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Ulcerative colitis (UC) is a common gastrointestinal disorder in adults. Recent advances in pathophysiology, immunology, and pharmaceutical science have resulted in a large number of medications including biologic agents with potential application to the treatment of UC. Clinical development of these drugs requires well-controlled trials evaluating safety and efficacy. The first randomized controlled trial in UC dates back to 1955 when cortisone was shown to be effective for the treatment of active disease. Further experience in clinical trial design for UC during the last 50 years has led to the creation of a large number of disease-specific measures of disease activity. Natural history studies have allowed the classification of UC patients into subpopulations based on anatomic extent of disease, severity of disease, and prolonged treatment with corticosteroid therapy. Currently, important differences exist among …