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"phase 3"

Kristian Reich, Craig Leonardi, Mark Lebwohl, Francisco Kerdel, Yukari Okubo, Ricardo Romiti, Orin Goldblum, Ellen B Dennehy, Lisa Kerr, Howard Sofen
BACKGROUND: Scalp is a frequently affected and difficult-to-treat area in psoriasis patients. OBJECTIVES: We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI). METHODS: In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12...
October 19, 2016: Journal of Dermatological Treatment
Leonard A Levin
Glaucoma is both the most common optic neuropathy worldwide and the most common cause of irreversible blindness in the world. The only proven treatment for glaucomatous optic neuropathy is lowering the intraocular pressure, achieved with a variety of pharmacological, laser, and surgical approaches. Over the past 2 decades there has been much basic and clinical research into achieving treatment of the underlying optic nerve damage with neuroprotective approaches. However, none has resulted in regulatory approval based on successful phase 3 studies...
October 18, 2016: Handbook of Experimental Pharmacology
Jesús F San-Miguel, Vania T M Hungria, Sung-Soo Yoon, Meral Beksac, Meletios A Dimopoulos, Ashraf Elghandour, Wieslaw W Jedrzejczak, Andreas Günther, Thanyaphong N Nakorn, Noppadol Siritanaratkul, Robert L Schlossman, Jian Hou, Philippe Moreau, Sagar Lonial, Jae H Lee, Hermann Einsele, Monika Sopala, Bourras-Rezki Bengoudifa, Florence Binlich, Paul G Richardson
BACKGROUND: Panobinostat plus bortezomib and dexamethasone significantly increased median progression-free survival compared with placebo plus bortezomib and dexamethasone in the phase 3 PANORAMA 1 trial. Here, we present the final overall survival analysis for this trial. METHODS: PANORAMA 1 is a randomised, placebo-controlled, double-blind, phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma with one to three previous treatments...
October 14, 2016: Lancet Haematology
Robert Flisiak, Mitchell Shiffman, Juan Arenas, Hugo Cheinquer, Igor Nikitin, Yuping Dong, Khurram Rana, Subasree Srinivasan
BACKGROUND: A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. METHODS: Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks...
2016: PloS One
Paul R Lambert, John Carey, Anthony A Mikulec, Carl LeBel
OBJECTIVE: To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease. STUDY DESIGN: Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months. SETTING: Fifty-two academic and community otolaryngology centers. PATIENTS: One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive. INTERVENTION: Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo...
September 30, 2016: Otology & Neurotology
Patrice Chevallier, Myriam Labopin, Regis Peffault de La Tour, Bruno Lioure, Claude-Eric Bulabois, Anne Huynh, Didier Blaise, Pascal Turlure, Etienne Daguindau, Natacha Maillard, Ibrahim Yakoub-Agha, Gaelle Guillerm, Jeremy Delage, Nathalie Contentin, Jacques-Olivier Bay, Florence Beckerich, Jean-Henri Bourhis, Marie Detrait, Stéphane Vigouroux, Sylvie François, Faezeh Legrand, Thierry Guillaume, Mohamad Mohty
We have retrospectively compared survivals between acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) patients who received either a clofarabine/busulfan (CloB2A2) or a fludarabine/busulfan (FB2A2) RIC regimen for allogeneic stem cell transplantation. Between 2009 and 2014, 355 allotransplanted cases were identified from the SFGM-TC registry as having received either the FB2A2 (n = 316, 56% males, median age: 59.2 years, AML 78.5%, first complete remission [CR1] 72%, median follow-up: 20 months) or the CloB2A2 (n = 39, 62% males, median age: 60...
October 17, 2016: Cancer Medicine
Alan Kivitz, Thomas Wallace, Ewa Olech, Michael Borofsky, Jenny Devenport, Jinglan Pei, Margaret Michalska
INTRODUCTION: To assess the long-term safety and efficacy of subcutaneous tocilizumab (TCZ-SC) in US patients with rheumatoid arthritis (RA) who rolled over from the two global phase 3 studies, SUMMACTA (NCT01194414) and BREVACTA (NCT1232569), into this open-label, single-arm, phase 3b study. METHODS: Patients continued to receive TCZ-SC 162 mg weekly or every other week or switched from intravenous TCZ to TCZ-SC 162 mg qw for up to 84 weeks. The primary endpoint was the proportion of patients with serious adverse events (SAEs)...
September 24, 2016: Rheumatol Ther
Philip Mease, Iain B McInnes
INTRODUCTION: Psoriatic arthritis (PsA) is an immune-mediated chronic inflammatory arthropathy associated with impaired physical function and reduced quality of life. Biologic therapies that target tumor necrosis factor (anti-TNF) have significantly improved clinical outcomes. Partial, non- and transient responses remain common comprising significant unmet clinical need. New therapies with novel modes of action are urgently required. OBJECTIVES: The interleukin (IL)-17 pathway has recently been attributed a critical role in the pathogenesis of spondyloarthritides...
