Clinical Trials Resource Center

Ankylosing Spondylitis

December 1, 2014

Novartis reported results from the MEASURE 1 and MEASURE 2 pivotal phase II study of AIN457 (secukinumab) in ankylosing spondylitis (AS). MEASURE 1 and MEASURE 2 are multi-center, randomized, placebo-controlled studies. Statistically significant improvements in signs and symptoms of AS were achieved with secukinumab v. placebo at week 16, as measured by at least 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20). More than 60% of secukinumab 150mg treated patients achieved an ASAS20 response in MEASURE 1 (p<0.0001) and MEASURE 2 (p<0.001). This is in comparison to 28.7% and 28.4% of placebo patients who achieved an ASAS20 response in MEASURE 1 and MEASURE 2, respectively. Secukinumab 150mg treated patients experienced ASAS20 responses at week one in both studies (p<0.01, MEASURE1; p<0.05, MEASURE 2) and were sustained through 52 weeks of treatment. Additionally, statistically significant improvements in ASAS20 at week 16 with secukinumab 150mg were observed, compared to placebo (p<0.05) in patients who had not been previously treated with anti-TNF therapies (anti-TNF naïve). These data are expected to form the basis of joint regulatory submissions planned for 2015.

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.

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