Prespecified exploratory outcomes included the proportion of patients in the overall population who had a CDAI-100 response at week 6 and proportions of patients in the overall and TNF antagonist–failure populations who had a CDAI-100 response at week 10, as well as changes from baseline to weeks 6 and
10 in CRP concentration (among patients with increased baseline CRP concentration [>2.87 mg/L]) and from baseline to week 6 in fecal calprotectin level. To summarize efficacy in important subgroups and further clarify primary and secondary BMS-354825 solubility dmso outcomes, additional prespecified exploratory analyses were performed, including clinical remission and CDAI-100 response at weeks 6 and 10 and remission at both Akt inhibitor weeks 6 and 10 in patients who were naive to TNF antagonist therapy and remission at weeks 6 and 10 and CDAI-100 response at week 6 in subgroups defined by concomitant corticosteroid or immunosuppressive use. Adverse events,
serious adverse events (SAEs), standard clinical laboratory test results, and vital signs were evaluated. Consistent with all vedolizumab clinical studies conducted since 2006, the development of new neurologic signs and symptoms potentially consistent with PML was monitored in a risk minimization program27 featuring standardized questionnaires and Etoposide cell line a stepwise diagnostic algorithm overseen by an independent committee of PML experts.
The committee adjudicated potential cases and provided further guidance for the investigator and study sponsor in situations of clinical uncertainty. Blood samples for pharmacokinetic evaluation were collected postdose at week 0, predose and postdose at week 6, and at any time during the study visit at week 10 and any unscheduled disease exacerbation -related visit. Blood samples for anti–vedolizumab antibody assessment were collected predose at weeks 0, 6, 10, and 22, and during any unscheduled disease exacerbation–related visit. All efficacy analyses were performed for patients from intention-to-treat populations who had received any amount of blinded study drug; missing efficacy data were considered therapy failure. The safety population was defined as all patients who received any amount of study drug. Populations for pharmacokinetic analyses were defined as all patients who received 1 or more doses of study drug and underwent sufficient blood sampling for pharmacokinetic evaluation.