This is a study evaluating the long-term safety of infliximab (Remicade)
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
2,971
This is an non-interventional study. Participants took the study product as part of their medical routine.
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.
Time frame: Five years
Number of patients with malignancies by malignancy type
Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies).
Time frame: Five years
Number of patients with serious infections by type of infection
Time frame: Five years
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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
...and 195 more locations