A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014188)

• Part 1:Evaluate the dose response; Select IV induction regimen(s) of CNTO 148 (golimumab), based on safety and efficacy; Part 2:Evaluate the safety and efficacy of IV induction regimens of CNTO 148 (golimumab) in inducing clinical response at Week 6. [ Time Frame: Part I: 176 subjects through Week 6 or subjects who ended participation before week 6, Part II: Week 6 ] [ Designated as safety issue: Yes ]
  

• Evaluate the efficacy of IV induction regimens of CNTO 148 (golimumab) in inducing clinical remission, mucosal healing, and improving disease-specific health-related quality of life at Week 6. [ Time Frame: Part II: Week 6 ] [ Designated as safety issue: No ]
  

CNTO 148 (golimumab) is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body that may cause long-term inflammation. CNTO 148 (golimumab) may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of ulcerative colitis(UC).This study will assess the safety and effectiveness of intravenously (through a vein in the arm) administered CNTO 148 (golimumab) and determine if there is a reduction of signs and symptoms (such as diarrhea and rectal bleeding) in patients with active ulcerative colitis. The effect of intravenously (IV) administered CNTO 148 (golimumab) on the quality of life in patients with ulcerative colitis will also be assessed. About 676 patients will take part in the study at approximately 150 centers. Participation in the study will last for six weeks. At week 6, patients will be asked to participate in an additional 54-week maintenance study and a long-term extension study (CR014188) that will last approximately 3 years. If the patient chooses not to participate in the maintenance study, their participation in this study will extend 16 weeks after the last dose of study medication at Week 0.There are two parts to this study. Part 1 is called "dose-ranging" and will enroll 176 patients. Patients enrolled in Part 1, will be equally assigned to a single intravenous (into the vein) infusion of either placebo or 1 mg/kg, 2 mg/kg or 4 mg/kg of CNTO 148 (golimumab). Part 2 of the study is called "dose confirming" and will enroll 500 patients. Patients will be equally assigned to the same doses studied in Part 1 until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled patients will be equally assigned to one of the selected doses or placebo. This entire study is "blinded." This means that neither the patient nor the study doctor will know which treatment the patient has received. The overall purpose of this trial is to determine if treatment with CNTO 148 (golimumab) is better than treatment with placebo in reducing a patient's signs and symptoms of ulcerative colitis. Patients will receive a single infusion at Week 0 of either placebo or CNTO 148 (golimumab) 1 mg/kg, 2 mg/kg or 4 mg/kg.