The basic safety results were in keeping with the known basic safety profile of HUMIRA no new safety signals were noticed.e., corticosteroids, azathioprine, or 6-mercaptopurine). Mayo score is a measure of disease activity that ranges from 0 to 12 and includes stool frequency, anal bleeding, endoscopic findings and physician’s global evaluation. Patients were randomized to treatment with HUMIRA 160/80 mg , HUMIRA 80/40 mg or placebo. Patients, including those randomized to placebo, continued regular therapy such as for example corticosteroids, immunosuppressants and aminosalicylates. The principal efficacy endpoint was clinical remission At week eight, 18 % of 130 patients in the HUMIRA 160/80 group and 10 % of the 130 in the HUMIRA 80/40 group compared with 9 % of the 130 sufferers in the placebo group had been in medical remission.Key End Points The primary efficacy composite end point was death from any cause, myocardial infarction, recurrent ischemia requiring urgent revascularization, or thrombotic bailout at 96 hours .7 The key secondary efficacy end stage was a composite of death from any cause or myocardial infarction within the initial 30 days. Safety end points included rates of hemorrhage, transfusion, medical reexploration, stroke, thrombocytopenia, and serious adverse occasions at 120 hours after randomization. Stroke and all efficacy parts, except death, were adjudicated by an unbiased clinical occasions committee whose users were unaware of study-group assignments. If classification of TIMI bleeding could not be determined by a programmed algorithm, blinded adjudication was performed. Statistical Analysis Efficacy analyses were performed according to the intention-to-treat theory.