|By PR Newswire||
|March 20, 2014 07:00 AM EDT||
NORTH CHICAGO, Ill., March 20, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the initiation of a pivotal Phase 3 clinical trial that will evaluate the use of HUMIRA® (adalimumab) as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis, an area of unmet need. Currently there are no approved treatments for fingernail psoriasis.
"Since treatment options are limited, we welcome research that evaluates new options for patients suffering from this disease and are excited to start evaluating adalimumab in this patient population," said Dr. Phoebe Rich, MD, Clinical Adjunct Professor of Dermatology at Oregon Health Science University.
Psoriasis is a non-contagious, chronic immune disease that speeds the growth cycle of skin cells and results in thick, scaly areas of skin. Psoriasis can also affect the fingernails causing pitting, discoloration, loosening and irregular contour of the fingernail.1 Although the prevalence of fingernail psoriasis in those with moderate to severe chronic plaque psoriasis is unknown, about 50% of the 125 million people world-wide with psoriasis have nail involvement.2,3
The 26-week clinical trial is a multinational, double-blind, placebo-controlled study that is expected to enroll 200 patients with moderate to severe chronic plaque psoriasis with fingernail psoriasis. It will be conducted at approximately 32 sites worldwide, including the United Kingdom, Ireland, Germany, Greece, Belgium, France, Australia, Canada, Mexico, and the United States. The primary endpoints for the trial will be evaluated after 26 weeks and are based on advice received from regulatory agencies. The trial will assess the percent of patients who achieve a Physicians Global Assessment of Fingernail Psoriasis (PGA-F) of either "clear" or "minimal" and evaluate the percent of patients who achieve a 75-percent reduction in fingernail psoriasis, as defined by the modified Nail Psoriasis Severity Index (mNAPSI).4,5
"For more than a decade, HUMIRA has served as an important treatment option for patients with chronic inflammatory diseases," said John Medich, Ph.D., vice president, Immunology Clinical Development, AbbVie. "This new clinical trial marks our ongoing commitment to patients living with psoriasis and we look forward to further evaluating the medicine's potential on clinical outcomes in this patient population."
More information on the trial is available at www.clinicaltrials.gov [NCT02016482].4
U.S. Product Information for HUMIRA® (adalimumab)6
HUMIRA is a prescription medicine used to:
- Reduce the signs and symptoms of:
- Moderate-to-severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate-to-severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate-to-severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.
- In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
- Treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
IMPORTANT SAFETY INFORMATION6
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.
For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.
Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions, including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines.
Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.
HUMIRA is given by injection under the skin.
In the European Summary of Product Characteristics, HUMIRA is contraindicated in people who are allergic to adalimumab or any other ingredients of HUMIRA, those who have a severe infection including active TB, or those who have moderate to severe heart failure.7
The benefits and risks of HUMIRA should be carefully considered before starting therapy.
This is not a complete list of the Important Safety Information for HUMIRA.
Globally, prescribing information varies; refer to the individual country product label for complete information.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission.
AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
- Questions and Answers about Psoriasis. National Institute of Arthritis and Musculoskeletal and Skin Diseases Web site. http://www.niams.nih.gov/Health_Info/Psoriasis/default.asp. Accessed March 11, 2014.
- Psoriasis Statistics. National Psoriasis Foundation Web site. https://www.psoriasis.org/learn_statistics. Accessed March 11, 2014.
- Van Voorhees A, Feldman SR, Koo JYM, et al. The Psoriasis and psoriatic Arthritis Pocket Guide: treatment algorithms and management options. National Psoriasis Foundation Web site. http://www.psoriasis.org/document.doc?id=354. Published 2009. Accessed March 11, 2014.
- A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis. US National Institutes of Health Web site. http://www.clinicaltrials.gov/ct2/show/NCT02016482?term=NCT02016482&rank=1. Accessed March 11, 2014.
- Data on file, AbbVie Inc.
- Humira Injection [package insert]. North Chicago, IL: AbbVie Inc.
- HUMIRA [Summary of Product Characteristics], Maidenhead, United Kingdom; AbbVie. September 2013.
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Aug. 27, 2016 12:15 AM EDT Reads: 2,248
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 26, 2016 11:15 PM EDT Reads: 1,743
Actian Corporation has announced the latest version of the Actian Vector in Hadoop (VectorH) database, generally available at the end of July. VectorH is based on the same query engine that powers Actian Vector, which recently doubled the TPC-H benchmark record for non-clustered systems at the 3000GB scale factor (see tpc.org/3323). The ability to easily ingest information from different data sources and rapidly develop queries to make better business decisions is becoming increasingly importan...
Aug. 26, 2016 10:45 PM EDT Reads: 2,056
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 26, 2016 10:00 PM EDT Reads: 1,838
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Aug. 26, 2016 09:15 PM EDT Reads: 1,425
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 26, 2016 07:15 PM EDT Reads: 396
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Aug. 26, 2016 07:00 PM EDT Reads: 695
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 26, 2016 07:00 PM EDT Reads: 651
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Aug. 26, 2016 06:00 PM EDT Reads: 1,923
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 26, 2016 05:00 PM EDT Reads: 666
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 26, 2016 04:45 PM EDT Reads: 1,530
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 26, 2016 04:30 PM EDT Reads: 2,308
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 26, 2016 04:00 PM EDT Reads: 3,932
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 26, 2016 03:45 PM EDT Reads: 560
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 26, 2016 03:15 PM EDT Reads: 435