Navigation Links
New Phase 3 Study Results Show REMICADE® is Effective in the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis
Date:5/9/2011

CHICAGO, May 9, 2011 /PRNewswire/ -- Data from a Phase 3 randomized, multicenter, open-label study demonstrated clinical response with REMICADE® (infliximab) in the treatment of pediatric patients with moderately to severely active ulcerative colitis (UC), and showed a safety profile consistent with previous clinical trials conducted in an adult population.  The pediatric UC findings, presented today at Digestive Disease Week, showed REMICADE induced clinical response in 73 percent of patients aged 6-17 years at week 8, the primary endpoint of the trial.  REMICADE received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with moderately to severely active UC in September 2005 and in October 2006, REMICADE received FDA approval for maintaining clinical remission and mucosal healing indications in adults living with UC.

UC is a chronic inflammatory bowel disease (IBD) of the colon.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with debilitating symptoms of IBD.(1)  

"The results of this study are consistent with findings from the Active Ulcerative Colitis (ACT) trials, which evaluated REMICADE in the treatment of adults with ulcerative colitis," said Jeffrey Hyams, Head of the Division of Digestive Diseases and Nutrition at Connecticut Children's Medical Center and Professor of Pediatrics at University of Connecticut School of Medicine, and lead study investigator.  "UC can be a devastating disease, particularly for children and adolescents.  It is encouraging to see such promising results in a patient population that is in need of additional treatment options."

In December 2010, Centocor Ortho Biotech Inc. submitted a supplemental Biologics License Application (sBLA) to the FDA requesting the approval of REMICADE (infliximab) for the treatment of modera
'/>"/>

SOURCE Centocor Ortho Biotech Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. Merrimack Pharmaceuticals Initiates Enrollment in a Phase 1 Study of MM-121, an ErbB3 Antagonist
2. BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
3. Dendreon Initiates Second of Two New Phase 2 Trials of PROVENGE for Prostate Cancer
4. Palatin Technologies, Inc. Reports Positive Results of Phase 2a Clinical Study with PL-3994 for the Treatment of Heart Failure
5. Logical Therapeutics Inc. Announces Results of Phase 1b Clinical Study of its Naproxen Prodrug
6. PTC124 Shows Promising Activity in Cystic Fibrosis; Phase 2 Proof-of-Concept Data Published in the Lancet
7. NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
8. Michigan Innovation Equipment Depot Launches Next Phase of Distribution
9. Phase 1b/2a Program Commences for RVX-208
10. Chiltern Early Phase: Fully Integrated and Business Ready
11. Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... Fla. , May 21, 2013  On ... FCN ), the global business advisory firm ... enterprise value (the "Company"), announced that it has ... that were formerly included within the Corporate Finance/Restructuring ... Consulting segment to form a single integrated practice ...
(Date:5/21/2013)... 21, 2013 Custom Learning Designs, ... eLearning solution using Tin Can API combined with ... CLD is a leading developer of training content ... companies worldwide. , Tin Can API is ... learners and trainers more accurately measure the Return ...
(Date:5/21/2013)... The results of a new study led by ... computational evidence that nucleation of ice in small ... understanding water,s behavior at the nanoscale. The formation ... basic scientific research question whose answer also has ... , The crystallization of ice from supercooled ...
(Date:5/21/2013)... , May 21, 2013 The ... and Transplant Association) is the biggest congress in ... therapy. Nearly 10,000 participants are in Istanbul ... latest research findings. New pioneering studies have been presented: ... FERRIC PYROPHOSPHATE (SFP) ADMINISTERED VIA HEMODIALYSATE REDUCES ESA USE" ...
Breaking Biology Technology:FTI Consulting Releases Realigned Segment Information Reflecting Newly Combined Health Solutions Practice 2CLD Integrates Tin CAN API with its eLearning Solutions and Launches its Excelerometer Tracking Statement Dashboard 2CLD Integrates Tin CAN API with its eLearning Solutions and Launches its Excelerometer Tracking Statement Dashboard 3Study led by GW professor provides better understanding of water's freezing behavior at nanoscale 2ERA-EDTA CONGRESS 2013: Late Breaking Clinical Trials 2ERA-EDTA CONGRESS 2013: Late Breaking Clinical Trials 3
... Madison Internet service provider SupraNet plans to ... the Aidmatrix Foundation, a global disaster-relief firm run by ... CEO Bryan Chan said in a press release that ... number of recent disasters the charity is responding to, ...
... of Wisconsin-Madison MBA program was ranked 51st in ... U.S. public university programs by the London Financial Times ... , ,These rankings are based on alumni careers and ... data provided by the schools and a survey of ...
... development assessment group for its high quality of life and ... States, released last week by the non-profit Corporation for Enterprise ... in business vitality and development capacity, based on 2004 data. ... subcategories that made up those three overall marks. , ,Perhaps ...
Cached Biology Technology:
(Date:5/21/2013)... path of insulin action in cells in precise detail ... understanding what goes wrong in diabetes. , The ... James from Sydney,s Garvan Institute of Medical Research, is ... prestigious journal Cell Metabolism . , First discovered ... role in the body because it helps us lower ...
(Date:5/20/2013)... 2013) University of Minnesota Medical School researchers from ... with the University,s Brain Tumor Program, have developed a ... (MPNST) that allow them to discover new genes and ... research was published this week in the journal ... method, researchers in the lab of David Largaespada, Ph.D., ...
(Date:5/20/2013)... planning grant will help establish the Center for Advanced ... University of Illinois at Urbana-Champaign and Worcester Polytechnic Institute ... to research in drying moist, porous materials such as ... chemical products; textiles; and biopharmaceuticals," said Hao Feng, a ... nutrition and the Illinois site director. , According to ...
Breaking Biology News(10 mins):Insight into the dazzling impact of insulin in cells 2Insight into the dazzling impact of insulin in cells 3U of M researchers develop model for better testing, targeting of MPNST 2NSF approves planning grant for Center for Advanced Research in Drying 2
... are two of the most invasive species on the planet yet ... Queen Mary, University of London. The study, published in the ... crayfish and carp in Kenya,s Lake Naivasha between 2001 and 2008. ... and have adopted a central role in the food web for ...
... research discovery by a team of Stanford and European scientists ... be able to avoid limb amputation related to ischemia. A ... Journal suggests that the delivery of genes for ... "VEGF" may successfully cause the body to grow new blood ...
... in the US, researchers at the University of Gothenburg have found ... to film how proteins work at molecular level. Mapping ... could be the key to cures for everything from cancer to ... of Gothenburg, and his research group were among the first in ...
Cached Biology News:Carp dominate crayfish in invasive species battleground 2Stanford scientists develop gene therapy approach to grow blood vessels in ischemic limbs 2More effective method of imaging proteins 2
... ductless exhaust hood ventilates and purifies ... release of exhaust. Bonded charcoal filters ... of vertical clearance (with access shield ... spill tray; options include final HEPA ...
Sigmas E-TOXATE (Limulus Amebocyte Lysate) test kits are intended for the detection and semiquantitation,of endotoxins for research purposes....
... modular cleanroom for biological safety labs ... cleanliness (to Class 10/ISO 3) and ... create ultra-smooth surfaces that are easy ... radius corners simplify cleaning. Unique double-wall ...
... These versatile enclosures ... with nitrogen or other ... a low-humidity environment. HEPA ... and ionization modules also ...
Biology Products: