Navigation Links
Janssen Announces Initiation Of Phase 3 Development Program For Sirukumab In Rheumatoid Arthritis

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 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
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:
(Date:10/12/2015)... Center for Innovation announced today that Elizabeth ... th recipient of the CME Group Melamed-Arditti Innovation ... Theranos , to change health care from reactive to proactive, ... care. CME Group will present the award at the eighth ... Naples, Florida , on Tuesday, November 17. ...
(Date:10/12/2015)... PUNE, India , October 12, 2015 ... new market research report "Spirometer Market by Product (Hand-held, Table-top, ... (Hospital, Clinic, Homecare), Application, & Geography - Global Forecast to ... reach USD 858.6 Million by 2020, at a CAGR of ... data Tables and 128 F igures spread th ...
(Date:10/12/2015)... ) ... "Personalized Medicine, Targeted Therapeutics and Companion Diagnostic ... Industry Trends, Technologies, Participants, and Environment" ... ) has announced the addition of ... Companion Diagnostic Market to 2019 - Strategic ...
Breaking Medicine Technology:
(Date:10/12/2015)... Carolina (PRWEB) , ... October 12, 2015 , ... Kevin Costello, winner of the “Check-In ... Carolina , embarks today for his dream vacation to Hawaii. , “I didn’t believe I ... out,” he says. “This contest encouraged me to get to the gym and invest in ...
(Date:10/12/2015)... ... October 12, 2015 , ... Amerec , a ... of spa and skin care equipment, will be displaying custom sauna and steam room ... With many high-end resorts and spas as customers, SpaEquip is recognized for their ability ...
(Date:10/12/2015)... ... October 12, 2015 , ... The ... by individuals who lack professional education and clinical training in a health care ... a variety of purposes such as: losing weight, managing pain, or stopping smoking, ...
(Date:10/12/2015)... ... ... American Family Care (AFC), the nation’s leading provider of urgent care and ... Located at 606A Boll Weevil Circle in Enterprise, it is the company’s ninth location ... quality health care accessible and economical with the opening of our medical center in ...
(Date:10/12/2015)... ... 12, 2015 , ... At first glance, it looks like a mini parachute ... a drink in a tiki bar. But the Parachute® Ventricular Partitioning Device being implanted ... (AGH) could potentially signal a new way of treating people with heart failure. , ...
Breaking Medicine News(10 mins):