 Subjects will be evaluated for safety and efficacy at Baseline Week 0, Weeks 2, 4, 8, 12, and 20, and at unscheduled visits. Efficacy evaluations include HBI, Short Inflammatory Bowel Disease Questionnaire SIBDQ, Work Productivity Activity Index WPAI questionnaire, fistula counts, health care resource utilization HCRU, and evaluation of CD-related extra-intestinal manifestations EIMs. Safety assessments include vital signs, physical examination, general laboratory analyses, urinalysis, and monitoring of adverse events AEs. 