Long-term Safety Follow-up of REMICADE (RESULTS)
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
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
Yes
Centocor, Inc. Clinical Trial
Study Director
Centocor, Inc.
United States: Food and Drug Administration
CR004780
NCT00261976
February 2002
March 2012
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Little Rock, Arkansas 72205-7199 | |
Kansas City, Kansas 66160 | |
Scarborough, Maine 04074 | |
Omaha, Nebraska 68114 | |
Hackensack, New Jersey 07601 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
South Burlington, Vermont | |
Milwaukee, Wisconsin | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Tulsa, Oklahoma | |
Las Vegas, Nevada 89109 | |
Jackson, Mississippi | |
Coeur D'alene, Idaho 83814 |