Study of Infliximab for the treatment of patients with active Ulcerative Colitis.

A research study to evaluate the safety and effectiveness of an investigational drug is currently being conducted in adults with moderate to severe ulcerative colitis. The aim of the international study is to evaluate the efficacy and safety of Infliximab in patients with active ulcerative colitis. The study is being conducted in the US, Canada, Denmark, Spain, UK, Belgium and Germany.

Official Title

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis.

Conditions

– Ulcerative Colitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further Details

Study Start

Eligibility & Criteria

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion CriteriaPatients may be eligible for this study if they:Have had ulcerative colitis of at least 3 months duration. Have active disease Are at least 18 years old. Agree to use a barrier method of birth control during the study. Exclusion CriteriaPatients will not be eligible for this study if they:Have severe colitis Are pregnant or breast-feeding. Have used investigational drug within 30 days prior to screening. Have received previous administration of infliximab. Have a concomitant diagnosis of congestive heart failure (CHF).

Total Enrolment

Contact Details

[1] Centocor