A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo

Drug: Infliximab 10 mg/kg

Drug: Infliximab 5 mg/kg

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT00207688

C0168T62 (Other Identifier)

CR004801

Details and patient eligibility

About

The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

Full description

This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. All patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (C0168T37 ,C0168T46, C0168T72) are eligible to participate in this long-term safety follow-up study (C0168T62). Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years. No study agent will be administered. Information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. In addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. All adverse events, including non-serious adverse events, will also be collected.

Enrollment

505 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion criteria

Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation