Clinical Trials Resource Center

New Medical Therapies™

Ankylosing Spondylitis

April 5, 2004

Celltech Group reported positive preliminary results from a phase III trial investigating CDP870 for the treatment of rheumatoid arthritis (RA). Results showed the study met its primary endpoint, determined by the number of subjects achieving a 20% reduction in the American College of Rheumatology score ACR20 at 24 weeks. A significant ACR20 response was seen at week 1 and was maintained for the duration of the study. The six-month study (Study 014) was designed to test the safety and efficacy of CDP870 in combination with methotrexate on signs and symptoms of disease over a six month period. They trial enrolled subjects who had active moderate to severe RA despite treatment with methotrexate and other disease modifying anti-rheumatic drugs. In addition, Celltech announced plans to develop CDP870 for new indications, such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

November 10, 2003

Centocor and Schering-Plough reported positive results from a phase III trial investigating Remicade (infliximab), a necrosis factor alpha therapy for the treatment of ankylosing spondylitis (AS). Results showed that subjects achieved a higher reduction in signs and symptoms associated with their disease when treated with Remicade compared with placebo. Data showed that 61.2% achieved an ASAS 20 in the infliximab group, compared with 19.2% placebo. The multi-center, randomized, placebo-controlled, double-blind study called ASSERT (Anklyosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) enrolled 279 subjects at 30 sites in North America and Europe. Subjects were given Remicade monotherapy 5 mg/kg infusions at weeks 0, 2, 6, followed by infusions every six weeks. The primary endpoint was the proportion of subjects demonstrating a 20% or greater improvement in signs and symptoms as measured by the ankylosing spondylitis assessment (ASAS 20) at 24 weeks.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.