Conditions: Ulcerative Colitis
Keywords: tofacitinib CP-690 550 Moderate to severe ulcerative colitis phase 3 clinical trial Mayo score
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 614
Healthy volunteers: no

Brief summary:
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tofacitinib intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg oral BID intervention 2: Plabebo oral BID

Protocol document: