: Florin A. Caruntu

given: Florin A.

family: Tak

full_name: Won Young Tak

given: Won Young

family: Elkashab

full_name: Magdy Elkashab

given: Magdy

family: Chuang

full_name: Wan-Long Chuang

given: Wan-Long

family: Lim

full_name: Seng-Gee Lim

given: Seng-Gee

family: Tabak

full_name: Fehmi Tabak

given: Fehmi

family: Mehta

full_name: Rajiv Mehta

given: Rajiv

family: Petersen

full_name: Joerg Petersen

given: Joerg

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: Lou

full_name: Lillian Lou

given: Lillian

family: Martins

full_name: Eduardo B. Martins

given: Eduardo B.

family: Dinh

full_name: Phillip Dinh

given: Phillip

family: Lin

full_name: Lanjia Lin

given: Lanjia

family: Corsa

full_name: Amoreena Corsa

given: Amoreena

family: Charuworn

full_name: Prista Charuworn

given: Prista

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: Reiser

full_name: Hans Reiser

given: Hans

family: Reesink

full_name: Hendrick W. Reesink

given: Hendrick W.

family: Fung

full_name: Scott Fung

given: Scott

family: Strasser

full_name: Simone I. Strasser

given: Simone I.

family: Trinh

full_name: Huy Trinh

given: Huy

family: Buti

full_name: Maria Buti

ReferenceCitation: Chan HL, Elkhashab M, Trinh H, Tak WY, Ma X, Chuang WL, Kim YJ, Martins EB, Lin L, Dinh P, Charuworn P, Foster GR, Marcellin P. Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B. J Hepatol. 2015 Nov;63(5):1086-92. doi: 10.1016/j.jhep.2015.06.025. Epub 2015 Jul 2.

location_country:
Italy
United States
India
Hong Kong
Netherlands
Spain
Germany
France
Poland
Greece
Romania
Singapore
Australia
Portugal
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Weill Cornell Medical College of Cornell University

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: University of Miami / Jackson Memorial Medical Center

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

location_facility: Liver Institute of Virginia, Bon Secours Health System

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: All India Institute of Medical Sciences, Ansari Nagar

location_facility: Pusan National University Yangsan Hospital

location_facility: Cabinet Particular Policlinic Algomed SRL-Gastroenterologie

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Institutul National de Boli Infectioase Prof.Dr. Matei Bals

location_facility: Digestive Disease Cntr, Konkuk Univ Hosp

location_facility: Institute of digestive and liver disease, Dispur Hospital Ganeshguri

location_facility: LSU Gastroenterology/Center for Digestive Diseases

location_facility: Advanced Liver Therapies at St. Luke's Episcopal Hospital

location_facility: Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil

location_facility: Chang Gung Medical Foundation.LinKou Branch

location_facility: Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel

location_facility: The Ottawa Hospital,Division of Infectious Diseases

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Hospital General Universitari Vall d' Hebron

location_facility: Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,

location_facility: University of Alberta, Zeidler Ledcore Centre

location_facility: Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16

location_facility: Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology

location_facility: SoonChunHyang University Hospital Cheonan

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico

location_facility: University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Seconda Universita degli Studi di Napoli

location_facility: Hippokration General Hospital of Thessaloniki

location_facility: Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku

location_facility: Heritage Med Research Clinic, Univ of Calgary

location_facility: Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi

location_facility: Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie

location_facility: Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza

location_facility: Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami

location_facility: Dharamasi Hospital,Chandni Chowk, South Shivajinagar,

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi

title: A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys®) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

summary:
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).

The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.


title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

acronym: OPERA

summary: Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

ReferenceCitation: Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.

apc_source: doaj

family: Saruta

full_name: Masayuki Saruta

given: Masayuki

family: Park

full_name: Dong Il Park

given: Dong Il

family: Kim

full_name: Young-Ho Kim

given: Young-Ho

family: Yang

full_name: Suk-Kyun Yang

given: Suk-Kyun

family: Jang

full_name: Byung-Ik Jang

given: Byung-Ik

family: Cheon

full_name: Jae Hee Cheon

given: Jae Hee

family: Im

full_name: Jong Pil Im

given: Jong Pil

family: Kanai

full_name: Takanori Kanai

given: Takanori

family: Katsuno

full_name: Tatsuro Katsuno

given: Tatsuro

family: Ishiguro

full_name: Yoh Ishiguro

given: Yoh

family: Nagaoka

full_name: Makoto Nagaoka

given: Makoto

family: Isogawa

full_name: Naoki Isogawa

given: Naoki

family: Li

full_name: Yinhua Li

given: Yinhua

family: Banerjee

full_name: Anindita Banerjee

given: Anindita

family: Ahmad

full_name: Alaa Ahmad

given: Alaa

family: Hassan-Zahraee

full_name: Mina Hassan-Zahraee

given: Mina

family: Clare

full_name: Robert Clare

given: Robert

family: Gorelick

full_name: Kenneth J. Gorelick

given: Kenneth J.

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

family: Watanabe

full_name: Mamoru Watanabe

given: Mamoru

family: Hibi

full_name: Toshifumi Hibi

given: Toshifumi

currency_apc_doaj: EUR

publisher_group: Korean Association for the Study of Intestinal Diseases

title: Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study

ReferenceCitation: Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hébuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.

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

title: Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn’s disease: report of the OPERA study

ReferenceCitation: Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ß7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.

title: Anti-MAdCAM Antibody Increases ß7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn’s Disease

location_country:
Austria
United States
South Africa
Serbia
Netherlands
Germany
France
Bulgaria
Japan
Poland
Slovakia
Norway
Belgium
Spain
Canada
Korea, Republic of

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Minneapolis Heart Institute, West Health Campus

location_facility: Beth Israel Medical Center - Phillip Ambulatory Care Center

location_facility: Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej

location_facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Charite - Campus Berlin Mitte Medizinische Klinik

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Nassau Gastroenterology Associates, P.C.

location_facility: Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Center for Digestive and Liver Diseases, Inc.

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie

location_facility: Barnes-Jewish Hospital - Investigational Drug Services

location_facility: Gastroenterology Specialists of Arkansas

location_facility: North Carolina Memorial Hospital Endoscopy Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: The Offices of Dr. Vincent Armenio, M.D.

location_facility: East side Endoscopy, LLC (for colonscopy testing only)

location_facility: Inland Gastroenterology Medical Associates, Inc.

location_facility: Consulting Radiology (Xray testing only)

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Washington University School of Medicine

location_facility: CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie

location_facility: Clinical Center Nis Clinic for Gastroenterology and Hepatology

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Vancouver Coastal Health - Vancouver Hospital

location_facility: Heartland Medical Research (Administrative Only)

location_facility: Connecticut Clinical Research Foundation

location_facility: Nassau Gastroenterology Associates Office Based Surgery

location_facility: Vancouver Coastal Health - Vancouver General Hospital

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Shands Hospital at the University of Florida

location_facility: MBAL Sofiamed OOD,Otdelenie po gastroenterologia

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie

location_facility: Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.

location_facility: Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center