GSK and J&J launch phase 3 rheumatoid arthritis drug trials

Hannah Blake

pharmaphorum

GlaxoSmithKline and Janssen Biologics, part of the J&amp,J group, have launched the phase 3 programme evaluating sirukumab (CNTO 136), following their collaboration to develop treatments for rheumatoid arthritis (RA) agreed in 2011.

The phase 3 clinical trial will evaluate sirukumab, which is a human anti-interleukin (IL) -6 monoclonal antibody, as a treatment for patients with moderately to severely active rheumatoid arthritis. The programme consists of two studies – SIRROUND-T and SIRROUND-D – with different objectives.

The primary objective of SIRROUND-T 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 agents.

SIRROUND-D will assess the efficacy of sirukumab as measured by the reduction of RA signs and symptoms and inhibition of radiographic progression in subjects with active RA who are refractory to DMARDs.

“The start of the Phase III programme in rheumatoid arthritis is an important milestone in our collaboration with Janssen Biologics. It shows progress in the challenging area of autoimmune diseases and our focus of bringing a promising new therapeutic option to patients living with this debilitating disease.”

Paul-Peter Tak, Senior Vice President at GSK Immuno-inflammation.

If GSK &amp, J&amp,J’s phase 3 trials of sirukumab are successful, the rheumatoid arthritis drug could become a contender with Pfizer’s tofacitinib, which is currently awaiting approval from the FDA.