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

July 4, 2018 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Federal, Argentina
  • Australia
      • Bedford, Australia
      • Box Hill, Australia
      • Garran, Australia
      • Herston, Australia
      • Kogarah, Australia
      • Parkville, Australia
      • Perth, Australia
      • South Brisbane, Australia
  • Austria
      • Innsbruck, Austria
      • Wien, Austria
  • Belgium
      • Antwerpen, Belgium
      • Brussel, Belgium
      • Imeldalaan 9, Belgium
      • Leuven, Belgium
  • Canada
      • Edmonton, Canada
      • Halifax, Canada
      • Quebec, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Vancouver N/A, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal N/A, Quebec, Canada
  • Czechia
      • Pardubice, Czechia
      • Praha 10, Czechia
  • Denmark
      • Aalborg, Denmark
      • Aarhus C., Denmark
      • Hvidovre N/A, Denmark
      • København, Denmark
  • France
      • Lille, France
      • Nancy Cedex, France
      • Paris, France
      • Strasbourg Cedex, France
      • Toulouse, France
  • Germany
      • Berlin N/A, Germany
      • München, Germany
      • Stade, Germany
  • Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Rehovot, Israel
      • Tel-Aviv, Israel
  • Netherlands
      • Eindhoven, Netherlands
      • Nijmegen, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
  • Switzerland
      • Basel, Switzerland
      • Bern, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Cardiff, United Kingdom
      • Dundee, United Kingdom
      • Glasgow, United Kingdom
      • Harrow, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Anaheim, California, United States
      • Los Angeles, California, United States
      • Oakland, California, United States
      • Orange, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
    • Florida
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maryland
      • Laurel, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Plymouth, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ulcerative colitis who have participated in infliximab clinical studies and must have received at least 1 dose of study medication to be eligible for participation in C0168T62.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infliximab 5 mg/kg
This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
Drug: Infliximab 5 mg/kg
Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
Infliximab 10 mg/kg
This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
Drug: Infliximab 10 mg/kg
Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
Placebo
This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
Drug: Placebo
Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 years
Number of patients with serious infections by type of infection
Time Frame: 5 years
5 years
Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis
Time Frame: 5 years
5 years
Number of patients with hospitalizations for the treatment of ulcerative colitis
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

Janssen Biologics BV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2004

Primary Completion (Actual)

September 9, 2015

Study Completion (Actual)

September 9, 2015

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004801
  • C0168T62 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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