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Completed

NCT Number: NCT00207688

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab 5 mg/kg

Drug

Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.

Infliximab 10 mg/kg

Drug

Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.

Placebo

Drug

Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.

Primary outcomes

  1. Number of patients with adverse events as a measure of safety

    Time frame: 5 years

    Long-term safety will be evaluated by assessment of serious infections,new malignancies (including colorectal cancer), new autoimmune diseases, death, delayed hypersensitivity (serum sickness-like) reactions, or dysplasia of the colon and other non-serious adverse events. Non-serious adverse events will be collected for participants continuing at the beginning of collection of non-serious adverse events.

Secondary outcomes

  1. Number of patients with malignancies by malignancy type

    Time frame: 5 years

    Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies)

  2. Number of patients with serious infections by type of infection

    Time frame: 5 years

  3. Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis

    Time frame: 5 years

  4. Number of patients with hospitalizations for the treatment of ulcerative colitis

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Janssen Biologics BV

Registry information

Official study title

A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2005
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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