A Long-term Safety Study of Infliximab (Remicade)

March 15, 2014 updated by: Centocor, Inc.

Long-term Safety Follow-up of REMICADE (RESULTS)

This is a study evaluating the long-term safety of infliximab (Remicade)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients in these studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after patients complete participation in the primary study.

Study Type

Observational

Enrollment (Actual)

2971

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
      • Buenos Aires, Argentina
      • Cordoba, Argentina
      • Cp, Argentina
      • Rosario, Argentina
      • San Miguel De Tucuman, Argentina
  • Austria
      • Graz, Austria
      • Innsbruck, Austria
      • Wien, Austria
  • Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Diepenbeek, Belgium
      • Edegem, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Canada
      • Halifax, Canada
      • Hamilton Ontario, Canada
      • Montreal, Canada
      • Quebec, Canada
      • Saskatoon, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Richmond, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Vancouver N/A, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
    • Newfoundland and Labrador
      • Saint-John'S, Newfoundland and Labrador, Canada
      • St. John'S, Newfoundland and Labrador, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kitchener, Ontario, Canada
      • London, Ontario, Canada
      • Markham, Ontario, Canada
      • Newmarket, Ontario, Canada
      • North Bay, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
      • Waterloo, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sainte-Foy, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • Ste-Foy, Quebec, Canada
  • Denmark
      • Aarhus, Denmark
      • Hellerup N/A, Denmark
      • Hvidovre, Denmark
      • Kobenhavn Nv, Denmark
      • Odense N/A, Denmark
  • Finland
      • Helsinki, Finland
      • Hus, Finland
      • Jyväskylä N/A, Finland
      • Pikonlinna, Finland
  • France
      • Créteil, France
      • Montpellier Cedex 5, France
      • Nantes Cedex 1, France
      • Nice, France
      • Nice Cedex, France
      • Paris, France
      • Paris Cedex 10, France
      • Paris Cedex 14, France
      • Pierre Benite, France
      • Poitiers, France
  • Germany
      • Berlin, Germany
      • Bochum, Germany
      • Dresden, Germany
      • Erlangen, Germany
      • Frankfurt, Germany
      • Hamburg, Germany
      • Köln, Germany
      • Leipzig, Germany
      • Mainz, Germany
      • Muenster, Germany
      • Oldenburg, Germany
      • Würzburg, Germany
      • Wÿrzburg, Germany
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
  • Ireland
      • Dublin, Ireland
  • Israel
      • Haifa, Israel
      • Tel Aviv, Israel
  • Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
      • Utrecht, Netherlands
  • Norway
      • Oslo, Norway
  • Poland
      • Bialystok N/A, Poland
      • Lublin, Poland
      • Szczecin, Poland
      • Warszawa, Poland
      • Wloszczowa, Poland
      • Wroclaw, Poland
  • Spain
      • Barcelona, Spain
      • Buenos Aires, Spain
      • Cordoba, Spain
      • Federal, Spain
      • Madrid, Spain
  • Sweden
      • Göteborg, Sweden
  • Switzerland
      • Geneve N/A, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Bath, United Kingdom
      • Birmingham, United Kingdom
      • Cambridge, United Kingdom
      • Cannock, United Kingdom
      • Leeds, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Norwich, United Kingdom
      • Oxford, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
      • Montgomery, Alabama, United States
    • Arizona
      • Paradise Valley, Arizona, United States
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Fresno, California, United States
      • Irvine, California, United States
      • Los Angeles, California, United States
      • Madera, California, United States
      • Orange, California, United States
      • Pasadena, California, United States
      • Rancho Mirage, California, United States
      • San Diego, California, United States
      • Santa Monica, California, United States
      • Stanford, California, United States
      • Torrance, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Hamden, Connecticut, United States
      • Hartford, Connecticut, United States
      • New Haven, Connecticut, United States
      • Waterbury, Connecticut, United States
    • Florida
      • Aventura, Florida, United States
      • Largo, Florida, United States
      • Ocala, Florida, United States
      • Orlando, Florida, United States
      • Palm Harbor, Florida, United States
      • Sarasota, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Alpharetta, Georgia, United States
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Idaho
      • Coeur D'Alene, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Evanston, Illinois, United States
      • Gurnee, Illinois, United States
      • Maywood, Illinois, United States
      • Normal, Illinois, United States
      • Rockford, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maine
      • Portland, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Greenbelt, Maryland, United States
      • Wheaton, Maryland, United States
    • Massachusetts
      • Andover, Massachusetts, United States
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroti, Michigan, United States
      • East Lansing, Michigan, United States
      • Grand Rapids, Michigan, United States
    • Minnesota
      • Edina, Minnesota, United States
      • Fridley, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
      • St Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Reno, Nevada, United States
    • New Jersey
      • Voorhees, New Jersey, United States
    • New York
      • Manhasset, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Lake Oswego, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Philadelphia Pennsylvan, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
      • Willow Grove, Pennsylvania, United States
    • South Carolina
      • North Charleston, South Carolina, United States
    • Tennessee
      • Goodlettsville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Lubbock, Texas, United States
      • San Antonio, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Salem, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Kirkland, Washington, United States
      • Seattle, Washington, United States
      • Spokane, 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies.

Description

Inclusion Criteria:

  • All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies that require long-term safety follow-up (ie, primary studies). Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion Criteria:

- Did not previously participate in Centocor sponsored infliximab clinical studies.

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
Patients in infliximab clinical studies
All patients enrolled in selected Centocor sponsored infliximab clinical studies.
Drug: Infliximab (Remicade)
This is an non-interventional study. Participants took the study product as part of their medical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with each of the following long-term safety events
Time Frame: Five years
Number of patients with each of the following long-term safety events: serious infections, new malignancies, new autoimmune diseases, death, or delayed hypersensitivity (serum sickness-like) reactions.
Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with malignancies by malignancy type
Time Frame: Five years
Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies).
Five years
Number of patients with serious infections by type of infection
Time Frame: Five years
Five years

Collaborators and Investigators

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

Sponsor

Centocor, Inc.

Collaborators

Centocor 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.

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

February 1, 2002

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

December 2, 2005

First Submitted That Met QC Criteria

December 2, 2005

First Posted (ESTIMATE)

December 6, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 15, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004780
  • C0168T45 (OTHER: Centocor, Inc)

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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