A Long-term Safety Study of Infliximab (Remicade)
Long-term Safety Follow-up of REMICADE (RESULTS)
2 other identifiers
observational
2,971
19 countries
205
Brief Summary
This is a study evaluating the long-term safety of infliximab (Remicade)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2002
Longer than P75 for all trials
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 18, 2014
March 1, 2014
10.1 years
December 2, 2005
March 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with each of the following long-term safety events
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 Outcomes (2)
Number of patients with malignancies by malignancy type
Five years
Number of patients with serious infections by type of infection
Five years
Study Arms (1)
Patients in infliximab clinical studies
All patients enrolled in selected Centocor sponsored infliximab clinical studies.
Interventions
This is an non-interventional study. Participants took the study product as part of their medical routine.
Eligibility Criteria
All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies.
You may qualify if:
- 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
You may not qualify if:
- \- Did not previously participate in Centocor sponsored infliximab clinical studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
- Centocor BVcollaborator
Study Sites (205)
Unknown Facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Fresno, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Madera, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Rancho Mirage, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Hamden, Connecticut, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Largo, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Gurnee, Illinois, United States
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Maywood, Illinois, United States
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Normal, Illinois, United States
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Rockford, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Greenbelt, Maryland, United States
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Wheaton, Maryland, United States
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Andover, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroti, Michigan, United States
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East Lansing, Michigan, United States
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Grand Rapids, Michigan, United States
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Edina, Minnesota, United States
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Fridley, Minnesota, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Reno, Nevada, United States
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Voorhees Township, New Jersey, United States
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Manhasset, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia Pennsylvan, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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North Charleston, South Carolina, United States
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Goodlettsville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Salem, Virginia, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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Córdoba, Argentina
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Cp, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Graz, Austria
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Innsbruck, Austria
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Vienna, Austria
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Brussels, Belgium
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Diepenbeek, Belgium
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Edegem, Belgium
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Genk, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Richmond, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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North Bay, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Halifax, Canada
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Hamilton Ontario, Canada
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Montreal, Canada
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Saskatoon, Canada
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Aarhus, Denmark
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Hellerup, Denmark
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Hvidovre, Denmark
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København NV, Denmark
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Odense, Denmark
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Helsinki, Finland
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Hus, Finland
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Jyväskylä, Finland
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Pikonlinna, Finland
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Créteil, France
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Montpellier, France
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Nantes, France
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Nice, France
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Paris, France
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Pierre-Bénite, France
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Poitiers, France
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Berlin, Germany
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Bochum, Germany
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Cologne, Germany
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Dresden, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Leipzig, Germany
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Mainz, Germany
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Münster, Germany
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Oldenburg, Germany
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Würzburg, Germany
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Wÿrzburg, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Dublin, Ireland
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Haifa, Israel
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Tel Aviv, Israel
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Amsterdam-Zuidoost, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Oslo, Norway
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Bialystok, Poland
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Lublin, Poland
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Szczecin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Włoszczowa, Poland
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Barcelona, Spain
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Buenos Aires, Spain
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Córdoba, Spain
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Federal, Spain
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Madrid, Spain
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Gothenburg, Sweden
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Geneva, Switzerland
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Zurich, Switzerland
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Bath, United Kingdom
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Birmingham, United Kingdom
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Cambridge, United Kingdom
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Cannock, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Norwich, United Kingdom
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Oxford, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 6, 2005
Study Start
February 1, 2002
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 18, 2014
Record last verified: 2014-03