June 2016: Rheumatol Ther
Jillian Mullen, Charles W Mathias, Tara E Karns, Yuanyuan Liang, Nathalie Hill-Kapturczak, John D Roache, Richard J Lamb, Donald M Dougherty
OBJECTIVE: The purpose of this study was to determine if behavioral impulsivity under multiple conditions (baseline, after alcohol consumption or after serotonin depletion) predicted naturalistic alcohol use or treatment outcomes from a moderation-based contingency management intervention. METHOD: The current data analysis pulls information from three phases of a large study: 1) Phase 1 examined baseline and the effects of alcohol use and serotonin depletion on three types of behavioral impulsivity: response initiation (IMT task), response inhibition (GoStop task), and delay discounting (SKIP task); 2) Phase 2 involved 28 days of naturalistic drinking; and 3) Phase 3 involved 3 months of contingency management...
September 2016: Addictive Disorders & Their Treatment
Corey J Langer, Shirish M Gadgeel, Hossein Borghaei, Vassiliki A Papadimitrakopoulou, Amita Patnaik, Steven F Powell, Ryan D Gentzler, Renato G Martins, James P Stevenson, Shadia I Jalal, Amit Panwalkar, James Chih-Hsin Yang, Matthew Gubens, Lecia V Sequist, Mark M Awad, Joseph Fiore, Yang Ge, Harry Raftopoulos, Leena Gandhi
BACKGROUND: Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer (NSCLC) setting. The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy. We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC...
October 10, 2016: Lancet Oncology
Jan Franko, Qian Shi, Jeffrey P Meyers, Timothy S Maughan, Richard A Adams, Matthew T Seymour, Leonard Saltz, Cornelis J A Punt, Miriam Koopman, Christophe Tournigand, Niall C Tebbutt, Eduardo Diaz-Rubio, John Souglakos, Alfredo Falcone, Benoist Chibaudel, Volker Heinemann, Joseph Moen, Aimery De Gramont, Daniel J Sargent, Axel Grothey
BACKGROUND: Patients with peritoneal metastatic colorectal cancer have reduced overall survival compared with patients with metastatic colorectal cancer without peritoneal involvement. Here we further investigated the effect of the number and location of metastases in patients receiving first-line systemic chemotherapy. METHODS: We analysed individual patient data for previously untreated patients enrolled in 14 phase 3 randomised trials done between 1997 and 2008...
October 12, 2016: Lancet Oncology
John J P Kastelein, Dean J Kereiakes, Christopher P Cannon, Harold E Bays, Pascal Minini, L Veronica Lee, Jaman Maroni, Michel Farnier
OBJECTIVES: The objective of this study is to report the dose response in ODYSSEY phase 3 clinical trials of proprotein convertase subtilisin kexin type 9 inhibition with alirocumab in patients not at prespecified lipid goals who received a per-protocol dose increase from 75 every 2 weeks (Q2W) to 150 mg Q2W. METHODS: Patients (n=2181) receiving statins were enrolled in six phase 3 randomized, double-blind, double-dummy trials (24-104 weeks): alirocumab versus placebo or ezetimibe 10 mg/day...
October 12, 2016: Coronary Artery Disease
Maribel Rodriguez-Torres, Eric Lawitz, Bienvenido Yangco, Lennox Jeffers, Steven-Huy Han, Paul J Thuluvath, Vinod Rustgi, Stephen Harrison, Reem Ghalib, John M Vierling, Velimir Luketic, Philippe J Zamor, Natarajan Ravendhran, Timothy R Morgan, Brian Pearlman, Christopher O'Brien, Hicham Khallafi, Nikolaos Pyrsopoulos, George Kong, Fiona McPhee, Philip D Yin, Eric Hughes, Michelle Treitel
:  Background. Patient race and ethnicity have historically impacted HCV treatment response. This phase 3 study evaluated daclatasvir with peginterferon-alfa-2a/ribavirin (pegIFN alfa-2a/RBV) in treatment-naive black/African American (AA), Latino, and white non-Latino patients with chronic HCV genotype 1 infection. MATERIAL AND METHODS: In this single-arm, open-label study, 246 patients received daclatasvir plus pegIFN alfa-2a and weight-based RBV. Patients with an extended rapid virologic response (eRVR; undetectable HCV-RNA at treatment weeks 4 and 12) received 24 weeks of treatment; those without eRVR received an additional 24 weeks of treatment with pegIFN alfa-2a/RBV...
