Navigation Links
Janssen Announces Initiation Of Phase 3 Development Program For Sirukumab In Rheumatoid Arthritis
Date:8/23/2012

CORK, Ireland and SPRING HOUSE, Pa., Aug. 23, 2012 /PRNewswire/ -- Janssen Biologics (Ireland) announced today it has initiated the Phase 3 development program for sirukumab (CNTO 136) as part of a collaboration with GlaxoSmithKline plc (GSK).  Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody being studied for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). 

"We are focused on advancing treatment options for chronic, debilitating autoimmune diseases such as rheumatoid arthritis," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.  "We are pleased to be collaborating with GlaxoSmithKline on the clinical development of sirukumab, a protein therapeutic that we believe may represent an important treatment option for immunological diseases in the future."

The two studies comprising the Phase 3 program are:

  • SIRROUND-T: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite anti-tumor necrosis factor (TNF)-alpha therapy. The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory or intolerant to anti-TNF-alpha agents.

 

  • SIRROUND-D: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite disease modifying anti-rheumatic drug (DMARD) therapy. The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA and inhibition of radiographic progression in subjects with active RA who are refractory to DMARDs.

About Sirukumab (CNTO 136)
Sirukumab is an investigational human monoclonal IgG1 kappa antibody in Phase 3 development for the treatment of moderately to severely active rheumatoid arthritis (RA).  It is not approved as a treatment for RA or any other indication anywhere in the world.  Sirukumab targets the cytokine interleukin (IL)-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. 

In December 2011, Janssen Biologics (Ireland) and GSK entered into a co-development and co-commercialisation license agreement with respect to sirukumab for RA.  Prior to the agreement, Janssen Research & Development, LLC, had been developing sirukumab for RA.

About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.  It is estimated that 1.5 million Americans and more than 23.5 million people worldwide are affected by the condition, for which there is no cure.

About Janssen Biologics (Ireland) and Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world.

Janssen Biologics (Ireland) and Janssen Research & Development, LLC, are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.  Please visit http://www.janssenrnd.com/ for more information.


'/>"/>
SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes
2. Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
3. WorkSmart MD Announces Expansion of its Synergy Billing Division to Help Community Health Centers
4. BiOptix Announces Fall 2012 Tradeshow and Symposia Schedule
5. Interventional Spine Announces its 75th Patient Treated with the PerX360 Percutaneous Spinal Fusion Technology
6. Precision Automation Expert DWFritz Automation Announces Website Launch www.DWFritz.com
7. CPhI South America Expands Offering for 2013, Announces Co-Location with Food Ingredients South America
8. EFJohnson Announces Impact Partner Dealer Program
9. Aethlon Medical Announces Renewal of DARPA Dialysis-Like Therapeutics Contract
10. Kallo Announces Purchase Order For Its Specialist EMR - EMCURx
11. CryoLife Announces Initiation of Quarterly Cash Dividend
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
(Date:6/23/2016)... -- Bracket , a leading clinical trial technology and ... platform, Bracket eCOA (SM) 6.0, at the 52 nd ... 2016 in Philadelphia , Pennsylvania.  A demonstration ... of its kind to fully integrate with RTSM, will be ... is a flexible platform for electronic clinical outcomes assessments that ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... ... fertility once they have been diagnosed with endometriosis. These women need a treatment ... also require a comprehensive approach that can help for preservation of fertility and ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are ... for this recognition are considered among the top 2 percent of lawyers practicing within ... of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented ... in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, ...
Breaking Medicine News(10 mins):