Safety & Efficacy CP-690,550 in Moderate to Severe Crohn's Disease
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE
Christopher S J Probert
This clinical study is being conducted by Pfizer Ltd to determine the efficacy and safety of an immunosuppressant drug, called CP-690,550, in subjects with moderate to severe Crohn??s Disease. CP-690,550 is an oral, investigational drug that blocks a signalling molecule called Janus Kinase (JAK) that activates the immune system. Crohn??s disease is an autoimmune disease where the inflammatory response is impaired and generated against the body's own cells. CP-690,550 seeks to block this impaired inflammatory response. This is a phase 2a, double-blind, placebo-controlled, parallel-group, multi-center study. Subjects who qualify for this study will be randomly assigned to study treatment, either active drug or placebo (a placebo is a pill that does not contain any drug). Subjects will have a 75% chance of getting active drug. Subjects will be required to take study treatment orally twice a day for 4 weeks. All subjects will be followed for 4 weeks after completion of study treatment or early withdrawal from the study.Study participation is up to 11 weeks duration: 1-3 week screening assessment period, 4 week study treatment period and then a 4 week follow-up period. Subjects will need to attend a minimum of 6 clinic visits during this time.In addition to 40 US centres, the study will be conducted in approximately 45 centres across Europe in 11 countries and will treat 136 subjects in total.The benefits to the subjects participating in this study will be a potential control of the disease activity by improving symptoms (stool frequency, abdominal pain) and general well-being. All subjects may also benefit from gaining knowledge about their health status through study tests and physician assessments, as well as having close monitoring of their inflammatory bowel disease.
East of England - Cambridge South Research Ethics Committee
Date of REC Opinion
16 Oct 2008
Further Information Favourable Opinion