November 2016: Annals of Hepatology
Maria-Victoria Mateos, Albert Oriol, Joaquín Martínez-López, Ana-Isabel Teruel, Enrique Bengoechea, Luis Palomera, Felipe de Arriba, Dixie-Lee Esseltine, Andrew Cakana, Lixia Pei, Helgi van de Velde, Jesus San Miguel
: Bortezomib-melphalan-prednisone (VMP) is a standard-of-care for previously untreated, transplant-ineligible multiple myeloma (MM). Here, we compared outcomes between VMP regimens in the VISTA trial (9-cycle VMP schedule, including 4 cycles of twice weekly bortezomib) and the PETHEMA/GEM05 trial (less intensive 6-cycle VMP schedule with 1 cycle of twice weekly and 5 cycles of weekly bortezomib, then bortezomib-based maintenance). A total of 113 patient pairs matched by propensity score (estimated using logistic regression and incorporating eight exposure/outcome-related parameters) were included in this retrospective analysis...
October 14, 2016: Annals of Hematology
Feng-Fei Li, Gu Gao, Qian Li, Hong-Hong Zhu, Xiao-Fei Su, Jin-Dan Wu, Lei Ye, Jian-Hua Ma
Objectives. To observe changes in blood glycemic variations and oxidative stress level before and after dapagliflozin treatment in patients with newly diagnosed T2DM. Methods. This was a randomized, double-blind, placebo-controlled, phase 3 trial. A total of 28 patients with newly diagnosed T2DM with HbA1c levels of 7.5-10.5% were randomly selected to receive dapagliflozin or placebo treatment for 24 weeks. After baseline data were collected, we analyzed glycemic variations and plasma 8-iso PGF2α level at baseline and at the endpoint...
2016: Journal of Diabetes Research
Junxiong Wang, Shuo Yang, Xiqiang Cai, Jiaqiang Dong, Zhangqian Chen, Rui Wang, Song Zhang, Haichao Cao, Di Lu, Tong Jin, Yongzhan Nie, Jianyu Hao, Daiming Fan
Cetuximab plus chemotherapy for advanced gastric cancer (GC) shows an active result in phase 2 trials. Unfortunately, Combination of cetuximab does not provide enough benefit to chemotherapy alone in phase 3 trials. Studies have demonstrated that berberine can suppress the activation of EGFR in tumors. In this study, we evaluated whether berberine could enhance the effects of EGFR-TKIs in GC cell lines and xenograft models. Our data suggest that berberine could effectively enhance the activity of erlotinib and cetuximab in vitro and in vivo...
October 12, 2016: Oncotarget
Christoph Sarrazin, Vasily Isakov, Evguenia Svarovskaia, Charlotte Hedskog, Ross Martin, Krishna Chodavarapu, Diana M Brainard, Michael D Miller, Hongmei Mo, Jean-Michel Molina, Mark S Sulkowski
BACKGROUND:  Development of direct-acting antivirals in recent years has dramatically enhanced rates of viral eradication to >90% in patients with chronic hepatitis C virus (HCV) infection. To determine true treatment efficacy and to define the most appropriate retreatment, it is important to distinguish virologic relapse from reinfection where patients who achieve HCV eradication during treatment become infected with a new HCV strain posttreatment. METHODS:  Here, we investigated prevalence of late recurrent viremia (patients who achieved SVR12 but had detectable HCV RNA at follow up week 24) and used refined phylogenetic analysis of multiple HCV genes to distinguish virologic relapse from reinfection...
October 12, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Emily Han-Chung Hsiue, Jih-Hsiang Lee, Chia-Chi Lin, James Chih-Hsin Yang
Gefitinib is recently approved by the US Food and Drug Administration as a first-line treatment for non-small cell lung cancer (NSCLC) patients harboring EGFR mutations. The therascreen® EGFR RGQ PCR Kit is approved as a companion diagnostic to select patients with EGFR exon 19 deletions and L858R mutation for treatment with gefitinib. Areas covered: This article reviews the methods for detecting EGFR mutations, the technology and indication of the therascreen® kit, and the clinical utility of the assay in phase 3 and phase 4 clinical trials...
October 13, 2016: Expert Review of Molecular Diagnostics
Tae Won Kim, Anneli Elme, Zvonko Kusic, Joon Oh Park, Anghel Adrian Udrea, Sun Young Kim, Joong Bae Ahn, Ricardo Villalobos Valencia, Srinivasan Krishnan, Ante Bilic, Nebojsa Manojlovic, Jun Dong, Xuesong Guan, Catherine Lofton-Day, A Scott Jung, Eduard Vrdoljak
BACKGROUND: We assessed the treatment effect of panitumumab plus best supportive care (BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS analysis in a phase 3 trial. METHODS: Patients with wild-type KRAS exon 2 mCRC were randomised 1 : 1 to panitumumab (6 mg kg(-1) Q2W) plus BSC or BSC. On-study crossover was prohibited. RAS mutation status was determined by central laboratory testing...
October 13, 2016: British Journal of Cancer
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