Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief summary:
The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).

Detailed description:
At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adverse events, including colectomy, severe infections \[including progressive multifocal leukoencephalopathy (PML)\], and dysplasia/cancer.

Arms:
arm 1: Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85. arm 2: Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 3: Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 4: Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.

Interventions: intervention 1: Vedolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion

Protocol document: