Navigation Links
ARCALYST® (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
Date:2/28/2011

patients who reported two or more flares by 66% (p<0.0001).

Detailed data from both the PRE-SURGE 2 and RE-SURGE studies will be presented at future scientific conferences.  The safety and efficacy of ARCALYST in the gout setting have not been evaluated by the U.S. Food and Drug Administration.  ARCALYST is not approved for use in gout.

About the PRE-SURGE 2 StudyThe Global PRE-SURGE 2 (PREventative Study against URate-lowering drug-induced Gout Exacerbations) study was a double-blind, placebo-controlled study which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy.  The trial was conducted in South Africa, Germany, and parts of Asia. In the trial, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-inflammatory therapeutic and involved at least three of four signs/symptoms (joint swelling, redness, tenderness, and pain) and one or more of the following: rapid onset of pain, decreased range of motion, joint warmth, or other symptoms similar to a prior gout flare.  A total of 248 patients were randomized on a 1:1:1 basis to receive one of the following treatment regimens:

  • ARCALYST 160 mg as an initial subcutaneous loading dose, followed by weekly 80 mg subcutaneous injections for a total of 16 weeks
  • ARCALYST 320 mg as an initial subcutaneous loading dose, followed by weekly 160 mg subcutaneous injections for a total of 16 weeks
  • Subcutaneous weekly placebo injections for 16 weeks

  • Primary and key secondary endpoint results were as follows:PlaceboARCALYST® (rilonacept) 80 mgARCALYST® (rilonacept) 160 mg n82

    82

    84*Primary endpointMean # of flares per patient (% reduction compared to placebo)1.23

    0.35

    (72% reduction)


    '/>"/>

    SOURCE Regeneron Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8 9 10

    Related medicine technology :

    1. Mindray Medical Meets 2010 Product Development Targets and Announces Strong 2011 Pipeline
    2. New IonWorks Barracuda Automated Patch Clamp System Meets Need for Affordable, Accelerated Screening of Ligand- & Voltage-Gated Ion Channels Via Direct Electrophysiology Assays
    3. US Oncology Meets With Leading Pharmaceutical and Biotech Companies to Design Clinical Trials for the Cancer Fighting Drugs of Tomorrow
    4. LEO Pharmas PEP005 Meets Primary Endpoint in Phase III Trial for Pre-Cancerous Skin Condition
    5. Poniard Pharmaceuticals Announces Phase 2 Trial of Picoplatin in Metastatic Colorectal Cancer Meets Primary Endpoint and Study Objectives
    6. Investigational Sublingual Allergy Immunotherapy Tablet Meets Primary Endpoint in a Study of Adult Subjects With a History of Grass Pollen Allergies
    7. Novartis drug Tasigna(R) meets primary endpoint in pivotal trial against Gleevec(R) as first-line treatment in chronic myeloid leukemia patients
    8. Intercept Pharmaceuticals FXR Agonist INT-747 Meets Primary Endpoint in a Phase II Clinical Trial in Type 2 Diabetic Patients with Nonalcoholic Fatty Liver Disease
    9. Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints
    10. MADIT-CRT Trial Meets Primary Endpoint
    11. VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:3/27/2015)... Wis. , March 27, 2015 ... unit shipments of incontinence devices for women. ... but the most gratifying part is the hundreds ... from women whose lives have been positively impacted ... president of InControl. InControl recently released ...
    (Date:3/27/2015)... 27, 2015 RnRMarketResearch.com adds ... market research report of 52 pages with latest ... intelligence library. The report "Visceral Pain - Pipeline ... therapeutic development for Visceral Pain, complete with comparative ... target, mechanism of action (MoA), route of administration ...
    (Date:3/26/2015)... 2015 /PRNewswire/ - Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or ... on Omega-3 therapies for cardiovascular disease and overall health, ... common shares of the Corporation (the "Common Shares"). The ... of December 5 th , 2014 to March 4 ... is due on or before April 1, 2015. Interest ...
    Breaking Medicine Technology:InControl Medical Surpasses 40,000 Shipments Of Incontinence Devices For Women 2Visceral Pain Pipeline Review H1 2015 Market Research Report 2Visceral Pain Pipeline Review H1 2015 Market Research Report 3Visceral Pain Pipeline Review H1 2015 Market Research Report 4Pivotal Therapeutics announces payment of interest on outstanding convertible notes 2
    ... - Millennium on track to file sNDA in ... 18 Millennium,Pharmaceuticals, Inc. (Nasdaq: MLNM ) ... large, international Phase III VISTA(1) trial in,patients with ... of,VELCADE, melphalan and prednisone (VMP) demonstrated a highly ...
    ... 10 minutes - - Landmark Study Reported in ... 18 A landmark publication that,appeared in the Journal ... site blinded clinical study. The paper is entitled "The ... Accuracy of,Melanoma and Equivocal Melanocytic Lesions." The study, ...
    Cached Medicine Technology:Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints 2Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints 3Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints 4Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints 5Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints 6Large Blinded Clinical Study Achieves High Accuracy for the Diagnosis of Melanoma Using In Vivo Confocal Microscopy 2Large Blinded Clinical Study Achieves High Accuracy for the Diagnosis of Melanoma Using In Vivo Confocal Microscopy 3
    (Date:3/27/2015)... Healthpointe is proud to announce that ... now treating knee and hip joint disorders in practice ... Beach, and La Mirada. Dr. Stanley Katz specializes in ... joint disorders as well as chronic conditions such as ... his patients back to their normal lives. Many ...
    (Date:3/27/2015)... March 27, 2015 Ticket Down is a ... CenturyLink Center in Omaha, Nebraska on Friday, May 8th ... more concert dates will be added in Omaha as Garth ... demand. , The Garth Brooks World Tour is continuing its ... announcement that Garth Brooks and Trisha Yearwood will bring their ...
    (Date:3/27/2015)... Dallas, TX (PRWEB) March 27, 2015 ... US” is an essential source of information on and ... the US. The population of the US in 2013 ... Annual Growth Rate (CAGR) of 0.8% from 2008. The ... incidence of chronic diseases will help to boost the ...
    (Date:3/27/2015)... (PRWEB) March 27, 2015 California’s ongoing ... blizzards in Boston and the United States Northeast, are ... Earth warming global atmosphere is creating changes in the ... historical climatologist and former NASA researcher, speaking on the ... result is not only a warmer and dryer global ...
    (Date:3/27/2015)... Approximately 300 advocates participated in ... Lobby Day to lobby for physical education, active ... Everlast Climbing was especially interested in voicing ... would strengthen physical education programs by adopting new ... measures to strengthen physical education in schools. , ...
    Breaking Medicine News(10 mins):Health News:Fellowship-Trained and Board-Certified Orthopedic Surgeon is Now Treating Knee and Hip Joint Disorders in Anaheim, California 2Health News:Fellowship-Trained and Board-Certified Orthopedic Surgeon is Now Treating Knee and Hip Joint Disorders in Anaheim, California 3Health News:Cheap Garth Brooks Tickets for CenturyLink Center in Omaha: Ticket Down Slashes Garth Brooks Concert Tickets in Omaha, NE at the CenturyLink Center 2Health News:Cheap Garth Brooks Tickets for CenturyLink Center in Omaha: Ticket Down Slashes Garth Brooks Concert Tickets in Omaha, NE at the CenturyLink Center 3Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 2Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 3Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 4Health News:California Drought, Boston Blizzards Both Attributed to Global Climate Change Reports Climatologist to Fresh Water Advocate 2Health News:California Drought, Boston Blizzards Both Attributed to Global Climate Change Reports Climatologist to Fresh Water Advocate 3Health News:Everlast Climbing Advocates to Strengthen Physical Education in Minnesota Schools 2
    ... Longtime environmental health researchers at Tufts University School ... chemicals (EDCs), ubiquitous chemicals that have hormone-like effects ... online May 25 in Nature Reviews Endocrinology ... complex strategies for studying how these chemicals affect ...
    ... Cleveland Clinic finds that patients suffering from cirrhosis preceded ... developing hepatocellular carcinoma than those who develop cirrhosis resulting ... study appear in the June issue of Hepatology ... the American Association for the Study of Liver Diseases ...
    ... ... Healthcare providers can now easily access critical patient information in MxChart EMR software wherever ... ... and medical transcription services provider, MxSecure, Inc., today announced that MxChart, their EMR system, ...
    ... , ... stem cell in the developing human brain. The cell produces nerve cells that help form the ... of the region in the lineages that lead to man, the researchers say. ... (Vocus) May 25, 2010 -- UCSF scientists ...
    ... ... and earn money for college, by entering the B’nai B’rith International Diverse Minds Youth ... grade-schoolers about tolerance and diversity. The winners take home $5,000 college scholarships and will ... ...
    ... ... on Aerohive Controller-less WLAN Solution to Improve Patient Care and Cost Efficiencies ... Santa Clara, CA ... control wireless LAN (WLAN) architecture, announced today that LaVie Administrative Services, a provider of ...
    Cached Medicine News:Health News:Endocrine-disrupting chemicals pose cancer risk 2Health News:New study confirms link between nonalcoholic steatohepatitis and liver cancer 2Health News:New study confirms link between nonalcoholic steatohepatitis and liver cancer 3Health News:MxSecure's Electronic Medical Record (EMR) Software, MxChart&#8482;, Now iPad Compatible 2Health News:Discovery of Stem Cell Illuminates Human Brain Evolution, Points To Therapies 2Health News:Discovery of Stem Cell Illuminates Human Brain Evolution, Points To Therapies 3Health News:Discovery of Stem Cell Illuminates Human Brain Evolution, Points To Therapies 4Health News:High School Students Well-Schooled In Diversity: Teen Winners of Book Writing Contest Earn College Scholarships and Have Entries Published 2Health News:LaVie Administrative Services Continues 1,200 Access Point Aerohive Roll Out to Address Electronic Medical Record Requirements 2Health News:LaVie Administrative Services Continues 1,200 Access Point Aerohive Roll Out to Address Electronic Medical Record Requirements 3Health News:LaVie Administrative Services Continues 1,200 Access Point Aerohive Roll Out to Address Electronic Medical Record Requirements 4
    ... Produces up to 12 L/min of Type ... On Demand, The Super-Q Plus System is ... water which has been pretreated by reverse ... consistently produce ultrapure water quality which exceeds ...
    ... Compact System Produces Type I Water Directly from ... designed for scientists who need 5 to 15 ... not have easy access to acceptable quality pretreated ... 0.6 L/min of ultrapure (Type I) water on ...
    ... UniBloc weighing mechanism for speed, stability ... control, analog display modes, multiple units ... measure functions, auto print, and GLP/GMP/ISO ... from built-in clock. Touch-key calibration with ...
    ... size AA required). Fast, Lightweight Strain Gage ... GN, dwt, mom, dwt, tael), Specific Gravity ... Auto Print. Optional hook (321-34532-03) available for ... ordered for AC Operation of ELB. External ...
    Medicine Products: