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:5/25/2016)... , May 25, 2016 ... Size, Share, Development, Growth and Demand Forecast to 2022 ... Insulin Pump and Others)" published by P&S Market Research, ... $9,998.3 million in 2015, and it is expected to ... on type, the insulin pump segment is expected to ...
(Date:5/25/2016)... MedDay, a biotechnology company focused on the treatment of ... doses of biotin in progressive multiple sclerosis: extension phase results ... Ayman Tourbah , Principal Investigator of the Phase 3 study, ... (EAN) in Copenhagen, Denmark . The oral ... Sunday, 29 May 2016 from 14:45 to 16:15 CEST in ...
(Date:5/24/2016)... Cirujanos holandeses han puesto en ... médicos a compartir sus mejores prácticas por el mundo ... médicos de Europa, África, Asia ... aplicación, que combina la transmisión en vivo con mensajería ... Educación   "Imagine un médico de Medicines ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses and employees ... which come courtesy of leaders in the nursing and health care industry. It also ... and associations—namely Abilene Christian University. , As the nursing industry is coming out ...
(Date:5/26/2016)... ... May 26, 2016 , ... Despite last week’s media reports hinting at a ... to wait until March 2017 for an interest rate increase, according to Rajeev Dhawan ... Business. , “The Federal Open Market Committee (FOMC) dot charts are of interest to ...
(Date:5/26/2016)... California (PRWEB) , ... May 26, 2016 , ... ... associated with discovery of thousands of defective respirators, according to court documents and ... the case of William and Becky Tyler v. American Optical Corporation, Case No. ...
(Date:5/26/2016)... ... ... Connor Sports, through its Connor Cares initiative, will continue to ... Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career and final ... and levels of the game, Connor Sports has committed to a significantly increased focus ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cardiac arrhythmia is ... impact on long-term patient survival, reports a team of UPMC researchers in the ... in the Journal of Thoracic and Cardiovascular Surgery, provide critical information that will ...
Breaking Medicine News(10 mins):